Status:
ACTIVE_NOT_RECRUITING
BFR Therapy for Post-Op Rehab of ACL Reconstruction With Quadriceps Tendon Autograft
Lead Sponsor:
Brooke Army Medical Center
Collaborating Sponsors:
American Orthopaedic Society for Sports Medicine
Congressionally Directed Medical Research Programs
Conditions:
ACL Injury
Eligibility:
All Genders
15-45 years
Phase:
NA
Brief 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 reg...
Detailed Description
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 reg...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04519801
Start Date
September 9 2022
End Date
April 1 2026
Last Update
August 27 2025
Active Locations (1)
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1
Brooke Army Medical Center- Clinical Research Center
San Antonio, Texas, United States, 78234