Stryker Trauma and Extremities
This study is a Multi-center, Prospective Follow-up, Non-significant risk, Post-Market Clinical Follow-Up (PMCF) study to Evaluate the Safety and Effectiveness of the Tornier Perform™ Reversed MonoPost System.
It is anticipated that a total of 150 subjects will be enrolled at up to ten sites over a one year enrollment period. The study has been designed to follow the surgeon's standard of care for subjects treated with shoulder arthroplasty with the device including imaging (x-rays and or CT scans). The primary endpoint of this study is to demonstrate pain relief and improved subjects' shoulder functionality by achieving a mean target of 25-points Total ASES Score improvement, for each type of glenoid (two sub cohorts: Standard with/without BIO-RSA and Augmented baseplate) at 2 years follow-up comp…
Inclusion Criteria: * 18 years or older at the time of the informed consent. * Informed and willing to sign an informed consent form (ICF) approved by Institutional Review Board (IRB) or Ethics Committee (EC). * Willing and able to comply with the requirements of the study protocol * Considered a candidate or having received shoulder arthroplasty with the device, having a functional deltoid muscle and with massive and non-repairable rotator cuff tear with pain disabled by: * Rheumatoid arthritis * Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)…
The Commercially available Tornier Perform™ Reversed MonoPost Glenoid is intended to replace the glenoid part of the scapulohumeral joint as part of a reverse shoulder prosthesis.
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