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New treatment option for Osteoarthritis of the Shoulder
Official title Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
ClinicalTrials.gov ID: NCT04468178
What this study is testing
- What it's testing
- The primary goal of the clinical trial is to determine that the GLOBAL ICON implant system from DePuy does not exhibit worse shoulder function after 2 years than the SIMPLICITY from Wright Medical. The primary endpoint is the Constant-Murley Shoulder Score (CMSS) of the implant after 2 years, the non-inferiority of which is to be demonstrated in comparison with an already established prosthetic system (SIMPLICITY, Wright Medical).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Trial participants need primary total shoulder replacement due to primary osteoarthritis or post-traumatic osteoarthritis
- Trial participants are willing to take part in the clinical trial and intend to be available for the planned follow-up examinations.
- Male, female and various people with age on the day of surgery from 18 to 80 years inclusive.
- people agree not to participate in any other clinical trial for at least 2 years (+ 3 weeks) using the index procedure. This includes clinical trials...
- Exclusion of intraoperative circumstances that require the implantation of a prosthesis type other than that provided for in the clinical trial...
You likely can't join if
- Previous operation on the rotator cuff of the affected shoulder
- Dysfunctional rotator cuff
- Infection of the affected shoulder joint or systemic infection
- Pregnant or breastfeeding women and those who are planning to become pregnant for up to 2 years (+3 weeks) using the index procedure
The study team makes the final eligibility decision.
Where it's taking place
- Hanover, Lower Saxony, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hanover, Lower Saxony, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.