<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/NCT03017261</url>
  </required_header>
  <id_info>
    <org_study_id>16-PROTO-01</org_study_id>
    <nct_id>NCT03017261</nct_id>
  </id_info>
  <brief_title>TSolution One® Total Knee Arthroplasty</brief_title>
  <official_title>TSolution One® Total Knee Arthroplasty Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Think Surgical Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MCRA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical Metrics Diagnostics, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Think Surgical 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 goal of this prospective, non-randomized, multicenter clinical trial is to determine&#xD;
      whether robotic-assisted total knee arthroplasty performed with TSolution One® System is safe&#xD;
      and effective for use as an alternative to the conventional manual techniques. Clinical and&#xD;
      radiographic outcomes for robotic-assisted total knee arthroplasty performed with the&#xD;
      TSolution One® System will be collected preoperatively, intraoperatively, and postoperatively&#xD;
      up to a follow-up period of no less than 6 months and no more than 12 months. These outcomes&#xD;
      will be compared to the ones reported in the literature for conventional manual techniques.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical investigation will be conducted as a prospective, non-randomized, multicenter&#xD;
      study. The primary objective of this study is to demonstrate that the TSolution One System is&#xD;
      safe and effective for use as an alternative to manual planning and sawing/cutting&#xD;
      techniques. The primary effectiveness objective of this study is to demonstrate that the&#xD;
      TSolution One® System is effective for use as an alternative to manual planning and&#xD;
      sawing/cutting techniques by comparing the rate of malalignment for mechanical axis greater&#xD;
      than 3° at 3 months to the rate reported in the literature (i.e. 32%) and to demonstrate&#xD;
      significant clinical benefit by reducing the number of malaligned patients by at least 50%&#xD;
      (i.e. from 32% to ≤ 16%). The safety objective of this study is based on the rate of&#xD;
      intraoperative and postoperative TKA complications, with a follow-up period of no less than 6&#xD;
      months and no more than 12 months, and to compare this rate to the rate reported in the&#xD;
      literature. The secondary objective of this study is to summarize the distribution of&#xD;
      improvements in patients' self-reported assessment of postoperative function and&#xD;
      quality-of-life from baseline to a maximum of 12 months. Additionally, other preoperative&#xD;
      planning alignment goals (e.g. Knee V-V Alignment; Femoral Joint Line Alignment Angle; Tibial&#xD;
      Joint Line Alignment Angle; Tibial Slope Angle) will be compared to the post-operative&#xD;
      alignment at 3 months.&#xD;
&#xD;
      Investigators will recruit subjects from patients in their practice who require unilateral&#xD;
      total knee arthroplasty. Patients will be screened to identify eligible candidates based on&#xD;
      the inclusion and exclusion criteria. A total of one hundred fifteen (115) patients will be&#xD;
      enrolled in the study across the participating sites. All patients will sign an informed&#xD;
      consent form prior to participating in the study.&#xD;
&#xD;
      Prior to undergoing the investigational procedure, the patients will complete baseline&#xD;
      surveys of function and quality of life (Knee Society Score survey and the SF-12 Health&#xD;
      Survey) and have baseline radiographs and a CT scan of the knee.&#xD;
&#xD;
      Each patient will then undergo robotic-assisted total knee arthroplasty with the TSolution&#xD;
      One® System. The investigators will evaluate intra- and postoperative complications.&#xD;
      Postoperative radiographs and a CT scan will be used to measure limb alignment using a&#xD;
      standardized radiographic evaluation protocol. Each patient will complete a postoperative&#xD;
      Knee Society Score survey and the SF-12 Health Survey to assess functional outcomes and&#xD;
      quality-of-life following the investigational procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 18, 2017</start_date>
  <completion_date type="Actual">June 26, 2019</completion_date>
  <primary_completion_date type="Actual">June 26, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment</measure>
    <time_frame>3 months follow-up</time_frame>
    <description>Comparison between planned and postoperative coronal limb alignment assessed as the difference between the planned hip-knee-ankle angle and the achieved hip-knee-ankle angle after surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Up to 12 months follow-up</time_frame>
    <description>Adverse events will be assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Experiencing a Composite of Relevant Safety Adverse Events</measure>
    <time_frame>Up to 12 months follow-up</time_frame>
    <description>Adverse events assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding Complications</measure>
    <time_frame>Up to 12 months follow-up</time_frame>
    <description>Number of patients experiencing bleeding complications will be assessed based on the incidence of transfusions required (autologous or allogenic).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in (KSS) Knee Society Objective Score From Baseline</measure>
    <time_frame>Baseline to 6 Weeks</time_frame>
    <description>The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Society Objective Score From Baseline</measure>
    <time_frame>Baseline to 3 Months</time_frame>
    <description>The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Society Objective Score From Baseline</measure>
    <time_frame>Baseline to 6 Months</time_frame>
    <description>The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Society Objective Score From Baseline</measure>
    <time_frame>Baseline to 12 Months</time_frame>
    <description>The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Society Satisfaction Score From Baseline</measure>
    <time_frame>Baseline to 6 Weeks</time_frame>
    <description>The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Society Satisfaction Score From Baseline</measure>
    <time_frame>Baseline to 3 Months</time_frame>
    <description>The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Society Satisfaction Score From Baseline</measure>
    <time_frame>Baseline to 6 Months</time_frame>
    <description>The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Society Satisfaction Score From Baseline</measure>
    <time_frame>Baseline to 12 Months</time_frame>
    <description>The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Society Functional Score From Baseline</measure>
    <time_frame>Baseline to 6 Weeks</time_frame>
    <description>The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Society Functional Score From Baseline</measure>
    <time_frame>Baseline to 3 Months</time_frame>
