Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder
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).
• 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).