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Search / Trial NCT06542705

Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft

Launched by NYU LANGONE HEALTH · Aug 5, 2024

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how an internal brace affects the healing process after surgery for a torn Anterior Cruciate Ligament (ACL) using a special type of graft called bone-tendon-bone autograft. The goal is to see if using this brace improves recovery outcomes, which includes how well the knee functions and how patients feel about their recovery.

To participate in the trial, individuals need to be between 18 and 35 years old and scheduled for ACL reconstruction surgery with this specific graft. They should also be able to follow a standard rehabilitation program and have full, painless movement in their knee at the time of surgery. Unfortunately, those with certain knee problems, previous knee surgeries, or other specific health conditions cannot take part in the study. Participants will be monitored throughout their recovery to gather information about their healing progress and overall outcomes.

Gender

ALL

Eligibility criteria

  • 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

About Nyu Langone Health

NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Michael J. Alaia, MD

Principal Investigator

NYU Langone Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported