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Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial
Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial (BRACE-trial)
Who can join
Ages 14 to 39 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
About the study
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.
What is being tested
- post-surgical functional bracing (device)
Sponsor: Wake Forest University Health Sciences · Participants: 96 · Started: Sep 11, 2025
Contact the study team
- Katherine Leonard · Phone: 336-716-3952
Official record on ClinicalTrials.gov — NCT06942754
Locations in the U.S.
| North Carolina | Wake Forest University Health Sciences, Winston-Salem |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.