NCT04436523

Blood Flow Restriction After Meniscus Repair

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-10-20
• Primary completion: 2023-06-08
• Completion: 2023-06-08
• First posted: 2020-06-18
• Last updated: 2026-02-20
• Results posted: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study