Comparing two shoulder surgeries for older patients with osteoarthritis

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.