NCT05128500

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

Prospective Multicentre Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica MIRAI Modular Shoulder Prosthesis System - an Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: Permedica spa · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
PROCEDURE	Total Shoulder Arthroplasty with Permedica's MIRAI	Total Shoulder Arthroplasty with Permedica's MIRAI Modular Shoulder Prosthesis System

Timeline

• Start date: 2019-07-12
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2021-11-22
• Last updated: 2025-09-02

Locations

4 sites across 3 countries: Germany, Italy, Switzerland