    <description>The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Society Functional Score From Baseline</measure>
    <time_frame>Baseline to 6 Months</time_frame>
    <description>The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Knee Society Functional Score From Baseline</measure>
    <time_frame>Baseline to 12 Months</time_frame>
    <description>The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-operative (KSS) Knee Society Patient Expectation Score</measure>
    <time_frame>Baseline</time_frame>
    <description>Patient reported expectations for anticipated improvement in pain level and increase in activities as a result of planned knee replacement surgery. Expectations are reported on a scale of 0-15 where higher numbers indicate higher patent expectations. A score of 0 indicates that a patient had no expectations. A score of 15 indicates the highest level of expectations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative (KSS) Knee Society Patient Expectation Score</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative (KSS) Knee Society Patient Expectation Score</measure>
    <time_frame>3 Months</time_frame>
    <description>Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative (KSS) Knee Society Patient Expectation Score</measure>
    <time_frame>6 Months</time_frame>
    <description>Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative (KSS) Knee Society Patient Expectation Score</measure>
    <time_frame>12 Months</time_frame>
    <description>Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline</measure>
    <time_frame>Baseline to 6 Weeks</time_frame>
    <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline</measure>
    <time_frame>Baseline to 3 Months</time_frame>
    <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline</measure>
    <time_frame>Baseline to 6 Months</time_frame>
    <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline</measure>
    <time_frame>Baseline to 12 Months</time_frame>
    <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-12 (Short Form 12 Question) Mental Component Score From Baseline</measure>
    <time_frame>Baseline to 6 Weeks</time_frame>
    <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline</measure>
    <time_frame>Baseline to 3 Months</time_frame>
    <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline</measure>
    <time_frame>Baseline to 6 Months</time_frame>
    <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline</measure>
    <time_frame>Baseline to 12 Months</time_frame>
    <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tibial Joint Line Alignment Angle (TJLA) Change From Pre-op Plan</measure>
    <time_frame>Baseline to 3 Months</time_frame>
    <description>Comparison between planned and postoperative TJLA will be assessed as the difference between the planned TJLA angle and the achieved TJLA angle after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Femoral Joint Line Alignment Angle (FJLA) Change From Pre-op Plan</measure>
    <time_frame>Baseline to 3 Months</time_frame>
    <description>Comparison between planned and postoperative FJLA will be assessed as the difference between the planned FJLA angle and the achieved FJLA angle after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tibial Slope Change From Pre-op Plan</measure>
    <time_frame>Baseline to 3 Months</time_frame>
    <description>Comparison between planned and postoperative Tibial Slope will be assessed as the difference between the planned Tibial Slope and the achieved Tibial Slope after surgery.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">115</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <arm_group>
    <arm_group_label>TSolution One®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TSolution One®</intervention_name>
    <description>Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
    <arm_group_label>TSolution One®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At least 21 years of age.&#xD;
&#xD;
          2. Skeletally mature, as evidenced by closed epiphyses.&#xD;
&#xD;
          3. Eligible for primary unilateral TKA due to osteoarthritis defined radiographically by&#xD;
             a Kellgren-Lawrence Grade of 3 or higher.&#xD;
&#xD;
          4. Able to understand and willing to comply with the requirements of the study.&#xD;
&#xD;
          5. Able to give voluntary, written informed consent to participate and has signed an&#xD;
             Informed Consent Form specific to this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Has undergone previous open knee surgery in the operative knee.&#xD;
&#xD;
          2. Has a body mass index (BMI) &gt; 40 kg/m2.&#xD;
&#xD;
          3. Is a candidate for bilateral TKA.&#xD;
&#xD;
          4. Has a coronal deformity greater than 20° or a sagittal flexion contracture greater&#xD;
             than 15°.&#xD;
&#xD;
          5. Has an active systemic infection or an active local infection in or near the operative&#xD;
             knee joint, or has a previous history of joint infection.&#xD;
&#xD;
          6. Has a pathological skeletal condition or skeletal immaturity which would significantly&#xD;
             compromise the ability of the bone to withstand the stress required for preparation of&#xD;
             the bones and proper implantation of the prostheses (e.g., severe osteoporosis,&#xD;
             Paget's disease, renal osteodystrophy, AVN, sickle cell disease, etc.).&#xD;
&#xD;
          7. Has femoral or tibial bone stock that is of poor quality or inadequate to provide&#xD;
             stability for femoral or tibial fixation.&#xD;
&#xD;
          8. Has any type of metallic implant in the operative leg.&#xD;
&#xD;
          9. Has a known or suspected sensitivity to any of the materials in the investigational&#xD;
             device or implant components (i.e. cobalt, chromium, titanium, stainless steel,&#xD;
             titanium nitride, aluminum, polyethylene, PVC plastic)&#xD;
&#xD;
         10. Has a systemic illness or a neuromuscular, neurosensory, or musculoskeletal deficiency&#xD;
             that would render the patient unable to perform appropriate postoperative&#xD;
             rehabilitation.&#xD;
&#xD;
         11. Has a neuromuscular disorder that would create an unacceptable risk of prosthesis&#xD;
             instability or fixation failure.&#xD;
&#xD;
         12. Has significant comorbidities or conditions associated with high risk for surgical or&#xD;
             anesthetic survival (e.g. peripheral vascular disease, unstable cardiac disease,&#xD;
             poorly controlled diabetes, immunosuppression, etc.).&#xD;
&#xD;
         13. Is pregnant or intends to become pregnant during the course of the study.&#xD;
&#xD;
         14. Has previously experienced a stroke.&#xD;
&#xD;
         15. Is participating concurrently in another clinical trial, or has participated in a&#xD;
             clinical trial within the last 90 days, or intends to during the course of the study.&#xD;
&#xD;
         16. Has a medical or psychiatric condition which, in the opinion of the investigator,&#xD;
