Clinical Trial

Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder

Recruiting
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Summary
The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2020-07-07; most recent amendment 2025-03-21.
Status change: Not Yet Recruiting → Recruiting 2021-09-24
Trial Details
NCT Number NCT04468178
Lead Sponsor Hannover Medical School
Conditions Osteoarthritis of the Shoulder
Enrollment 60 participants
Start Date 2021-09-17
Primary Completion 2024-01-25 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-25