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Blood Flow Restriction After Meniscus Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04436523
Recruitment Status : Not yet recruiting
First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Meniscus Disorder Meniscus, Torn Tibial Meniscus Lesion Meniscus Tear, Tibial Atrophy, Muscular Device: Blood flow restriction (Delfi Personalized Tourniquet System) Other: Standard rehabilitation Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Outcomes of Blood Flow Restriction Training in Post-operative Rehabilitation After Meniscus Repair Surgery
Estimated Study Start Date : June 15, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : October 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Blood flow restriction
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.
Device: Blood flow restriction (Delfi Personalized Tourniquet System)
The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol.
Other Name: Delfi Personalized Tourniquet System

Other: Standard rehabilitation
Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.

Sham Comparator: Standard rehabilitation
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.
Other: Standard rehabilitation
Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.




Primary Outcome Measures :
  1. Knee extension torque at Week 1 [ Time Frame: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer

  2. Knee extension torque at Week 2 [ Time Frame: Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer

  3. Knee extension torque at Week 3 [ Time Frame: Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer

  4. Knee extension torque at Week 4 [ Time Frame: Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer

  5. Knee extension torque at Week 5 [ Time Frame: Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer

  6. Knee extension torque at Week 6 [ Time Frame: Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer

  7. Knee extension torque at Week 7 [ Time Frame: Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer

  8. Knee extension torque at Week 8 [ Time Frame: Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer

  9. Knee extension torque at Week 9 [ Time Frame: Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer

  10. Knee extension torque at Week 10 [ Time Frame: Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer

  11. Knee extension torque at Week 11 [ Time Frame: Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer

  12. Knee extension torque at Week 12 [ Time Frame: Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer

  13. Thigh circumference at Week 1 [ Time Frame: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh

  14. Thigh circumference at Week 2 [ Time Frame: Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh

  15. Thigh circumference at Week 3 [ Time Frame: Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh

  16. Thigh circumference at Week 4 [ Time Frame: Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh

  17. Thigh circumference at Week 5 [ Time Frame: Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh

  18. Thigh circumference at Week 6 [ Time Frame: Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh

  19. Thigh circumference at Week 7 [ Time Frame: Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh

  20. Thigh circumference at Week 8 [ Time Frame: Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh

  21. Thigh circumference at Week 9 [ Time Frame: Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh

  22. Thigh circumference at Week 10 [ Time Frame: Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh

  23. Thigh circumference at Week 11 [ Time Frame: Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh

  24. Thigh circumference at Week 12 [ Time Frame: Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks) ]
    Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh


Secondary Outcome Measures :
  1. International Knee Documentation Committee (IKDC) Score at Week 6 [ Time Frame: 6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively) ]
    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

  2. International Knee Documentation Committee (IKDC) Score at Week 12 [ Time Frame: 3 months (measured at 6 weeks, 3 months, and 6 months post-operatively) ]
    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

  3. International Knee Documentation Committee (IKDC) Score at Week 24 [ Time Frame: 6 months (measured at 6 weeks, 3 months, and 6 months post-operatively) ]
    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

  4. Y-balance testing at Week 12 [ Time Frame: 3 months (performed at 3 months and 6 months post-operatively) ]
    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.

  5. Y-balance testing at Week 24 [ Time Frame: 6 months (performed at 3 months and 6 months post-operatively) ]
    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.

  6. 3-hop test at Week 12 [ Time Frame: 3 months (performed at 3 months and 6 months post-operatively) ]
    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.

  7. 3-hop test at Week 24 [ Time Frame: 6 months (performed at 3 months and 6 months post-operatively) ]
    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.

  8. Single leg squat testing at Week 12 [ Time Frame: 3 months (performed at 3 months and 6 months post-operatively) ]
    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

  9. Single leg squat testing at Week 24 [ Time Frame: 6 months (performed at 3 months and 6 months post-operatively) ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who undergo surgery for arthroscopic meniscus repair

Exclusion Criteria:

  • Participants undergoing surgery for concomitant ligamentous surgeries
  • Patients with Diabetes Mellitus, vascular disease, or infections of the involved extremity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04436523


Contacts
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Contact: Sachin Allahabadi, MD 415-514-6120 sachin.allahabadi@ucsf.edu
Contact: Mya S Aung 415-514-6120 myasandi.aung@ucsf.edu

Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94158
Contact: Sachin Allahabadi, MD    415-514-6120    sachin.allahabadi@ucsf.edu   
Contact: Mya S Aung    415-514-6120    myasandi.aung@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Sachin Allahabadi, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04436523    
Other Study ID Numbers: 19-29641
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of California, San Francisco:
blood flow restriction
rehabilitation
meniscus repair
Additional relevant MeSH terms:
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Muscular Atrophy
Atrophy
Tibial Meniscus Injuries
Pathological Conditions, Anatomical
Leg Injuries
Wounds and Injuries
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms