Actively Recruiting
Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
Led by Hannover Medical School · Updated on 2025-03-25
60
Participants Needed
1
Research Sites
328 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Trial participants need primary total shoulder replacement due to primary osteoarthritis or post-traumatic osteoarthritis
- Participants are willing to take part in the clinical trial and intend to be available for the planned follow-up examinations
- Male, female, and various subjects aged 18 to 80 years inclusive on the day of surgery
- Participants agree not to participate in any other clinical trial involving the index procedure for at least 2 years plus 3 weeks
- No intraoperative circumstances requiring implantation of a prosthesis type other than that provided for in the clinical trial
You will not qualify if you...
- Previous operation on the rotator cuff of the affected shoulder
- Dysfunctional rotator cuff
- Infection of the affected shoulder joint or systemic infection
- Pregnant or breastfeeding women and those planning to become pregnant for up to 2 years plus 3 weeks after the index procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
Research Team
T
Tomas Smith, PD Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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