Internal Bracing Following ACL Reconstruction

NCT ID: NCT06289153

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2026-09-26

Brief Summary

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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

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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

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ACL Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Arthrex Internal Brace

Intervention Type DEVICE

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.

ACL Reconstruction

Intervention Type PROCEDURE

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

Standard ACLR

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.

Group Type ACTIVE_COMPARATOR

ACL Reconstruction

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type DEVICE

ACL Reconstruction

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillem Gonzalez-Lomas, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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23-01182

Identifier Type: -

Identifier Source: org_study_id

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