Functional knee bracing after quadriceps ACL reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.