Evaluating outcomes after shoulder replacement surgery

A Multicentric Study Evaluating Clinical and Radiological Outcomes of PRIMA Humeral Stem in Total Shoulder Arthroplasty

This study looks at how well the PRIMA shoulder implant works and how patients feel after having shoulder replacement surgery over the first two years.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Limacorporate S.p.a (Industry-sponsored)
• Locations: 1 site (Cattolica, Rimini)
• Trial ID: NCT06371833 on ClinicalTrials.gov

What this trial studies

This observational study evaluates clinical, radiographic, and patient-reported outcomes following total anatomic or reverse shoulder replacement using the PRIMA humeral stem for up to 24 months post-surgery. The study aims to assess the short-term performance of the implant, including its survivorship and the incidence of complications. By collecting data from patients who have undergone this procedure, the study seeks to provide insights into the effectiveness and safety of the PRIMA implant.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with specific shoulder conditions suitable for anatomic or reverse shoulder replacement.

Not a fit: Patients with contraindications for shoulder replacement surgery or those with a life expectancy of less than 24 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve understanding of shoulder replacement outcomes and enhance patient care.

How similar studies have performed: Other studies have shown success in evaluating shoulder replacement outcomes, making this approach well-established.

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.

Where this trial is running

Cattolica, Rimini

• Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy — Cattolica, Rimini, Italy (Recruiting)

Study contacts

• Principal investigator: Alessandro Castagna — Humanitas Rozzano, Italy
• Study coordinator: Camilla Vianello

Conditions Arthroplasty; Replacement; Shoulder; TSA; RSA; Shoulder replacement