Actively Recruiting
Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial (BRACE-trial)
Led by Wake Forest University Health Sciences · Updated on 2026-04-01
96
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of postoperative functional bracing following quadriceps autograft anterior cruciate ligament (ACL) reconstruction in younger athletic and military patients. This randomized controlled trial, called the Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy trial (BRACE-trial), aims to compare psychological readiness, patient-reported outcomes, clinical stability, return to sport, and failure rates over a two-year period. The study addresses the current lack of consensus on the benefits of functional bracing after ACL surgery, especially for high-risk patients. Participants will undergo quadriceps autograft ACL reconstruction and be randomly assigned to one of two groups: those who use a post-surgical functional brace (DonJoy Defiance Pro) and those who do not use any bracing after surgery. This trial monitors patients for two years following surgery to assess various outcomes related to knee function and recovery. During the study, participants will complete several assessments at baseline and at 3, 6, 12, and 24 months after surgery. These include psychological readiness to return to sport, knee function scores, pain scales, strength testing, and activity levels. Researchers will also track return to sport, reoperation rates, failure rates, brace compliance, and any complications related to the brace. The total participation duration spans two years to fully evaluate recovery and outcomes.
CONDITIONS
Brief Title
Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with unilateral complete ACL injury
- Patients involved in sports and desire to return to sports
- Patients undergoing quadriceps autograft ACL reconstruction
- Age between 14 and 39 years old
You will not qualify if you...
- Multiligamentous knee injuries involving two ligaments requiring surgical stabilization
- Concomitant suture tape augmentation, extra-articular tenodesis, or anterolateral ligament reconstruction
- Concomitant femoral, tibial, or patellar fractures
- Significant osteoarthritis
- Concomitant ipsilateral knee dislocation or patellar dislocation
- Significant lower leg malalignment requiring corrective osteotomies
- Prior ACL surgery, including on the opposite knee
- Pregnancy during injury or surgery
- Unable to provide consent
- Prolonged use of prednisolone or cytostatics
- Comorbidities affecting rehabilitation such as muscular, neurological, or vascular conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and immediate recovery period
Participants undergo quadriceps autograft ACL reconstruction surgery, followed by immediate post-operative care with or without the use of a functional brace.
1 surgical visit and initial post-operative assessment
Duration - Up to 24 months
Participants are monitored for recovery, including psychological readiness, clinical stability, and functional outcomes over 2 years following surgery.
Visits at baseline and 3, 6, 12, and 24 months
Trial Site Locations
Total: 1 location
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
K
Katherine Leonard
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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