Clinical trial Recruiting at 1 site Interventional Ages 45 to 80

Comparing two types of shoulder replacement surgeries

Official title: 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?).

Run by Lovisenberg Diakonale Hospital · NCT06025331 · Data updated 2026-11-12

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

Study typeInterventional
Ages45 Years to 80 Years
SexAll
Enrollment130 (estimated)
SponsorLovisenberg Diakonale Hospital
Academic / other
Locations2 sites (Skien, Telemark and 1 other locations)
StatusRecruiting
StartedSeptember 15, 2023
Main results expectedAugust 1, 2033
Study endsAugust 1, 2033
Registry record updatedNovember 7, 2023
Trial IDNCT06025331 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals eligible for primary reverse shoulder arthroplasty due to osteoarthritis or related conditions.

Probably not a fit

Patients with severe osteoporosis, dementia, or those requiring revision surgery may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Lovisenberg Diaconal Hospital
    Oslo, Norway
    Recruiting
  • Sykehuset Telemark HF
    Skien, Telemark, Norway
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.