Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial (BRACE)

Wake Forest University (WFU)

Status

Not yet enrolling

Conditions

Anterior Cruciate Ligament Injuries

Treatments

Device: post-surgical functional bracing

Study type

Interventional

Funder types

Other

Identifiers

NCT06942754

IRB00123098

Details and patient eligibility

About

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.

Full description

Given the increased popularity in quadriceps tendon graft, the biomechanical advantages of postoperative functional bracing, and the graft elongation that occurs predominantly with soft tissue grafts, there might be a role for functional bracing following quadriceps ACL reconstruction. Additionally, no studies to date have assessed the role of psychological readiness of return to sport, kinesiophobia and return to sport rates with and without functional bracing following ACL reconstruction (ACLR).

The purpose of this randomized controlled trial is to assess the 2-year outcomes of psychological readiness, patient-reported outcome measures (PROMs), clinical stability, return to sport and failure rates following quadriceps autograft ACL reconstruction with and without functional bracing in the postoperative phase in younger athletic patients and military patients with a higher risk of failure or not returning to sports or duty, respectively, in a randomized study: the Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy trial (BRACE-trial).

Enrollment

96 estimated patients

Sex

All

Ages

14 to 39 years old

Volunteers

No Healthy Volunteers

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