Overview
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
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
- uncontrolled diabetes (Hgb A1C >7%)
- pregnant
- local or systemic infection
- inability to cooperate with and/or comprehend post-operative instructions
- MRI proven non-vascular sites
- poor nutritional state (Alb <30 g/L)
- cancer
- paralysis of the shoulder
- contracture of the shoulder
- patients unable to provide informed consent for the study