Comparing shoulder function of two implant systems for osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the performance of the GLOBAL ICON implant system from DePuy against the established SIMPLICITY implant from Wright Medical in patients undergoing total shoulder replacement due to osteoarthritis. The primary endpoint is to demonstrate that the GLOBAL ICON does not result in worse shoulder function after two years, measured by the Constant-Murley Shoulder Score (CMSS). Secondary endpoints include assessing the migration of the implant components over time using radiostereometric analysis (RSA) and evaluating patient satisfaction and clinical outcomes through standardized scores. Follow-up assessments will occur at multiple intervals post-surgery to monitor recovery and functionality.

Why it matters

Who can join: the full rules

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

Where it's running

• Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
  Hanover, Lower Saxony, Germany Recruiting

Study contacts

• Principal investigator: Tomas Smith, PD Dr. — Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
• Study coordinator: Tomas Smith, PD Dr.
• Email: tomas.smith@diakovere.de
• Phone: +49 511 5354 310

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.