TSA vs RSA in Glenohumeral Osteoarthritis
Recruiting · NCT04228419 · Interventional (participants receive a specific treatment) · Lead sponsor: Ottawa Hospital Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Reverse Shoulder ArthroplastyTotal Shoulder Arthroplasty
What this trial is about
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.
Who can take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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:
- 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 glenohumeral cartilage loss
- Patients may present with a glenoid deficiency and \</=15 degrees of retroversion
- 65 years of age and older
Exclusion criteria
- Active joint or systemic infection
- Rotator cuff arthropathy
- Significant muscle paralysis
- Charcot's arthropathy
- Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
- Unable to understand the consent form/process
- Pregnancy
- Psychiatric illness that precludes informed consent
- Unwilling to be followed for the duration of the study
- Retroversion cannot be surgically corrected to within 10 degrees of neutral
- History of previous shoulder surgery on affected side
Where it is running
4 locations listed.
- University of Alberta - Edmonton, Alberta, Canada
- Pan Am Clinic Foundation - Winnipeg, Manitoba, Canada
- Kingston General Hospital (Site-Watkins 3) - Kingston, Ontario, Canada
- The Ottawa Hospital - Ottawa, Ontario, Canada