Comparing two methods of shoulder joint replacement for stability
From Cuff Arthropathy to Reverse Shoulder Arthroplasty - a Multicentre Randomized Control Trial (CARS 2: Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability Measured With CT-based Motion Analysis (CTMA)?).
This study is testing whether a new metal-based shoulder replacement technique is just as stable as the traditional bone-based method for people with shoulder arthritis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Lovisenberg Diakonale Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06025448 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the stability of two different techniques for reverse shoulder arthroplasty: metallic lateralization (MIO-RSA) and bony lateralization (BIO-RSA). Patients with shoulder osteoarthritis and significant glenoid medialization will be randomized to receive either procedure. The study will utilize CT-based motion analysis to assess the 3-dimensional migration patterns of the glenoid components over a two-year period post-surgery. The goal is to determine if the new metallic approach is as stable as the traditional bony method.
Who should consider this trial
Good fit: Ideal candidates are individuals with shoulder osteoarthritis and significant glenoid medialization who can read or write Norwegian.
Not a fit: Patients with severe osteoporosis, osteonecrosis of the humeral head, or those requiring revision surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into a potentially less invasive and equally effective method for shoulder joint replacement, improving patient outcomes.
How similar studies have performed: There is limited comparative literature on metallic versus bony lateralization in reverse shoulder arthroplasty, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eligible for primary RSA due to OA, massive RC tear, failed RC repair or post-instability osteoarthritis * massive glenoid medialization * Able to read or write Norwegian Exclusion Criteria: * Severe osteoporosis * Osteonecrosis of the humeral head * Dementia * Poor deltoid function * Revision surgery * ASA IV * Suspected chronic infection * Acute fracture
Where this trial is running
Oslo
- Lovisenberg Diaconal Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Sigbjørn Dimmen, Prof. — University of Oslo
- Study coordinator: Christian Owesen, PhD
- Email: cow@lds.no
- Phone: +4790515843
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.