TSA v RSA in Osteoarthritic Shoulders With Greater Than 15 Degrees of Retroversion
Study Evaluating Reverse Versus Anatomic Total Shoulder Arthroplasty in Shoulders With Greater Than 15 Degrees of Retroversion in the Treatment of Osteoarthritis: Protocol
Ottawa Hospital Research Institute
108 participants
Aug 9, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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.)
- years of age and older
Exclusion Criteria12
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Replacement of the shoulder joint (ball and socket, or humeral head and glenoid) using prosthetic components. A prosthetic component is also implanted to correct for the amount of bone loss in the shoulder and restore stability.
Replacement of the shoulder joint like the TSA, however the orientation of the ball and socket is reversed.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05487274