Assessing ACL healing after surgery with and without internal bracing
Effect of Internal Brace on Outcomes Following ACL Reconstruction With Bone Patellar Bone (BTB) Autograft: A Randomized Controlled Trial
This study is testing if using an internal brace during ACL surgery helps patients heal better compared to those who don’t get the brace.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06542705 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-35 who are scheduled for ACL reconstruction with a bone-tendon-bone autograft and can follow a standard rehabilitation protocol.
Not a fit: Patients with significant knee injuries, prior surgeries on the knee, or those outside the age range of 18-35 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery protocols and improve outcomes for patients undergoing ACL reconstruction.
How similar studies have performed: While there is ongoing research in ACL reconstruction techniques, the specific use of an internal brace in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.