TSA vs RSA in Glenohumeral Osteoarthritis
Recruiting now · Not applicable
Conditions studied: Osteoarthritis of the Shoulder
In brief
This study will compare total shoulder arthroplasty (TSA) reverse shoulder arthroplasty (RSA) procedures, in the context of a prospective, randomized-controlled trial to determine the optimal treatment in patients 65 years of age and older, and equal to or less than 15 degrees of glenoid retroversion, who have glenohumeral osteoarthritis.
Key facts
- Study ID
- NCT04228419
- Run by
- Ottawa Hospital Research Institute
- People needed
- 108
- Starts
- 2020-03-09
- Expected to finish
- 2032-12-31
- Last updated by the study team
- 2025-03-25
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
- Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.)
- Activity modification
- Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss
- Patients may present with a glenoid deficiency and </=15 degrees of retroversion
- 65 years of age and older
You may not qualify if…
- Active joint or systemic infection
- Rotator cuff arthropathy
- Significant muscle paralysis
- Charcot's arthropathy
- Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
- Unable to understand the consent form/process
- Pregnancy
- Psychiatric illness that precludes informed consent
- Unwilling to be followed for the duration of the study
- Retroversion cannot be surgically corrected to within 10 degrees of neutral
- History of previous shoulder surgery on affected side
Where it is running
- Kingston General Hospital (Site-Watkins 3) — Kingston, Ontario, Canada (enrolling)
- The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
- University of Alberta — Edmonton, Alberta, Canada
- Pan Am Clinic Foundation — Winnipeg, Manitoba, Canada
Full record on ClinicalTrials.gov
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