RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 bone-tendon-bone autograft with and without internal bracing.

Official Title

Effect of Internal Brace on Outcomes Following ACL Reconstruction With Bone Patellar Bone (BTB) Autograft: A Randomized Controlled Trial

Quick Facts

Study Start:2025-03-17

Study Completion:2029-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06542705

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Ivanka Bhambhani

CONTACT

646-831-8314

Ivanka.Bhambhani@nyulangone.org

Principal Investigator

Michael J. Alaia, MD

PRINCIPAL_INVESTIGATOR

NYU Langone Health

Study Locations (Sites)

NYU Langone Health

New York, New York, 10016

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Michael J. Alaia, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-17

Study Completion Date2029-03

Study Record Updates

Study Start Date2025-03-17

Study Completion Date2029-03

Terms related to this study

Additional Relevant MeSH Terms

ACL Reconstruction