Blood Flow Restriction After Meniscus Repair

Not Applicable

Recruiting

• Conditions: Meniscus Disorder; Meniscus, Torn Tibial; Meniscus Lesion; Meniscus Tear, Tibial; Atrophy, Muscular
• Interventions: Device: Blood flow restriction (Delfi Personalized Tourniquet System); Other: Standard rehabilitation

• Registration Number: NCT04436523
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-18
• Study Start: 2020-10-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Participants who undergo surgery for arthroscopic meniscus repair

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blood flow restriction	Blood flow restriction (Delfi Personalized Tourniquet System)	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.
Standard rehabilitation	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.
Blood flow restriction	Standard rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Knee extension torque at Week 12	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
Knee extension torque at Week 9	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
Knee extension torque at Week 10	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
Thigh circumference at Week 6	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
Knee extension torque at Week 1	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
Knee extension torque at Week 3	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
Knee extension torque at Week 5	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
Knee extension torque at Week 6	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
Knee extension torque at Week 4	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
Thigh circumference at Week 2	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
Thigh circumference at Week 8	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
Thigh circumference at Week 11	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
Thigh circumference at Week 7	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
Thigh circumference at Week 12	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
Knee extension torque at Week 2	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
Knee extension torque at Week 7	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
Knee extension torque at Week 8	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
Thigh circumference at Week 3	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
Thigh circumference at Week 5	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
Thigh circumference at Week 9	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
Thigh circumference at Week 10	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
Knee extension torque at Week 11	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
Thigh circumference at Week 1	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
Thigh circumference at Week 4	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

Secondary Outcome Measures

Name	Time	Method
Y-balance testing at Week 12	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.
International Knee Documentation Committee (IKDC) Score at Week 24	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
International Knee Documentation Committee (IKDC) Score at Week 6	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
International Knee Documentation Committee (IKDC) Score at Week 12	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-hop test at Week 12	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.
Y-balance testing at Week 24	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.
Single leg squat testing at Week 24	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
3-hop test at Week 24	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.
Single leg squat testing at Week 12	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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States