Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis
Key facts
- Who runs it
- University of Alberta
- Where
- Canada7 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 40 people, planned
- Started
- 30 May 2022
- Expected to end
- 30 May 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Reverse Total Shoulder Arthroplasty (RTSA)
- Total Shoulder Arthroplasty (TSA)
- Record updated
- 9 July 2026
Who can take part
- Age
- 65 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Patients who have failed standard non-surgical management of their 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 gleno-humeral cartilage loss
- Patients may present with a glenoid deficiency and >15 degrees of retroversion
- 65 years of age and older
Who cannot take part
- History of previous shoulder surgery on affected side
- Active joint or systemic infection
- Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
- Psychiatric illness that precludes informed consent
- Rotator cuff arthropathy
- Need for an augmented glenoid component or a bone graft to correct version to within 10 degrees of neutral
- Retroversion cannot be surgically corrected to within 10 degrees of neutral with a "high- side" ream technique
- Significant muscle paralysis
- Charcot's arthropathy
- Active Workers Compensation Board (WCB) claim
- Unable to understand the consent form/process
- Unwilling to be followed for the duration of the study
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Osteoarthritis (OA) is the most common form of arthritis, affecting millions of people worldwide and it is common in an aging population. Surgical shoulder replacement (arthroplasty) is typically considered when non-surgical measures, such as physiotherapy or medication, have failed. There are two commonly performed surgical replacement procedures in patients who have advanced shoulder OA, and are 65 years of age and older: "Total Shoulder replacement or Arthroplasty (TSA)" and "Reverse Total Shoulder Arthroplasty (RTSA)".
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Few studies have compared the two procedures. Surgeons face uncertainty regarding which procedure to perform in patients 65 years of age and older. This pilot Randomized Controlled Trial (RCT) will compare the "TSA" and "RTSA" procedures, in patients 65 years of age and older. Participants will be assigned at random, (like flipping a coin), to one of the two groups (TSA or RTSA). The overall goal of this pilot study is to determine which procedure produces better functional and quality of life outcomes with fewer complications within the first 12-months after surgery. Moreover, pilot data will help determining the feasibility of conducting a larger trial comparing TSA versus RTSA surgical management in 65 years of age and older participants with advanced shoulder OA.
The 2 groups in the trial
- Reverse Total Shoulder Arthroplasty (RTSA)Treatment being tested
Patient will undergo a RTSA as per standard technique. It uses a stemmed metal humeral component attached to the glenoid and the shallow glenoid component attached to the humerus. Pre-operative CT imaging and surgical planning software based on pre-operative CT scans will be used in each case to determine the degree of eccentric ("high side") anterior reaming to within \< 10 degrees of neutral glenoid version. Standard instruments including a spherical burr and power reamers will be used to achieve this.
- Total Shoulder Arthroplasty (TSA)Existing treatment, for comparison
Patients will undergo standard glenoid preparation and implantation of a TSA. It uses a stemmed metal humeral component to replace the arthritic head of humerus and a shallow polyethylene glenoid component to replace the arthritic glenoid surface. The degree of anterior- reaming will be based on pre-operative CT scan assessment and templating software with the goal of correcting glenoid retroversion to within 10 degrees of neutral version.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis: A Pilot Randomized Control Trial
- Record updated
- 9 July 2026