Is MIO-RSA Noninferior to BIO-RSA When it Comes to Mechanical Implant Stability?

Launched by LOVISENBERG DIAKONALE HOSPITAL · Aug 29, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to compare two different types of shoulder surgeries for patients with specific shoulder problems, such as arthritis or severe tears in the rotator cuff. The researchers want to find out if a new method called MIO-RSA (which uses metal for support) is just as stable as the traditional BIO-RSA (which uses bone for support) during the first two years after surgery. They will use special imaging techniques to measure how well the implants hold up over time.

To participate in this trial, individuals need to be adults between 16 and 92 years old who are eligible for reverse shoulder arthroplasty due to conditions like osteoarthritis or previous shoulder issues. Candidates must be able to read or write in Norwegian. However, those with severe bone weakness, certain infections, or other specific health problems will not be eligible. Participants can expect to undergo a shoulder surgery and will be monitored over a two-year period to assess the stability of their implants. This study aims to improve treatment options for patients facing shoulder surgery.

Gender

ALL

Eligibility criteria

• 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