The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty. This will be done by analysis of standard scoring systems, radiographs and adverse event records. Data will be collected and analyzed to monitor pain, function, and survivorship and to confirm the performance of the Trabecular Metal Reverse Shoulder System. Performance will be evaluated by monitoring the frequency and incidence of adverse events as well as by assessment of the overall pain and functional performances, survivorship, health status and radiographic parameters of all enrolled study subjects who receive the Trabecular metal Reverse Shoulder System. Pain and functional performance will be measured using the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE), survivorship will be based on removal or intended removal of the device, health status will be determined by evaluation of the Short Form Survey12 (SF-12) as well as Adverse Events (AEs) and radiographic parameters analysis of x-rays.
Study Type
OBSERVATIONAL
Enrollment
200
Trabecular Metal Reverse Shoulder System used in primary or revision total shoulder arthroplasty
University of California, San Francisco
San Francisco, California, United States
Norton Orthopaedic & Sports Medicine
Louisville, Kentucky, United States
The Rothman Institute
Egg Harbor, New Jersey, United States
The Rothman Institute
Philadelphia, Pennsylvania, United States
Royal Blackburn Hospital
Blackburn, Lancashire, United Kingdom
Survivorship
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Time frame: 10 Years
Pain and Functional Performance
Measurements will be based on the American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment and the Single Assessment Numeric Evaluation (SANE)
Time frame: 10 Years
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