Rheumatoid Arthritis Clinical Trial
Official title:
Retrospective and Prospective Post Market Clinical Follow-up Study of the Zimmer Trabecular Metal Humeral Stem
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Humeral Stem when used in primary, total or hemi shoulder arthroplasty.
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal
Humeral Stem when used in primary, total or hemi 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 Humeral Stem.
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 Humeral Stem.
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 SF-12 as well as AEs and radiographic parameters by
analysis of x-rays.
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