Effects of Blood Flow Restriction (BFR) Therapy on ACL Graft Maturation

NCT ID: NCT04528992

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-20
• Study Completion Date: 2024-09-20

Brief Summary

This is a study comparing the effects of blood flow restriction (BFR) therapy on the maturation of the Anterior Cruciate Ligament (ACL) graft after reconstruction surgery compared to physical therapy without the use of BFR.

Detailed Description

The study will be a randomized controlled trial to compare outcomes between physical therapy with BFR and physical therapy without BFR on the ACL graft maturation following reconstruction surgery. BFR therapy will begin as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR, will consist of the physical therapy following the surgeon's postoperative protocol.

To be considered for participation in this study, patients must be 18 years and older undergoing primary ACL reconstruction. In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.

Conditions

Knee Injuries; Anterior Cruciate Ligament Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physical Therapy with BFR

Participants will begin BFR therapy as early as 2 weeks after surgery. The initial 2 weeks after surgery, or prior to initiation of BFR will consist of the physical therapy following the surgeon's postoperative protocol.

Group Type: EXPERIMENTAL

Blood Flow Restriction Therapy

Intervention Type: OTHER

BFR is a rehabilitation method that involves wearing a tight band around the exercising extremity to briefly limit blood flow while doing light weight exercises. The response is similar to heavy weight training or lifting but without the stress on the extremity that is still healing from surgery. Will be given after 2 weeks standard postoperative physical therapy per surgeon's ACL reconstruction protocol following surgery.

Physical Therapy without BFR

Participants will undergo standard physical therapy following the surgeon's postoperative protocol.

Group Type: ACTIVE_COMPARATOR

Standard Postoperative Physical Therapy

Intervention Type: OTHER

This is the surgeon's standard postoperative physical therapy protocol after ACL reconstruction.

Interventions

Blood Flow Restriction Therapy

BFR is a rehabilitation method that involves wearing a tight band around the exercising extremity to briefly limit blood flow while doing light weight exercises. The response is similar to heavy weight training or lifting but without the stress on the extremity that is still healing from surgery. Will be given after 2 weeks standard postoperative physical therapy per surgeon's ACL reconstruction protocol following surgery.

Intervention Type: OTHER

Standard Postoperative Physical Therapy

This is the surgeon's standard postoperative physical therapy protocol after ACL reconstruction.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Ages 18 or older, all gender
• Patients receiving any type of ACL graft, either autograft or allograft, and any type of tissue

Exclusion Criteria

• Patients who do not meet the the comprehensive BFR screening criteria based on predetermined contraindications and precautions
• Patients undergoing any additional concomitant ligament repair or reconstruction at the same surgery
• Revision procedures
• Patients unable to lay still in an MRI scanner
• Patients receiving treatment outside Stanford
• Patients undergoing concomitant meniscus treatment that restricts patients' weight bearing or prolongs their immobilization compared to their surgeons standard postoperative ACL reconstruction protocol
• Patients who are unable to lay still in an MRI scanner
• Patients with a torn ACL or previous ACL reconstruction in the contralateral knee

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Seth Sherman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seth Sherman, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford

Redwood City, California, United States

Countries

United States

Other Identifiers

IRB-56716

Identifier Type: -

Identifier Source: org_study_id