PRIMA EU Retrospective & Prospective

Inclusion criteria

• Age ≥ 18 years old;
• Full skeletal maturity;
• Life expectancy over 24 months;
• Patient's joint anatomically and structurally suited to receive the selected implants and functional deltoid muscle;
• Patient meets at least one of the following indications:

For Anatomic configuration:

• non-inflammatory degenerative joint disease (i.e., osteoarthritis);
• inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis;
• avascular necrosis of the humeral head;
• cuff tear arthropathy (CTA Heads only);

For Reverse configuration:

• rotator cuff tear arthropathy;
• osteoarthritiswith rotator cuff tear;
• rheumatoid arthritis with rotator cuff tear;
• massive irreparable rotator cuff tear;
• Patient is able to understand the conditions of the study, to comply with the prescribed rehabilitation as well as willing to perform all scheduled follow-up visits;
• Patient has signed the Informed Consent form previously approved by the Ethics Committee before study activities.

Exclusion criteria

• Patients who lack capacity to be able to provide informed consent to participate in the study.
• Local or systemic general infection;
• Septicaemia;
• Persistent acute or chronic local or systemic osteomyelitis;
• Confirmed neurologic lesion compromising shoulder joint function;
• Deltoid muscle insufficiency;
• Poor meta-epiphyseal bone stock compromising stability of the implant (severe fracture of the proximal humerus, meta-epiphyseal pseudoarthrosis, osteoporosis, osteomalacia, extended bone loss after previous prosthetic or non-prosthetic surgery);
• Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course;
• Serious muscular, neurological, or arterial vascular diseases compromising stability of the implant;
• Proximal humerus fracture sequelae with inadequate bone stock;
• Vascular or nerve diseases affecting the concerned limb;
• Metabolic disorders which may impair fixation and stability of the implant;
• Any concomitant disease that might affect the implanted prosthesis;
• Metal hypersensitivity to implant materials (CoCrMo);
• Patient with significant renal impairment;
• Lower mobility issues that may affect the study evaluation;
• Unwillingness or inability (due to physical or mental issues) to comply with rehabilitation and to return for follow-up visits and any psychiatric illness that would prevent comprehension of the details and nature of the study;
• Women of childbearing potential who are pregnant, nursing, or planning to become pregnant;
• Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation.