Internal Bracing Following ACL Reconstruction

Not Applicable

Not yet recruiting

• Conditions: ACL Injury
• Interventions: Device: Arthrex Internal Brace; Procedure: ACL Reconstruction

• Registration Number: NCT06289153
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

The primary objective is to compare functional outcomes at one year in patients who underwent ACLR with or without internal bracing. The secondary outcomes are to characterize the evidence of ACL healing at 1 year by MRI imaging of the knee and obtain data on clinical and patient reported outcomes at 1 year follow-up.

Study Timeline

• Study First Submitted: 2024-02-23
• Study First Submitted QC: 2024-02-23
• Study First Posted: 2024-03-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Study Start: 2025-04-01
• Primary Completion: 2026-03-26
• Study Completion: 2026-09-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internal Brace	Arthrex Internal Brace	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.
Internal Brace	ACL Reconstruction	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.
Standard ACLR	ACL Reconstruction	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Lysholm Knee Scoring System Score at Month 6 Post-Operation	Baseline, 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.
Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 12 Post-Operation	Baseline, 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.
Change from Baseline in Visual Analogue Scale (VAS) - Pain Score at Month 6 Post-Operation	Baseline, 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.
Change from Baseline in 2000 IKDC Subjective Knee Evaluation Form Score at Month 12 Post-Operation	Baseline, 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).
Change from Baseline in Lysholm Knee Scoring System Score at Month 12 Post-Operation	Baseline, 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.
Change from Baseline in 2000 International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form at Month 6 Post-Operation	Baseline, 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).

Trial Locations

Locations (2)

NYU Langone Health; 🇺🇸 New York, New York, United States

NYU Langone Health; 🇺🇸 New York, New York, United States