Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial
Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial (BRACE-trial)
Wake Forest University Health Sciences
96 participants
Sep 11, 2025
INTERVENTIONAL
Conditions
Summary
Several attempts have been made to reduce these failure rates and improve return to sports rates in high-risk populations, and one of these approaches has been postoperative bracing. A recent survey of the Anterior cruciate ligament (ACL) Study Group has shown that 53% of surgeons prefers functional bracing following ACL reconstruction. Currently, however, there is no clear consensus on whether functional bracing following ACL reconstruction leads to lower failure rates, improved stability or better patient-reported outcomes when compared to ACL reconstruction without bracing.
Eligibility
Inclusion Criteria4
- patients with unilateral complete ACL injury
- patients involved in sports and the desire to return to sports
- patients undergoing quadriceps autograft ACL reconstruction
- must be 14 to 39 years old
Exclusion Criteria11
- multiligamentous knee injuries defined as two ligaments requiring surgical stabilization
- concomitant suture tape augmentation, extra-articular tenodesis or anterolateral ligament reconstruction
- concomitant femoral, tibial, or patellar fracture(s)
- patients with significant osteoarthritis
- concomitant ipsilateral knee dislocation or patellar dislocation
- significant lower leg malalignment requiring correcting osteotomies
- prior ACL surgery, including contralateral knee
- pregnancy during injury or surgery
- unable to provide consent
- prolonged use of prednisolone or cytostatics
- comorbidities (e.g., muscular, neurological, vascular) that influence rehabilitation
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Interventions
Quadriceps Autograft ACL Reconstruction with the use of post-surgical functional bracing, using the DonJoy Defiance Pro brace
Locations(1)
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NCT06942754