Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft
Effect of Internal Brace on Outcomes Following ACL Reconstruction With Bone Patellar Bone (BTB) Autograft: A Randomized Controlled Trial
NYU Langone Health
90 participants
Mar 17, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria8
- 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
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Interventions
The Arthrex Internal Brace method for ACL reconstruction consists of suture tape used to reinforce the ACL during surgery. This suture tape is secured in place with bioabsorbable anchors that gradually degrade within the body over time.
All patients will undergo ACL reconstruction (ACLR) with or without an internal brace. ACLR technique will be standardized to standard anteromedial (AM) portal femoral drilling to ensure consistency between surgeons.
Locations(1)
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NCT06542705