Status:

RECRUITING

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

Lead Sponsor:

Lovisenberg Diakonale Hospital

Collaborating Sponsors:

Haukeland University Hospital

Sykehuset Telemark

Conditions:

Arthroplasty, Replacement, Shoulder

Shoulder Osteoarthritis

Eligibility:

All Genders

45-80 years

Phase:

NA

Brief Summary

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 shou...

Detailed Description

Many studies have showed pain relief and improvement in shoulder function following reverse shoulder arthroplasty (RSA), but medialization of the centre of rotation (COR) in RSA may cause complication...

Eligibility Criteria

Inclusion

  • Eligible for primary RSA due to OA, massive RC tear, failed RC repair or post-instability osteoarthritis
  • 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 :

September 15 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2033

Estimated Enrollment :

130 Patients enrolled

Trial Details

Trial ID

NCT06025331

Start Date

September 15 2023

End Date

August 1 2033

Last Update

November 7 2023

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Sykehuset Telemark HF

Skien, Telemark, Norway, 3710

2

Lovisenberg Diaconal Hospital

Oslo, Norway, 0456

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