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

NCT06542705 | Recruiting DMC FDA Device

• 1 other identifier: 24-00423
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Side to side difference in laxity as measured by the KT-1000 Arthrometer

  The KT-1000 knee arthrometer (KT-1000) is an objective instrument to measure anterior tibial motion relative to the femur for anterior cruciate ligament (ACL) reconstruction. The side-to-side differences comparing the injured and normal extremity allow the determination of a diagnosis of increased anterior-posterior laxity. A side-to-side difference of less than 3mm at 30lb and the manual maximum is considered normal. A side-to-side difference between 3 and 5mm is considered a grey area. A side-to-side difference of more than 5mm is considered diagnostic of an ACL tear.

  Month 12 Post-Operation

• Side to side difference in laxity as measured by the KT-1000 Arthrometer

  The KT-1000 knee arthrometer (KT-1000) is an objective instrument to measure anterior tibial motion relative to the femur for anterior cruciate ligament (ACL) reconstruction. The side-to-side differences comparing the injured and normal extremity allow the determination of a diagnosis of increased anterior-posterior laxity. A side-to-side difference of less than 3mm at 30lb and the manual maximum is considered normal. A side-to-side difference between 3 and 5mm is considered a grey area. A side-to-side difference of more than 5mm is considered diagnostic of an ACL tear.

  Month 24 Post-Operation

Secondary Outcomes (9)

• Pivot Shift Grade

  Month 12 Post-Operation

• Pivot Shift Grade

  Month 24 Post-Operation

• Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation

  Baseline, Month 12 Post-Operation

• Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 24 Post-Operation

  Baseline, Month 24 Post-Operation

• Change from Baseline in International Knee Documentation Committee (IKDC) Survey at Month 12 Post-Operation

  Baseline, Month 12 Post-Operation

Study Arms (2)

Internal Brace

EXPERIMENTAL

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.

Device: Arthrex Internal Brace; Procedure: ACL Reconstruction

Standard ACLR

ACTIVE COMPARATOR

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.

Procedure: ACL Reconstruction

Interventions

Arthrex Internal Brace DEVICE

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.

Also known as: AR-1593-BC

Internal Brace

ACL Reconstruction PROCEDURE

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.

Internal Brace; Standard ACLR

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Study Officials

• Michael J. Alaia, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sangmin Lee

CONTACT

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

Kobe Rodney

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 7, 2024
• Study Start: March 17, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to Michael.Alaia@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)