<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03286543</url>
  </required_header>
  <id_info>
    <org_study_id>0144-CSP-000</org_study_id>
    <nct_id>NCT03286543</nct_id>
  </id_info>
  <brief_title>Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System</brief_title>
  <official_title>A Prospective, Comparative Effectiveness Randomized Controlled Trial of SPR Peripheral Nerve Stimulation (PNS) Therapy for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Utilizing Preoperative Lead Placement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SPR Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SPR Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if electrical stimulation (small levels of&#xD;
      electricity) in addition to the standard of care can safely and effectively reduce pain&#xD;
      following total knee replacement more than the standard of care, alone. This study involves a&#xD;
      device called the SPRINT Beta System. The SPRINT Beta System delivers mild electrical&#xD;
      stimulation to nerves in the leg that received the knee replacement. The SPRINT Beta System&#xD;
      includes a small wire (called a &quot;lead&quot;) that is placed through the skin in the upper leg. It&#xD;
      also includes a device worn on the body that delivers stimulation (called the SPRINT Beta&#xD;
      Stimulator). About half the subjects in this study will receive the SPRINT Beta system&#xD;
      (treatment group) and half will not (control group). Both groups will receive the standard of&#xD;
      care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">April 15, 2020</completion_date>
  <primary_completion_date type="Actual">April 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Half of the subjects enrolled will be randomized (like flipping a coin) to the treatment group and half will be randomized to the control group. Both groups will receive the standard of care for pain management following total knee replacement surgery. Subjects in the treatment group will receive SPR's SPRINT Beta Peripheral Nerve Stimulation (PNS) System in addition to standard of care.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average Knee Pain While Walking</measure>
    <time_frame>Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA)</time_frame>
    <description>All subjects were asked to complete daily diaries to record their average pain intensity while walking during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents &quot;No Pain&quot; and 10 represents &quot;Pain as bad as you can imagine.&quot; For each subject, the mean score for each diary period was calculated and a mean of all four diary periods was calculated (weeks 1-4). The mean group scores for weeks 1-4 are reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects That Experienced at Least One Study-Related Adverse Event</measure>
    <time_frame>30 months (from when the first Treatment Group subject enrolled to when the last Treatment Group subject completed the study)</time_frame>
    <description>At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of Treatment Group subjects that experienced at least one study-related adverse event is reported here.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average Knee Pain Over the Last 24 Hours</measure>
    <time_frame>Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))</time_frame>
    <description>All subjects were asked to complete daily diaries to track their average pain intensity during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents &quot;No Pain&quot; and 10 represents &quot;Pain as bad as you can imagine.&quot; The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Knee Pain at Rest</measure>
    <time_frame>Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))</time_frame>
    <description>All subjects were asked to complete daily diaries to track their average pain intensity at rest during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents &quot;No Pain&quot; and 10 represents &quot;Pain as bad as you can imagine.&quot; The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Right Now as Measured by the Brief Pain Inventory</measure>
    <time_frame>Baseline (Visit 2a/2b), Visit 3 (Day of Total Knee Arthroplasty (TKA)), Visit 4 (in-hospital), Visit 6 (2-weeks post TKA), and Visit 8 (4-weeks post TKA)</time_frame>
    <description>Subjects were asked to rate their pain right now on an 11-point numerical scale where 0 represents &quot;No Pain&quot; and 10 represents &quot;Pain as bad as you can imagine.&quot; The median score for each time point is reported. Baseline is considered Visit 2a (Lead Placement) for Treatment Group subjects and Visit 2b for Control Group subjects. For Treatment Group subjects for Visits 3, 4, 6, and 8, pain right now was assessed while peripheral nerve stimulation was on for at least one Lead. For Visit 4, the score reported during the last in-hospital day was used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Analgesic Usage</measure>
    <time_frame>Visits 5-8 (weeks 1-4 post-Total Knee Arthroplasty (TKA))</time_frame>
    <description>Subjects recorded the amount/type of analgesics used in daily diaries. Narcotic usage was converted into morphine milligram equivalents (MME). Diaries were collected at various visits and were translated into post-operative days. The average MME was calculated for each subject for the first 28 days (4 weeks) following surgery, and the median of these averages across subjects was determined. If subjects had ceased opioid use (per the Recovery Milestones log), then missing scores following the date of opioid cessation were replaced with 0 MME. If diary entries were missing but the subject had not yet reported opioid cessation, then the missing value was replaced with the mean usage of the available days for the corresponding week. Subjects missing data from one or more entire diaries (i.e., weeks) and had not yet reported opioid cessation by the date of any missing diary were not included in this analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects That Experienced at Least One Opioid-Related Side Effect</measure>
    <time_frame>Baseline (Visit 2a/2b), Visits 4-11 (in-hospital days through 12-months post-Total Knee Arthroplasty (TKA))</time_frame>
    <description>Throughout the study, subjects were asked if they experienced any side effects related to opioid pain medications. The occurrences of these side effects were recorded and were not considered Adverse Events. The number of subjects that experienced at least one opioid-related side effect at each visit is reported. Baseline is considered Visit 2a (Lead Placement) for Treatment Group subjects and Visit 2b for Control Group subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Timed Up and Go (TUG) Test</measure>
    <time_frame>Visit 1 (Baseline), Visit 4 (In-Hospital), Visit 6 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 8 (4-weeks Post-TKA)</time_frame>
    <description>Subjects began this test from a seated position in a standard chair and were timed while they stood up, walked to a marked point 10 feet away (at a normal, safe pace), returned to the chair, and sat down. Timed Up and Go (TUG) test times are expected to be greater immediately after surgery as compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six Minute Walk Test (6MWT)</measure>
    <time_frame>Visit 1 (Baseline), Visit 6 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 8 (4-weeks post-TKA)</time_frame>
    <description>The total distance that a subject could walk in 6 minutes was recorded, and subjects unable to walk at all were given a score of 0 meters. The median distance was then determined across subjects. 6 Minute Walk Test distances are expected to be reduced immediately after surgery as compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)</measure>
    <time_frame>Visit 1 (Baseline), Visit 3 (Day of Total Knee Arthroplasty (TKA)), Visit 6 (2-weeks post-TKA), Visit 8 (4-weeks post-TKA), Visit 10 (3-months post-TKA), and Visit 11 (12-months post-TKA)</time_frame>
    <description>The Western Ontario McMaster University Osteoarthritis Index (WOMAC) questionnaire consists of 24 items that evaluate pain, stiffness, and physical functional disability. Each item is scored on an 11-point numerical rating scale from 0 to 10, where higher scores indicate greater pain, stiffness, and disability. For each subject, the scores from each of the 24 items were summed to calculate the subject's total score, with a minimum score of 0 and a maximum score of 240. The mean total score was then calculated across subjects for each time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey</measure>
    <time_frame>Visits 3-11 (Day of Total Knee Arthroplasty (TKA) through 12-months post-TKA)</time_frame>
    <description>The Patient Global Impression of Change (PGIC) asks subjects to rate their improvement with treatment on a 7-point scale ranging from &quot;very much worse&quot; to &quot;very much improved&quot; as compared to before their knee replacement surgery. The subjects combine all the components of their experience into one overall score. Ratings of Much- or Very Much Improved are considered &quot;Meaningful Improvements&quot;; similarly, ratings of Much- or Very Much Worse are categorized as &quot;Meaningfully Worse.&quot; Ratings of Minimally Improved, No Change, or Minimally Worse are considered &quot;Minimal or No Change.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing Scale (PCS)</measure>
    <time_frame>Visit 1 (Baseline), Visit 8 (4 weeks post-Total Knee Arthroplasty (TKA)), Visit 10 (3-months Post-TKA)</time_frame>
    <description>The Pain Catastrophizing Scale (PCS) questionnaire has 13 questions that assess rumination, magnification, and helplessness. Subjects are asked to think back on painful experiences in the past and reflect on how often they had specific thoughts or feelings. Each of the 13 questions is scored on a 5-point scale where 0 represents &quot;not at all,&quot; and 4 represents &quot;all the time.&quot; The scores from each question were summed for each subject to provide a total PCS score, with a possible range from 0 to 52 with higher scores indicating a greater tendency to catastrophize pain (i.e. a higher score indicates a worse outcome). The median scores were then calculated across all subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Meet Recovery Milestones up to Twelve Months Post-Total Knee Arthroplasty (TKA)</measure>
    <time_frame>From Day of Surgery through completion of milestone or 12-months from Day of Surgery, whichever came first</time_frame>
    <description>Participants were queried at each visit from the date of their Total Knee Arthroplasty (TKA) until they met specific, post-surgical recovery milestones. Participants were queried up through the time at which they met each milestone or through their completion of the study, whichever came first (up to twelve months post-surgery). For each milestone, the median number of days between the date of TKA and date to achieve the milestone was calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Satisfaction Survey</measure>
    <time_frame>Visit 8 (4-weeks post-total knee arthroplasty (TKA))</time_frame>