             poses a risk of the patient being unable to complete the study or presents risks&#xD;
             associated with study participation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernard N Stulberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Vincent Charity Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Francis Hospital, The Heart Center®</name>
      <address>
        <city>Roslyn</city>
        <state>New York</state>
        <zip>11576</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Carolina Specialty Hospital</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent Charity Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist West Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77094</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 19, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <results_first_submitted>April 14, 2020</results_first_submitted>
  <results_first_submitted_qc>May 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 22, 2020</results_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Osteoarthritis</keyword>
  <keyword>Arthroplasty</keyword>
  <keyword>Robotic Surgery</keyword>
  <keyword>Knee</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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>September 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03017261/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>TSolution One®</title>
          <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>6 Week Follow up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>3 Month Follow up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="115">1 failed to compete 3M imaging so only 114 have 3M data for tibial slope and KSS Objective Score.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>6 Month Follow up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>12 Month Follow up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="59">1 failed to compete 12M imaging so only 58 have 12M data for KSS Objective Score.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TSolution One®</title>
          <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="115"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Age at surgery</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.91" spread="8.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="96"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment</title>
        <description>Comparison between planned and postoperative coronal limb alignment assessed as the difference between the planned hip-knee-ankle angle and the achieved hip-knee-ankle angle after surgery.</description>
        <time_frame>3 months follow-up</time_frame>
        <population>8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment</title>
          <description>Comparison between planned and postoperative coronal limb alignment assessed as the difference between the planned hip-knee-ankle angle and the achieved hip-knee-ankle angle after surgery.</description>
          <population>8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" lower_limit="6.3" upper_limit="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Adverse Events</title>
        <description>Adverse events will be assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events</description>
        <time_frame>Up to 12 months follow-up</time_frame>
        <population>8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events</title>
          <description>Adverse events will be assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events</description>
          <population>8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.</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="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Experiencing a Composite of Relevant Safety Adverse Events</title>
        <description>Adverse events assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events.</description>
        <time_frame>Up to 12 months follow-up</time_frame>
        <population>8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Experiencing a Composite of Relevant Safety Adverse Events</title>
          <description>Adverse events assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events.</description>
          <population>8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.</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="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bleeding Complications</title>
        <description>Number of patients experiencing bleeding complications will be assessed based on the incidence of transfusions required (autologous or allogenic).</description>
        <time_frame>Up to 12 months follow-up</time_frame>
        <population>8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Bleeding Complications</title>
          <description>Number of patients experiencing bleeding complications will be assessed based on the incidence of transfusions required (autologous or allogenic).</description>
          <population>8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.</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="107"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in (KSS) Knee Society Objective Score From Baseline</title>
        <description>The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.</description>
        <time_frame>Baseline to 6 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in (KSS) Knee Society Objective Score From Baseline</title>
          <description>The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.</description>
          <units>Units 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="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.1" spread="19.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Society Objective Score From Baseline</title>
        <description>The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.</description>
        <time_frame>Baseline to 3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Society Objective Score From Baseline</title>
          <description>The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.</description>
          <units>Units 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="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.1" spread="19.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Society Objective Score From Baseline</title>
        <description>The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.</description>
        <time_frame>Baseline to 6 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Society Objective Score From Baseline</title>
          <description>The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.</description>
          <units>Units 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="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.4" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Society Objective Score From Baseline</title>
        <description>The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.</description>
        <time_frame>Baseline to 12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Society Objective Score From Baseline</title>
          <description>The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.</description>
          <units>Units 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="58"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.2" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Society Satisfaction Score From Baseline</title>
        <description>The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.</description>
        <time_frame>Baseline to 6 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Society Satisfaction Score From Baseline</title>
          <description>The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.</description>
          <units>Units 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="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" spread="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Society Satisfaction Score From Baseline</title>
        <description>The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.</description>
        <time_frame>Baseline to 3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Society Satisfaction Score From Baseline</title>
          <description>The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.</description>
          <units>Units 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="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Society Satisfaction Score From Baseline</title>
        <description>The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.</description>
        <time_frame>Baseline to 6 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Society Satisfaction Score From Baseline</title>
          <description>The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.</description>
          <units>Units 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="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Society Satisfaction Score From Baseline</title>
        <description>The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.</description>
        <time_frame>Baseline to 12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Society Satisfaction Score From Baseline</title>
          <description>The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.</description>
          <units>Units 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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Society Functional Score From Baseline</title>
        <description>The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.</description>
        <time_frame>Baseline to 6 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Society Functional Score From Baseline</title>
          <description>The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.</description>
          <units>Units 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="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.2" spread="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Society Functional Score From Baseline</title>
        <description>The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.</description>
        <time_frame>Baseline to 3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Society Functional Score From Baseline</title>
          <description>The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.</description>
          <units>Units 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="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.2" spread="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Society Functional Score From Baseline</title>
        <description>The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.</description>
        <time_frame>Baseline to 6 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Society Functional Score From Baseline</title>
          <description>The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.</description>
          <units>Units 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="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.2" spread="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Knee Society Functional Score From Baseline</title>
        <description>The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.</description>
        <time_frame>Baseline to 12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Knee Society Functional Score From Baseline</title>
          <description>The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.</description>
          <units>Units 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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.3" spread="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pre-operative (KSS) Knee Society Patient Expectation Score</title>
        <description>Patient reported expectations for anticipated improvement in pain level and increase in activities as a result of planned knee replacement surgery. Expectations are reported on a scale of 0-15 where higher numbers indicate higher patent expectations. A score of 0 indicates that a patient had no expectations. A score of 15 indicates the highest level of expectations.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Pre-operative (KSS) Knee Society Patient Expectation Score</title>
          <description>Patient reported expectations for anticipated improvement in pain level and increase in activities as a result of planned knee replacement surgery. Expectations are reported on a scale of 0-15 where higher numbers indicate higher patent expectations. A score of 0 indicates that a patient had no expectations. A score of 15 indicates the highest level of expectations.</description>
          <units>Units 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="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative (KSS) Knee Society Patient Expectation Score</title>
        <description>Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.</description>
        <time_frame>6 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative (KSS) Knee Society Patient Expectation Score</title>
          <description>Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.</description>
          <units>Units 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="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative (KSS) Knee Society Patient Expectation Score</title>
        <description>Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.</description>
        <time_frame>3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative (KSS) Knee Society Patient Expectation Score</title>
          <description>Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.</description>
          <units>Units 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="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative (KSS) Knee Society Patient Expectation Score</title>
        <description>Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.</description>
        <time_frame>6 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative (KSS) Knee Society Patient Expectation Score</title>
          <description>Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.</description>
