Clinical trial Recruiting at 1 site Interventional Ages 45 to 80

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 typeInterventional
Ages45 Years to 80 Years
SexAll
Enrollment20 (estimated)
SponsorLovisenberg Diakonale Hospital
Academic / other
Locations1 site (Oslo)
StatusRecruiting
StartedOctober 30, 2023
Main results expectedMarch 1, 2033
Study endsMarch 1, 2033
Registry record updatedNovember 7, 2023
Trial IDNCT06025448 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

Similar studies

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.