Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant 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)?).
Lovisenberg Diakonale Hospital
20 participants
Oct 30, 2023
INTERVENTIONAL
Conditions
Summary
This clinical trial will investigate whether metallic lateralization in reverse shoulder arthroplasty is as stable as bony lateralization during the first two postsurgical years, measured with CT-based motion analysis (CTMA).
Eligibility
Inclusion Criteria3
- 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 Criteria8
- Severe osteoporosis
- Osteonecrosis of the humeral head
- Dementia
- Poor deltoid function
- Revision surgery
- ASA IV
- Suspected chronic infection
- Acute fracture
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Interventions
Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using bony lateralization (BIO-RSA).
Patients will have a reversed shoulder arthroplasty with lateralization of the joint centre using metallic lateralization (MIO-RSA).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06025448