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

Stanford University

Status: Withdrawn

Conditions: Knee Injuries; Anterior Cruciate Ligament Injuries

Treatments: Other: Blood Flow Restriction Therapy; Other: Standard Postoperative Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04528992

IRB-56716

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Physical Therapy with BFR

Experimental group

Description:

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.

Treatment:

Other: Blood Flow Restriction Therapy

Physical Therapy without BFR

Active Comparator group

Description:

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

Treatment:

Other: Standard Postoperative Physical Therapy