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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

Who can join

Ages 18 to 35 · All sexes

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

About the study

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.

What is being tested

• Arthrex Internal Brace (device)
• ACL Reconstruction (procedure)

Sponsor: NYU Langone Health · Participants: 90 · Started: Mar 17, 2025

Contact the study team

• Sangmin Lee · Phone: 201-835-9117
• Kobe Rodney · Phone: 347-988-9129

Official record on ClinicalTrials.gov — NCT06542705

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.