Actively Recruiting
Study Evaluating Reverse Versus Anatomic Total Shoulder Arthroplasty in Shoulders With Greater Than 15 Degrees of Retroversion for Osteoarthritis
Led by Ottawa Hospital Research Institute · Updated on 2024-04-30
108
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates treatment options for older adults aged 65 and above with advanced osteoarthritis of the shoulder joint, specifically those with more than 15 degrees of glenoid retroversion. It compares two surgical procedures: total shoulder arthroplasty (TSA) with an augmented glenoid component versus reverse shoulder arthroplasty (RSA). The study aims to determine which surgery offers better functional outcomes and quality of life in this patient group. The TSA procedure replaces the worn shoulder joint with prosthetic parts and includes an augmented glenoid component to address bone loss and restore joint stability. The RSA procedure reverses the ball and socket configuration of the joint. Both surgeries are performed as standard care for patients with shoulder osteoarthritis. Participants are randomly assigned to receive either TSA with augmentation or RSA. Participants will be followed for up to five years after surgery, with assessments at 24 months and 5 years. Researchers will measure disease-specific quality of life using the Western Ontario Osteoarthritis of the Shoulder Index (WOOS) and other shoulder function scores. Imaging with CT scans will evaluate the implant's condition and alignment. Safety, adverse events, pain levels, and healthcare use will also be monitored throughout the study.
CONDITIONS
Brief Title
TSA v RSA in Osteoarthritic Shoulders With Greater Than 15 Degrees of Retroversion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic shoulder osteoarthritis
- Failed standard non-surgical treatment for at least 6 months, including medication, physiotherapy, and activity modification
- Imaging and surgery findings confirming advanced cartilage loss in the shoulder joint
- Glenoid retroversion greater than 15 degrees and up to 26 degrees
- Age 65 years or older
You will not qualify if you...
- Active joint or systemic infection
- Rotator cuff arthropathy
- Significant muscle paralysis
- Charcot's arthropathy
- Major medical illness with life expectancy less than 1 year or high surgical risk
- Inability to understand the consent process
- Pregnancy
- Psychiatric illness preventing informed consent
- Unwillingness to be followed for the study duration
- Retroversion not correctable to within 10 degrees of neutral
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus immediate recovery period
Participants undergo either Total Shoulder Arthroplasty with an augmented glenoid component or Reverse Shoulder Arthroplasty to treat shoulder osteoarthritis.
1 surgical visit and immediate post-operative care
Duration - Up to 5 years post-surgery
Participants receive follow-up assessments including functional outcome measures, imaging, and safety monitoring to evaluate recovery and treatment effectiveness.
Multiple visits including assessments at 24 months and 5 years post-operative
Trial Site Locations
Total: 1 location
1
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H8L6
Actively Recruiting
Research Team
K
Katie McIlquham
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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