Assessing ACL healing after surgery with and without internal bracing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the healing outcomes of the Anterior Cruciate Ligament (ACL) following reconstruction using a bone-tendon-bone autograft, comparing results between patients who receive an internal brace and those who do not. It will analyze various outcomes, including clinical assessments, radiographic imaging, functional performance, and patient-reported experiences. The goal is to determine if the internal brace improves recovery and overall results after ACL surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients undergoing ACLR with BTB autograft
* Patients ages 18-35, inclusive
* Ability to undergo standard rehab protocol and full, painless range of motion at the time of surgery of their operative knee

Exclusion Criteria:

* Osteoarthritis defined by Kellgren-Lawrence grade 2 or higher on preoperative weightbearing radiographs
* Significant chondral injury as defined by grade 3-4 lesion greater than 2cm2
* History of autoimmune or inflammatory disease
* Prior ipsilateral knee ligament surgery or multi-ligament knee injury
* Concomitant Lateral extra-articular tenodesis (LET) procedure
* History of contralateral ACL surgery
* Younger than 18 years of age
* Older than 35 years of age

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Michael J. Alaia, MD — NYU Langone Health
• Study coordinator: Sangmin Lee
• Email: sangmin.lee3@nyulangone.org
• Phone: 201-835-9117

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.