Comparing two shoulder replacement techniques for osteoarthritis in older adults

Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis: A Pilot Randomized Control Trial

This study is testing which shoulder replacement surgery works better for older adults with severe shoulder arthritis to help them feel better and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: University of Alberta (Academic / other)
• Locations: 8 sites (Edmonton, Alberta and 7 other locations)
• Trial ID: NCT05395819 on ClinicalTrials.gov

What this trial studies

This pilot randomized controlled trial aims to compare the clinical outcomes and health-related quality of life between Total Shoulder Arthroplasty (TSA) and Reverse Total Shoulder Arthroplasty (RTSA) in patients aged 65 and older suffering from advanced shoulder osteoarthritis. Participants will be randomly assigned to either the TSA or RTSA group, and their progress will be monitored over the first 12 months post-surgery. The study also seeks to assess the feasibility of conducting a larger definitive trial comparing these two surgical techniques. By addressing the uncertainty surrounding the optimal surgical approach for this demographic, the study aims to provide valuable insights for clinical decision-making.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 65 and older who have not responded to standard non-surgical management for shoulder osteoarthritis.

Not a fit: Patients with active joint infections, rotator cuff arthropathy, or those requiring complex surgical interventions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help determine the most effective surgical approach for older patients with shoulder osteoarthritis, potentially improving their quality of life.

How similar studies have performed: While few studies have directly compared TSA and RTSA, the approach of evaluating surgical techniques in older adults is supported by existing literature, though this specific comparison is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients who have failed standard non-surgical management of their 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 gleno-humeral 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. Need for an augmented glenoid component or a bone graft to correct version to within 10 degrees of neutral
4. Retroversion cannot be surgically corrected to within 10 degrees of neutral with a "high- side" ream technique
5. Significant muscle paralysis
6. Charcot's arthropathy
7. Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
8. Active Workers Compensation Board (WCB) claim
9. Unable to understand the consent form/process
10. Psychiatric illness that precludes informed consent
11. Unwilling to be followed for the duration of the study
12. History of previous shoulder surgery on affected side

Where this trial is running

Edmonton, Alberta and 7 other locations

• Royal Alexandra Hospital (Orthopaedic Surgical Centre) — Edmonton, Alberta, Canada (Recruiting)
• Glen Sather Sports Medicine Clinic (University of Alberta) — Edmonton, Alberta, Canada (Recruiting)
• Kaye Edmonton Clinic — Edmonton, Alberta, Canada (Recruiting)
• Collaborative Orthopaedic Research (CORe), Clinical Sciences Building — Edmonton, Alberta, Canada (Recruiting)
• University of Alberta Hospital — Edmonton, Alberta, Canada (Recruiting)
• Grey Nuns Community Hospital — Edmonton, Alberta, Canada (Recruiting)
• Sturgeon Community Hospital — St. Albert, Alberta, Canada (Recruiting)
• The Ottawa Hospital — Ottawa, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Ailar Ramadi, PhD

Conditions Shoulder Osteoarthritis