          <units>Units 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="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-operative (KSS) Knee Society Patient Expectation Score</title>
        <description>Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.</description>
        <time_frame>12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Post-operative (KSS) Knee Society Patient Expectation Score</title>
          <description>Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.</description>
          <units>Units 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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.3" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline</title>
        <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
        <time_frame>Baseline to 6 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline</title>
          <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
          <units>Units 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="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline</title>
        <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
        <time_frame>Baseline to 3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline</title>
          <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
          <units>Units 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="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" spread="10.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline</title>
        <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
        <time_frame>Baseline to 6 Months</time_frame>
        <population>8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline</title>
          <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
          <population>8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.</population>
          <units>Units 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="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.3" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline</title>
        <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
        <time_frame>Baseline to 12 Months</time_frame>
        <population>8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.</population>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline</title>
          <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
          <population>8 patients did not complete the surgical procedure with the investigational device and were not included in the per protocol cohort.</population>
          <units>Units 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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-12 (Short Form 12 Question) Mental Component Score From Baseline</title>
        <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
        <time_frame>Baseline to 6 Weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-12 (Short Form 12 Question) Mental Component Score From Baseline</title>
          <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
          <units>Units 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="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline</title>
        <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
        <time_frame>Baseline to 3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline</title>
          <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
          <units>Units 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="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline</title>
        <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
        <time_frame>Baseline to 6 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline</title>
          <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
          <units>Units 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="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline</title>
        <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
        <time_frame>Baseline to 12 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline</title>
          <description>The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.</description>
          <units>Units 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="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tibial Joint Line Alignment Angle (TJLA) Change From Pre-op Plan</title>
        <description>Comparison between planned and postoperative TJLA will be assessed as the difference between the planned TJLA angle and the achieved TJLA angle after surgery.</description>
        <time_frame>Baseline to 3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Tibial Joint Line Alignment Angle (TJLA) Change From Pre-op Plan</title>
          <description>Comparison between planned and postoperative TJLA will be assessed as the difference between the planned TJLA angle and the achieved TJLA angle after surgery.</description>
          <units>Angle</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".35" spread="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Femoral Joint Line Alignment Angle (FJLA) Change From Pre-op Plan</title>
        <description>Comparison between planned and postoperative FJLA will be assessed as the difference between the planned FJLA angle and the achieved FJLA angle after surgery.</description>
        <time_frame>Baseline to 3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Femoral Joint Line Alignment Angle (FJLA) Change From Pre-op Plan</title>
          <description>Comparison between planned and postoperative FJLA will be assessed as the difference between the planned FJLA angle and the achieved FJLA angle after surgery.</description>
          <units>Angle</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.93" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tibial Slope Change From Pre-op Plan</title>
        <description>Comparison between planned and postoperative Tibial Slope will be assessed as the difference between the planned Tibial Slope and the achieved Tibial Slope after surgery.</description>
        <time_frame>Baseline to 3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>TSolution One®</title>
            <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</description>
          </group>
        </group_list>
        <measure>
          <title>Tibial Slope Change From Pre-op Plan</title>
          <description>Comparison between planned and postoperative Tibial Slope will be assessed as the difference between the planned Tibial Slope and the achieved Tibial Slope after surgery.</description>
          <units>Angle</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.01" spread="1.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months for all subjects. 12 Months for those subjects that completed 12 months of follow-up.</time_frame>
      <desc>AE: Untoward medical occurrence, disease, injury, or untoward clinical signs, whether related or unrelated to the investigational device or its use.&#xD;
