Comparing two shoulder surgeries for older patients with osteoarthritis
Study Evaluating Reverse Versus Anatomic Total Shoulder Arthroplasty in Shoulders With Greater Than 15 Degrees of Retroversion in the Treatment of Osteoarthritis: Protocol
This study is testing which shoulder surgery works better for older patients with severe arthritis: a total shoulder replacement or a reverse shoulder replacement.
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 | 1 site (Ottawa, Ontario) |
| Trial ID | NCT05487274 on ClinicalTrials.gov |
What this trial studies
This study compares total shoulder arthroplasty (TSA) with an augmented glenoid component to reverse shoulder arthroplasty (RSA) in patients aged 65 and older who have advanced glenohumeral osteoarthritis and greater than 15 degrees of glenoid retroversion. The research aims to determine which surgical approach provides better outcomes for this specific patient population. Participants will be randomly assigned to receive either TSA or RSA, and their clinical and functional outcomes will be assessed over time. The study addresses a gap in existing research regarding optimal surgical interventions for older patients with complex shoulder conditions.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 and older with idiopathic shoulder osteoarthritis who have not responded to standard non-surgical treatments and have specific glenoid retroversion.
Not a fit: Patients with active infections, rotator cuff arthropathy, or significant muscle paralysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for older patients suffering from shoulder osteoarthritis.
How similar studies have performed: While few studies have compared these surgical techniques in older populations, existing literature suggests that RSA may offer significant improvements in certain cases, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ottawa, Ontario
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Peter Lapner, MD FRCSC — The Ottawa Hospital
- Study coordinator: Katie McIlquham
- Email: kmcilquham@ohri.ca
- Phone: 613-737-8899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.