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Anterior Cruciate Ligament (ACL) Reconstruction With Bone Tendon Bone Autograft With Versus Without Internal Bracing
Sponsor: Columbia University
Summary
There is no consensus regarding the best surgical management of primary ACL tears. Recent evidence suggests that internal brace augmentation may increase load failure and therefore stabilize the graft in-situ at the time of ACL reconstruction. This prospective randomized controlled trial aims to compare the time to return to activity, and participant reported outcomes in participants with bone-tendon-bone ACL reconstruction with and without (control) internal brace augmentation.
Official title: ACL Reconstruction With Bone Tendon Bone (BTB) Autograft With Versus Without Internal Brace - Clinical and Radiographic Outcomes
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-09
Completion Date
2032-09
Last Updated
2025-09-22
Healthy Volunteers
Yes
Conditions
Interventions
ACL reconstruction with BTB autograft with internal brace augmentation (suture tape)
The ACL will be reconstructed using a participant's own patella tendon (BTB autograft), and the graft will be fortified by suture tape during the surgery in order to strengthen it.
ACL reconstruction with BTB autograft without internal brace augmentation (suture tape)
The ACL will be reconstructed using a participant's own patella tendon (BTB autograft). The graft will not be fortified by suture tape in this group. It will be used as is without any modification.
Standardized Rehabilitation Protocol
Participants will undergo a standardized rehabilitation protocol with twice weekly physical therapy
Locations (1)
Columbia University Irving Medical Center
New York, New York, United States