<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/NCT04436523</url>
  </required_header>
  <id_info>
    <org_study_id>19-29641</org_study_id>
    <nct_id>NCT04436523</nct_id>
  </id_info>
  <brief_title>Blood Flow Restriction After Meniscus Repair</brief_title>
  <official_title>Outcomes of Blood Flow Restriction Training in Post-operative Rehabilitation After Meniscus Repair Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate post-operative outcomes after meniscus surgery in&#xD;
      participants undergoing blood flow restriction training as a rehabilitative adjunct compared&#xD;
      to those with standard rehabilitation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a double-blinded, single-institution, randomized controlled&#xD;
      trial to compare patients undergoing arthroscopic meniscus repair with post-operative&#xD;
      rehabilitation protocol as (1) a standard-of-care rehabilitative protocol with a&#xD;
      non-occlusive blood pressure cuff (inflated to 20-30 mm Hg) applied to the operative&#xD;
      extremity versus (2) blood flow restriction training with cuff occlusion applied to the&#xD;
      operative extremity. Patients will be enrolled prospectively and pre-operatively at their&#xD;
      initial clinic visit after meniscus injury.&#xD;
&#xD;
      Rehabilitative exercises would be advanced per the physical therapists' discretion with&#xD;
      similar exercises for patients in both groups for direct comparison. These exercises are part&#xD;
      of an already-established post-operative protocol that is in place, with the only difference&#xD;
      being the addition of the blood flow restriction protocol in the intervention group. All&#xD;
      patients would undergo their supervised post-operative rehabilitation at our institution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 20, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knee extension torque at Week 1</measure>
    <time_frame>Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee extension torque at Week 2</measure>
    <time_frame>Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee extension torque at Week 3</measure>
    <time_frame>Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee extension torque at Week 4</measure>
    <time_frame>Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee extension torque at Week 5</measure>
    <time_frame>Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee extension torque at Week 6</measure>
    <time_frame>Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee extension torque at Week 7</measure>
    <time_frame>Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee extension torque at Week 8</measure>
    <time_frame>Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee extension torque at Week 9</measure>
    <time_frame>Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee extension torque at Week 10</measure>
    <time_frame>Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee extension torque at Week 11</measure>
    <time_frame>Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knee extension torque at Week 12</measure>
    <time_frame>Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thigh circumference at Week 1</measure>
    <time_frame>Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thigh circumference at Week 2</measure>
    <time_frame>Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thigh circumference at Week 3</measure>
    <time_frame>Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thigh circumference at Week 4</measure>
    <time_frame>Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thigh circumference at Week 5</measure>
    <time_frame>Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thigh circumference at Week 6</measure>
    <time_frame>Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thigh circumference at Week 7</measure>
    <time_frame>Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thigh circumference at Week 8</measure>
    <time_frame>Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thigh circumference at Week 9</measure>
    <time_frame>Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thigh circumference at Week 10</measure>
    <time_frame>Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thigh circumference at Week 11</measure>
    <time_frame>Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thigh circumference at Week 12</measure>
    <time_frame>Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)</time_frame>
    <description>Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>International Knee Documentation Committee (IKDC) Score at Week 6</measure>
    <time_frame>6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively)</time_frame>
    <description>Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Knee Documentation Committee (IKDC) Score at Week 12</measure>
    <time_frame>3 months (measured at 6 weeks, 3 months, and 6 months post-operatively)</time_frame>
    <description>Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Knee Documentation Committee (IKDC) Score at Week 24</measure>
    <time_frame>6 months (measured at 6 weeks, 3 months, and 6 months post-operatively)</time_frame>
    <description>Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Y-balance testing at Week 12</measure>
    <time_frame>3 months (performed at 3 months and 6 months post-operatively)</time_frame>
    <description>Functional outcome measure (numerical score). The lower quarter Y-balance test evaluates dynamic stability and functional symmetry. The subject stands on a single leg and reaches in three directions (anterior, posteromedial, posterolateral) and a composite score is calculated as a percentage: (sum of reach distances in each direction) / (3*limb length) * 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Y-balance testing at Week 24</measure>
    <time_frame>6 months (performed at 3 months and 6 months post-operatively)</time_frame>
    <description>Functional outcome measure (numerical score). The lower quarter Y-balance test evaluates dynamic stability and functional symmetry. The subject stands on a single leg and reaches in three directions (anterior, posteromedial, posterolateral) and a composite score is calculated as a percentage: (sum of reach distances in each direction) / (3*limb length) * 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-hop test at Week 12</measure>