SAE: AE which: Led to a death, Resulted in: life threatening illness or injury, patient hospitalization or prolongation of existing hospitalization, patient disability or permanent damage or required intervention to prevent permanent impairment/damage, Led to a congenital abnormality or birth defect</desc>
      <group_list>
        <group group_id="E1">
          <title>TSolution One®</title>
          <description>This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.&#xD;
TSolution One®: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.</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="115"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Congestive Heart Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Proctocolitis</sub_title>
                <description>with diverticulitis</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Bleed</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Stiffness of the joint</sub_title>
                <description>Index Side</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <description>Non-index side</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hip Fracture</sub_title>
                <description>Due to injury</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Finger Fracture</sub_title>
                <description>Due to injury</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Phimosis</sub_title>
                <description>With difficulty urinating</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Non-malignant asbestosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </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="55" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Exacerbation of anemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Temporary hearing loss</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Delayed Wound Healing</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Dental Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <description>Index side</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <description>Non-index side</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <description>Lower Extremity</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Effusion</sub_title>
                <description>Index Side</description>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Insect bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Nasal polyps</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Seroma</sub_title>
                <description>Index side</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Seroma</sub_title>
                <description>Surgical site</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Rheumatoid Arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bladder Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Dental Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Systemic Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Surgical Incision Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Toe fungus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <description>Due to prescribed narcotics</description>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <description>Due to injury</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index knee pain</sub_title>
                <description>Due to injury</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>MCL Injury</sub_title>
                <description>Due to injury</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Retained device pins</sub_title>
                <description>Surgical site</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <description>With neck pain</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hip pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Index knee pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Non-index knee pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <description>Index side</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <description>Non-index side</description>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <description>Cervical</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Thigh pain</sub_title>
                <description>Index side</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Pain (other musculoskeletal)</sub_title>
                <description>Gout</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Pain (other musculoskeletal)</sub_title>
                <description>Bruise due to injury</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Worsening of Parkinson's Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Generalized anxiety disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Kidney Stone</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <description>With shortness of breath</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Difficulty Breathing</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <description>Upper</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Anal Fissure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Lichen Sclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <description>Surgical site</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Pressure sores</sub_title>
                <description>Surgical site</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Bleeding, unrelated to surgical site/procedure</sub_title>
                <description>Nose bleed</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <description>Index Side</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </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>PI must submit proposed publications to Sponsor for review per contract timelines.&#xD;
Hospital &amp; PI shall:&#xD;
not publish the Hospital's and PI's results until a multi-center publication is released; however, if a multi-center publication is not released within 1 year after the study, Hospital &amp; PI may publish the results of their activities.&#xD;
keep all unpublished data &amp; results confidential and not disclose such in greater detail than disclosed in any publications, presentations or disclosures.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Valentina Campanelli</name_or_title>
      <organization>Think Surgical</organization>
      <phone>510-249-2314</phone>
      <email>vcampanelli@thinksurgical.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/NCT03017261
org study id: 16-PROTO-01
nct id: NCT03017261
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The goal of this prospective, non-randomized, multicenter clinical trial is to determine
      whether robotic-assisted total knee arthroplasty performed with TSolution One® System is safe
      and effective for use as an alternative to the conventional manual techniques. Clinical and
      radiographic outcomes for robotic-assisted total knee arthroplasty performed with the
      TSolution One® System will be collected preoperatively, intraoperatively, and postoperatively
      up to a follow-up period of no less than 6 months and no more than 12 months. These outcomes
      will be compared to the ones reported in the literature for conventional manual techniques.
