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BFR Therapy for Post-Op Rehab of ACL Reconstruction With Quadriceps Tendon Autograft
Sponsor: Brooke Army Medical Center
Summary
The overall objective of the proposed research is to conduct a prospective, randomized controlled trial to investigate whether the addition of BFR therapy to standard post-operative rehabilitation regimen significantly improves clinical outcomes following anterior cruciate ligament reconstruction (ACLR) standardized with respect to both surgical technique and graft selection. Patients indicated for ACLR will be screened and offered enrollment into this prospective, randomized controlled trial. MRI of bilateral thighs will be performed within 7 days of ACLR. Patients will be randomized to either REHAB or REHAB + BFR (study intervention) using a block randomization scheme. Patients will undergo repeat MRI of bilateral thighs pre-surgery, at 12 weeks, and at 52 weeks post-operatively (primary outcome measure.) Patient reported outcome (PRO) instruments will be administered pre-operatively to establish pre-operative debility related to ACL injury and subsequently after ACLR at 24 weeks, 36 weeks, and 52 weeks post-operative (secondary outcome measures).
Official title: Blood Flow Restriction Therapy for the Post-Operative Rehabilitation of Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Autograft: A Randomized, Controlled Trial
Key Details
Gender
All
Age Range
15 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2022-09-09
Completion Date
2026-04-01
Last Updated
2025-08-27
Healthy Volunteers
No
Conditions
Interventions
Blood Flow Restriction (BFR) therapy
BFR therapy beginning after first MD follow up appointment after ACL reconstruction with quadriceps tendon autograft and the following functional criteria have been met: 1.) incisions healing or healed without signs of infection or dehiscence. 2.) ROM to at least 90 degree flexion. 3.) Able to perform unilateral weight bearing for 5 seconds. 4.) Pain under control and minimal knee effusion.
Standard REHAB
Standard post-operative rehabilitation regimen (REHAB) beginning after first MD follow up appointment ACL reconstruction with quadriceps tendon autograft and the following functional criteria have been met: 1.) incisions healing or healed without signs of infection or dehiscence. 2.) ROM to at least 90 degree flexion. 3.) Able to perform unilateral weight bearing for 5 seconds. 4.) Pain under control and minimal knee effusion
Locations (1)
Brooke Army Medical Center- Clinical Research Center
San Antonio, Texas, United States