Internal Bracing Following ACL Reconstruction

NYU Langone Health

Status: Not yet enrolling

Conditions: ACL Injury

Treatments: Procedure: ACL Reconstruction; Device: Arthrex Internal Brace

Study type: Interventional

Funder types: Other

Identifiers

NCT06289153

23-01182

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Internal Brace

Experimental group

Description:

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.

Treatment:

Device: Arthrex Internal Brace

Procedure: ACL Reconstruction

Standard ACLR

Active Comparator group

Description:

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.

Treatment:

Procedure: ACL Reconstruction