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

Palo Alto (17 mi)

Overseen byDavid Trofa, MD

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

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.

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.

Treatment Details

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: ACL reconstruction with internal brace augmentation (suture tape)Experimental Treatment2 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 augmentationActive Control2 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.