This clinical investigation will be conducted as a prospective, non-randomized, multicenter
      study. The primary objective of this study is to demonstrate that the TSolution One System is
      safe and effective for use as an alternative to manual planning and sawing/cutting
      techniques. The primary effectiveness objective of this study is to demonstrate that the
      TSolution One® System is effective for use as an alternative to manual planning and
      sawing/cutting techniques by comparing the rate of malalignment for mechanical axis greater
      than 3° at 3 months to the rate reported in the literature (i.e. 32%) and to demonstrate
      significant clinical benefit by reducing the number of malaligned patients by at least 50%
      (i.e. from 32% to ≤ 16%). The safety objective of this study is based on the rate of
      intraoperative and postoperative TKA complications, with a follow-up period of no less than 6
      months and no more than 12 months, and to compare this rate to the rate reported in the
      literature. The secondary objective of this study is to summarize the distribution of
      improvements in patients' self-reported assessment of postoperative function and
      quality-of-life from baseline to a maximum of 12 months. Additionally, other preoperative
      planning alignment goals (e.g. Knee V-V Alignment; Femoral Joint Line Alignment Angle; Tibial
      Joint Line Alignment Angle; Tibial Slope Angle) will be compared to the post-operative
      alignment at 3 months.

      Investigators will recruit subjects from patients in their practice who require unilateral
      total knee arthroplasty. Patients will be screened to identify eligible candidates based on
      the inclusion and exclusion criteria. A total of one hundred fifteen (115) patients will be
      enrolled in the study across the participating sites. All patients will sign an informed
      consent form prior to participating in the study.

      Prior to undergoing the investigational procedure, the patients will complete baseline
      surveys of function and quality of life (Knee Society Score survey and the SF-12 Health
      Survey) and have baseline radiographs and a CT scan of the knee.

      Each patient will then undergo robotic-assisted total knee arthroplasty with the TSolution
      One® System. The investigators will evaluate intra- and postoperative complications.
      Postoperative radiographs and a CT scan will be used to measure limb alignment using a
      standardized radiographic evaluation protocol. Each patient will complete a postoperative
      Knee Society Score survey and the SF-12 Health Survey to assess functional outcomes and
      quality-of-life following the investigational procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Patients With Postoperative Coronal Limb Alignment More Than ±3 Deg From the Planned Coronal Limb Alignment
time frame: 3 months follow-up
description: Comparison between planned and postoperative coronal limb alignment assessed as the difference between the planned hip-knee-ankle angle and the achieved hip-knee-ankle angle after surgery.
measure: Adverse Events
time frame: Up to 12 months follow-up
description: Adverse events will be assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events
measure: Percentage of Patients Experiencing a Composite of Relevant Safety Adverse Events
time frame: Up to 12 months follow-up
description: Adverse events assessed as the percentage of patients with TCAT (TSolutionOne Computer Assisted Tool)-assisted implantation experiencing the composite safety endpoint of typical adverse events.
measure: Bleeding Complications
time frame: Up to 12 months follow-up
description: Number of patients experiencing bleeding complications will be assessed based on the incidence of transfusions required (autologous or allogenic).
measure: Change in (KSS) Knee Society Objective Score From Baseline
time frame: Baseline to 6 Weeks
description: The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.
measure: Change in Knee Society Objective Score From Baseline
time frame: Baseline to 3 Months
description: The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.
measure: Change in Knee Society Objective Score From Baseline
time frame: Baseline to 6 Months
description: The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.
measure: Change in Knee Society Objective Score From Baseline
time frame: Baseline to 12 Months
description: The computed difference in the total KSS objective score measured before surgery and after the surgery at this timepoint. The minimum KSS objective score is 0. The typical maximum KSS objective score is approximately 105 and depends on patient anatomy. Lower scores indicate a less functional knee joint reported as the result of an examination performed by a surgeon. The outcome measure reported is the difference between the objective score measured prior to surgery and the objective score measured at this time point.
measure: Change in Knee Society Satisfaction Score From Baseline
time frame: Baseline to 6 Weeks
description: The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.
measure: Change in Knee Society Satisfaction Score From Baseline
time frame: Baseline to 3 Months
description: The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.
measure: Change in Knee Society Satisfaction Score From Baseline
time frame: Baseline to 6 Months
description: The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.
measure: Change in Knee Society Satisfaction Score From Baseline
time frame: Baseline to 12 Months
description: The computed difference in the total KSS satisfaction score measured before surgery and after the surgery at this timepoint. The minimum KSS satisfaction score is 0. The maximum KSS satisfaction score is 40. Lower scores indicate lower levels of patient reported satisfaction with knee pain and function. The outcome measure reported is the difference between the satisfaction score measured prior to surgery and the satisfaction score measured at this time point.
