About this trial
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.
Eligibility criteria
Qualifiers
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 gleno-humeral cartilage loss
Disqualifiers
Active joint or systemic infection
Rotator cuff arthropathy
Need for an augmented glenoid component or a bone graft to correct version to within 10 degrees of neutral
Retroversion cannot be surgically corrected to within 10 degrees of neutral with a "high- side" ream technique
Trial design
Treatments tested in this trial
- Reverse Total Shoulder Arthroplasty (RTSA)
- Total Shoulder Arthroplasty (TSA)
Treatment groups
Sponsors and collaborators
University of Alberta
Lead sponsor
University Hospital Foundation
Collaborator
Canadian Orthopaedic Foundation
Collaborator