Clinical trial NCT04436523: Blood Flow Restriction After Meniscus Repair
Official title: Outcomes of Blood Flow Restriction Training in Post-operative Rehabilitation After Meniscus Repair Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meniscus Disorder
Meniscus, Torn Tibial
Meniscus Lesion
Meniscus Tear, Tibial
Atrophy, Muscular
Keywords: blood flow restriction
rehabilitation
meniscus repair
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Knee extension torque at Week 1
timeFrame: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Knee extension torque at Week 2
timeFrame: Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Knee extension torque at Week 3
timeFrame: Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Knee extension torque at Week 4
timeFrame: Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Knee extension torque at Week 5
timeFrame: Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Knee extension torque at Week 6
timeFrame: Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Knee extension torque at Week 7
timeFrame: Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Knee extension torque at Week 8
timeFrame: Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Knee extension torque at Week 9
timeFrame: Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Knee extension torque at Week 10
timeFrame: Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Knee extension torque at Week 11
timeFrame: Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Knee extension torque at Week 12
timeFrame: Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Thigh circumference at Week 1
timeFrame: Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Thigh circumference at Week 2
timeFrame: Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Thigh circumference at Week 3
timeFrame: Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Thigh circumference at Week 4
timeFrame: Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Thigh circumference at Week 5
timeFrame: Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Thigh circumference at Week 6
timeFrame: Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Thigh circumference at Week 7
timeFrame: Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Thigh circumference at Week 8
timeFrame: Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Thigh circumference at Week 9
timeFrame: Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Thigh circumference at Week 10
timeFrame: Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Thigh circumference at Week 11
timeFrame: Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)
measure: Thigh circumference at Week 12
timeFrame: Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)
Secondary outcomes:
measure: International Knee Documentation Committee (IKDC) Score at Week 6
timeFrame: 6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively)
measure: International Knee Documentation Committee (IKDC) Score at Week 12
timeFrame: 3 months (measured at 6 weeks, 3 months, and 6 months post-operatively)
measure: International Knee Documentation Committee (IKDC) Score at Week 24
timeFrame: 6 months (measured at 6 weeks, 3 months, and 6 months post-operatively)
measure: Y-balance testing at Week 12
timeFrame: 3 months (performed at 3 months and 6 months post-operatively)
measure: Y-balance testing at Week 24
timeFrame: 6 months (performed at 3 months and 6 months post-operatively)
measure: 3-hop test at Week 12
timeFrame: 3 months (performed at 3 months and 6 months post-operatively)
measure: 3-hop test at Week 24
timeFrame: 6 months (performed at 3 months and 6 months post-operatively)
measure: Single leg squat testing at Week 12
timeFrame: 3 months (performed at 3 months and 6 months post-operatively)
measure: Single leg squat testing at Week 24
timeFrame: 6 months (performed at 3 months and 6 months post-operatively)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Sachin Allahabadi, MD
role: PRINCIPAL_INVESTIGATOR
References: