Actively Recruiting
TSA Techniques in Glenohumeral OA
Led by Ottawa Hospital Research Institute · Updated on 2024-04-30
216
Participants Needed
1
Research Sites
605 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Osteoarthritis (OA) of the shoulder is a disease resulting from the wearing down of cartilage over time. OA can produce pain and dysfunction at the affected joint and is a growing occurrence in an aging population. Total shoulder arthroplasty (TSA) is a surgical treatment used to treat patients with shoulder OA which involves replacing the worn-out ball and socket shoulder joint with prosthetic components. TSA is performed today with high success rates, however, complication rates associated with TSA remain prevalent particularly when the arthritis is associated with bone erosion on the glenoid (socket). Given the high rate of revisions associated with TSA treatment in the setting of glenoid bone erosion, a number of surgical strategies have been developed. These surgical techniques include eccentric reaming which involves removing bone from the front of the socket, augmented glenoid component implantation, and posterior bone grafting to compensate for glenoid bone loss, and reverse shoulder arthroplasty. Few research studies have compared these different surgical techniques to one another. Previous studies have been limited to case series with small sample sizes and respective designs. This study is being conducted to determine which approach produces better outcomes. For the purpose of this study we will be comparing total shoulder arthroplasty techniques a) augmented glenoid component and eccentric reaming and b) augmented glenoid component and bone grafting in participants with advanced glenohumeral osteoarthritis.
CONDITIONS
Official Title
TSA Techniques in Glenohumeral OA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Both men and women with advanced osteoarthritis of the shoulder joint
- Considered candidates for shoulder replacement by their surgeon
- Failed at least 6 months of standard non-surgical management including medication, physiotherapy, and activity modification
- Glenoid retroversion between 10 and 26 degrees
- Imaging and surgery confirm advanced cartilage loss of the humeral head
- Age 18 years or older
You will not qualify if you...
- Glenoid retroversion less than 10 degrees or greater than 27 degrees
- Active joint or systemic infection
- Rotator cuff arthropathy
- Significant muscle paralysis
- Charcot's arthropathy
- Major medical illness with life expectancy under 1 year or high surgical risk
- Unable to understand the consent process
- Pregnancy
- Psychiatric illness preventing informed consent
- Unwillingness to be followed for the study duration
- Glenoid retroversion cannot be corrected to within 10 degrees of neutral surgically
- Previous shoulder surgery on the affected side
- Rheumatoid arthritis in the affected shoulder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H8L6
Actively Recruiting
Research Team
P
Peter Lapner, MD
CONTACT
K
Katie McIlquham
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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