Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 12, 24, 60 and 120 months post-operative
Awards & highlights
Global ICON Trial 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.Check my eligibility
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.See study design
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.
Global ICON Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe joint pain or disability from osteoarthritis or injury-related arthritis.
Global ICON Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 12, 24, 60 and 120 months post-operative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 12, 24, 60 and 120 months post-operative
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Composite success, comprised of radiographs, Constant-Murley, no revisions or serious adverse events.
Secondary outcome measures
EQ-5D-5L Scores by dimension
EQ-VAS (subscore of EQ-5D-5L)
GLOBAL ICON stemless humeral component survivorship
+1 moreOther outcome measures
Adjusted Constant-Murley Score
EQ-5D-5L dimension score
EQ-VAS score (subscore of EQ-5D-5L)
+3 moreGlobal ICON 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
79 Previous Clinical Trials
25,667 Total Patients Enrolled
14 Trials studying Arthritis
4,046 Patients Enrolled for Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the post-surgery plan.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.I do not have any health conditions that could affect the study results.I have severe joint pain or disability from osteoarthritis or injury-related arthritis.I am between 21 and 80 years old.My bones are still growing.I have a shoulder fracture that may affect shoulder replacement parts.I have had previous shoulder treatments that could affect new implant stability.I need a revision of my previous shoulder replacement surgery.I currently have an infection.My shoulder muscles are damaged and cannot be repaired.
Research Study Groups:
This trial has the following groups:- Group 1: Global ICON
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still enrollments open for this experiment?
"The clinicaltrials.gov registry indicates that this trial is not accepting any new participants at present; it was first posted on October 18th 2017 and last updated November 28th 2022. Although, there are 615 other active trials currently searching for enrollees."
Answered by AI
What criteria must a prospective participant meet to be considered for this trial?
"This experimental treatment is available to those suffering from arthrosis and aged between 21-79. A total of 172 eligible patients are required for the trial."
Answered by AI
Does the trial extend to individuals of a certain seniority?
"This research is enrolling individuals who are below 79 years old and at least 21."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger