Shoulder Replacement Device for Osteoarthritis
(Global ICON Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a Post Market Clinical Follow Up (PMCF) study to monitor the safety and performance of the GLOBAL ICON stemless humeral component. The data gathered will be used to support post market surveillance of the device, and may potentially be used for additional market access purposes.
Are You a Good Fit for This Trial?
This trial is for adults with severe joint pain or disability from non-inflammatory arthritis, like osteoarthritis. Participants must be able to follow the study schedule and give consent. It's not for those under 21 or over 80, with previous shoulder treatments that could affect results, pregnant/breastfeeding women, people with certain bone diseases or conditions affecting bone quality, known allergies to implant materials, substance abuse issues, psychological disorders impacting treatment outcomes, or fractures compromising implant fixation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the GLOBAL ICON stemless humeral component implant
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Extended monitoring of device survivorship and performance
What Are the Treatments Tested in This Trial?
Interventions
- Global ICON
Find a Clinic Near You
Who Is Running the Clinical Trial?
DePuy Orthopaedics
Lead Sponsor
Massimo Calafiore
DePuy Orthopaedics
Chief Executive Officer since 2023
MBA from Harvard Business School
Dr. Michael Stein
DePuy Orthopaedics
Chief Medical Officer since 2023
MD from University of Michigan