    <time_frame>3 months (performed at 3 months and 6 months post-operatively)</time_frame>
    <description>Functional outcome measure (numerical score). The 3-hop test assesses dynamic stability and limb control. The subject hops three times consecutively forward in a same line and at the final landing, pauses in position while a measurement is made from the starting line to the toe at the end of the final hop in centimeters. The test is compared to the contralateral, uninjured limb, and scoring is reported as a percentage of the uninjured limb.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3-hop test at Week 24</measure>
    <time_frame>6 months (performed at 3 months and 6 months post-operatively)</time_frame>
    <description>Functional outcome measure (numerical score). The 3-hop test assesses dynamic stability and limb control. The subject hops three times consecutively forward in a same line and at the final landing, pauses in position while a measurement is made from the starting line to the toe at the end of the final hop in centimeters. The test is compared to the contralateral, uninjured limb, and scoring is reported as a percentage of the uninjured limb.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single leg squat testing at Week 12</measure>
    <time_frame>3 months (performed at 3 months and 6 months post-operatively)</time_frame>
    <description>Functional outcome measure (numerical score). Single leg squat testing evaluates core stability and ability to perform functional movement safely. Subjects will be asked to perform a single leg squat and will be evaluated on 5 criteria, with one point for clinician-rated good performance in each (A) maintenance in balance, depth, speed (B) trunk posture (C) pelvic rotation &amp; tilt (D) Hip adduction or femoral internal rotation (E) knee joint apparent valgus. Min: 0 = poor balance and motor control; Max: 5 = good balance and motor control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single leg squat testing at Week 24</measure>
    <time_frame>6 months (performed at 3 months and 6 months post-operatively)</time_frame>
    <description>Functional outcome measure (numerical score). Single leg squat testing evaluates core stability and ability to perform functional movement safely. Subjects will be asked to perform a single leg squat and will be evaluated on 5 criteria, with one point for clinician-rated good performance in each (A) maintenance in balance, depth, speed (B) trunk posture (C) pelvic rotation &amp; tilt (D) Hip adduction or femoral internal rotation (E) knee joint apparent valgus. Min: 0 = poor balance and motor control; Max: 5 = good balance and motor control</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Meniscus Disorder</condition>
  <condition>Meniscus, Torn Tibial</condition>
  <condition>Meniscus Lesion</condition>
  <condition>Meniscus Tear, Tibial</condition>
  <condition>Atrophy, Muscular</condition>
  <arm_group>
    <arm_group_label>Blood flow restriction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The blood flow restriction arm will include the use of the pneumatic tourniquet applied to the operative lower extremity throughout post-operative rehabilitation sessions. The tourniquet pressure will be titrated to 80% of the measured extremity arterial limb occlusion pressure with the participant lying supine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard rehabilitation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The standard rehabilitation arm will undergo the same rehabilitation protocol as the experimental arm. A tourniquet will still be applied, but will only be inflated to 20 mmHg, a pressure that will not occlude blood flow.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Blood flow restriction (Delfi Personalized Tourniquet System)</intervention_name>
    <description>The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol.</description>
    <arm_group_label>Blood flow restriction</arm_group_label>
    <other_name>Delfi Personalized Tourniquet System</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard rehabilitation</intervention_name>
    <description>Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.</description>
    <arm_group_label>Blood flow restriction</arm_group_label>
    <arm_group_label>Standard rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants who undergo surgery for arthroscopic meniscus repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants undergoing surgery for concomitant ligamentous surgeries&#xD;
&#xD;
          -  Patients with Diabetes Mellitus, vascular disease, or infections of the involved&#xD;
             extremity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sachin Allahabadi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sachin Allahabadi, MD</last_name>
    <phone>415-514-6120</phone>
    <email>sachin.allahabadi@ucsf.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jocelyn Carpio</last_name>
    <phone>415-514-6120</phone>
    <email>jocelyn.carpio@ucsf.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sachin Allahabadi, MD</last_name>
      <phone>415-514-6120</phone>
      <email>sachin.allahabadi@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Joceyln Carpio</last_name>
      <phone>415-514-6120</phone>
      <email>jocelyn.carpio@ucsf.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Drew A Lansdown, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Brian T Feeley, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ivan Arriaga-Martinez, DPT</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>blood flow restriction</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>meniscus repair</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscular Atrophy</mesh_term>
    <mesh_term>Tibial Meniscus Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04436523
org study id: 19-29641
nct id: NCT04436523
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to evaluate post-operative outcomes after meniscus surgery in
      participants undergoing blood flow restriction training as a rehabilitative adjunct compared
      to those with standard rehabilitation.
