NCT06542705

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

Effect of Internal Brace on Outcomes Following ACL Reconstruction With Bone Patellar Bone (BTB) Autograft: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 35 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 bone-tendon-bone autograft with and without internal bracing.

Conditions

• ACL Reconstruction

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. ACLR technique will be standardized to standard anteromedial (AM) portal femoral drilling to ensure consistency between surgeons.

Timeline

• Start date: 2025-03-17
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2024-08-07
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study