Maximal Repair Versus Bridging Reconstruction with BioBrace®
Recruiting
N/A
Interventional Study
Rotator Cuff Tears
Bioinductive Implant
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Nova Scotia Health Authority · Other
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About This Trial
The purpose of this study is to determine if using BioBrace® to reconstruct the gap in the rotator cuff tears lead to better results for patients compared to the traditional maximal repair method. This study will use a variety of clinical, radiographic, and functional outcome measures. Specifically, the researchers will be comparing the re-tear rate, patient reported outcomes, shoulder strength, r…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* magnetic resonance imaging (MRI) proven diagnosis of a large or massive (\> 3cm), two-tendon (supraspinatus and infraspinatus) tear of the shoulder rotator cuff
* over 18 years of age
Exclusion Criteria:
* glenohumeral osteoarthritis
* Western Ontario rotator cuff score \>60…
Contacts