    <description>Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the treatment they received following total knee arthroplasty (TKA) surgery. Treatment Group subjects were asked to report on their experience using the SPRINT Beta Stimulation System as a method for managing post-surgical pain. Depending on the question, subjects were asked to indicate their agreement with the question (strongly disagree, agree, neutral, disagree, strongly disagree), their comfort with the therapy (very uncomfortable, a little bit uncomfortable, fairly comfortable, very comfortable), or when pain relief was felt (immediately, a few minutes later, a few hours later, more than a day later or never). Responses are presented for Treatment Group subjects for key groups of questions related to the therapy whereby answer options are considered affirmative for strongly agree/agree, very easy/easy, very comfortable/comfortable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Physical Therapy Sessions Attended Following Total Knee Arthroplasty</measure>
    <time_frame>Visit 5 (1-week post-Total Knee Arthroplasty (TKA)), Visit 6 (2-weeks post-TKA), Visit 7 (3-weeks post-TKA), Visit 8 (4-weeks post-TKA), Visit 9 (2-months post-TKA), and Visit 10 (3-months post-TKA)</time_frame>
    <description>Following discharge after total knee arthroplasty (TKA) surgery, subjects were asked to report how many physical therapy sessions they attended since the previous study visit. The median number of physical therapy sessions attended is reported for each group at each time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject's Use of Device (Compliance)</measure>
    <time_frame>Visit 4 (In-Hospital), Visit 6 (2-weeks post-Total Knee Arthroplasty (TKA)), and Visit 8 (4-weeks Post-TKA)</time_frame>
    <description>The hours of usage were recorded for each Lead (femoral and sciatic) from the SPRINT Beta stimulator throughout the study to assess the level of subject compliance with the peripheral nerve stimulation therapy. Treatment Group subjects were asked to use the device for up to 24 hrs each day. The stimulator provided the cumulative number of hours in use since the device was activated. For each timepoint for Treatment Group participants (subjects who received stimulation therapy), the median cumulative number of hours of use for each lead is presented for each timepoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inpatient Pain Management Experience Survey (Pain Management During Hospital Stay)</measure>
    <time_frame>1-week post-Total Knee Arthroplasty (TKA)</time_frame>
    <description>Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. Questions regarding experience with in-hospital pain management are reported below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inpatient Pain Management Experience Survey (Pain Medicine During Hospital Stay)</measure>
    <time_frame>1-week post-Total Knee Arthroplasty (TKA)</time_frame>
    <description>Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. The number of subjects that responded affirmatively to the following question are reported below: &quot;During this hospital stay, did you need medicine for pain?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inpatient Pain Management Experience Survey (Discharge Facility)</measure>
    <time_frame>1-week post-Total Knee Arthroplasty (TKA)</time_frame>
    <description>Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. The question regarding discharge location following hospital stay is reported below.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inpatient Pain Management Experience Survey (Overall Rating of Hospital)</measure>
    <time_frame>1-week post-Total Knee Arthroplasty (TKA))</time_frame>
    <description>Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. As part of this survey, subjects were asked to rate their hospital stay on an 11-point numerical rating scale where 0 represents &quot;worst hospital possible&quot; and 10 represents &quot;best hospital possible.&quot; The median score for each group is reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Total Knee Replacement</condition>
  <condition>Total Knee Arthroplasty</condition>
  <condition>Pain</condition>
  <condition>Postoperative Pain</condition>
  <condition>Orthopedic Disorder</condition>
  <arm_group>
    <arm_group_label>Treatment Group (SPRINT Beta System)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the treatment group will have up to 2 leads placed in their leg that underwent total knee replacement, will use the SPRINT Beta System, and will receive electrical stimulation in addition to the standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in the control group will receive the standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SPRINT Beta System</intervention_name>
    <description>The SPRINT Beta System is an Investigational Device which delivers mild electrical stimulation to nerves in the leg that underwent lead placement. The SPRINT Beta System includes a small wire (called a &quot;Lead&quot;) that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Beta Stimulator).</description>
    <arm_group_label>Treatment Group (SPRINT Beta System)</arm_group_label>
    <other_name>SPRINT Beta Peripheral Nerve Stimulation (PNS) System</other_name>
    <other_name>SPRINT Peripheral Nerve Stimulation (PNS) System</other_name>
    <other_name>SPRINT System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled to undergo a primary unilateral total knee replacement procedure&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index &gt; 40 kg/m2&#xD;
&#xD;
          -  Conditions that place the subject at increased risk of infection&#xD;
&#xD;
          -  History of valvular heart disease&#xD;
&#xD;
          -  Implanted electronic device&#xD;
&#xD;
          -  Bleeding disorder&#xD;
&#xD;
          -  Allergy to skin surface electrodes and/or medical-grade adhesive tapes&#xD;
&#xD;
          -  Pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>22710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joint Implant Surgeons</name>
      <address>
        <city>New Albany</city>
        <state>Ohio</state>
        <zip>43054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HD Research</name>
      <address>
        <city>Bellaire</city>
        <state>Texas</state>
        <zip>77401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>April 13, 2021</results_first_submitted>
  <results_first_submitted_qc>May 10, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 12, 2021</results_first_posted>
  <last_update_submitted>May 10, 2021</last_update_submitted>
  <last_update_submitted_qc>May 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>electrical stimulation</keyword>
  <keyword>neurostimulation</keyword>
  <keyword>TKA pain</keyword>
  <keyword>pain following total knee replacement</keyword>
  <keyword>total knee arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal Diseases</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 22, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03286543/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment began in July 2017 (with first subject enrollment in September 2017) and was concluded in February 2020. Subjects were screened from the available pool of candidates scheduled to undergo a primary unilateral total knee replacement procedure.</recruitment_details>
      <pre_assignment_details>After obtaining informed consent, subjects were evaluated for eligibility.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Consented Subjects</title>
          <description>Subjects who signed an informed consent form.</description>
        </group>
        <group group_id="P2">
          <title>Treatment Group</title>
          <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
        </group>
        <group group_id="P3">
          <title>Control Group</title>
          <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Consented</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Randomized</title>
              <participants_list>
                <participants group_id="P1" count="45"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Enrolled</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Intent to Treat Set</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per Protocol Set</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Screen failure before randomization</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Screen failure before enrollment</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>TKA cancelled after enrollment</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawn from study</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Study Enrollment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Intent to Treat Set</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per Protocol Set</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="12"/>
                <participants group_id="P3" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>TKA cancelled after enrollment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawn from study</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Treatment Group</title>
          <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
            <count group_id="B2" value="23"/>
            <count group_id="B3" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>One Control Group subject withdrew after randomization due to their unwillingness to participate as a control, and Demographic information was not collected.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <population>One Control Group subject withdrew after randomization due to their unwillingness to participate as a control, and Demographic information was not collected.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.0" spread="5.5"/>
                    <measurement group_id="B2" value="63.0" spread="10.3"/>
                    <measurement group_id="B3" value="63.9" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>One Control Group subject withdrew after randomization due to their unwillingness to participate as a control, and Demographic information was not collected.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <population>One Control Group subject withdrew after randomization due to their unwillingness to participate as a control, and Demographic information was not collected.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <population>One Control Group subject withdrew after randomization due to their unwillingness to participate as a control, and Demographic information was not collected.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="23"/>
                    <count group_id="B3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Affected Leg</title>
          <population>One Control Group subject withdrew after randomization due to their unwillingness to participate as a control, and Demographic information was not collected.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Right Leg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left Leg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Reason for Total Knee Arthroplasty (TKA)</title>
          <population>One Control Group subject withdrew after randomization due to their unwillingness to participate as a control, and Demographic information was not collected.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Osteoarthritis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Traumatic Arthritis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Degenerative Joint Disease</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="40"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Average Knee Pain While Walking</title>
        <description>All subjects were asked to complete daily diaries to record their average pain intensity while walking during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents &quot;No Pain&quot; and 10 represents &quot;Pain as bad as you can imagine.&quot; For each subject, the mean score for each diary period was calculated and a mean of all four diary periods was calculated (weeks 1-4). The mean group scores for weeks 1-4 are reported.</description>
        <time_frame>Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA)</time_frame>
        <population>Per Protocol Set</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Knee Pain While Walking</title>
          <description>All subjects were asked to complete daily diaries to record their average pain intensity while walking during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents &quot;No Pain&quot; and 10 represents &quot;Pain as bad as you can imagine.&quot; For each subject, the mean score for each diary period was calculated and a mean of all four diary periods was calculated (weeks 1-4). The mean group scores for weeks 1-4 are reported.</description>
          <population>Per Protocol Set</population>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.70" spread="1.97"/>
                    <measurement group_id="O2" value="4.14" spread="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects That Experienced at Least One Study-Related Adverse Event</title>
        <description>At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of Treatment Group subjects that experienced at least one study-related adverse event is reported here.</description>
        <time_frame>30 months (from when the first Treatment Group subject enrolled to when the last Treatment Group subject completed the study)</time_frame>
        <population>All enrolled Treatment Group subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects That Experienced at Least One Study-Related Adverse Event</title>
          <description>At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of Treatment Group subjects that experienced at least one study-related adverse event is reported here.</description>
          <population>All enrolled Treatment Group subjects</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Knee Pain Over the Last 24 Hours</title>
        <description>All subjects were asked to complete daily diaries to track their average pain intensity during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents &quot;No Pain&quot; and 10 represents &quot;Pain as bad as you can imagine.&quot; The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported.</description>
        <time_frame>Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))</time_frame>
        <population>Per Protocol Set</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Knee Pain Over the Last 24 Hours</title>
          <description>All subjects were asked to complete daily diaries to track their average pain intensity during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents &quot;No Pain&quot; and 10 represents &quot;Pain as bad as you can imagine.&quot; The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported.</description>
          <population>Per Protocol Set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.24" spread="1.52"/>
                    <measurement group_id="O2" value="4.32" spread="1.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Knee Pain at Rest</title>
        <description>All subjects were asked to complete daily diaries to track their average pain intensity at rest during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents &quot;No Pain&quot; and 10 represents &quot;Pain as bad as you can imagine.&quot; The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported.</description>
        <time_frame>Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))</time_frame>
        <population>Per Protocol Set</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Knee Pain at Rest</title>
          <description>All subjects were asked to complete daily diaries to track their average pain intensity at rest during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents &quot;No Pain&quot; and 10 represents &quot;Pain as bad as you can imagine.&quot; The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported.</description>
          <population>Per Protocol Set</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.86" spread="1.23"/>
                    <measurement group_id="O2" value="3.48" spread="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Right Now as Measured by the Brief Pain Inventory</title>
        <description>Subjects were asked to rate their pain right now on an 11-point numerical scale where 0 represents &quot;No Pain&quot; and 10 represents &quot;Pain as bad as you can imagine.&quot; The median score for each time point is reported. Baseline is considered Visit 2a (Lead Placement) for Treatment Group subjects and Visit 2b for Control Group subjects. For Treatment Group subjects for Visits 3, 4, 6, and 8, pain right now was assessed while peripheral nerve stimulation was on for at least one Lead. For Visit 4, the score reported during the last in-hospital day was used.</description>
        <time_frame>Baseline (Visit 2a/2b), Visit 3 (Day of Total Knee Arthroplasty (TKA)), Visit 4 (in-hospital), Visit 6 (2-weeks post TKA), and Visit 8 (4-weeks post TKA)</time_frame>
        <population>Per Protocol Set - Data were not available for one Treatment Group subject at Visit 3 and for one Control Group subject at Visit 6.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Right Now as Measured by the Brief Pain Inventory</title>
          <description>Subjects were asked to rate their pain right now on an 11-point numerical scale where 0 represents &quot;No Pain&quot; and 10 represents &quot;Pain as bad as you can imagine.&quot; The median score for each time point is reported. Baseline is considered Visit 2a (Lead Placement) for Treatment Group subjects and Visit 2b for Control Group subjects. For Treatment Group subjects for Visits 3, 4, 6, and 8, pain right now was assessed while peripheral nerve stimulation was on for at least one Lead. For Visit 4, the score reported during the last in-hospital day was used.</description>
          <population>Per Protocol Set - Data were not available for one Treatment Group subject at Visit 3 and for one Control Group subject at Visit 6.</population>
          <units>Scores on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="3.0" lower_limit="1" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3 (Day of TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="0" upper_limit="8"/>
                    <measurement group_id="O2" value="2.0" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (In-Hospital)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1" upper_limit="6"/>
                    <measurement group_id="O2" value="3.5" lower_limit="0" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (2-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1" upper_limit="8"/>
                    <measurement group_id="O2" value="3.0" lower_limit="0" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 8 (4-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount of Analgesic Usage</title>
        <description>Subjects recorded the amount/type of analgesics used in daily diaries. Narcotic usage was converted into morphine milligram equivalents (MME). Diaries were collected at various visits and were translated into post-operative days. The average MME was calculated for each subject for the first 28 days (4 weeks) following surgery, and the median of these averages across subjects was determined. If subjects had ceased opioid use (per the Recovery Milestones log), then missing scores following the date of opioid cessation were replaced with 0 MME. If diary entries were missing but the subject had not yet reported opioid cessation, then the missing value was replaced with the mean usage of the available days for the corresponding week. Subjects missing data from one or more entire diaries (i.e., weeks) and had not yet reported opioid cessation by the date of any missing diary were not included in this analysis.</description>
        <time_frame>Visits 5-8 (weeks 1-4 post-Total Knee Arthroplasty (TKA))</time_frame>
        <population>Per Protocol Set - Data were not available for one Control Group subject at Visits 6-8.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of Analgesic Usage</title>
          <description>Subjects recorded the amount/type of analgesics used in daily diaries. Narcotic usage was converted into morphine milligram equivalents (MME). Diaries were collected at various visits and were translated into post-operative days. The average MME was calculated for each subject for the first 28 days (4 weeks) following surgery, and the median of these averages across subjects was determined. If subjects had ceased opioid use (per the Recovery Milestones log), then missing scores following the date of opioid cessation were replaced with 0 MME. If diary entries were missing but the subject had not yet reported opioid cessation, then the missing value was replaced with the mean usage of the available days for the corresponding week. Subjects missing data from one or more entire diaries (i.e., weeks) and had not yet reported opioid cessation by the date of any missing diary were not included in this analysis.</description>
          <population>Per Protocol Set - Data were not available for one Control Group subject at Visits 6-8.</population>
          <units>MME</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 5 (1-week Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.9" lower_limit="3.2" upper_limit="49.3"/>
                    <measurement group_id="O2" value="31.4" lower_limit="0.0" upper_limit="107.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (2-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.4" lower_limit="2.1" upper_limit="31.1"/>
                    <measurement group_id="O2" value="22.5" lower_limit="0.0" upper_limit="88.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 7 (3-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.6" lower_limit="1.1" upper_limit="20.0"/>
                    <measurement group_id="O2" value="17.1" lower_limit="0.0" upper_limit="69.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 8 (4-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" lower_limit="0.0" upper_limit="20.7"/>
                    <measurement group_id="O2" value="2.9" lower_limit="0.0" upper_limit="47.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average Across Visits 5-8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1" lower_limit="2.1" upper_limit="26.8"/>
                    <measurement group_id="O2" value="16.8" lower_limit="0.13" upper_limit="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects That Experienced at Least One Opioid-Related Side Effect</title>
        <description>Throughout the study, subjects were asked if they experienced any side effects related to opioid pain medications. The occurrences of these side effects were recorded and were not considered Adverse Events. The number of subjects that experienced at least one opioid-related side effect at each visit is reported. Baseline is considered Visit 2a (Lead Placement) for Treatment Group subjects and Visit 2b for Control Group subjects.</description>
