Status:
RECRUITING
Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
University Hospital Foundation
Canadian Orthopaedic Foundation
Conditions:
Shoulder Osteoarthritis
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
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 cons...
Detailed Description
1. Statement of objectives Primary objective: To compare clinical and health related quality of life (HRQL) outcomes of Total Shoulder Arthroplasty (TSA) or Reverse Total Shoulder Arthroplasty (RT...
Eligibility Criteria
Inclusion
- 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:
- 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
- Patients may present with a glenoid deficiency and \>15 degrees of retroversion
- 65 years of age and older
Exclusion
- 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
- Significant muscle paralysis
- Charcot's arthropathy
- Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
- Active Workers Compensation Board (WCB) claim
- Unable to understand the consent form/process
- Psychiatric illness that precludes informed consent
- Unwilling to be followed for the duration of the study
- History of previous shoulder surgery on affected side
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05395819
Start Date
May 30 2022
End Date
May 30 2026
Last Update
May 30 2025
Active Locations (8)
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1
Royal Alexandra Hospital (Orthopaedic Surgical Centre)
Edmonton, Alberta, Canada, T5H 3V9
2
Glen Sather Sports Medicine Clinic (University of Alberta)
Edmonton, Alberta, Canada, T6G 1Z1
3
Kaye Edmonton Clinic
Edmonton, Alberta, Canada, T6G 1Z1
4
Collaborative Orthopaedic Research (CORe), Clinical Sciences Building
Edmonton, Alberta, Canada, T6G 2B7