Internal Bracing Following ACL Reconstruction

ACL Injury Clinical Trial

Official title:

Effect of Internal Bracing on Outcomes Following ACL Reconstruction With Quadriceps Tendon: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06289153
• Other study ID #: 23-01182
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: August 26, 2025

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Michael Moore
• Phone: 3475540183
• Email: Michael.moore[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 26, 2025
• Est. primary completion date: February 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

Device:
• 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.

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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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