PRIMA EU Retrospective & Prospective

NCT ID: NCT06371833

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-25
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Arthroplasty; Replacement; Shoulder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Adult patients requiring a primary TSA or RSA

Device: PRIMA humeral stem in anatomic or reverse configuration Shoulder arthroplasty according to the instruction for use.

Shoulder Arthroplasy with PRIMA humeral stem

Intervention Type: DEVICE

Data collection of population that underwent a total shoulder arthroplasty with PRIMA humeral stem (anatomic configuration or reverse configuration)

Interventions

Shoulder Arthroplasy with PRIMA humeral stem

Data collection of population that underwent a total shoulder arthroplasty with PRIMA humeral stem (anatomic configuration or reverse configuration)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Limacorporate S.p.a

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alessandro Castagna

Role: PRINCIPAL_INVESTIGATOR

Humanitas Rozzano, Italy

Paolo Paladini

Role: PRINCIPAL_INVESTIGATOR

Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy

Jörn Kircher

Role: PRINCIPAL_INVESTIGATOR

ATOS Klinik Fleetinsel Hamburg, Germany

Amar Malhas

Role: PRINCIPAL_INVESTIGATOR

Royal Berkshire NHS Trust, UK

Fernando Marco Martinez

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico San Carlos, Spain

Iain Packham

Role: PRINCIPAL_INVESTIGATOR

North Bristol NHS Trust, UK

Locations

Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy

Cattolica, Rimini, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Camilla Vianello

Role: CONTACT

camilla.vianello@limacorporate.com

+390432945357

Francesca Citossi

Role: CONTACT

francesca.citossi@limacorporate.com

+390432945357

Facility Contacts

Paolo Paladini

Role: primary

Other Identifiers

S-52

Identifier Type: -

Identifier Source: org_study_id