Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft

Last updated: April 8, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

ACL Reconstruction

Arthrex Internal Brace

Clinical Study ID

NCT06542705
24-00423
  • Ages 18-35
  • All Genders

Study 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

Inclusion

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 thetime of surgery of their operative knee

Exclusion

Exclusion Criteria:

  • Osteoarthritis defined by Kellgren-Lawrence grade 2 or higher on preoperativeweightbearing 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

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: ACL Reconstruction
Phase:
Study Start date:
March 17, 2025
Estimated Completion Date:
March 31, 2029

Connect with a study center

  • NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

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