Internal Bracing Following ACL Reconstruction

NCT06289153 | Withdrawn FDA Device

• 1 other identifier: 23-01182
• Study Type: interventional
• Target: N/A
• 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 quadriceps graft with and without internal bracing.

Conditions

ACL Injury

Outcome Measures

Primary Outcomes (6)

• Change from Baseline in 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at Month 6 Post-Operation

  The IKDC is a patient-completed tool assessing knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  Baseline, Month 6 Post-Operation

• Change from Baseline in 2000 IKDC Subjective Knee Evaluation Form Score at Month 12 Post-Operation

  The IKDC is a patient-completed tool assessing knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  Baseline, Month 12 Post-Operation

• Change from Baseline in Lysholm Knee Scoring System Score at Month 6 Post-Operation

  The Lysholm Knee Scoring System is an 8-item assessment of the prevalence of knee problems. The total score ranges from 0-100; scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor.

  Baseline, Month 6 Post-Operation

• Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation

  The Lysholm Knee Scoring System is an 8-item assessment of the prevalence of knee problems. The total score ranges from 0-100; scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor.

  Baseline, Month 12 Post-Operation

• Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 6 Post-Operation

  Participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable); the response is the total score.

  Baseline, Month 6 Post-Operation

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

  Participants rate their pain on a scale from 0 (no pain) to 10 (worst pain imaginable); the response is the total score.

  Baseline, Month 12 Post-Operation

Study Arms (2)

Internal Brace

EXPERIMENTAL

Patients will undergo ACL Reconstruction (ACLR) with an internal brace. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee.

Device: Arthrex Internal Brace; Procedure: ACL Reconstruction

Standard ACLR

ACTIVE COMPARATOR

Patients will undergo ACLR without an internal brace. At 6 months post-operation patients will fill out clinical outcome surveys. At the routine 1 year postoperative visit, all patients will fill out clinical outcome surveys and undergo MRI evaluation of the knee.

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.

Internal Brace

ACL Reconstruction PROCEDURE

All patients will undergo ACL reconstruction (ACLR) with or without an internal brace.

Internal Brace; Standard ACLR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of ACL injury indicated for isolated reconstruction, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.

You may not qualify if:

• Patients who underwent concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.
• History of blood-borne diseases including HIV, HBV, HCV, HTLV, and syphilis.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Guillem Gonzalez-Lomas, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: March 1, 2024
• Study Start: April 1, 2025
• Primary Completion: March 26, 2026
• Study Completion (Estimated): September 26, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)