Comparing two types of shoulder replacement surgeries
From Cuff Arthropathy to Reverse Shoulder Arthroplasty - a Multicentre Randomized Control Trial (Study 1: Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?).
This study is testing whether a new type of shoulder replacement surgery can help people with shoulder arthritis do better and have fewer problems than the standard surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | Lovisenberg Diakonale Hospital Academic / other |
| Locations | 2 sites (Skien, Telemark and 1 other locations) |
| Trial ID | NCT06025331 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the outcomes of two different reverse shoulder arthroplasties: a conventional reverse shoulder arthroplasty (RSA) and a lateralized version known as BIO-RSA. The study will assess the functional results and complications experienced by patients after two years of surgery. By lateralizing the center of rotation in the BIO-RSA, researchers hope to improve range of motion and stability while reducing complications such as scapular notching. The trial will involve 130 patients across four hospitals, providing valuable insights into the best treatment options for shoulder osteoarthritis and related conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals eligible for primary reverse shoulder arthroplasty due to osteoarthritis or related conditions.
Not a fit: Patients with severe osteoporosis, dementia, or those requiring revision surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients undergoing shoulder replacement surgery.
How similar studies have performed: While there have been studies on reverse shoulder arthroplasty, the specific approach of lateralizing the center of rotation with BIO-RSA is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Skien, Telemark and 1 other locations
- Sykehuset Telemark HF — Skien, Telemark, Norway (Not_yet_recruiting)
- Lovisenberg Diaconal Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Sigbjørn Dimmen, PhD — University of Oslo
- Study coordinator: Kjersti Kaul Jenssen, PhD
- Email: KjerstiKaul.Jenssen@lds.no
- Phone: +4790200650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.