Blood Flow Restriction After Meniscus Repair

NCT ID: NCT04436523

Last Updated: 2023-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Blood flow restriction

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.

Group Type EXPERIMENTAL

Blood flow restriction (Delfi Personalized Tourniquet System)

Intervention Type DEVICE

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

Standard rehabilitation

Intervention Type OTHER

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

Standard rehabilitation

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.

Group Type SHAM_COMPARATOR

Standard rehabilitation

Intervention Type OTHER

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

Interventions

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Blood flow restriction (Delfi Personalized Tourniquet System)

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

Intervention Type DEVICE

Standard rehabilitation

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

Intervention Type OTHER

Other Intervention Names

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Delfi Personalized Tourniquet System

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sachin Allahabadi, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sachin Allahabadi, MD

Role: CONTACT

415-514-6120

Jocelyn Carpio

Role: CONTACT

415-514-6120

Facility Contacts

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Sachin Allahabadi, MD

Role: primary

415-514-6120

Joceyln Carpio

Role: backup

415-514-6120

Other Identifiers

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19-29641

Identifier Type: -

Identifier Source: org_study_id

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