Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis

Launched by UNIVERSITY OF ALBERTA · May 24, 2022

Keywords

ClinConnect Summary

This clinical trial is comparing two types of shoulder replacement surgeries—Total Shoulder Arthroplasty (TSA) and Reverse Total Shoulder Arthroplasty (RTSA)—to find out which one works better for older patients suffering from severe shoulder osteoarthritis. Osteoarthritis is a common joint condition that can cause pain and difficulty moving. The trial is specifically looking at patients aged 65 and older who have not found relief from non-surgical treatments, such as medications or physical therapy, for at least six months. To participate, patients must have advanced cartilage loss in their shoulders and meet other specific health criteria.

Participants in the trial will be randomly assigned to receive either the TSA or RTSA surgery, similar to flipping a coin. The study aims to evaluate how well each surgery helps improve shoulder function and quality of life within the first year after the operation, while also keeping track of any complications that may arise. This pilot study will help researchers determine whether a larger trial is feasible in the future. If you or a loved one are considering shoulder surgery and meet the eligibility criteria, this trial could provide valuable insights into the best surgical option for managing severe shoulder osteoarthritis.

Gender

ALL

Eligibility 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