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)".
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 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
Active joint or systemic infection
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
Parallel
Reverse Total Shoulder Arthroplasty (RTSA)
Procedure/SurgeryPatient 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)
Procedure/SurgeryPatients 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.
Change in Western Ontario Osteoarthritis of the Shoulder (WOOS)
WOOS is a valid, reliable and responsive 19-item self-administered questionnaire that assesses health-related quality of life in patients with osteoathritis undergoing arthroplasty. It consists of 4 domains: pain and physical symptoms; sports, recreation, and work; lifestyle function; and emotional function. The score ranges from 0 to 1,900, with a higher raw score corresponding with the worse outcome.
Number of re-operations
Number of re-operations related to their shoulder condition during the first 12-months after surgery.
Change in Shoulder Range of Motion (ROM)
Degree of active shoulder flexion, abduction, external and internal rotation using goniometry.
Change in Shoulder Pain
Shoulder pain will be assessed using a visual analogue scale (VAS) where zero equals no pain and 10 the worst possible pain. Participants will rate pain at rest, with activity and at night.
Change in Shoulder Strength
Isometric shoulder flexion, abduction, external rotation and internal rotation will be measured with the arm in neutral (neutral abduction, 90° elbow flexion), using a dynamometer (microFET3, Hoggan Health Industries Inc., West Jordan, UT). Peak values will be recorded for each contraction that will be held for 3 seconds.
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University of Alberta
Lead sponsor
University Hospital Foundation
Collaborator
Canadian Orthopaedic Foundation
Collaborator
