171 Participants Needed

Shoulder Replacement Device for Osteoarthritis

(Global ICON Trial)

Recruiting at 11 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I am willing and able to follow the post-surgery plan.
I have severe joint pain or disability from osteoarthritis or injury-related arthritis.
Patient has provided written Informed Consent to participate

Exclusion Criteria

My bones are either too soft or too hard for safe implant surgery.
My shoulder bone is too weak to support certain types of shoulder implants.
I am receiving treatment that may affect my bone health.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the GLOBAL ICON stemless humeral component implant

Immediate post-operative

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Visits at 3, 12, 24, 60, and 120 months post-operative

Long-term follow-up

Extended monitoring of device survivorship and performance

60 to 120 months

What Are the Treatments Tested in This Trial?

Interventions

  • Global ICON
Trial Overview The GLOBAL ICON stemless humeral component is being tested in this study. The aim is to monitor its safety and performance after it has been marketed. This involves collecting data on how well it works and any potential issues in patients who have received this shoulder replacement device.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Global ICONExperimental Treatment1 Intervention
The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head.

Find a Clinic Near You

Who Is Running the Clinical Trial?

DePuy Orthopaedics

Lead Sponsor

Trials
81
Recruited
26,000+

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

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