Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial

Recruiting now · Not applicable

Conditions studied: Anterior Cruciate Ligament Injuries

In brief

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.

Key facts

Study ID

NCT06942754

Run by

Wake Forest University Health Sciences

People needed

96

Starts

2025-09-11

Expected to finish

2028-12-01

Last updated by the study team

2026-04-01

Who can join

Age: 14 and older, up to 39. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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