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, range of motion, muscle activation, in-vivo biomechanics, and other radiographic outcomes using x-ray and MRI.
Eligibility criteria
Qualifiers
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
Disqualifiers
glenohumeral osteoarthritis
Western Ontario rotator cuff score >60
uncontrolled diabetes (Hgb A1C >7%)
pregnant
Trial design
Treatments tested in this trial
- Bridging Reconstruction using BioBrace
- Repair
Treatment groups
Sponsors and collaborators
Nova Scotia Health Authority
Lead sponsor
CONMED Corporation
Collaborator