Actively Recruiting

Phase Not Applicable
Age: 45Years - 80Years
All Genders
NCT06025448

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

Led by Lovisenberg Diakonale Hospital · Updated on 2023-11-07

20

Participants Needed

1

Research Sites

487 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 45Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Eligible for primary reverse shoulder arthroplasty due to osteoarthritis, massive rotator cuff tear, failed rotator cuff repair, or post-instability osteoarthritis
  • Presence of massive glenoid medialization
  • Ability to read or write Norwegian
Not Eligible

You will not qualify if you...

  • Severe osteoporosis
  • Osteonecrosis of the humeral head
  • Dementia
  • Poor deltoid function
  • Revision surgery
  • ASA physical status classification IV
  • Suspected chronic infection
  • Acute fracture

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Lovisenberg Diaconal Hospital

Oslo, Norway, 0456

Actively Recruiting

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Research Team

C

Christian Owesen, PhD

CONTACT

H

Hanne Fuglø, MPTh

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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