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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Page 1 of 1 (1 locations)

1

Brooke Army Medical Center- Clinical Research Center

San Antonio, Texas, United States, 78234