Blood Flow Restriction After Meniscus Repair

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Outcomes of Blood Flow Restriction Training in Post-operative Rehabilitation After Meniscus Repair Surgery

Conditions
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Meniscus Disorder, Meniscus, Torn Tibial, Meniscus Lesion, Meniscus Tear, Tibial, Atrophy, Muscular

Intervention / Treatment
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* Device: Blood flow restriction (Delfi Personalized Tourniquet System)
* Other: Standard rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood flow restriction<br>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)<br>* The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol.<br>* Other names: Delfi Personalized Tourniquet System;Other: Standard rehabilitation<br>* Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.<br>|
| Sham Comparator: Standard rehabilitation<br>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<br>* Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee extension torque at Week 1 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Knee extension torque at Week 2 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Knee extension torque at Week 3 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Knee extension torque at Week 4 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Knee extension torque at Week 5 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Knee extension torque at Week 6 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Knee extension torque at Week 7 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Knee extension torque at Week 8 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Knee extension torque at Week 9 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Knee extension torque at Week 10 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Knee extension torque at Week 11 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Knee extension torque at Week 12 | Peak knee extension torque (Newton-meters/kilogram) evaluated with a hand-held dynamometer | Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Thigh circumference at Week 1 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Thigh circumference at Week 2 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Thigh circumference at Week 3 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Thigh circumference at Week 4 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Thigh circumference at Week 5 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Thigh circumference at Week 6 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Thigh circumference at Week 7 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Thigh circumference at Week 8 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Thigh circumference at Week 9 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Thigh circumference at Week 10 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Thigh circumference at Week 11 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 
| Thigh circumference at Week 12 | Measurement of thigh circumference (centimeters) will be performed utilizing tape measures at specified distances along the thigh | Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Documentation Committee (IKDC) Score at Week 6 | 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 | 6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively) | 
| International Knee Documentation Committee (IKDC) Score at Week 12 | 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 months (measured at 6 weeks, 3 months, and 6 months post-operatively) | 
| International Knee Documentation Committee (IKDC) Score at Week 24 | 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 | 6 months (measured at 6 weeks, 3 months, and 6 months post-operatively) | 
| Y-balance testing at Week 12 | 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. | 3 months (performed at 3 months and 6 months post-operatively) | 
| Y-balance testing at Week 24 | 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 months (performed at 3 months and 6 months post-operatively) | 
| 3-hop test at Week 12 | 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. | 3 months (performed at 3 months and 6 months post-operatively) | 
| 3-hop test at Week 24 | 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. | 6 months (performed at 3 months and 6 months post-operatively) | 
| Single leg squat testing at Week 12 | 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 | 3 months (performed at 3 months and 6 months post-operatively) | 
| Single leg squat testing at Week 24 | 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 | 6 months (performed at 3 months and 6 months post-operatively) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood flow restriction, rehabilitation, meniscus repair