NCT05487274 TSA v RSA in Osteoarthritic Shoulders With Greater Than 15 Degrees of Retroversion
| NCT ID | NCT05487274 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ottawa Hospital Research Institute |
| Condition | Osteoarthritis Shoulder |
| Study Type | INTERVENTIONAL |
| Enrollment | 108 participants |
| Start Date | 2022-08-09 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 108 participants in total. It began in 2022-08-09 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will compare total shoulder arthroplasty (TSA) with an augmented glenoid component and reverse shoulder arthroplasty (RSA) procedures, in participants with advanced glenohumeral osteoarthritis aged 65 years and older, who also present with greater than 15 degrees of glenoid retroversion, in the context of a prospective, randomized controlled trial to determine the optimal treatment in this patient population.
Eligibility 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
Contact & Investigator
Peter Lapner, MD FRCSC
PRINCIPAL INVESTIGATOR
The Ottawa Hospital
Frequently Asked Questions
Who can join the NCT05487274 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Osteoarthritis Shoulder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05487274 currently recruiting?
Yes, NCT05487274 is actively recruiting participants. Contact the research team at kmcilquham@ohri.ca for enrollment information.
Where is the NCT05487274 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT05487274 clinical trial?
NCT05487274 is sponsored by Ottawa Hospital Research Institute. The principal investigator is Peter Lapner, MD FRCSC at The Ottawa Hospital. The trial plans to enroll 108 participants.