💬In plain words
What the trial is, and whether it could suit you
This clinical study aims at evaluating clinical, radiographic and patient-reported outcomes after total anatomic or reverse shoulder replacement using PRIMA humeral stem up to 24 months after surgery, in order to assess the short-term performance of the implant. Furthermore, the objective is also to collect short-term data on the survivorship of the implant and the incidence of complications.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- Shoulder Arthroplasy with PRIMA humeral stem
Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy
Cattolica, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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