        <time_frame>Baseline (Visit 2a/2b), Visits 4-11 (in-hospital days through 12-months post-Total Knee Arthroplasty (TKA))</time_frame>
        <population>Per Protocol Set - Data were not available for one Treatment Group subject at Visit 6 and Visit 11.&#xD;
Data were not available for the following Control Group subjects: one at Visits 5, 6, 7, and 9, and three at Visits 10 and 11.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects That Experienced at Least One Opioid-Related Side Effect</title>
          <description>Throughout the study, subjects were asked if they experienced any side effects related to opioid pain medications. The occurrences of these side effects were recorded and were not considered Adverse Events. The number of subjects that experienced at least one opioid-related side effect at each visit is reported. Baseline is considered Visit 2a (Lead Placement) for Treatment Group subjects and Visit 2b for Control Group subjects.</description>
          <population>Per Protocol Set - Data were not available for one Treatment Group subject at Visit 6 and Visit 11.&#xD;
Data were not available for the following Control Group subjects: one at Visits 5, 6, 7, and 9, and three at Visits 10 and 11.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (In-Hospital)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5 (1-week Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (2-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 7 (3-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 8 (4-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 9 (2-months Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 10 (3-months Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 11 (12-months Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Timed Up and Go (TUG) Test</title>
        <description>Subjects began this test from a seated position in a standard chair and were timed while they stood up, walked to a marked point 10 feet away (at a normal, safe pace), returned to the chair, and sat down. Timed Up and Go (TUG) test times are expected to be greater immediately after surgery as compared to baseline.</description>
        <time_frame>Visit 1 (Baseline), Visit 4 (In-Hospital), Visit 6 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 8 (4-weeks Post-TKA)</time_frame>
        <population>Per Protocol Set - Data were not available for the following Control Group subjects: one at Visit 1 (subject was unable to complete test), three at Visit 4 (two subjects were unable to complete test), and one at Visit 6.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Timed Up and Go (TUG) Test</title>
          <description>Subjects began this test from a seated position in a standard chair and were timed while they stood up, walked to a marked point 10 feet away (at a normal, safe pace), returned to the chair, and sat down. Timed Up and Go (TUG) test times are expected to be greater immediately after surgery as compared to baseline.</description>
          <population>Per Protocol Set - Data were not available for the following Control Group subjects: one at Visit 1 (subject was unable to complete test), three at Visit 4 (two subjects were unable to complete test), and one at Visit 6.</population>
          <units>seconds</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time at Visit 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.44" lower_limit="4.82" upper_limit="13.7"/>
                    <measurement group_id="O2" value="10.25" lower_limit="7" upper_limit="26.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time at Visit 4 (In-Hospital)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.80" lower_limit="11.13" upper_limit="141.32"/>
                    <measurement group_id="O2" value="42.22" lower_limit="13.81" upper_limit="82.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time at Visit 6 (2-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.28" lower_limit="7.63" upper_limit="32.36"/>
                    <measurement group_id="O2" value="15.93" lower_limit="7.39" upper_limit="56.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time at Visit 8 (4-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.68" lower_limit="6.59" upper_limit="17.07"/>
                    <measurement group_id="O2" value="10.38" lower_limit="6.9" upper_limit="40.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Six Minute Walk Test (6MWT)</title>
        <description>The total distance that a subject could walk in 6 minutes was recorded, and subjects unable to walk at all were given a score of 0 meters. The median distance was then determined across subjects. 6 Minute Walk Test distances are expected to be reduced immediately after surgery as compared to baseline.</description>
        <time_frame>Visit 1 (Baseline), Visit 6 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 8 (4-weeks post-TKA)</time_frame>
        <population>Per Protocol Set - Data were not available for one Control Group subject at Visit 6.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Six Minute Walk Test (6MWT)</title>
          <description>The total distance that a subject could walk in 6 minutes was recorded, and subjects unable to walk at all were given a score of 0 meters. The median distance was then determined across subjects. 6 Minute Walk Test distances are expected to be reduced immediately after surgery as compared to baseline.</description>
          <population>Per Protocol Set - Data were not available for one Control Group subject at Visit 6.</population>
          <units>meters</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="458.5" lower_limit="320.0" upper_limit="555.0"/>
                    <measurement group_id="O2" value="351.3" lower_limit="0" upper_limit="504.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (2-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="280.0" lower_limit="150.0" upper_limit="504.7"/>
                    <measurement group_id="O2" value="281.0" lower_limit="0" upper_limit="680.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 8 (4-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="410.0" lower_limit="270.0" upper_limit="693.0"/>
                    <measurement group_id="O2" value="329.0" lower_limit="0" upper_limit="518.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)</title>
        <description>The Western Ontario McMaster University Osteoarthritis Index (WOMAC) questionnaire consists of 24 items that evaluate pain, stiffness, and physical functional disability. Each item is scored on an 11-point numerical rating scale from 0 to 10, where higher scores indicate greater pain, stiffness, and disability. For each subject, the scores from each of the 24 items were summed to calculate the subject's total score, with a minimum score of 0 and a maximum score of 240. The mean total score was then calculated across subjects for each time point.</description>
        <time_frame>Visit 1 (Baseline), Visit 3 (Day of Total Knee Arthroplasty (TKA)), Visit 6 (2-weeks post-TKA), Visit 8 (4-weeks post-TKA), Visit 10 (3-months post-TKA), and Visit 11 (12-months post-TKA)</time_frame>
        <population>Per Protocol Set - Data were not available for one Treatment Group subject at Visit 11. Data were not available for the following Control Group subjects: three at Visit 3, one at Visit 6, three at Visit 10, and two at Visit 11.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)</title>
          <description>The Western Ontario McMaster University Osteoarthritis Index (WOMAC) questionnaire consists of 24 items that evaluate pain, stiffness, and physical functional disability. Each item is scored on an 11-point numerical rating scale from 0 to 10, where higher scores indicate greater pain, stiffness, and disability. For each subject, the scores from each of the 24 items were summed to calculate the subject's total score, with a minimum score of 0 and a maximum score of 240. The mean total score was then calculated across subjects for each time point.</description>
          <population>Per Protocol Set - Data were not available for one Treatment Group subject at Visit 11. Data were not available for the following Control Group subjects: three at Visit 3, one at Visit 6, three at Visit 10, and two at Visit 11.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.00" spread="30.34"/>
                    <measurement group_id="O2" value="111.31" spread="38.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3 (Day of TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.71" spread="47.87"/>
                    <measurement group_id="O2" value="99.23" spread="51.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (2-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.57" spread="33.24"/>
                    <measurement group_id="O2" value="81.13" spread="38.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 8 (4-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.29" spread="26.56"/>
                    <measurement group_id="O2" value="51.94" spread="30.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 10 (3-months Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.86" spread="22.13"/>
                    <measurement group_id="O2" value="29.38" spread="21.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 11 (12-months Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.83" spread="4.36"/>
                    <measurement group_id="O2" value="12.79" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey</title>
        <description>The Patient Global Impression of Change (PGIC) asks subjects to rate their improvement with treatment on a 7-point scale ranging from &quot;very much worse&quot; to &quot;very much improved&quot; as compared to before their knee replacement surgery. The subjects combine all the components of their experience into one overall score. Ratings of Much- or Very Much Improved are considered &quot;Meaningful Improvements&quot;; similarly, ratings of Much- or Very Much Worse are categorized as &quot;Meaningfully Worse.&quot; Ratings of Minimally Improved, No Change, or Minimally Worse are considered &quot;Minimal or No Change.&quot;</description>
        <time_frame>Visits 3-11 (Day of Total Knee Arthroplasty (TKA) through 12-months post-TKA)</time_frame>
        <population>Per Protocol Set: Data were not available for one Treatment Group subject at Visit 11. Data were not available for the following Control Group subjects: one at Visit 4, one at Visit 6, one at Visit 9, three at Visit 10, and two at Visit 11.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey</title>
          <description>The Patient Global Impression of Change (PGIC) asks subjects to rate their improvement with treatment on a 7-point scale ranging from &quot;very much worse&quot; to &quot;very much improved&quot; as compared to before their knee replacement surgery. The subjects combine all the components of their experience into one overall score. Ratings of Much- or Very Much Improved are considered &quot;Meaningful Improvements&quot;; similarly, ratings of Much- or Very Much Worse are categorized as &quot;Meaningfully Worse.&quot; Ratings of Minimally Improved, No Change, or Minimally Worse are considered &quot;Minimal or No Change.&quot;</description>
          <population>Per Protocol Set: Data were not available for one Treatment Group subject at Visit 11. Data were not available for the following Control Group subjects: one at Visit 4, one at Visit 6, one at Visit 9, three at Visit 10, and two at Visit 11.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 3 (Day of TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Meaningful Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Minimal or No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Meaningfully Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (In-Hospital)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Meaningful Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Minimal or No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Meaningfully Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 5 (1-week Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Meaningful Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Minimal or No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Meaningfully Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (2-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Meaningful Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Minimal or No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Meaningfully Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 7 (3-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Meaningful Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Minimal or No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Meaningfully Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 8 (4-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Meaningful Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Minimal or No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Meaningfully Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 9 (2-months Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Meaningful Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Minimal or No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Meaningfully Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 10 (3-months Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Meaningful Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Minimal or No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Meaningfully Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 11 (12-months Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Meaningful Improvement</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Minimal or No Change</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Meaningfully Worse</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Catastrophizing Scale (PCS)</title>
        <description>The Pain Catastrophizing Scale (PCS) questionnaire has 13 questions that assess rumination, magnification, and helplessness. Subjects are asked to think back on painful experiences in the past and reflect on how often they had specific thoughts or feelings. Each of the 13 questions is scored on a 5-point scale where 0 represents &quot;not at all,&quot; and 4 represents &quot;all the time.&quot; The scores from each question were summed for each subject to provide a total PCS score, with a possible range from 0 to 52 with higher scores indicating a greater tendency to catastrophize pain (i.e. a higher score indicates a worse outcome). The median scores were then calculated across all subjects.</description>
        <time_frame>Visit 1 (Baseline), Visit 8 (4 weeks post-Total Knee Arthroplasty (TKA)), Visit 10 (3-months Post-TKA)</time_frame>
        <population>Per Protocol Set - Data were not available for three Control Group subjects at Visit 10.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Catastrophizing Scale (PCS)</title>
          <description>The Pain Catastrophizing Scale (PCS) questionnaire has 13 questions that assess rumination, magnification, and helplessness. Subjects are asked to think back on painful experiences in the past and reflect on how often they had specific thoughts or feelings. Each of the 13 questions is scored on a 5-point scale where 0 represents &quot;not at all,&quot; and 4 represents &quot;all the time.&quot; The scores from each question were summed for each subject to provide a total PCS score, with a possible range from 0 to 52 with higher scores indicating a greater tendency to catastrophize pain (i.e. a higher score indicates a worse outcome). The median scores were then calculated across all subjects.</description>
          <population>Per Protocol Set - Data were not available for three Control Group subjects at Visit 10.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 1 (Baseline)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="0" upper_limit="13"/>
                    <measurement group_id="O2" value="7" lower_limit="0" upper_limit="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 8 (4-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="0" upper_limit="14"/>
                    <measurement group_id="O2" value="4" lower_limit="0" upper_limit="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 10 (3-months Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="13"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Meet Recovery Milestones up to Twelve Months Post-Total Knee Arthroplasty (TKA)</title>
        <description>Participants were queried at each visit from the date of their Total Knee Arthroplasty (TKA) until they met specific, post-surgical recovery milestones. Participants were queried up through the time at which they met each milestone or through their completion of the study, whichever came first (up to twelve months post-surgery). For each milestone, the median number of days between the date of TKA and date to achieve the milestone was calculated.</description>
        <time_frame>From Day of Surgery through completion of milestone or 12-months from Day of Surgery, whichever came first</time_frame>
        <population>Per Protocol Set- Treatment Group: Data were not available for: 1 subject in &quot;walked without assistive device&quot;, 1 in &quot;cleared to drive&quot;. 1 subject did not cease opioids during the study. 5 subjects were retired and did not work.&#xD;
Control Group: Data were not collected for: 3 in &quot;walked without assistive device&quot;, 2 in &quot;able to climb stairs&quot;, 1 in &quot;cleared to drive&quot;, 1 in &quot;opioid cessation&quot; (2 more did not cease opioids during the study). 9 subjects were retired and did not work.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Meet Recovery Milestones up to Twelve Months Post-Total Knee Arthroplasty (TKA)</title>
          <description>Participants were queried at each visit from the date of their Total Knee Arthroplasty (TKA) until they met specific, post-surgical recovery milestones. Participants were queried up through the time at which they met each milestone or through their completion of the study, whichever came first (up to twelve months post-surgery). For each milestone, the median number of days between the date of TKA and date to achieve the milestone was calculated.</description>
          <population>Per Protocol Set- Treatment Group: Data were not available for: 1 subject in &quot;walked without assistive device&quot;, 1 in &quot;cleared to drive&quot;. 1 subject did not cease opioids during the study. 5 subjects were retired and did not work.&#xD;
Control Group: Data were not collected for: 3 in &quot;walked without assistive device&quot;, 2 in &quot;able to climb stairs&quot;, 1 in &quot;cleared to drive&quot;, 1 in &quot;opioid cessation&quot; (2 more did not cease opioids during the study). 9 subjects were retired and did not work.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain controlled without nerve block</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="5"/>
                    <measurement group_id="O2" value="2" lower_limit="1" upper_limit="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Walked with assistive device</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Walked without assistive device</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" lower_limit="2" upper_limit="52"/>
                    <measurement group_id="O2" value="16" lower_limit="2" upper_limit="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Walked 30 meters</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="16"/>
                    <measurement group_id="O2" value="4" lower_limit="0" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Able to climb flight of stairs</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="13" lower_limit="1" upper_limit="251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Met hospital discharge criteria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O2" value="1" lower_limit="0.8" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discharged from hospital</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O2" value="1" lower_limit="0.9" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cleared to drive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" lower_limit="14" upper_limit="62"/>
                    <measurement group_id="O2" value="21" lower_limit="15" upper_limit="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Returned to work</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="1" upper_limit="17"/>
                    <measurement group_id="O2" value="20" lower_limit="7" upper_limit="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cessation of all opioid medications</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37" lower_limit="10" upper_limit="61"/>
                    <measurement group_id="O2" value="28" lower_limit="6" upper_limit="336"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Satisfaction Survey</title>
        <description>Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the treatment they received following total knee arthroplasty (TKA) surgery. Treatment Group subjects were asked to report on their experience using the SPRINT Beta Stimulation System as a method for managing post-surgical pain. Depending on the question, subjects were asked to indicate their agreement with the question (strongly disagree, agree, neutral, disagree, strongly disagree), their comfort with the therapy (very uncomfortable, a little bit uncomfortable, fairly comfortable, very comfortable), or when pain relief was felt (immediately, a few minutes later, a few hours later, more than a day later or never). Responses are presented for Treatment Group subjects for key groups of questions related to the therapy whereby answer options are considered affirmative for strongly agree/agree, very easy/easy, very comfortable/comfortable.</description>
        <time_frame>Visit 8 (4-weeks post-total knee arthroplasty (TKA))</time_frame>
        <population>Per Protocol Set</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Satisfaction Survey</title>
          <description>Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the treatment they received following total knee arthroplasty (TKA) surgery. Treatment Group subjects were asked to report on their experience using the SPRINT Beta Stimulation System as a method for managing post-surgical pain. Depending on the question, subjects were asked to indicate their agreement with the question (strongly disagree, agree, neutral, disagree, strongly disagree), their comfort with the therapy (very uncomfortable, a little bit uncomfortable, fairly comfortable, very comfortable), or when pain relief was felt (immediately, a few minutes later, a few hours later, more than a day later or never). Responses are presented for Treatment Group subjects for key groups of questions related to the therapy whereby answer options are considered affirmative for strongly agree/agree, very easy/easy, very comfortable/comfortable.</description>
