BFR Therapy for Post-Op Rehab of ACL Reconstruction With Quadriceps Tendon Autograft

Completed · Not applicable

Conditions studied: ACL Injury

In brief

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 16 weeks, and at 56 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 28 weeks, 40 weeks, and 56 weeks post-operative (secondary outcome measures).

Key facts

Study ID: NCT04519801
Run by: Brooke Army Medical Center
People needed: 60
Starts: 2022-09-09
Expected to finish: 2026-03-01
Last updated by the study team: 2026-06-29

Who can join

Age: 15 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Active duty member or Department of Defense Military Health System beneficiary
15 to 45 years of age
Indicated for ACL reconstruction with quadriceps tendon autograft with evidence of skeletal maturity; no open physes/growth plates

You may not qualify if…

Patients undergoing a concomitant surgical procedure that would otherwise require a period of immobilization and/or restricted weight bearing (i.e. meniscal repair, meniscal allograft transplantation, osteochondral allograft transplantation, high tibial osteotomy) will be excluded.
Undergoing combined multiligamentous knee injury reconstruction
Unable to consistently participate in the prescribed post-operative rehabilitation regimen
No patients with a history of recent lower extremity deep vein thrombosis, within the 12 months or on active treatment with anticoagulants, a history of ipsilateral lower extremity lymph node dissection or a history of endothelial dysfunction.
Patients that are unable to obtain MRI secondary to either intolerance and/or implanted medical devices that preclude the safe completion of the MRI.

Where it is running

Brooke Army Medical Center- Clinical Research Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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