Actively Recruiting
Effect of Internal Brace on Outcomes Following ACL Reconstruction With Bone Patellar Bone (BTB) Autograft: A Randomized Controlled Trial
Led by NYU Langone Health · Updated on 2026-03-05
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying healing after Anterior Cruciate Ligament (ACL) reconstruction using a bone-tendon-bone autograft, with and without an internal brace. The study aims to compare clinical, imaging, functional, and patient-reported outcomes between these two methods to better understand their effects on ACL healing. Participants will receive ACL reconstruction surgery either with an Arthrex Internal Brace device, which uses suture tape and bioabsorbable anchors to support the ligament, or without the internal brace following standard surgical techniques. Both groups will follow the same perioperative care and rehabilitation protocols. Follow-up visits will occur at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after surgery, with MRI scans at 12 months and KT-1000 arthrometer testing at 12 and 24 months to assess ligament laxity. During the study, participants will undergo various assessments including clinical exams, MRI imaging, and functional tests like the KT-1000 arthrometer measurement of knee laxity. Pain levels, knee function surveys, and activity scales will also be collected at baseline and follow-up visits. The trial will continue monitoring outcomes through 24 months after surgery to evaluate the differences in healing and knee stability between the two surgical approaches.
CONDITIONS
Brief Title
Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing ACL reconstruction with bone-tendon-bone autograft
- Patients aged 18 to 35 years, inclusive
- Ability to follow a standard rehabilitation protocol
- Full, painless range of motion of the operative knee at the time of surgery
You will not qualify if you...
- Osteoarthritis with Kellgren-Lawrence grade 2 or higher on preoperative weightbearing X-rays
- Significant cartilage injury with grade 3-4 lesion larger than 2 cm²
- History of autoimmune or inflammatory disease
- Previous ligament surgery on the same knee or multi-ligament knee injury
- Undergoing lateral extra-articular tenodesis (LET) procedure
- History of ACL surgery on the opposite knee
- Younger than 18 years or older than 35 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 weeks or until discharge.
Participants undergo ACL reconstruction surgery with or without the Arthrex Internal Brace device and receive standard perioperative care.
1 surgery visit and approximately 1 to 2 immediate post-operative visits
Duration - 12 months
Participants attend follow-up visits to monitor recovery and healing after surgery.
Follow-up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months post-surgery
Duration - 12 months
Participants undergo further assessments including MRI at 12 months and KT-1000 testing at 12 and 24 months to evaluate knee stability and healing.
1 MRI visit at 12 months and KT-1000 testing visits at 12 and 24 months
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
S
Sangmin Lee
K
Kobe Rodney
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here