BFR Therapy for Post-Op Rehab of ACL Reconstruction With Quadriceps Tendon Autograft (NCT04519801) | Clinical Trial Compass
CompletedNot Applicable
BFR Therapy for Post-Op Rehab of ACL Reconstruction With Quadriceps Tendon Autograft
United States60 participantsStarted 2022-09-09
Plain-language 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 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).
Who can participate
Age range
15 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Knee extensor strength
Timeframe: [Time Frame: approximately withing 7-10 days of ACLR] [Time Frame: 16 weeks post operatively] [Time Frame: 28 weeks post-operatively] [Time Frame: 40 weeks post-operatively] [Time Frame: 56 weeks post-operatively]