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NCT05128500

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

Completed Last updated 2 September 2025
What this trial tests

trial testing Total Shoulder Arthroplasty with Permedica's MIRAI in Cuff Tear Arthropathy in 76 participants. Completed in 31 January 2025.

Timeline
12 July 2019
Primary endpoint
31 January 2025
31 January 2025

Quick facts

Lead sponsorPermedica spa
StatusCompleted
Study typeOBSERVATIONAL
Enrollment76
Start date12 July 2019
Primary completion31 January 2025
Estimated completion31 January 2025
Sites4 locations across Italy, Switzerland, Germany

Drugs / interventions tested

Conditions studied

Sponsor

Permedica spa

Who can join

18 and older, any sex, with Cuff Tear Arthropathy or Primary Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Stemless total shoulder arthroplasty with nonspherical polyethylene humeral head.
    Bloch HR, Agneskirchner J, Meyer P, Di Fabio S, et al · · 2025 · PMID 41049673 · DOI 10.1016/j.jseint.2025.05.010

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Other Permedica spa trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05128500.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing