TSA v RSA in Osteoarthritic Shoulders With Greater Than 15 Degrees of Retroversion
Recruiting · NCT05487274 · 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 + augmented glenoid component
What this trial is about
This study will compare total shoulder arthroplasty (TSA) with an augmented glenoid component and reverse shoulder arthroplasty (RSA) procedures, in participants with advanced glenohumeral osteoarthritis aged 65 years and older, who also present with greater than 15 degrees of glenoid retroversion, in the context of a prospective, randomized controlled trial to determine the optimal treatment in this patient population.
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
- Diagnosis of idiopathic shoulder OA.
- Patients who have failed standard non-surgical management of their shoulder OA 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 at least 6 months. Medical management will be defined as: a) The use of drugs including analgesics and nonsteroidal anti-inflammatory drugs, b) Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.), c) Activity modification
- Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss
- Patients with a glenoid deficiency and \>15 degrees of glenoid retroversion up to a maximum of 26 degrees of glenoid retroversion (i.e. -15.1, -17, -20…etc.)
- 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
- Rheumatoid arthritis in the affected shoulder
Where it is running
1 location listed.
- Ottawa Hospital Research Institute - Ottawa, Ontario, Canada