NCT06542705NARecruiting
Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft
NYU Langone Health
Start Date
3/17/2025
Completion Date
3/1/2029
Summary
The purpose of this study is to assess Anterior Cruciate Ligament (ACL) healing through analyzing clinical, radiographic, functional and patient-reported outcomes following ACL reconstruction with bone-tendon-bone autograft with and without internal bracing.
Eligibility Criteria
Age Range: 18 years to 35 years
Inclusion Criteria:
* Patients undergoing ACLR with BTB autograft
* Patients ages 18-35, inclusive
* Ability to undergo standard rehab protocol and full, painless range of motion at the time of surgery of their operative knee
Exclusion Criteria:
* Osteoarthritis defined by Kellgren-Lawrence grade 2 or higher on preoperative weightbearing radiographs
* Significant chondral injury as defined by grade 3-4 lesion greater than 2cm2
* History of autoimmune or inflammatory disease
* Prior ipsilateral knee ligament surgery or multi-ligament knee injury
* Concomitant Lateral extra-articular tenodesis (LET) procedure
* History of contralateral ACL surgery
* Younger than 18 years of age
* Older than 35 years of age
Interventions
DEVICE
Arthrex Internal Brace
PROCEDURE
ACL Reconstruction
Conditions
ACL Reconstruction
Locations
NYU Langone Health
New York, New York 10016
United States