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

Study Evaluating Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis: Protocol

This study is testing whether total shoulder surgery or reverse shoulder surgery works better for older adults with shoulder arthritis who haven't found relief from other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (Academic / other)
• Locations: 4 sites (Edmonton, Alberta and 3 other locations)
• Trial ID: NCT04228419 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 65 and older who have failed non-surgical management for their shoulder osteoarthritis and have specific anatomical criteria.

Not a fit: Patients with active joint infections, significant muscle paralysis, or major medical illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify the most effective surgical treatment for older patients suffering from shoulder osteoarthritis, potentially improving their quality of life.

How similar studies have performed: While few studies have directly compared TSA and RSA in this specific older population, existing literature suggests that RSA has shown promising outcomes in similar cases, indicating potential for success.

Eligibility criteria

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 this trial is running

Edmonton, Alberta and 3 other locations

• University of Alberta — Edmonton, Alberta, Canada (Not_yet_recruiting)
• Pan Am Clinic Foundation — Winnipeg, Manitoba, Canada (Not_yet_recruiting)
• Kingston General Hospital (Site-Watkins 3) — Kingston, Ontario, Canada (Recruiting)
• The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Peter Lapner, MD — The Ottawa Hospital
• Study coordinator: Peter Lapner Lapner, MD

Conditions Osteoarthritis of the Shoulder; arthroplasty; glenohumeral osteoarthritis; idiopathic osteoarthritis