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PRIMA EU Retrospective & Prospective

NCT06371833 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-02-05

No results posted yet for this study

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

Interventions

DEVICE

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)

Sponsors & Collaborators

  • Limacorporate S.p.a

    lead INDUSTRY

Principal Investigators

  • Alessandro Castagna · Humanitas Rozzano, Italy

  • Paolo Paladini · Unit of Shoulder Surgery Romagna/ Cervesi Hospital, Italy

  • Jörn Kircher · ATOS Klinik Fleetinsel Hamburg, Germany

  • Amar Malhas · Royal Berkshire NHS Trust, UK

  • Fernando Marco Martinez · Hospital Clinico San Carlos, Spain

  • Iain Packham · North Bristol NHS Trust, UK

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-25
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06371833 on ClinicalTrials.gov