NCT06542705 Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft
| NCT ID | NCT06542705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | ACL Reconstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2025-03-17 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Michael J. Alaia, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT06542705 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying ACL Reconstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06542705 currently recruiting?
Yes, NCT06542705 is actively recruiting participants. Contact the research team at sangmin.lee3@nyulangone.org for enrollment information.
Where is the NCT06542705 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06542705 clinical trial?
NCT06542705 is sponsored by NYU Langone Health. The principal investigator is Michael J. Alaia, MD at NYU Langone Health. The trial plans to enroll 90 participants.