TSA v RSA in Osteoarthritic Shoulders With Greater Than 15 Degrees of Retroversion

Recruiting now · Not applicable

Conditions studied: Osteoarthritis Shoulder

In brief

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.

Key facts

Study ID

NCT05487274

Run by

Ottawa Hospital Research Institute

People needed

108

Starts

2022-08-09

Expected to finish

2029-12-31

Last updated by the study team

2024-04-30

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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