Comparing two methods of shoulder joint replacement for stability
Official title: 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)?).
Run by Lovisenberg Diakonale Hospital · NCT06025448 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 80 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Lovisenberg Diakonale Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Status | Recruiting |
| Started | October 30, 2023 |
| Main results expected | March 1, 2033 |
| Study ends | March 1, 2033 |
| Registry record updated | November 7, 2023 |
| Trial ID | NCT06025448 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with shoulder osteoarthritis and significant glenoid medialization who can read or write Norwegian.
✕Probably not a fit
Patients with severe osteoporosis, osteonecrosis of the humeral head, or those requiring revision surgery may not benefit from this study.
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 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.
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 gone: There is limited comparative literature on metallic versus bony lateralization in reverse shoulder arthroplasty, making this approach relatively novel.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.