Comparing shoulder function of two implant systems for osteoarthritis

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

This study is testing whether a new shoulder implant helps people with osteoarthritis recover and function better after surgery compared to a standard implant.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Hannover Medical School (other)
• Locations: 1 site (Hanover, Lower Saxony)
• Trial ID: NCT04468178 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18 to 80 requiring primary total shoulder replacement due to osteoarthritis.

Not a fit: Patients with previous rotator cuff surgery or dysfunctional rotator cuffs may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with a new implant option that maintains or improves shoulder function post-surgery.

How similar studies have performed: Other studies have shown success with similar implant comparisons, indicating the potential for meaningful advancements in shoulder arthroplasty.

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

Where this trial is running

Hanover, Lower Saxony

• 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.

Conditions: Osteoarthritis of the Shoulder, osteoarthritis, shoulder, joint replacement