Comparing total and reverse shoulder arthroplasty for shoulder osteoarthritis in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA) procedures in patients aged 65 and older with glenohumeral osteoarthritis. The study will involve a prospective, randomized-controlled design to assess which surgical approach provides better outcomes for patients with specific anatomical considerations, such as glenoid retroversion. By evaluating the effectiveness and safety of these two surgical options, the research seeks to provide valuable insights for surgeons treating this aging population. The trial will include patients who have not responded to standard non-surgical management for their shoulder condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients who have failed standard non-surgical management of their idiopathic shoulder osteoarthritis 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 6 months. Medical management will be defined as:

   1. The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
   2. Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.)
   3. Activity modification
2. Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss
3. Patients may present with a glenoid deficiency and \</=15 degrees of retroversion
4. 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

Where it's running

• Kingston General Hospital (Site-Watkins 3)
  Kingston, Ontario, Canada Recruiting
• The Ottawa Hospital
  Ottawa, Ontario, Canada Recruiting
• University of Alberta
  Edmonton, Alberta, Canada Not yet recruiting
• Pan Am Clinic Foundation
  Winnipeg, Manitoba, Canada Not yet recruiting

Study contacts

• Principal investigator: Peter Lapner, MD — The Ottawa Hospital
• Study coordinator: Peter Lapner Lapner, MD
• Email: plapner@toh.ca
• Phone: 613-737-8899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.