          <population>Per Protocol Set</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tolerated Lead placement with some or no discomfort</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reported stimulation felt comfortable/soothing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Reported immediate pain relief (0-5 minutes)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Would recommend therapy to a friend</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Would want to receive again if having another TKA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer stimulation therapy to pain medication use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wanted stimulation for longer time period before TKA surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wanted stimulation for longer time period after TKA surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Physical Therapy Sessions Attended Following Total Knee Arthroplasty</title>
        <description>Following discharge after total knee arthroplasty (TKA) surgery, subjects were asked to report how many physical therapy sessions they attended since the previous study visit. The median number of physical therapy sessions attended is reported for each group at each time point.</description>
        <time_frame>Visit 5 (1-week post-Total Knee Arthroplasty (TKA)), Visit 6 (2-weeks post-TKA), Visit 7 (3-weeks post-TKA), Visit 8 (4-weeks post-TKA), Visit 9 (2-months post-TKA), and Visit 10 (3-months post-TKA)</time_frame>
        <population>Per Protocol Set - Data were not available for the following Control Group subjects: one at Visit 6, two Visit 9, and three at Visit 10.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Physical Therapy Sessions Attended Following Total Knee Arthroplasty</title>
          <description>Following discharge after total knee arthroplasty (TKA) surgery, subjects were asked to report how many physical therapy sessions they attended since the previous study visit. The median number of physical therapy sessions attended is reported for each group at each time point.</description>
          <population>Per Protocol Set - Data were not available for the following Control Group subjects: one at Visit 6, two Visit 9, and three at Visit 10.</population>
          <units>Count of visits</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 5 (1-week Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="O2" value="2" lower_limit="1" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (2-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="2" upper_limit="5"/>
                    <measurement group_id="O2" value="3" lower_limit="2" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 7 (3-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="O2" value="3" lower_limit="0" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 8 (4-weeks Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="1" upper_limit="3"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 9 (2-months Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="4" upper_limit="12"/>
                    <measurement group_id="O2" value="5" lower_limit="0" upper_limit="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 10 (3-months Post-TKA)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="0" upper_limit="12"/>
                    <measurement group_id="O2" value="6" lower_limit="0" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject's Use of Device (Compliance)</title>
        <description>The hours of usage were recorded for each Lead (femoral and sciatic) from the SPRINT Beta stimulator throughout the study to assess the level of subject compliance with the peripheral nerve stimulation therapy. Treatment Group subjects were asked to use the device for up to 24 hrs each day. The stimulator provided the cumulative number of hours in use since the device was activated. For each timepoint for Treatment Group participants (subjects who received stimulation therapy), the median cumulative number of hours of use for each lead is presented for each timepoint.</description>
        <time_frame>Visit 4 (In-Hospital), Visit 6 (2-weeks post-Total Knee Arthroplasty (TKA)), and Visit 8 (4-weeks Post-TKA)</time_frame>
        <population>Per Protocol Set - Treatment Group. Data were not available for the femoral or sciatic Leads for one subject at Visit 4 and two subjects at Visit 6. One subject at Visits 4, 6, 8 did not have a sciatic Lead in place.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
        </group_list>
        <measure>
          <title>Subject's Use of Device (Compliance)</title>
          <description>The hours of usage were recorded for each Lead (femoral and sciatic) from the SPRINT Beta stimulator throughout the study to assess the level of subject compliance with the peripheral nerve stimulation therapy. Treatment Group subjects were asked to use the device for up to 24 hrs each day. The stimulator provided the cumulative number of hours in use since the device was activated. For each timepoint for Treatment Group participants (subjects who received stimulation therapy), the median cumulative number of hours of use for each lead is presented for each timepoint.</description>
          <population>Per Protocol Set - Treatment Group. Data were not available for the femoral or sciatic Leads for one subject at Visit 4 and two subjects at Visit 6. One subject at Visits 4, 6, 8 did not have a sciatic Lead in place.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Visit 4 (In-Hospital): Femoral Lead</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79" lower_limit="31" upper_limit="207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4 (In-Hospital): Sciatic Lead</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73" lower_limit="28" upper_limit="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (2-weeks Post-TKA): Femoral Lead</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="358" lower_limit="190" upper_limit="519"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 6 (2-weeks Post-TKA): Sciatic Lead</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="373.5" lower_limit="269" upper_limit="429"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 8 (4-weeks Post-TKA): Femoral Lead</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="646" lower_limit="266" upper_limit="744"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 8 (4-weeks Post-TKA): Sciatic Lead</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="633" lower_limit="271" upper_limit="673"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inpatient Pain Management Experience Survey (Pain Management During Hospital Stay)</title>
        <description>Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. Questions regarding experience with in-hospital pain management are reported below.</description>
        <time_frame>1-week post-Total Knee Arthroplasty (TKA)</time_frame>
        <population>Per Protocol Set - Data were not available for three Control Group subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Inpatient Pain Management Experience Survey (Pain Management During Hospital Stay)</title>
          <description>Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. Questions regarding experience with in-hospital pain management are reported below.</description>
          <population>Per Protocol Set - Data were not available for three Control Group subjects.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>During this hospital stay, how often was your pain well controlled?</title>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Usually</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>During hospital stay, how often did hospital staff do everything they could to help with your pain?</title>
              <category_list>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Sometimes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Usually</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Always</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inpatient Pain Management Experience Survey (Pain Medicine During Hospital Stay)</title>
        <description>Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. The number of subjects that responded affirmatively to the following question are reported below: &quot;During this hospital stay, did you need medicine for pain?&quot;</description>
        <time_frame>1-week post-Total Knee Arthroplasty (TKA)</time_frame>
        <population>Per Protocol - Data were not available for three Control Group subjects</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Inpatient Pain Management Experience Survey (Pain Medicine During Hospital Stay)</title>
          <description>Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. The number of subjects that responded affirmatively to the following question are reported below: &quot;During this hospital stay, did you need medicine for pain?&quot;</description>
          <population>Per Protocol - Data were not available for three Control Group subjects</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inpatient Pain Management Experience Survey (Discharge Facility)</title>
        <description>Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. The question regarding discharge location following hospital stay is reported below.</description>
        <time_frame>1-week post-Total Knee Arthroplasty (TKA)</time_frame>
        <population>Per Protocol Set - Data were not available for three Control Group subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Inpatient Pain Management Experience Survey (Discharge Facility)</title>
          <description>Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. The question regarding discharge location following hospital stay is reported below.</description>
          <population>Per Protocol Set - Data were not available for three Control Group subjects.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Own home</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Someone else's home</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Another healthcare facility</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Inpatient Pain Management Experience Survey (Overall Rating of Hospital)</title>
        <description>Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. As part of this survey, subjects were asked to rate their hospital stay on an 11-point numerical rating scale where 0 represents &quot;worst hospital possible&quot; and 10 represents &quot;best hospital possible.&quot; The median score for each group is reported.</description>
        <time_frame>1-week post-Total Knee Arthroplasty (TKA))</time_frame>
        <population>Per Protocol Set - Data were not available for three Control Group subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Group</title>
            <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
          </group>
        </group_list>
