Status:
RECRUITING
Bracing and Reconstruction of the Anterior Cruciate Ligament for Efficacy Trial
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Anterior Cruciate Ligament Injuries
Eligibility:
All Genders
14-39 years
Phase:
NA
Brief Summary
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 o...
Detailed Description
Given the increased popularity in quadriceps tendon graft, the biomechanical advantages of postoperative functional bracing, and the graft elongation that occurs predominantly with soft tissue grafts,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06942754
Start Date
September 11 2025
End Date
December 1 2028
Last Update
September 18 2025
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157