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Internal Bracing Following ACL Reconstruction

NCT06289153 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-01-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Guillem Gonzalez-Lomas, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-03-26
Completion
2026-09-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06289153 on ClinicalTrials.gov