This study focuses on people who have been treated for a degenerative disease or trauma of the shoulder using an implant called the Comprehensive Primary Revision Stem. The Comprehensive Primary Revision Stem and its related instruments are part of a shoulder system meant to relieve pain caused by shoulder-related problems. When conservative treatments like steroids and/or pain-medication have failed, a shoulder replacement can be performed as an alternative treatment (surgical procedure during which the affected joint is replaced by an artificial shoulder implant/prosthesis). The purpose of this study is to evaluate health status and wellbeing of patients after they are implanted with the Comprehensive Primary Revision Stem. Specifically, researchers aim to confirm the safety, performance and clinical benefits of the Comprehensive Primary Revision Stem and their related instruments. Participants will be asked to complete questionnaires regarding health status and wellbeing during follow-up visits. Implant components have been approved by the U.S. Food and Drug Administration (FDA) and commercially available.
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What is the full name of this clinical trial?
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive® Primary Revision Stems - A Retrospective and Prospective Consecutive Series Study