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Search / Trial NCT06025331

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

Launched by LOVISENBERG DIAKONALE HOSPITAL · Aug 29, 2023

Trial Information

Current as of June 27, 2025

Recruiting

Keywords

Reverse Shoulder Arthroplasty Bio Rsa Orthopedic Surgery

ClinConnect Summary

This clinical trial is looking at two types of shoulder surgeries called reverse shoulder replacements to see which one helps patients get better results. One type is the conventional reverse shoulder replacement, and the other is a newer approach known as the lateralized reverse shoulder replacement. The goal is to find out if patients who receive the lateralized version have better function and recovery after two years compared to those who have the conventional procedure.

To participate in this trial, you need to be eligible for this type of shoulder surgery due to conditions like shoulder arthritis or a significant tear in your rotator cuff. You should also be able to read or write in Norwegian. However, if you have certain health issues, such as severe bone loss, dementia, or a recent shoulder fracture, you may not qualify. If you join the study, you can expect to receive one of the two surgeries and be monitored for your progress over the next two years. This research could help improve shoulder surgery outcomes for future patients.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Eligible for primary RSA due to OA, massive RC tear, failed RC repair or post-instability osteoarthritis
  • Able to read or write Norwegian
  • Exclusion Criteria:
  • Severe osteoporosis
  • Osteonecrosis of the humeral head
  • Dementia
  • Poor deltoid function
  • Revision surgery
  • ASA IV
  • Suspected chronic infection
  • Acute fracture

About Lovisenberg Diakonale Hospital

Lovisenberg Diakonale Hospital is a reputable healthcare institution located in Oslo, Norway, dedicated to providing high-quality medical care and advancing clinical research. As a clinical trial sponsor, the hospital is committed to fostering innovation in medical treatments and improving patient outcomes through rigorous scientific investigation. With a multidisciplinary team of healthcare professionals and researchers, Lovisenberg Diakonale Hospital prioritizes ethical standards, patient safety, and collaboration with various stakeholders to facilitate groundbreaking studies that address pressing health challenges. The hospital's focus on compassionate care and evidence-based practices positions it as a leader in the clinical research landscape.

Locations

Oslo, , Norway

Skien, Telemark, Norway

Patients applied

0 patients applied

Trial Officials

Sigbjørn Dimmen, PhD

Principal Investigator

University of Oslo

Kjersti Kaul Jenssen, PhD

Principal Investigator

Lovisenberg Diaconal Hospital

Christian Owesen, PhD

Study Director

Lovisenberg Diaconal Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported