Blood Flow Restriction After Meniscus Repair

University of California San Francisco (UCSF)

Status: Enrolling

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

Treatments: Device: Blood flow restriction (Delfi Personalized Tourniquet System); Other: Standard rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04436523

19-29641

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Blood flow restriction

Experimental group

Description:

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.

Treatment:

Device: Blood flow restriction (Delfi Personalized Tourniquet System)

Other: Standard rehabilitation

Standard rehabilitation

Sham Comparator group

Description:

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.

Treatment:

Other: Standard rehabilitation