TSA v RSA in Osteoarthritic Shoulders With Greater Than 15 Degrees of Retroversion (NCT05487274) | Clinical Trial Compass
RecruitingNot Applicable
TSA v RSA in Osteoarthritic Shoulders With Greater Than 15 Degrees of Retroversion
Canada108 participantsStarted 2022-08-09
Plain-language summary
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 participate
Age range65 Years
SexALL
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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
What they're measuring
1
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Timeframe: 24-Months Post-Operative
2
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)