        <measure>
          <title>Inpatient Pain Management Experience Survey (Overall Rating of Hospital)</title>
          <description>Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. As part of this survey, subjects were asked to rate their hospital stay on an 11-point numerical rating scale where 0 represents &quot;worst hospital possible&quot; and 10 represents &quot;best hospital possible.&quot; The median score for each group is reported.</description>
          <population>Per Protocol Set - Data were not available for three Control Group subjects.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="8" upper_limit="10"/>
                    <measurement group_id="O2" value="10" lower_limit="7" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Each participant enrolled was assessed for adverse events from the time of informed consent through the 12-month follow up visit. The total assessment period was approximately 13 months for each participant.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment Group</title>
          <description>Subjects in the Treatment Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects had at least one Lead placed in their affected leg prior to TKA and used the SPRINT Beta System to receive electrical stimulation therapy in addition to the standard of care.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Subjects in the Control Group were consented, scheduled to undergo a unilateral total knee arthroplasty (TKA), and met all eligibility criteria prior to randomization. These subjects did not undergo Lead placement, and they received the standard of care following TKA.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Myopericarditis</sub_title>
                <description>Not study-related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Pancreatitis and Gall Stones</sub_title>
                <description>Not study-related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis due to Urinary Tract Infection</sub_title>
                <description>Not study-related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain at TKA Surgical Site</sub_title>
                <description>Not study-related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <description>Not study-related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Adverse Drug Reaction During TKA</sub_title>
                <description>Not study-related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="18"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Elevated blood pressure</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Hearing loss</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Worsening cataract</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Illness</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>New hip pain</sub_title>
                <description>One event was study-related, and the other was not</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Pain at TKA surgical site</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Worsening knee pain</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Ankylosis of knee</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Knee effusion</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Muscle spasming</sub_title>
                <description>Study-Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Sciatica and Piriformis Syndrome</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Thumb pain</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Shoulder pain</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Restless Leg Syndrome flare up</sub_title>
                <description>Unable to determine relationship to study</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Soreness after Lead placement</sub_title>
                <description>Study-Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Shocking at Lead site</sub_title>
                <description>Study-Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchial asthma</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin irritation at bandage site</sub_title>
                <description>Study-Related</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Skin irritation or bruising at pad and/or Lead exit site</sub_title>
                <description>Study-Related</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Generalized itching</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Discharge from TKA surgical incision</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Burning sensation and swelling of knee</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Ulcers</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <description>Not Study-Related</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="23"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Affairs</name_or_title>
      <organization>SPR Therapeutics</organization>
      <phone>216-378-9106</phone>
      <email>support@sprtherapeutics.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03286543
org study id: 0144-CSP-000
nct id: NCT03286543
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this study is to determine if electrical stimulation (small levels of
      electricity) in addition to the standard of care can safely and effectively reduce pain
      following total knee replacement more than the standard of care, alone. This study involves a
      device called the SPRINT Beta System. The SPRINT Beta System delivers mild electrical
      stimulation to nerves in the leg that received the knee replacement. The SPRINT Beta System
      includes a small wire (called a "lead") that is placed through the skin in the upper leg. It
      also includes a device worn on the body that delivers stimulation (called the SPRINT Beta
      Stimulator). About half the subjects in this study will receive the SPRINT Beta system
      (treatment group) and half will not (control group). Both groups will receive the standard of
      care.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Half of the subjects enrolled will be randomized (like flipping a coin) to the treatment group and half will be randomized to the control group. Both groups will receive the standard of care for pain management following total knee replacement surgery. Subjects in the treatment group will receive SPR's SPRINT Beta Peripheral Nerve Stimulation (PNS) System in addition to standard of care.
primary purpose: Treatment
masking: None (Open Label)
measure: Average Knee Pain While Walking
time frame: Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA)
description: All subjects were asked to complete daily diaries to record their average pain intensity while walking during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." For each subject, the mean score for each diary period was calculated and a mean of all four diary periods was calculated (weeks 1-4). The mean group scores for weeks 1-4 are reported.
measure: Number of Subjects That Experienced at Least One Study-Related Adverse Event
time frame: 30 months (from when the first Treatment Group subject enrolled to when the last Treatment Group subject completed the study)
description: At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of Treatment Group subjects that experienced at least one study-related adverse event is reported here.
measure: Average Knee Pain Over the Last 24 Hours
time frame: Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))
description: All subjects were asked to complete daily diaries to track their average pain intensity during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported.
measure: Average Knee Pain at Rest
time frame: Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA))
description: All subjects were asked to complete daily diaries to track their average pain intensity at rest during the past 24 hours over a 7-day period on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average score for each diary period was calculated across subjects, and the mean score for weeks 1-4 is reported.
measure: Pain Right Now as Measured by the Brief Pain Inventory
time frame: Baseline (Visit 2a/2b), Visit 3 (Day of Total Knee Arthroplasty (TKA)), Visit 4 (in-hospital), Visit 6 (2-weeks post TKA), and Visit 8 (4-weeks post TKA)
description: Subjects were asked to rate their pain right now on an 11-point numerical scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The median score for each time point is reported. Baseline is considered Visit 2a (Lead Placement) for Treatment Group subjects and Visit 2b for Control Group subjects. For Treatment Group subjects for Visits 3, 4, 6, and 8, pain right now was assessed while peripheral nerve stimulation was on for at least one Lead. For Visit 4, the score reported during the last in-hospital day was used.
measure: Amount of Analgesic Usage
time frame: Visits 5-8 (weeks 1-4 post-Total Knee Arthroplasty (TKA))
description: Subjects recorded the amount/type of analgesics used in daily diaries. Narcotic usage was converted into morphine milligram equivalents (MME). Diaries were collected at various visits and were translated into post-operative days. The average MME was calculated for each subject for the first 28 days (4 weeks) following surgery, and the median of these averages across subjects was determined. If subjects had ceased opioid use (per the Recovery Milestones log), then missing scores following the date of opioid cessation were replaced with 0 MME. If diary entries were missing but the subject had not yet reported opioid cessation, then the missing value was replaced with the mean usage of the available days for the corresponding week. Subjects missing data from one or more entire diaries (i.e., weeks) and had not yet reported opioid cessation by the date of any missing diary were not included in this analysis.
measure: Number of Subjects That Experienced at Least One Opioid-Related Side Effect
time frame: Baseline (Visit 2a/2b), Visits 4-11 (in-hospital days through 12-months post-Total Knee Arthroplasty (TKA))
description: Throughout the study, subjects were asked if they experienced any side effects related to opioid pain medications. The occurrences of these side effects were recorded and were not considered Adverse Events. The number of subjects that experienced at least one opioid-related side effect at each visit is reported. Baseline is considered Visit 2a (Lead Placement) for Treatment Group subjects and Visit 2b for Control Group subjects.
measure: Timed Up and Go (TUG) Test
time frame: Visit 1 (Baseline), Visit 4 (In-Hospital), Visit 6 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 8 (4-weeks Post-TKA)
description: Subjects began this test from a seated position in a standard chair and were timed while they stood up, walked to a marked point 10 feet away (at a normal, safe pace), returned to the chair, and sat down. Timed Up and Go (TUG) test times are expected to be greater immediately after surgery as compared to baseline.
measure: Six Minute Walk Test (6MWT)
time frame: Visit 1 (Baseline), Visit 6 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 8 (4-weeks post-TKA)
description: The total distance that a subject could walk in 6 minutes was recorded, and subjects unable to walk at all were given a score of 0 meters. The median distance was then determined across subjects. 6 Minute Walk Test distances are expected to be reduced immediately after surgery as compared to baseline.
