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Clinical Trials in Canada / NCT04228419
Recruiting Not applicable

TSA vs RSA in Glenohumeral Osteoarthritis

NCT04228419 · tracked via the Priya Life Science Canada tracker
Sponsor
Ottawa Hospital Research Institute
Phase
Not applicable
Started
2020-03-09
Last updated
2025-03-25

Condition(s) studied

Osteoarthritis of the Shoulder

Investigational drug(s) / intervention(s)

Total Shoulder ArthroplastyReverse Shoulder Arthroplasty

Total Shoulder Arthroplasty: Replacement of the shoulder joint (ball and socket, or humeral head and glenoid) using prosthetic components.

Reverse Shoulder Arthroplasty: Replacement of the shoulder joint like the TSA, however the orientation of the ball and socket is reversed.

Study summary

This study will compare total shoulder arthroplasty (TSA) reverse shoulder arthroplasty (RSA) procedures, in the context of a prospective, randomized-controlled trial to determine the optimal treatment in patients 65 years of age and older, and equal to or less than 15 degrees of glenoid retroversion, who have glenohumeral osteoarthritis.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients who have failed standard non-surgical management of their idiopathic 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 glenohumeral 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. Significant muscle paralysis 4. Charcot's arthropathy 5. Major medical illness (life expectancy less than 1 year or unacceptably high operative risk) 6. Unable to understand the consent form/process 7. Pregnancy 8. Psychiatric illness that precludes informed consent 9. Unwilling to be followed for the duration of the study 10. Retroversion cannot be surgically corrected to within 10 degrees of neutral 11. History of previous shoulder surgery on affected side

Primary outcome measure(s)

  • Western Ontario Osteoarthritis of the Shoulder Index (WOOS) — 24-Months and 5-Years Post-Operative
    The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.

Trial sites (4)

FacilityCityRegionStatus
University of Alberta Edmonton Alberta Not Yet Recruiting
Pan Am Clinic Foundation Winnipeg Manitoba Not Yet Recruiting
Kingston General Hospital (Site-Watkins 3) Kingston Ontario Recruiting
The Ottawa Hospital Ottawa Ontario Recruiting

More Ottawa Hospital Research Institute trials in Canada

Unravelling the Etiology of Shoulder Osteoarthritis Active, not recruiting
Lower Trapezius Tendon Transfer vs Partial Cuff Repair in Massive Rotator Cuff Tears Starting soon
Adverse Long-term Consequences of Sleep Disordered Breathing: The Ottawa Hospital (TOH) Sleep Database Active, not recruiting
The VICTORY Trial: Virtual, Innovative, Postsurgical Care To Optimize Return Home for Older People With frailtY Recruiting
The ACCELERATE Pilot Trial Starting soon

Other trials for the same condition

Unravelling the Etiology of Shoulder Osteoarthritis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04228419 on ClinicalTrials.gov ↗ ← All trials in Canada