Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis
Shoulder OsteoarthritisOsteoarthritis (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.
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Participation Requirements
-
Sex:
ALL -
Eligible Ages:
65 and up
Participation Criteria
Inclusion Criteria:
1. Patients who have failed standard non-surgical management of their 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:
1. The use of drugs including analgesics and non-steroidal anti-inflammatory drugs
2. Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.)
3. Activity modification
2. Imaging, and intra-operative findings confirming advanced gleno-humeral cartilage loss
3. Patients may present with a glenoid deficiency and \>15 degrees of retroversion
4. 65 years of age and older
Exclusion Criteria:
1. Active joint or systemic infection
2. Rotator cuff arthropathy
3. Need for an augmented glenoid component or a bone graft to correct version to within 10 degrees of neutral
4. Retroversion cannot be surgically corrected to within 10 degrees of neutral with a "high- side" ream technique
5. Significant muscle paralysis
6. Charcot's arthropathy
7. Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
8. Active Workers Compensation Board (WCB) claim
9. Unable to understand the consent form/process
10. Psychiatric illness that precludes informed consent
11. Unwilling to be followed for the duration of the study
12. History of previous shoulder surgery on affected side
Study Location
Glen Sather Sports Medicine Clinic (University of Alberta)
Glen Sather Sports Medicine Clinic (University of Alberta)Edmonton, Alberta
Canada
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Grey Nuns Community Hospital
Grey Nuns Community HospitalEdmonton, Alberta
Canada
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University of Alberta Hospital
University of Alberta HospitalEdmonton, Alberta
Canada
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Royal Alexandra Hospital (Orthopaedic Surgical Centre)
Royal Alexandra Hospital (Orthopaedic Surgical Centre)Edmonton, Alberta
Canada
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Kaye Edmonton Clinic
Kaye Edmonton ClinicEdmonton, Alberta
Canada
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Sturgeon Community Hospital
Sturgeon Community HospitalSt. Albert, Alberta
Canada
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Collaborative Orthopaedic Research (CORe), Clinical Sciences Building
Collaborative Orthopaedic Research (CORe), Clinical Sciences BuildingEdmonton, Alberta
Canada
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The Ottawa Hospital
The Ottawa HospitalOttawa, Ontario
Canada
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- Study Sponsored By
- University of Alberta
- Participants Required
- More Information
- Study ID:
NCT05395819