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
time frame: Visit 1 (Baseline), Visit 3 (Day of Total Knee Arthroplasty (TKA)), Visit 6 (2-weeks post-TKA), Visit 8 (4-weeks post-TKA), Visit 10 (3-months post-TKA), and Visit 11 (12-months post-TKA)
description: The Western Ontario McMaster University Osteoarthritis Index (WOMAC) questionnaire consists of 24 items that evaluate pain, stiffness, and physical functional disability. Each item is scored on an 11-point numerical rating scale from 0 to 10, where higher scores indicate greater pain, stiffness, and disability. For each subject, the scores from each of the 24 items were summed to calculate the subject's total score, with a minimum score of 0 and a maximum score of 240. The mean total score was then calculated across subjects for each time point.
measure: Number of Subjects Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey
time frame: Visits 3-11 (Day of Total Knee Arthroplasty (TKA) through 12-months post-TKA)
description: The Patient Global Impression of Change (PGIC) asks subjects to rate their improvement with treatment on a 7-point scale ranging from "very much worse" to "very much improved" as compared to before their knee replacement surgery. The subjects combine all the components of their experience into one overall score. Ratings of Much- or Very Much Improved are considered "Meaningful Improvements"; similarly, ratings of Much- or Very Much Worse are categorized as "Meaningfully Worse." Ratings of Minimally Improved, No Change, or Minimally Worse are considered "Minimal or No Change."
measure: Pain Catastrophizing Scale (PCS)
time frame: Visit 1 (Baseline), Visit 8 (4 weeks post-Total Knee Arthroplasty (TKA)), Visit 10 (3-months Post-TKA)
description: The Pain Catastrophizing Scale (PCS) questionnaire has 13 questions that assess rumination, magnification, and helplessness. Subjects are asked to think back on painful experiences in the past and reflect on how often they had specific thoughts or feelings. Each of the 13 questions is scored on a 5-point scale where 0 represents "not at all," and 4 represents "all the time." The scores from each question were summed for each subject to provide a total PCS score, with a possible range from 0 to 52 with higher scores indicating a greater tendency to catastrophize pain (i.e. a higher score indicates a worse outcome). The median scores were then calculated across all subjects.
measure: Time to Meet Recovery Milestones up to Twelve Months Post-Total Knee Arthroplasty (TKA)
time frame: From Day of Surgery through completion of milestone or 12-months from Day of Surgery, whichever came first
description: Participants were queried at each visit from the date of their Total Knee Arthroplasty (TKA) until they met specific, post-surgical recovery milestones. Participants were queried up through the time at which they met each milestone or through their completion of the study, whichever came first (up to twelve months post-surgery). For each milestone, the median number of days between the date of TKA and date to achieve the milestone was calculated.
measure: Subject Satisfaction Survey
time frame: Visit 8 (4-weeks post-total knee arthroplasty (TKA))
description: Subjects completed a sponsor-developed survey with questions pertaining to their feelings about the treatment they received following total knee arthroplasty (TKA) surgery. Treatment Group subjects were asked to report on their experience using the SPRINT Beta Stimulation System as a method for managing post-surgical pain. Depending on the question, subjects were asked to indicate their agreement with the question (strongly disagree, agree, neutral, disagree, strongly disagree), their comfort with the therapy (very uncomfortable, a little bit uncomfortable, fairly comfortable, very comfortable), or when pain relief was felt (immediately, a few minutes later, a few hours later, more than a day later or never). Responses are presented for Treatment Group subjects for key groups of questions related to the therapy whereby answer options are considered affirmative for strongly agree/agree, very easy/easy, very comfortable/comfortable.
measure: Number of Physical Therapy Sessions Attended Following Total Knee Arthroplasty
time frame: Visit 5 (1-week post-Total Knee Arthroplasty (TKA)), Visit 6 (2-weeks post-TKA), Visit 7 (3-weeks post-TKA), Visit 8 (4-weeks post-TKA), Visit 9 (2-months post-TKA), and Visit 10 (3-months post-TKA)
description: Following discharge after total knee arthroplasty (TKA) surgery, subjects were asked to report how many physical therapy sessions they attended since the previous study visit. The median number of physical therapy sessions attended is reported for each group at each time point.
measure: Subject's Use of Device (Compliance)
time frame: Visit 4 (In-Hospital), Visit 6 (2-weeks post-Total Knee Arthroplasty (TKA)), and Visit 8 (4-weeks Post-TKA)
description: The hours of usage were recorded for each Lead (femoral and sciatic) from the SPRINT Beta stimulator throughout the study to assess the level of subject compliance with the peripheral nerve stimulation therapy. Treatment Group subjects were asked to use the device for up to 24 hrs each day. The stimulator provided the cumulative number of hours in use since the device was activated. For each timepoint for Treatment Group participants (subjects who received stimulation therapy), the median cumulative number of hours of use for each lead is presented for each timepoint.
measure: Inpatient Pain Management Experience Survey (Pain Management During Hospital Stay)
time frame: 1-week post-Total Knee Arthroplasty (TKA)
description: Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. Questions regarding experience with in-hospital pain management are reported below.
measure: Inpatient Pain Management Experience Survey (Pain Medicine During Hospital Stay)
time frame: 1-week post-Total Knee Arthroplasty (TKA)
description: Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. The number of subjects that responded affirmatively to the following question are reported below: "During this hospital stay, did you need medicine for pain?"
measure: Inpatient Pain Management Experience Survey (Discharge Facility)
time frame: 1-week post-Total Knee Arthroplasty (TKA)
description: Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. The question regarding discharge location following hospital stay is reported below.
measure: Inpatient Pain Management Experience Survey (Overall Rating of Hospital)
time frame: 1-week post-Total Knee Arthroplasty (TKA))
description: Subjects completed a survey comprised of a subset of questions from the Hospital Consumer Assessment of Healthcare Providers and Systems to assess subject satisfaction with pain management during their time in the hospital for total knee arthroplasty surgery. As part of this survey, subjects were asked to rate their hospital stay on an 11-point numerical rating scale where 0 represents "worst hospital possible" and 10 represents "best hospital possible." The median score for each group is reported.
arm group label: Treatment Group (SPRINT Beta System)
arm group type: Experimental
description: Subjects in the treatment group will have up to 2 leads placed in their leg that underwent total knee replacement, will use the SPRINT Beta System, and will receive electrical stimulation in addition to the standard of care.
arm group label: Control Group
arm group type: No Intervention
description: Subjects in the control group will receive the standard of care.
intervention type: Device
intervention name: SPRINT Beta System
description: The SPRINT Beta System is an Investigational Device which delivers mild electrical stimulation to nerves in the leg that underwent lead placement. The SPRINT Beta System includes a small wire (called a "Lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Beta Stimulator).
arm group label: Treatment Group (SPRINT Beta System)
other name: SPRINT Beta Peripheral Nerve Stimulation (PNS) System
other name: SPRINT Peripheral Nerve Stimulation (PNS) System
other name: SPRINT System
criteria: 
gender: All
minimum age: 21 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Musculoskeletal Diseases
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 