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Orthopedic Implant

Shoulder Replacement Device for Osteoarthritis (Global ICON Trial)

N/A
Waitlist Available
Research Sponsored by DePuy Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Severely painful and/or severely disabled Non-Inflammatory Degenerative Joint Disease (NIDJD) resulting from osteoarthritis (OA) or post traumatic arthritis
Be older than 18 years old
Must not have
Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the GLOBAL ICON stemless humeral components
Subjects under the age of 21 or over the age of 80 on the day of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 12, 24, 60 and 120 months post-operative
Awards & highlights
No Placebo-Only Group

Summary

This trial is monitoring the safety and performance of a shoulder replacement device called the GLOBAL ICON stemless humeral component. The data will be used to make sure the device is safe and effective and to help make the case for it to be used more widely.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here as it's a post-market study focusing on overall safety and performance of the device; generally speaking, possible side effects may include pain at the surgery site, infection risk increase around the implant area and potential problems related to improper fitting of the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe joint pain or disability from osteoarthritis or injury-related arthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My shoulder bone is too weak to support certain types of shoulder implants.
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I am between 21 and 80 years old.
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My bones are still growing.
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My bones are either too soft or too hard for safe implant surgery.
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I have a shoulder fracture that may affect shoulder replacement parts.
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I have had previous shoulder treatments that could affect new implant stability.
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I need a revision of my previous shoulder replacement surgery.
Select...
I currently have an infection.
Select...
My shoulder muscles are damaged and cannot be repaired.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 12, 24, 60 and 120 months post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 12, 24, 60 and 120 months post-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite success, comprised of radiographs, Constant-Murley, no revisions or serious adverse events.
Secondary study objectives
GLOBAL ICON stemless humeral component survivorship
Other study objectives
Adjusted Constant-Murley Score
EQ-5D-5L dimension score
EQ-VAS score (subscore of EQ-5D-5L)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

DePuy OrthopaedicsLead Sponsor
80 Previous Clinical Trials
25,785 Total Patients Enrolled
45 Trials studying Osteoarthritis
10,859 Patients Enrolled for Osteoarthritis

Media Library

Global ICON (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT03168672 — N/A
Osteoarthritis Research Study Groups: Global ICON
Osteoarthritis Clinical Trial 2023: Global ICON Highlights & Side Effects. Trial Name: NCT03168672 — N/A
Global ICON (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03168672 — N/A
~21 spots leftby Dec 2025
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