BFR therapy for rehabilitation after ACL surgery
Blood Flow Restriction Therapy for the Post-Operative Rehabilitation of Anterior Cruciate Ligament Reconstruction With Quadriceps Tendon Autograft: A Randomized, Controlled Trial
This study is testing if adding Blood Flow Restriction therapy to regular rehab helps military personnel recover faster and stronger after ACL surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 15 Years to 45 Years |
| Sex | All |
| Sponsor | Brooke Army Medical Center Federal |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT04519801 on ClinicalTrials.gov |
What this trial studies
This research investigates the effectiveness of Blood Flow Restriction (BFR) therapy combined with standard rehabilitation for patients recovering from anterior cruciate ligament reconstruction (ACLR) using quadriceps tendon autograft. The study involves a prospective, randomized controlled trial where patients will be assigned to either a standard rehabilitation program or a program that includes BFR therapy. MRI scans will be conducted to assess quadriceps muscle cross-sectional area and strength at various intervals post-surgery, alongside patient-reported outcomes to evaluate functional improvement. The goal is to determine if BFR therapy can enhance recovery and return-to-duty times for active duty military personnel.
Who should consider this trial
Good fit: Ideal candidates are active duty military members aged 15 to 45 who require ACL reconstruction with quadriceps tendon autograft.
Not a fit: Patients with concurrent knee surgeries or those unable to adhere to rehabilitation protocols may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery times and functional outcomes for patients undergoing ACL reconstruction.
How similar studies have performed: Previous studies have shown promising results with BFR therapy in rehabilitation settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Antonio, Texas
- Brooke Army Medical Center- Clinical Research Center — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Andrew J Sheean, MD — Brooke Army Medical Center
- Study coordinator: Andrew J Sheean, MD
- Email: ajsheean@gmail.com
- Phone: 210-916-5425
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.