FiberLocker® System for Rotator Cuff Repairs
This study is looking at a new way to help rotator cuff repairs heal better. If you have a full-thickness rotator cuff tear that is at least 2 cm and are planning to have arthroscopic surgery, you might be able to join. Researchers are testing a device called the FiberLocker® System, which includes an implant (SpeedPatch® PET) and a tool (FiberLocker® Instrument) to attach it. They want to see how well your rotator cuff heals after surgery with this system, using MRI scans at least 6 months later. They will also look at how well your shoulder works and your pain levels. This study is for people aged 30 to 70 years old.
- Study design
- This is an interventional study with a planned enrollment of 60 participants. It is designed to evaluate the FiberLocker® System during rotator cuff repair surgery.
- What's involved
- You would undergo arthroscopic surgery for your rotator cuff tear. You would also have MRI scans before surgery and at least 6 months after surgery.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your healing will be evaluated with an MRI at a minimum of 6 months post-operatively.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
FiberLocker® System Augmentation of Rotator Cuff Repairs
At a glance
Conditions
NCT06918041
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
MedStar Health Research Institute
Columbia, Marylandstudy coordinator listed
Recruiting
Rush University Medical Center
Chicago, Illinoisstudy coordinator listed
Recruiting
Southern Oregon Orthopedics Research Foundation
Medford, Oregonstudy coordinator listed
Recruiting
Wake Forest University
Winston-Salem, North Carolinastudy 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
- Healing EvaluationPre-operatively & minimum 6 months post-operatively
The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively. A standard shoulder MRI protocol utilizing a minimum of a 1.5 Tesla magnet will be utilized. The cuff integrity will be classified using the 5 categories described by Sugaya et al. Thereby, type IV and V are considered as retear and type I, II, and III as healed. The healing rate will be estimated and reported descriptively, and a 95% confidence interval will be reported assuming a binomial distribution (unless otherwise noted).