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Search / Trial NCT05487274

TSA v RSA in Osteoarthritic Shoulders With Greater Than 15 Degrees of Retroversion

Launched by OTTAWA HOSPITAL RESEARCH INSTITUTE · Aug 2, 2022

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Shoulder Arthroplasty Glenohumeral Osteoarthritis Idiopathic Osteoarthritis

ClinConnect Summary

This clinical trial is studying two different surgical treatments for older adults with advanced shoulder arthritis, specifically those who have a certain bone alignment issue called glenoid retroversion. The trial will compare total shoulder arthroplasty (TSA) with a special component designed to help with this alignment, against reverse shoulder arthroplasty (RSA) to see which procedure works better for relieving pain and improving function in these patients. To be eligible for the study, participants must be 65 years or older, have been experiencing ongoing pain and difficulty moving their shoulder despite trying standard treatments like medication and physical therapy for at least six months, and have imaging tests that confirm significant cartilage loss in the shoulder.

If you choose to participate, you will be randomly assigned to one of the two surgical options, and the study aims to track your progress over time to see how well the surgeries work. It’s essential to note that certain conditions, such as infections or previous shoulder surgeries, could prevent someone from being eligible for the trial. Overall, this study aims to find the best treatment option for patients with this specific type of shoulder arthritis to help improve their quality of life.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Diagnosis of idiopathic shoulder OA.
  • 2. Patients who have failed standard non-surgical management of their shoulder OA who would benefit from a shoulder arthroplasty. Failed medical management will be defined as persistent pain and disability despite adequate standard non-operative management for at least 6 months. Medical management will be defined as: a) The use of drugs including analgesics and nonsteroidal anti-inflammatory drugs, b) Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.), c) Activity modification
  • 3. Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss
  • 4. Patients with a glenoid deficiency and \>15 degrees of glenoid retroversion up to a maximum of 26 degrees of glenoid retroversion (i.e. -15.1, -17, -20...etc.)
  • 5. 65 years of age and older
  • Exclusion Criteria:
  • 1. Active joint or systemic infection
  • 2. Rotator cuff arthropathy
  • 3. Significant muscle paralysis
  • 4. Charcot's arthropathy
  • 5. Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
  • 6. Unable to understand the consent form/process
  • 7. Pregnancy
  • 8. Psychiatric illness that precludes informed consent
  • 9. Unwilling to be followed for the duration of the study
  • 10. Retroversion cannot be surgically corrected to within 10 degrees of neutral
  • 11. History of previous shoulder surgery on affected side
  • 12. Rheumatoid arthritis in the affected shoulder

About Ottawa Hospital Research Institute

The Ottawa Hospital Research Institute (OHRI) is a leading academic research institute dedicated to advancing health and healthcare through innovative research and evidence-based practices. Affiliated with The Ottawa Hospital and the University of Ottawa, OHRI fosters a collaborative environment that brings together clinicians, scientists, and trainees to conduct groundbreaking clinical trials and translational research. With a focus on improving patient outcomes, OHRI specializes in a wide range of fields, including cancer, cardiovascular health, and regenerative medicine. The institute is committed to ethical research practices and the dissemination of knowledge to enhance public health and inform healthcare policy.

Locations

Ottawa, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Peter Lapner, MD FRCSC

Principal Investigator

The Ottawa Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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