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

Launched by HANNOVER MEDICAL SCHOOL · Jul 7, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new shoulder implant called the GLOBAL ICON, which is designed for people with osteoarthritis of the shoulder. The main goal is to see if this new implant provides similar or better shoulder function compared to an existing implant called SIMPLICITY after two years. Researchers will measure the shoulder function using a specific scoring system called the Constant-Murley Shoulder Score.

To be eligible for this trial, participants should be between 18 and 80 years old and need a total shoulder replacement due to primary osteoarthritis or post-traumatic osteoarthritis. They should not have had previous surgery on the rotator cuff of the affected shoulder and should be able to commit to follow-up visits. Those who join the trial can expect to receive the new implant and take part in assessments over the next two years to help determine how well it works. It's important for potential participants to know that they shouldn't participate in other clinical trials for two years after joining this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Trial participants need primary total shoulder replacement due to primary osteoarthritis or post-traumatic osteoarthritis
• • 2. Trial participants are willing to take part in the clinical trial and intend to be available for the planned follow-up examinations.
• • 3. Male, female and various subjects with age on the day of surgery from 18 to 80 years inclusive.
• • 4. 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.
• • 5. 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 Criteria:
• • 1. Previous operation on the rotator cuff of the affected shoulder
• • 2. Dysfunctional rotator cuff
• • 3. Infection of the affected shoulder joint or systemic infection
• • 4. Pregnant or breastfeeding women and those who are planning to become pregnant for up to 2 years (+3 weeks) using the index procedure