ACL Reconstruction With/Without Internal Bracing for Anterior Cruciate Ligament Injury

Overseen By Christian A Pearsall, BS, BA

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Columbia University

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing whether adding an internal brace during ACL surgery helps patients recover faster and have better outcomes. It focuses on young adults and athletes who need strong and stable knees. The brace is supposed to make the new ligament stronger and more stable while it heals. Internal bracing of the anterior cruciate ligament (ACL) reinforces the ligament and encourages natural healing by protecting it during the healing phase and supporting early mobilization.

Research Team

David Trofa, MD

Principal Investigator

Assistant Professor of Orthopedic Surgery

Eligibility Criteria

This trial is for patients treated by Columbia University Sports Medicine Service, aged 12 or older, with a first-time ACL injury confirmed by clinical exam and MRI. It's not suitable for those with previous knee surgery, other knee injuries, neuromuscular disorders affecting the leg, anesthesia risks, or who can't/won't follow the study plan.

Inclusion Criteria

I have been diagnosed with a first-time ACL injury.

Patients seen by the Columbia University Sports Medicine Service

I am 12 years old or older.

Exclusion Criteria

I have had knee surgery in the past.

Inability or unwillingness to adhere to protocol

I have a muscle or nerve condition affecting my legs.

Treatment Details

Interventions

• ACL Reconstruction (Procedure)
• Standardized Rehabilitation Protocol (Behavioural Intervention)

Trial Overview The study compares two ways to fix an ACL tear: both use a patient's own bone-tendon-bone graft but one adds internal brace augmentation (suture tape). The goal is to see if this extra support helps people get back to activities faster and improves their experience post-surgery.

Participant Groups

Group I: ACL reconstruction with internal brace augmentation (suture tape) Experimental Treatment 2 Interventions

This group will receive a standard ACL reconstruction using a BTB autograft with suture tape augmentation on the graft to strengthen it during the surgical procedure.

Group II: ACL reconstruction without internal brace augmentation Active Control 2 Interventions

This group will only receive a standard ACL reconstruction using a BTB autograft. No suture tape will be added to the graft during the surgical procedure.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+