Actively Recruiting

Phase Not Applicable
Age: 45Years - 80Years
All Genders
NCT06025331

Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?

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

130

Participants Needed

2

Research Sites

515 weeks

Total Duration

On this page

Sponsors

L

Lovisenberg Diakonale Hospital

Lead Sponsor

H

Haukeland University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to compare two different types of reverse shoulder replacements. Researchers will compare a conventional reverse shoulder replacement with a lateralized reverse shoulder replacement to see if there is a difference in how well the patients function after two years.

CONDITIONS

Official Title

Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?

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
  • Able 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 IV status
  • 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: 2 locations

1

Sykehuset Telemark HF

Skien, Telemark, Norway, 3710

Not Yet Recruiting

2

Lovisenberg Diaconal Hospital

Oslo, Norway, 0456

Actively Recruiting

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Research Team

K

Kjersti Kaul Jenssen, 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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