measure: Change in Knee Society Functional Score From Baseline
time frame: Baseline to 6 Weeks
description: The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.
measure: Change in Knee Society Functional Score From Baseline
time frame: Baseline to 3 Months
description: The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.
measure: Change in Knee Society Functional Score From Baseline
time frame: Baseline to 6 Months
description: The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.
measure: Change in Knee Society Functional Score From Baseline
time frame: Baseline to 12 Months
description: The computed difference in the total KSS functional score measured before surgery and after the surgery at this timepoint. The minimum KSS functional score is 0. The maximum KSS satisfaction score is 100. Lower scores indicate increased functional limitations reported by patients. The outcome measure reported is the difference between the functional score measured prior to surgery and the functional score measured at this time point.
measure: Pre-operative (KSS) Knee Society Patient Expectation Score
time frame: Baseline
description: Patient reported expectations for anticipated improvement in pain level and increase in activities as a result of planned knee replacement surgery. Expectations are reported on a scale of 0-15 where higher numbers indicate higher patent expectations. A score of 0 indicates that a patient had no expectations. A score of 15 indicates the highest level of expectations.
measure: Post-operative (KSS) Knee Society Patient Expectation Score
time frame: 6 Weeks
description: Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.
measure: Post-operative (KSS) Knee Society Patient Expectation Score
time frame: 3 Months
description: Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.
measure: Post-operative (KSS) Knee Society Patient Expectation Score
time frame: 6 Months
description: Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.
measure: Post-operative (KSS) Knee Society Patient Expectation Score
time frame: 12 Months
description: Patient reported evaluation of improvement in pain level and increase in activities after knee replacement surgery as compared to their pre-operative expectations. Expectations are reported on a scale of 0-15 where higher numbers indicate more fully met or exceeded expectations. A score of 0 indicates that none of the patient's pre-operative expectations were met. A score of 15 indicates that all of the patient's pre-operative expectations were exceeded.
measure: Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
time frame: Baseline to 6 Weeks
description: The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
measure: Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
time frame: Baseline to 3 Months
description: The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
measure: Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
time frame: Baseline to 6 Months
description: The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
measure: Change in SF-12 (Short-form 12 Question) Physical Component Score From Baseline
time frame: Baseline to 12 Months
description: The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported physical health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
measure: Change in SF-12 (Short Form 12 Question) Mental Component Score From Baseline
time frame: Baseline to 6 Weeks
description: The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
measure: Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
time frame: Baseline to 3 Months
description: The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
measure: Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
time frame: Baseline to 6 Months
description: The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
measure: Change in SF-12 (Short-form 12 Question) Mental Component Score From Baseline
time frame: Baseline to 12 Months
description: The computed difference in the total SF-12 physical component score measured before surgery and after the surgery at this timepoint. The minimum SF-12 physical component score is 0. The maximum SF-12 physical component score is 100. Lower scores indicate lower levels of patient reported mental health reported by patients The outcome measure reported is the difference between the SF-12 physical component score measured prior to surgery and the SF-12 physical component score measured at this time point.
measure: Tibial Joint Line Alignment Angle (TJLA) Change From Pre-op Plan
time frame: Baseline to 3 Months
description: Comparison between planned and postoperative TJLA will be assessed as the difference between the planned TJLA angle and the achieved TJLA angle after surgery.
measure: Femoral Joint Line Alignment Angle (FJLA) Change From Pre-op Plan
time frame: Baseline to 3 Months
description: Comparison between planned and postoperative FJLA will be assessed as the difference between the planned FJLA angle and the achieved FJLA angle after surgery.
measure: Tibial Slope Change From Pre-op Plan
time frame: Baseline to 3 Months
description: Comparison between planned and postoperative Tibial Slope will be assessed as the difference between the planned Tibial Slope and the achieved Tibial Slope after surgery.
arm group label: TSolution One®
arm group type: Experimental
description: This group will undergo total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
intervention type: Device
intervention name: TSolution One®
description: Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
arm group label: TSolution One®
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Bernard N Stulberg, MD
role: Principal Investigator
affiliation: St. Vincent Charity Medical Center
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country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
sharing ipd: No
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