PRIMA EU Retrospective & Prospective

Launched by LIMACORPORATE S.P.A · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial, known as PRIMA EU, is studying the outcomes of two types of shoulder replacements—total anatomic and reverse shoulder replacements—using a specific implant called the PRIMA humeral stem. The goal is to see how well these implants work in the short term, up to 24 months after surgery, by looking at factors such as patient satisfaction, any complications that might arise, and how long the implants last. This study is open to adults aged 18 and older who have specific shoulder conditions, like arthritis or rotator cuff tears, and who can follow the study's instructions and attend follow-up appointments.

If you decide to participate, you can expect to undergo shoulder replacement surgery and then attend regular check-ups to monitor your recovery and the implant's performance. It's important to note that certain medical conditions may prevent you from joining the study, such as severe infections or issues that could affect your shoulder's stability. Before participating, you will need to sign a consent form, which confirms you understand the study and agree to take part in it.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥ 18 years old;
• • 2. Full skeletal maturity;
• • 3. Life expectancy over 24 months;
• • 4. Patient's joint anatomically and structurally suited to receive the selected implants and functional deltoid muscle;
• 5. 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;
• • 6. 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;
• • 7. Patient has signed the Informed Consent form previously approved by the Ethics Committee before study activities.
• Exclusion Criteria:
• • 1. Patients who lack capacity to be able to provide informed consent to participate in the study.
• • 2. Local or systemic general infection;
• • 3. Septicaemia;
• • 4. Persistent acute or chronic local or systemic osteomyelitis;
• • 5. Confirmed neurologic lesion compromising shoulder joint function;
• • 6. Deltoid muscle insufficiency;
• • 7. 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);
• • 8. Affected by malignant cancer with life expectancy less than 2 years or where cancer treatment might affect the normal postoperative course;
• • 9. Serious muscular, neurological, or arterial vascular diseases compromising stability of the implant;
• • 10. Proximal humerus fracture sequelae with inadequate bone stock;
• • 11. Vascular or nerve diseases affecting the concerned limb;
• • 12. Metabolic disorders which may impair fixation and stability of the implant;
• • 13. Any concomitant disease that might affect the implanted prosthesis;
• • 14. Metal hypersensitivity to implant materials (CoCrMo);
• • 15. Patient with significant renal impairment;
• • 16. Lower mobility issues that may affect the study evaluation;
• • 17. 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;
• • 18. Women of childbearing potential who are pregnant, nursing, or planning to become pregnant;
• • 19. Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation.