Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
Key facts
- Where
- Hanover, GermanySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT04468178, who can take part
Where in Germany
- Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE AnnastiftHanover, GermanyContact: Tomas Smith, PD Dr.Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Hannover Medical School
- Trial code
- NCT04468178
- Record updated
- 25 March 2025
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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 subjects with age on the day of surgery from 18 to 80 years inclusive; Subjects agree not to participate in any other clinical trial for at least 2 years (+ 3 weeks) using the index procedure. This includes clinical trials of medication, invasive procedures and medical devices. Questionnaire-based studies or other studies that are non-invasive and do not involve drug use are allowed; Exclusion of intraoperative circumstances that require the implantation of a prosthesis type other than that provided for in the clinical trial (depending on the surgeon).
Exclusion: Previous operation on the rotator cuff of the affected shoulder; Infection of the affected shoulder joint or systemic infection; Dysfunctional rotator cuff; Pregnant or breastfeeding women and those who are planning to become pregnant for up to 2 years (+3 weeks) using the index procedure.