Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?
Launched by LOVISENBERG DIAKONALE HOSPITAL · Aug 29, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two types of shoulder surgeries called reverse shoulder replacements to see which one helps patients get better results. One type is the conventional reverse shoulder replacement, and the other is a newer approach known as the lateralized reverse shoulder replacement. The goal is to find out if patients who receive the lateralized version have better function and recovery after two years compared to those who have the conventional procedure.
To participate in this trial, you need to be eligible for this type of shoulder surgery due to conditions like shoulder arthritis or a significant tear in your rotator cuff. You should also be able to read or write in Norwegian. However, if you have certain health issues, such as severe bone loss, dementia, or a recent shoulder fracture, you may not qualify. If you join the study, you can expect to receive one of the two surgeries and be monitored for your progress over the next two years. This research could help improve shoulder surgery outcomes for future patients.
Gender
ALL
Eligibility criteria
- 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
About Lovisenberg Diakonale Hospital
Lovisenberg Diakonale Hospital is a reputable healthcare institution located in Oslo, Norway, dedicated to providing high-quality medical care and advancing clinical research. As a clinical trial sponsor, the hospital is committed to fostering innovation in medical treatments and improving patient outcomes through rigorous scientific investigation. With a multidisciplinary team of healthcare professionals and researchers, Lovisenberg Diakonale Hospital prioritizes ethical standards, patient safety, and collaboration with various stakeholders to facilitate groundbreaking studies that address pressing health challenges. The hospital's focus on compassionate care and evidence-based practices positions it as a leader in the clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oslo, , Norway
Skien, Telemark, Norway
Patients applied
Trial Officials
Sigbjørn Dimmen, PhD
Principal Investigator
University of Oslo
Kjersti Kaul Jenssen, PhD
Principal Investigator
Lovisenberg Diaconal Hospital
Christian Owesen, PhD
Study Director
Lovisenberg Diaconal Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported