Recruiting

ACL Reconstruction

Sponsor:

NYU Langone Health

Code:

NCT06542705

Conditions

ACL Reconstruction

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

Interventions

Arthrex Internal Brace

ACL Reconstruction

Study Details

Brief 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.

Conditions

ACL Reconstruction

Study ID

NCT06542705

Start date

Mar 17, 2025

Status verified date

Mar, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Internal Brace

Patients will undergo ACL Reconstruction (ACLR) with an internal brace. Patients will undergo standard perioperative protocol and be followed at typical time points after surgery (2 weeks, 6 weeks, 3 months, 6 months, 12 months). At 12 months postoperative, a follow-up MRI will be obtained to evaluate healing and at 12 months and 24 months follow up KT-1000 testing will be conducted.

active comparator: Standard ACLR

Patients will undergo ACLR without an internal brace. Patients will undergo standard perioperative protocol and be followed at typical time points after surgery (2 weeks, 6 weeks, 3 months, 6 months, 12 months). At 12 months postoperative, a follow-up MRI will be obtained to evaluate healing and at 12 months and 24 months follow up KT-1000 testing will be conducted.

Interventions

Arthrex Internal Brace

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.

ACL Reconstruction

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.

Primary outcome measure

  • Side to side difference in laxity as measured by the KT-1000 Arthrometer [ Time Frame: Month 12 Post-Operation ]
  • Side to side difference in laxity as measured by the KT-1000 Arthrometer [ Time Frame: Month 24 Post-Operation ]

Central Contacts and Locations

Central contacts

Sangmin Lee

201-835-9117sangmin.lee3@nyulangone.org

Kobe Rodney

347-988-9129kobe.rodney@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-03-05.