Functional knee bracing after quadriceps ACL reconstruction
Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial (BRACE-trial)
This trial will test whether wearing a functional knee brace after quadriceps-tendon ACL reconstruction helps young athletes and military personnel return to sport and reduces graft failures over two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 14 Years to 39 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06942754 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial comparing postoperative functional bracing versus no bracing in patients undergoing quadriceps autograft ACL reconstruction. Participants are athletic or military patients aged 14–39 with a unilateral complete ACL tear who plan to return to sport or duty. Outcomes measured over two years include psychological readiness, patient-reported outcome measures, clinical stability, return-to-sport rates, and graft failure. The study is conducted at Wake Forest University Health Sciences and excludes patients with multiligament injuries, prior ACL surgery, significant osteoarthritis, or other conditions that would affect rehabilitation.
Who should consider this trial
Good fit: Ideal candidates are athletic or military patients aged 14–39 with a unilateral complete ACL tear undergoing quadriceps autograft reconstruction who want to return to sport or duty.
Not a fit: Patients with multiligament injuries, prior ACL surgery, significant osteoarthritis, major malalignment, fractures, pregnancy, or comorbidities affecting rehabilitation are excluded and unlikely to benefit from the intervention tested here.
Why it matters
Potential benefit: If successful, functional bracing could reduce graft failures and improve knee stability, confidence, and return-to-sport rates after quadriceps ACL reconstruction.
How similar studies have performed: Surveys and previous studies have reported mixed results and no clear consensus on functional bracing after ACL reconstruction, and there are no prior randomized trials specifically focused on quadriceps grafts and psychological readiness.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Brian Waterman, MD — Wake Forest University Health Sciences
- Study coordinator: Katherine Leonard
- Email: Katherine.Leonard@Advocatehealth.org
- Phone: 336-716-3952
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.