NCT05128500Completed
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
Source: ClinicalTrials.gov · Last updated 2 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 76 (actual)
- First submitted
- 9 Nov 2021
- Start date
- 12 Jul 2019
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- Permedica spa
- Diseases
- Psoriasis, Psoriatic arthritis, Rheumatoid arthritis
- NCT number
- NCT05128500
What you commit to
- Study type: Observational
- Participants enrolled: 76
- From 12 Jul 2019 to the primary completion date, 31 Jan 2025
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Persistent chronic or acute infections and all septic conditions
- Allergy or hypersensitivity to the substances contained in the materials of the implanted components
- Acute or chronic neurological and/or musculoskeletal impairment which compromises the shoulder joint function such as an axillary nerve injury affecting the deltoid muscle
- Several vascular, nerve or muscular disorders, which compromise related extremities
- Dysmetabolic diseases such as, for example, kidney failure or systemic diseases
- Muscular insufficiency
- Active neoplastic or metastatic diseases
- Any other clinical or physical condition that can invalidate the surgery, the rehabilitation or the prosthesis stability
Other
- Patients requiring a revision shoulder arthroplasty
- Persistent osteomyelitis local or systemic
- Inadequate bone structure which cannot guarantee stability to the prosthetic components
- Marked osteoporosis, osteomalacia
- Hypotrophy of the periarticular soft tissues
- Patient unwilling or unable to undergo the rehabilitation or to return to follow-up visits
- Women in pregnancy, childbearing potential or breastfeeding
- Involvement in other ongoing studies or clinical trial.
Who the study is looking for
- both genders
- at least 18 years old of age
- undergoing a primary total shoulder arthroplasty with MIRAI® Prosthesis System (anatomic or reverse, stemless or stemmed).
- Signed informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Orthopädische Klinik Luzern - OKL Coordinator of this site? Confirm its status | Lucerne | Switzerland | Unknown status |
| go:h - Gelenkchirurgie Orthopädie: Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Krankenhaus Reinbek St. Adolf-Stilt Coordinator of this site? Confirm its status | Reinbek | Germany | Unknown status |
| ULSS 1 Dolomiti - Presidio Ospedaliero Santa Maria del Prato di Feltre Coordinator of this site? Confirm its status | Feltre | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.