Status:

RECRUITING

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

Lead Sponsor:

Lovisenberg Diakonale Hospital

Conditions:

Arthroplasty Complications

Shoulder Osteoarthritis

Eligibility:

All Genders

45-80 years

Phase:

NA

Brief 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-base...

Detailed Description

Lateralization of reverse shoulder arthroplasties may reduce the risk for complications such as limited range of motion (ROM), and scapular notching, where the lower part of the scapular neck becomes ...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

October 30 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2033

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06025448

Start Date

October 30 2023

End Date

March 1 2033

Last Update

November 7 2023

Active Locations (1)

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Lovisenberg Diaconal Hospital

Oslo, Norway, 0456