NCT06289153

Internal Bracing Following ACL Reconstruction

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ACL Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-03-26
• Completion: 2026-09-26
• First posted: 2024-03-01
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study