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Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica's MIRAI Prosthesis

NCT05128500 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 76

Last updated 2025-09-02

No results posted yet for this study

Summary

This observational study is conducted in order to evaluate the effectiveness of the primary total shoulder arthroplasty with the Permedica's MIRAI Modular Shoulder Prosthesis System on the general population of patients who are about to undergo this surgery for every indication. Patients requiring a revision shoulder arthroplasty will not be enrolled.

The effectiveness will be evaluated in terms of recovery of shoulder function and stability of the prosthetic implant. The incidence of complications, adverse and serious adverse events will also be studied. Additional study aim is to evaluate a medium/long term survival of the prosthesis.

The duration of the study per single subject is 5 years.

Conditions

  • Cuff Tear Arthropathy
  • Primary Osteoarthritis
  • Secondary Osteoarthritis
  • Shoulder Osteoarthritis
  • Rheumatoid Arthritis Shoulder
  • Psoriatic Arthritis
  • Fracture, Shoulder
  • Avascular Necrosis of Humerus

Interventions

PROCEDURE

Total Shoulder Arthroplasty with Permedica's MIRAI

Total Shoulder Arthroplasty with Permedica's MIRAI Modular Shoulder Prosthesis System

Sponsors & Collaborators

  • Permedica spa

    lead INDUSTRY

Principal Investigators

  • Lorenzo Banci · Permedica

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-12
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Germany
  • Italy
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT05128500 on ClinicalTrials.gov