The investigators will conduct a double-blinded, single-institution, randomized controlled
      trial to compare patients undergoing arthroscopic meniscus repair with post-operative
      rehabilitation protocol as (1) a standard-of-care rehabilitative protocol with a
      non-occlusive blood pressure cuff (inflated to 20-30 mm Hg) applied to the operative
      extremity versus (2) blood flow restriction training with cuff occlusion applied to the
      operative extremity. Patients will be enrolled prospectively and pre-operatively at their
      initial clinic visit after meniscus injury.

      Rehabilitative exercises would be advanced per the physical therapists' discretion with
      similar exercises for patients in both groups for direct comparison. These exercises are part
      of an already-established post-operative protocol that is in place, with the only difference
      being the addition of the blood flow restriction protocol in the intervention group. All
      patients would undergo their supervised post-operative rehabilitation at our institution.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Knee extension torque at Week 1
time frame: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
measure: Knee extension torque at Week 2
time frame: Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
measure: Knee extension torque at Week 3
time frame: Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
measure: Knee extension torque at Week 4
time frame: Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
measure: Knee extension torque at Week 5
time frame: Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
measure: Knee extension torque at Week 6
time frame: Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
measure: Knee extension torque at Week 7
time frame: Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
measure: Knee extension torque at Week 8
time frame: Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
measure: Knee extension torque at Week 9
time frame: Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
measure: Knee extension torque at Week 10
time frame: Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
measure: Knee extension torque at Week 11
time frame: Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
measure: Knee extension torque at Week 12
time frame: Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer
measure: Thigh circumference at Week 1
time frame: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
measure: Thigh circumference at Week 2
time frame: Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
measure: Thigh circumference at Week 3
time frame: Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
measure: Thigh circumference at Week 4
time frame: Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
measure: Thigh circumference at Week 5
time frame: Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
measure: Thigh circumference at Week 6
time frame: Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
measure: Thigh circumference at Week 7
time frame: Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
measure: Thigh circumference at Week 8
time frame: Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
measure: Thigh circumference at Week 9
time frame: Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
measure: Thigh circumference at Week 10
time frame: Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
measure: Thigh circumference at Week 11
time frame: Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
measure: Thigh circumference at Week 12
time frame: Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)
description: Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh
measure: International Knee Documentation Committee (IKDC) Score at Week 6
time frame: 6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively)
description: Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
measure: International Knee Documentation Committee (IKDC) Score at Week 12
time frame: 3 months (measured at 6 weeks, 3 months, and 6 months post-operatively)
description: Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
measure: International Knee Documentation Committee (IKDC) Score at Week 24
time frame: 6 months (measured at 6 weeks, 3 months, and 6 months post-operatively)
description: Patient-reported outcome measure (numerical score) from survey. Min: 0 = lowest level of function/highest level of symptoms. Max: 100 = highest level of function/lowest level of symptoms
measure: Y-balance testing at Week 12
time frame: 3 months (performed at 3 months and 6 months post-operatively)
description: Functional outcome measure (numerical score). The lower quarter Y-balance test evaluates dynamic stability and functional symmetry. The subject stands on a single leg and reaches in three directions (anterior, posteromedial, posterolateral) and a composite score is calculated as a percentage: (sum of reach distances in each direction) / (3*limb length) * 100.
measure: Y-balance testing at Week 24
time frame: 6 months (performed at 3 months and 6 months post-operatively)
description: Functional outcome measure (numerical score). The lower quarter Y-balance test evaluates dynamic stability and functional symmetry. The subject stands on a single leg and reaches in three directions (anterior, posteromedial, posterolateral) and a composite score is calculated as a percentage: (sum of reach distances in each direction) / (3*limb length) * 100.
measure: 3-hop test at Week 12
time frame: 3 months (performed at 3 months and 6 months post-operatively)
description: Functional outcome measure (numerical score). The 3-hop test assesses dynamic stability and limb control. The subject hops three times consecutively forward in a same line and at the final landing, pauses in position while a measurement is made from the starting line to the toe at the end of the final hop in centimeters. The test is compared to the contralateral, uninjured limb, and scoring is reported as a percentage of the uninjured limb.
measure: 3-hop test at Week 24
time frame: 6 months (performed at 3 months and 6 months post-operatively)
description: Functional outcome measure (numerical score). The 3-hop test assesses dynamic stability and limb control. The subject hops three times consecutively forward in a same line and at the final landing, pauses in position while a measurement is made from the starting line to the toe at the end of the final hop in centimeters. The test is compared to the contralateral, uninjured limb, and scoring is reported as a percentage of the uninjured limb.
measure: Single leg squat testing at Week 12
time frame: 3 months (performed at 3 months and 6 months post-operatively)
description: Functional outcome measure (numerical score). Single leg squat testing evaluates core stability and ability to perform functional movement safely. Subjects will be asked to perform a single leg squat and will be evaluated on 5 criteria, with one point for clinician-rated good performance in each (A) maintenance in balance, depth, speed (B) trunk posture (C) pelvic rotation & tilt (D) Hip adduction or femoral internal rotation (E) knee joint apparent valgus. Min: 0 = poor balance and motor control; Max: 5 = good balance and motor control
measure: Single leg squat testing at Week 24
time frame: 6 months (performed at 3 months and 6 months post-operatively)
description: Functional outcome measure (numerical score). Single leg squat testing evaluates core stability and ability to perform functional movement safely. Subjects will be asked to perform a single leg squat and will be evaluated on 5 criteria, with one point for clinician-rated good performance in each (A) maintenance in balance, depth, speed (B) trunk posture (C) pelvic rotation & tilt (D) Hip adduction or femoral internal rotation (E) knee joint apparent valgus. Min: 0 = poor balance and motor control; Max: 5 = good balance and motor control
arm group label: Blood flow restriction
arm group type: Experimental
description: The blood flow restriction arm will include the use of the pneumatic tourniquet applied to the operative lower extremity throughout post-operative rehabilitation sessions. The tourniquet pressure will be titrated to 80% of the measured extremity arterial limb occlusion pressure with the participant lying supine.
arm group label: Standard rehabilitation
arm group type: Sham Comparator
description: The standard rehabilitation arm will undergo the same rehabilitation protocol as the experimental arm. A tourniquet will still be applied, but will only be inflated to 20 mmHg, a pressure that will not occlude blood flow.
intervention type: Device
intervention name: Blood flow restriction (Delfi Personalized Tourniquet System)
description: The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol.
arm group label: Blood flow restriction
other name: Delfi Personalized Tourniquet System
intervention type: Other
intervention name: Standard rehabilitation
description: Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.
arm group label: Blood flow restriction
arm group label: Standard rehabilitation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Sachin Allahabadi, MD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Sachin Allahabadi, MD
phone: 415-514-6120
email: sachin.allahabadi@ucsf.edu
last name: Jocelyn Carpio
phone: 415-514-6120
email: jocelyn.carpio@ucsf.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Muscular Atrophy
mesh term: Tibial Meniscus Injuries
sharing ipd: No