ACL Reconstruction with Internal Brace Study
This study is looking at how well Anterior Cruciate Ligament (ACL) reconstruction surgery works when an Arthrex Internal Brace is used. The Arthrex Internal Brace is a special suture tape that helps reinforce the ACL during surgery and is held in place by anchors that dissolve over time. All participants will have ACL reconstruction surgery using a bone-tendon-bone autograft. Researchers want to see if adding the Internal Brace improves healing and outcomes compared to surgery without it. They will measure knee looseness at 12 and 24 months after surgery. You may be able to join if you are between 18 and 35 years old, need ACL reconstruction with a bone-tendon-bone autograft, and can do standard physical therapy. The study is currently unclear on its recruitment status.
- Study design
- This interventional study plans to enroll 90 participants. It compares ACL reconstruction with and without the Arthrex Internal Brace.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 24 months after their surgery to measure knee looseness.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effect of Internal Brace on Outcomes Following ACL Reconstruction With BTB Autograft
At a glance
Conditions
NCT06542705
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
NYU Langone Health
New York, New Yorkno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Michael J. Alaia, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
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Inclusion
Exclusion
What this trial measures
- Side to side difference in laxity as measured by the KT-1000 ArthrometerMonth 12 Post-Operation
The KT-1000 knee arthrometer (KT-1000) is an objective instrument to measure anterior tibial motion relative to the femur for anterior cruciate ligament (ACL) reconstruction. The side-to-side differences comparing the injured and normal extremity allow the determination of a diagnosis of increased anterior-posterior laxity. A side-to-side difference of less than 3mm at 30lb and the manual maximum is considered normal. A side-to-side difference between 3 and 5mm is considered a grey area. A side-to-side difference of more than 5mm is considered diagnostic of an ACL tear.
- Side to side difference in laxity as measured by the KT-1000 ArthrometerMonth 24 Post-Operation
The KT-1000 knee arthrometer (KT-1000) is an objective instrument to measure anterior tibial motion relative to the femur for anterior cruciate ligament (ACL) reconstruction. The side-to-side differences comparing the injured and normal extremity allow the determination of a diagnosis of increased anterior-posterior laxity. A side-to-side difference of less than 3mm at 30lb and the manual maximum is considered normal. A side-to-side difference between 3 and 5mm is considered a grey area. A side-to-side difference of more than 5mm is considered diagnostic of an ACL tear.