Maximal Repair Versus Bridging Reconstruction with BioBrace®

Maximal Repair Versus Bridging Reconstruction with BioBrace® for the Treatment of Chronic, Massive Rotator Cuff Tears: Clinical, Radiographic, and In-vivo Biomechanical Analysis

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.

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