Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?
Recruiting · NCT06025331 · Interventional (participants receive a specific treatment) · Lead sponsor: Lovisenberg Diakonale Hospital
View the official record on ClinicalTrials.gov →Interventions studied
BIO-RSARSA
What this trial is about
The goal of this clinical trial is to compare two different types of reverse shoulder replacements. Researchers will compare a conventional reverse shoulder replacement with a lateralized reverse shoulder replacement to see if there is a difference in how well the patients function after two years.
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
- 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
2 locations listed.
- Lovisenberg Diaconal Hospital - Oslo, Norway
- Sykehuset Telemark HF - Skien, Telemark, Norway