Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial
Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Apr 16, 2025
Trial Information
Current as of June 02, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of using a special brace after surgery for a complete tear of the anterior cruciate ligament (ACL) in the knee. The goal is to find out if wearing a brace after ACL reconstruction can help patients recover better and return to sports more successfully compared to not using a brace. Many surgeons believe that braces can be helpful, but there isn’t enough agreement on whether they really make a difference in recovery outcomes.
To participate in this trial, you need to be between 14 and 39 years old, have a complete ACL injury on one knee, and be involved in sports with the intention of returning to play. The trial is not currently recruiting participants, but if you qualify, you can expect to receive either the brace treatment or standard care after your surgery. It's important to note that certain conditions, like having other knee injuries or serious health issues, may prevent you from joining the study. This trial aims to provide clearer answers about the role of braces in ACL recovery, which could help many athletes in the future.
Gender
ALL
Eligibility 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
About Wake Forest University Health Sciences
Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Winston Salem, North Carolina, United States
Patients applied
Trial Officials
Brian Waterman, MD
Principal Investigator
Wake Forest University Health Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported