RecruitingNot ApplicableNCT06025331

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

From Cuff Arthropathy to Reverse Shoulder Arthroplasty - a Multicentre Randomized Control Trial (Study 1: Does BIO-RSA Provides Superior Clinical Outcome Compared to Conventional RSA?).


Sponsor

Lovisenberg Diakonale Hospital

Enrollment

130 participants

Start Date

Sep 15, 2023

Study Type

INTERVENTIONAL

Conditions

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 shoulder replacement to see if there is a difference in how well the patients function after two years.


Eligibility

Min Age: 45 YearsMax Age: 80 Years

Inclusion Criteria2

  • Eligible for primary RSA due to OA, massive RC tear, failed RC repair or post-instability osteoarthritis
  • Able to read or write Norwegian

Exclusion Criteria8

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

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Interventions

PROCEDUREBIO-RSA

Bony increased offset-reversed shoulder arthroplasty(BIO-RSA) will be performed.

PROCEDURERSA

Conventional reversed shoulder arthroplasty(RSA) will be performed.


Locations(2)

Sykehuset Telemark HF

Skien, Telemark, Norway

Lovisenberg Diaconal Hospital

Oslo, Norway

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NCT06025331


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