NCT06942754 Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial

Trial Parameters

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Brief 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 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

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