Clinical Evaluation of Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis

Condition(s) studied

Investigational drug(s) / intervention(s)

Reverse Total Shoulder Arthroplasty (RTSA): 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): 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Western Ontario Osteoarthritis of the Shoulder (WOOS) — Baseline, 6 weeks, 3-, 6- and 12-months
  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.

Trial sites (7)

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