BioBrace® Augmentation in ACL Reconstruction Procedures
This study is looking at how well the BioBrace® Reinforced Implant works when used to help strengthen a tissue graft during surgery for an anterior cruciate ligament (ACL) tear. This is an observational study, meaning researchers will watch how patients do over time. You might be able to join if you are between 14 and 70 years old and have had or are scheduled to have ACL reconstruction surgery using the BioBrace® implant. The study will measure improvements in your function and any side effects over three years after surgery. The current status of this study is unclear.
- Study design
- This is an observational study involving 500 participants across multiple centers. It is a single-arm, open-label study, meaning all participants receive the same intervention and both you and the researchers will know what treatment you are receiving.
- What's involved
- You will have clinical evaluations at baseline (before surgery) and then at 6 months, 1 year, 2 years, and 3 years after your surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for three years after their surgery to assess function and adverse events.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
At a glance
Conditions
NCT06948591
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.
ConMed
New Haven, Connecticutstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Improvement in Function3 years post-op
Improvement in function measured with International Knee Documentation Committee (IKDC) from baseline to 3 years post-surgery.
- Adverse EventsBaseline, 6-months, 1-, 2-, and 3-years post-op
Evaluation of device-related adverse events