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 compared to baseline. Secondary objectives are to collect postoperative data on the related clinical complications and functional outcomes of the device to demonstrate the safety and performance of these implants in a real-world setting.
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) * Correction of functional deformity * Fracture of the Humeral Head * Traumatic arthritis * Revision of the devices if sufficient bone stock remains * Enrollment occurred up to 1 year after date of surgery provided that mandatory data are accessible: including ASES, Constant, and Active ROM.
Exclusion Criteria: * Contraindications or hypersensitivity to the use of the Tornier Perform™ Reversed MonoPost System or their components (e.g., metal sensitivity). * Participation in the treatment period of another clinical trial during the clinical investigation. * Any subject that meets the definition of a Vulnerable Subject per ISO 14155 Section 3.44. Examples include any subject "with lack of or loss of autonomy due to immaturity or through mental disability, persons in nursing homes, children, impoverished
[{"measure":"Performance: change in functional ability of the treated shoulder","timeFrame":"from baseline to 2 years"}]