RecruitingNot Applicable

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

Norway20 participantsStarted 2023-10-30

Plain-language summary

This clinical trial will investigate whether metallic lateralization in reverse shoulder arthroplasty is as stable as bony lateralization during the first two postsurgical years, measured with CT-based motion analysis (CTMA).

Who can participate

Age range45 Years – 80 Years

SexALL

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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

What they're measuring

Migration of glenoid component from baseline until 24 months

Timeframe: At baseline and 3, 6, 12 and 24 months postoperatively. 24 months will be the primary outcome.

Trial details

NCT IDNCT06025448

SponsorLovisenberg Diakonale Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2033-03-01

Contact for this trial

Christian Owesen, PhD

+4790515843 cow@lds.no

View on ClinicalTrials.gov More Arthroplasty Complications trials