Blood Flow Restriction After Meniscus Repair

Meniscus Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04436523
• Other study ID #: 19-29641
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: University of California, San Francisco
• Contact: Sachin Allahabadi, MD
• Phone: 415-514-6120
• Email: sachin.allahabadi[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy, Muscular
• Meniscus Disorder
• Meniscus Lesion
• Meniscus Tear, Tibial
• Meniscus, Torn Tibial
• Muscular Atrophy
• Tibial Meniscus Injuries

Intervention

Device:
• Blood flow restriction (Delfi Personalized Tourniquet System)
The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol.

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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)