<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/NCT03840096</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00075229</org_study_id>
    <nct_id>NCT03840096</nct_id>
  </id_info>
  <brief_title>Effectiveness of BREG Flex in 12-week Peri-operative Total Knee Arthroplasty</brief_title>
  <official_title>Effect of Augmenting a Standard Total Knee Pathway Protocol With a 12-week Peri-Operative Program of BREG Flex</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hawkins Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BREG, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hawkins Foundation</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patient outcomes following total knee replacement and standard physical therapy will be&#xD;
      compared between subjects who use the Breg Flex study device vs those who do not. Subjects&#xD;
      will be evaluated for knee range of motion, strength and patient reported outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">June 15, 2021</completion_date>
  <primary_completion_date type="Actual">June 15, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Acceptable Symptoms State (PASS)</measure>
    <time_frame>52 weeks post op</time_frame>
    <description>Patient reported outcome recording patient satisfaction with level of recovery. Patients report that they are either satisfied or not.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knee Osteoarthritis Outcome Score-JR (KOOS-JR)</measure>
    <time_frame>6 week and 1 week preoperatively and 3 ,6, 12, 52 week post op</time_frame>
    <description>Patient reported outcome measuring knee joint specific pain and physical function. The answer values range from none to extreme to describe pain and physical limitation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participant Physical Therapy Visits</measure>
    <time_frame>3 ,6, 12, 52 week post op</time_frame>
    <description>The number of Physical therapy visits between data collection time points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Range of motion</measure>
    <time_frame>6 week and 1 week preoperatively and 3 ,6, 12 week post op</time_frame>
    <description>Passive flexion and extension range of motion of knee</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Strength</measure>
    <time_frame>6 week and 1 week preoperatively and 3 ,6, 12 week post op</time_frame>
    <description>Strength of quadriceps as measured on Biodex</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Quadriceps NMES using Breg Flex</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Breg Flex</intervention_name>
    <description>All subjects in the treatment group will receive quadriceps Neuro Muscular Electrical Stimulation using Breg Flex device on the affected leg to guide and monitor of knee HEP during the 6 weeks prior to surgery and 12 weeks following surgery.</description>
    <arm_group_label>Quadriceps NMES using Breg Flex</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Individuals who are scheduled for Total Knee Arthroplasty by a single surgeon&#xD;
             (Burnikel)&#xD;
&#xD;
          2. Individuals who are at least 55 years of age&#xD;
&#xD;
          3. Individuals with a body mass index (BMI) &lt;45&#xD;
&#xD;
          4. Must be able and willing to complete all study assessments and to be followed for the&#xD;
             full course of the study.&#xD;
&#xD;
          5. Must be able to read, write and follow instructions in English.&#xD;
&#xD;
          6. Must be able and willing to provide informed consent.&#xD;
&#xD;
          7. Must be willing and able to attend the pre-op assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals with a history of any underlying neurological conditions&#xD;
&#xD;
          2. Individuals with a history of stroke&#xD;
&#xD;
          3. Individuals with a history of neurological disorder that affects lower extremity&#xD;
             function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis,&#xD;
             etc.)&#xD;
&#xD;
          4. Individuals with physical conditions which would make them unable to perform study&#xD;
             procedures&#xD;
&#xD;
          5. Pregnant women or inadequate precautions to prevent pregnancy&#xD;
&#xD;
          6. Diagnosis of a medical condition that would contraindicate treatment with the product,&#xD;
             e.g. skin lesions at electrode site.&#xD;
&#xD;
          7. Individuals with a diagnosis of inflammatory arthritis (Rheumatoid arthritis, gout or&#xD;
             psoriatic arthritis)?&#xD;
&#xD;
          8. Individuals with muscle diseases (i.e. muscular dystrophy)&#xD;
&#xD;
          9. Visible skin injury or disease on their legs&#xD;
&#xD;
         10. Principal investigator for this study, or member of study staff&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ATI Physical Therapy</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Steadman Hawkins Clinic of the Carolinas - Greenville Health System</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>September 8, 2021</last_update_submitted>
  <last_update_submitted_qc>September 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03840096
org study id: Pro00075229
nct id: NCT03840096
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Patient outcomes following total knee replacement and standard physical therapy will be
      compared between subjects who use the Breg Flex study device vs those who do not. Subjects
      will be evaluated for knee range of motion, strength and patient reported outcomes.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient Acceptable Symptoms State (PASS)
time frame: 52 weeks post op
description: Patient reported outcome recording patient satisfaction with level of recovery. Patients report that they are either satisfied or not.
measure: Knee Osteoarthritis Outcome Score-JR (KOOS-JR)
time frame: 6 week and 1 week preoperatively and 3 ,6, 12, 52 week post op
description: Patient reported outcome measuring knee joint specific pain and physical function. The answer values range from none to extreme to describe pain and physical limitation.
measure: Number of Participant Physical Therapy Visits
time frame: 3 ,6, 12, 52 week post op
description: The number of Physical therapy visits between data collection time points
measure: Range of motion
time frame: 6 week and 1 week preoperatively and 3 ,6, 12 week post op
description: Passive flexion and extension range of motion of knee
measure: Strength
time frame: 6 week and 1 week preoperatively and 3 ,6, 12 week post op
description: Strength of quadriceps as measured on Biodex
arm group label: Quadriceps NMES using Breg Flex
arm group type: Experimental
arm group label: Control
arm group type: No Intervention
intervention type: Device
intervention name: Breg Flex
description: All subjects in the treatment group will receive quadriceps Neuro Muscular Electrical Stimulation using Breg Flex device on the affected leg to guide and monitor of knee HEP during the 6 weeks prior to surgery and 12 weeks following surgery.
arm group label: Quadriceps NMES using Breg Flex
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee