Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability?
Recruiting · NCT06025448 · Interventional (participants receive a specific treatment) · Lead sponsor: Lovisenberg Diakonale Hospital
View the official record on ClinicalTrials.gov →Interventions studied
BIO-RSAMIO-RSA
What this trial is about
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).
Who can take part
Age range
45 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Lovisenberg Diaconal Hospital - Oslo, Norway