Prospective Multicentre Follow-up Evaluating Clinical and Radiological Outcomes of Total Shoulder Arthroplasty With Permedica MIRAI Modular Shoulder Prosthesis System - an Observational Study
Sponsor study identifier
observational
76
3 countries
4
Study Start
July 12, 2019
Actual (reported)Primary Completion
January 31, 2025
Actual (reported)Study Completion
January 31, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 12, 2019
Actual (reported)November 9, 2021
Actual (reported)November 22, 2021
Actual (reported)January 31, 2025
Actual (reported)January 31, 2025
Actual (reported)Clinical outcome: Change of shoulder function
Change of "American Shoulder and Elbow Surgeons" (ASES) Score. Total score 0-100 ASES points, 0 = worse pain and functional loss/disability.
5 years
Clinical outcome: Change of shoulder function
Change of "Disabilities of the Arm, Shoulder and Hand" (DASH) Score. A higher score indicates greater disability. DASH disability/symptom score = \[(sum of n responses) - 1\]/n x 25, where n is equal to the number of completed responses.
5 years
Clinical outcome: Change of shoulder function
Change of Constant Score. Total score 0-100 Constant points, 0 = worse outcome and functional loss/disability; 100 = better outcome, shoulder function improvement.
Total Shoulder Arthroplasty with Permedica's MIRAI Modular Shoulder Prosthesis System
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients who are about to undergo a primary total shoulder arthroplasty in daily clinical practice, referring to one of the project investigator at the study site will be proposed to partecipate to the study.
go:h - Gelenkchirurgie Orthopädie: Hannover
Hanover, Germany
Krankenhaus Reinbek St. Adolf-Stilt
Reinbek, Germany
ULSS 1 Dolomiti - Presidio Ospedaliero Santa Maria del Prato di Feltre
Feltre, 32032, Italy
Orthopädische Klinik Luzern - OKL
Lucerne, Switzerland
Lorenzo Banci
Permedica
76 participants (actual enrollment reported by the registry).
First Submitted
November 9, 2021
First Posted
November 22, 2021
Study Start
July 12, 2019
Actual (reported)Clinical and Radiological Outcomes of Medacta Shoulder System FR
5 years
Clinical outcome: Change of shoulder function
Change of active Range of Motion (ROM)
5 years
Radiological outcome: Radiological implant stability
5 years
Radiological outcome: Radiological implant stability
2 years
Safety Outcome
5 years
Implant survival rate
5 years
Implant survival rate
2 years
Contact the study team to confirm eligibility.
Primary Completion
January 31, 2025
Actual (reported)Study Completion
January 31, 2025
Actual (reported)Last Updated
September 2, 2025
Record last verified: 2025-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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