Last reviewed · How we verify
NCT05128500
Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica's MIRAI Prosthesis
trial testing Total Shoulder Arthroplasty with Permedica's MIRAI in Cuff Tear Arthropathy in 76 participants. Completed in 31 January 2025.
31 January 2025
Quick facts
| Lead sponsor | Permedica spa |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 76 |
| Start date | 12 July 2019 |
| Primary completion | 31 January 2025 |
| Estimated completion | 31 January 2025 |
| Sites | 4 locations across Italy, Switzerland, Germany |
Drugs / interventions tested
- Total Shoulder Arthroplasty with Permedica's MIRAI
Conditions studied
- Cuff Tear Arthropathy — all drugs for Cuff Tear Arthropathy →
- Primary Osteoarthritis — all drugs for Primary Osteoarthritis →
- Secondary Osteoarthritis — all drugs for Secondary Osteoarthritis →
- Shoulder Osteoarthritis — all drugs for Shoulder Osteoarthritis →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05128500
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Permedica spa trials
Trials by the same sponsor.
- NCT05810285 — Total Knee Arthroplasty With Vitamin E Polyethylene · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05128500 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Permedica spa
- Last refreshed: 2 September 2025
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