Actively Recruiting
Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis
Led by University of Alberta · Updated on 2025-05-30
40
Participants Needed
8
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University of Alberta
Lead Sponsor
U
University Hospital Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Osteoarthritis (OA) is the most common form of arthritis, affecting millions of people worldwide and it is common in an aging population. Surgical shoulder replacement (arthroplasty) is typically considered when non-surgical measures, such as physiotherapy or medication, have failed. There are two commonly performed surgical replacement procedures in patients who have advanced shoulder OA, and are 65 years of age and older: "Total Shoulder replacement or Arthroplasty (TSA)" and "Reverse Total Shoulder Arthroplasty (RTSA)". Few studies have compared the two procedures. Surgeons face uncertainty regarding which procedure to perform in patients 65 years of age and older. This pilot Randomized Controlled Trial (RCT) will compare the "TSA" and "RTSA" procedures, in patients 65 years of age and older. Participants will be assigned at random, (like flipping a coin), to one of the two groups (TSA or RTSA). The overall goal of this pilot study is to determine which procedure produces better functional and quality of life outcomes with fewer complications within the first 12-months after surgery. Moreover, pilot data will help determining the feasibility of conducting a larger trial comparing TSA versus RTSA surgical management in 65 years of age and older participants with advanced shoulder OA.
CONDITIONS
Official Title
Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who have failed standard non-surgical management of their shoulder osteoarthritis for at least 6 months, including use of analgesics, non-steroidal anti-inflammatory drugs, physiotherapy, and activity modification
- Imaging and intra-operative confirmation of advanced gleno-humeral cartilage loss
- May have glenoid deficiency and more than 15 degrees of retroversion
- 65 years of age and older
You will not qualify if you...
- Active joint or systemic infection
- Rotator cuff arthropathy
- Need for augmented glenoid component or bone graft to correct version within 10 degrees of neutral
- Retroversion cannot be surgically corrected to within 10 degrees of neutral with the "high-side" ream technique
- Significant muscle paralysis
- Charcot's arthropathy
- Major medical illness with life expectancy less than 1 year or high operative risk
- Active Workers Compensation Board claim
- Unable to understand the consent form or process
- Psychiatric illness that prevents informed consent
- Unwilling to be followed for the duration of the study
- History of previous shoulder surgery on the affected side
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Royal Alexandra Hospital (Orthopaedic Surgical Centre)
Edmonton, Alberta, Canada, T5H 3V9
Actively Recruiting
2
Glen Sather Sports Medicine Clinic (University of Alberta)
Edmonton, Alberta, Canada, T6G 1Z1
Actively Recruiting
3
Kaye Edmonton Clinic
Edmonton, Alberta, Canada, T6G 1Z1
Actively Recruiting
4
Collaborative Orthopaedic Research (CORe), Clinical Sciences Building
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
5
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
6
Grey Nuns Community Hospital
Edmonton, Alberta, Canada, T6L 5X8
Actively Recruiting
7
Sturgeon Community Hospital
St. Albert, Alberta, Canada, T8N 6C4
Actively Recruiting
8
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
Research Team
A
Ailar Ramadi, PhD
CONTACT
L
Lauren Beaupre, PhD
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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