Blood Flow Restriction After Meniscus Repair

NCT04436523 | Terminated Results DMC FDA Device

• 1 other identifier: 19-29641
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

blood flow restriction; rehabilitation; meniscus repair

Outcome Measures

Primary Outcomes (24)

• Knee Extension Force at Week 1

  Peak knee extension force (lbs) evaluated with a hand-held dynamometer

  Week 1 (Evaluated weekly at physical therapy visits from 0-12 weeks)

• Knee Extension Force at Week 2

  Peak knee extension force (lbs) evaluated with a hand-held dynamometer

  Week 2 (Evaluated weekly at physical therapy visits from 0-12 weeks)

• Knee Extension Force at Week 3

  Peak knee extension force (lbs) evaluated with a hand-held dynamometer

  Week 3 (Evaluated weekly at physical therapy visits from 0-12 weeks)

• Knee Extension Force at Week 4

  Peak knee extension force (lbs) evaluated with a hand-held dynamometer

  Week 4 (Evaluated weekly at physical therapy visits from 0-12 weeks)

• Knee Extension Force at Week 5

  Peak knee extension force (lbs) evaluated with a hand-held dynamometer

  Week 5 (Evaluated weekly at physical therapy visits from 0-12 weeks)

• Knee Extension Force at Week 6

  Peak knee extension force (lbs) evaluated with a hand-held dynamometer

  Week 6 (Evaluated weekly at physical therapy visits from 0-12 weeks)

• Knee Extension Force at Week 7

  Peak knee extension force (lbs) evaluated with a hand-held dynamometer

  Week 7 (Evaluated weekly at physical therapy visits from 0-12 weeks)

• Knee Extension Force at Week 8

  Peak knee extension force (lbs) evaluated with a hand-held dynamometer

  Week 8 (Evaluated weekly at physical therapy visits from 0-12 weeks)

• Knee Extension Force at Week 9

  Peak knee extension force (lbs) evaluated with a hand-held dynamometer

  Week 9 (Evaluated weekly at physical therapy visits from 0-12 weeks)

• Knee Extension Force at Week 10

  Peak knee extension force (lbs) evaluated with a hand-held dynamometer

  Week 10 (Evaluated weekly at physical therapy visits from 0-12 weeks)

• Knee Extension Force at Week 11

  Peak knee extension force (lbs) evaluated with a hand-held dynamometer

  Week 11 (Evaluated weekly at physical therapy visits from 0-12 weeks)

• Knee Extension Force at Week 12

  Peak knee extension force (lbs) evaluated with a hand-held dynamometer

  Week 12 (Evaluated weekly at physical therapy visits from 0-12 weeks)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (9)

• International Knee Documentation Committee (IKDC) Score at Week 6

  6 weeks (measured at 6 weeks, 3 months, and 6 months post-operatively)

• International Knee Documentation Committee (IKDC) Score at Week 12

  3 months (measured at 6 weeks, 3 months, and 6 months post-operatively)

• International Knee Documentation Committee (IKDC) Score at Week 24

  6 months (measured at 6 weeks, 3 months, and 6 months post-operatively)

• Y-balance Testing at Week 12

  3 months (performed at 3 months and 6 months post-operatively)

• Y-balance Testing at Week 24

  6 months (performed at 3 months and 6 months post-operatively)

Study Arms (2)

Blood flow restriction

EXPERIMENTAL

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.

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

Standard rehabilitation

SHAM COMPARATOR

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.

Other: Standard rehabilitation

Interventions

Standard rehabilitation OTHER

Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.

Blood flow restriction; Standard rehabilitation

Blood flow restriction (Delfi Personalized Tourniquet System) DEVICE

The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol.

Also known as: Delfi Personalized Tourniquet System

Blood flow restriction

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants who undergo surgery for arthroscopic meniscus repair

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Tibial Meniscus Injuries; Muscular Atrophy

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Limitations and Caveats

We had a difficult time enrolling subjects. Subjects could be included if they had an isolated meniscus tear and were doing physical therapy at our university-based PT practice. Many of our patients had associated injuries (ACL tear, etc) that were disqualifying. We excluded meniscus root tears or radial tears that required different rehab plans. We are a tertiary/quaternary referral center and many patients live farther away, so in-person PT was not possible at our location.

Results Point of Contact

• Title: Drew Lansdown
• Organization: University of California, San Francisco

drew.lansdown@ucsf.edu

415-353-8208

Study Officials

• Sachin Allahabadi, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 18, 2020
• Study Start: October 20, 2020
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)