FiberLocker® System Augmentation of Rotator Cuff Repairs
Recruiting
N/A
Interventional Study
Rotator Cuff Tear
Rotator Cuff Tears
Rotator Cuff Tears of the Shoulder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 30 – 70
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- ZuriMED Technologies Inc. · Industry
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About This Trial
The purpose of this study is to prospectively evaluate healing, functional clinical outcomes, and safety of arthroscopic rotator cuff repairs augmented with the FiberLocker® System (encompassing the SpeedPatch® PET and the FiberLocker® Instrument).
The primary outcome measure is healing evaluation based on Magnetic Resonance Imaging (MRI) at a minimum of 6 months post-operatively.
The secondary …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. The Subject is between the ages of 30 and 70 years.
2. Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
3. Tear size ≥ 2 cm
4. Primary rotator cuff repair
5. Subject preoperative MRI obtained within 1 year prior to surgery
Exclus…
Contacts
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