Shoulder Replacement Device for Osteoarthritis
(Global ICON Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: DePuy Orthopaedics

No Placebo Group

Trial Summary

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.

Research Team

Eligibility Criteria

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

Treatment Details

Interventions

Global ICON (Orthopedic Implant)

Trial OverviewThe 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.

Participant Groups

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.