TSA vs RSA in Glenohumeral Osteoarthritis

Osteoarthritis of the Shoulder Clinical Trial

— SERVASA  

Official title:

Study Evaluating Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis: Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04228419
• Other study ID #: 20190674-01H
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2020
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: Ottawa Hospital Research Institute
• Contact: Peter Lapner Lapner, MD
• Phone: 613-737-8899
• Email: plapner[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare total shoulder arthroplasty (TSA) reverse shoulder arthroplasty (RSA) procedures, in the context of a prospective, randomized-controlled trial to determine the optimal treatment in patients 65 years of age and older, and equal to or less than 15 degrees of glenoid retroversion, who have glenohumeral osteoarthritis.

Description:

Osteoarthritis (OA) of the shoulder is a disease resulting from the wearing down of cartilage over time. OA can be the cause of pain and dysfunction and is a growing occurrence in the investigator's aging population. TSA or RSA are common surgical procedures used to treat patients with shoulder OA. TSA is able to keep the "natural anatomy" of the shoulder and involves replacing the worn-out ball and socket shoulder joint with prosthetic components. TSA is performed today with high success rates, however, complication rates associated with TSA remain prevalent, particularly when the arthritis is associated with bone erosion on the glenoid (socket). RSA is an alternative surgical procedure commonly used and involves replacing and reversing the ball and the socket (i.e. opposite of TSA). RSA is typically performed in patients with a rotator cuff deficiency and more severe OA. Though RSA procedures show marked increase in clinical and functional outcomes, evidence of its long-term results are sparse, and as such is typically reserved for when treating an older patient population. Few research studies have compared these different surgical techniques to one another, in the older patient population. This research will provide surgeons with new information regarding the best treatment for patients in this population. This Randomized Controlled Trial (RCT) will compare TSA and RSA procedures in those 65 years of age and older, who have equal to or less than 15 degrees of glenoid retroversion, in an effort to determine which approach produces better functional outcomes and improved quality of life in this patient population. Primary Objective: Determine the difference in disease specific quality of life between patients diagnosed with glenohumeral OA who undergo either a TSA or RSA as measured by the Western Osteoarthritis of the Shoulder (WOOS) score at 24-months and 5-years post-operative. Secondary Objectives: i) Determine the difference in disease specific quality of life between patients diagnosed with a glenohumeral osteoarthritis who undergo a shoulder replacement with RSA or TSA as measured by the Constant score, the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES), the EuroQol Group EQ-5D-5L score, pain (using a Visual Analog Scale), and Subjective Shoulder Value (SSV) at 24-months and 5-years post-operative as well as adverse events, and health care utilization. ii) To determine the survivorship of the components as measured by the degree of radiographic lucencies and component alignment determined by a CT scan at 1- and 5-years post-surgery. Clinical Relevance: Shoulder OA results in pain and dysfunction, which negatively impacts quality of life. As such, determination of superior treatment approach will lead to significant improvement in quality of life, and cost savings through avoidance of recurrence and/or reoperation, as well as decreased morbidity for patients in this population.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 31, 2028
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Patients who have failed standard non-surgical management of their idiopathic 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:

1. The use of drugs including analgesics and non-steroidal anti-inflammatory drugs

2. Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.)

3. Activity modification

2. Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss

3. Patients may present with a glenoid deficiency and </=15 degrees of retroversion

4. 65 years of age and older

Exclusion Criteria:

1. Active joint or systemic infection

2. Rotator cuff arthropathy

3. Significant muscle paralysis

4. Charcot's arthropathy

5. Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)

6. Unable to understand the consent form/process

7. Pregnancy

8. Psychiatric illness that precludes informed consent

9. Unwilling to be followed for the duration of the study

10. Retroversion cannot be surgically corrected to within 10 degrees of neutral

11. History of previous shoulder surgery on affected side

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Shoulder

Intervention

Procedure:
• Total Shoulder Arthroplasty
Replacement of the shoulder joint (ball and socket, or humeral head and glenoid) using prosthetic components.
• Reverse Shoulder Arthroplasty
Replacement of the shoulder joint like the TSA, however the orientation of the ball and socket is reversed.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Kingston General Hospital (Site-Watkins 3)	Kingston	Ontario
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Pan Am Clinic Foundation	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario Osteoarthritis of the Shoulder Index (WOOS)	The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.	24-Months and 5-Years Post-Operative
Secondary	Standard CT Scans	Radiological parameters will be examined using Computed Tomography (CT). These scans will be analyzed for abnormalities in component alignment, and evidence of lucencies or loosening. Higher incidence of loosening, or noted abnormalities will be compared between groups. A higher incidence indicates worse outcomes.	24-Months and 5-Years Post-Operative
Secondary	American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)	The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.	24-Months and 5-Years Post-Operative
Secondary	Pain Level	Subjective pain value of the shoulder will be assessed using a questionnaire. Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. The higher the score, the worse the outcome.	24-Months and 5-Years Post-Operative
Secondary	Subjective Shoulder Value	A participant's subjective value on shoulder function will be assessed using a questionnaire. The overall functional value of the shoulder is written as a percentage from 0-100% of a normal shoulder. The higher the score, the better the outcome.	24-Months and 5-Years Post-Operative
Secondary	EuroQol EQ-5D-5L	The EQ-5D-5L quality of life questionnaire is a brief, easy to administer generic health status questionnaire, consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take one of five responses (each question rated 1-5), lower scores indicate better outcome. It also includes a visual analogue scale for recording an individual's rating of their current health-related quality of life (scale 0 to 100), where a higher score indicates a better outcome.	24-Months and 5-Years Post-Operative
Secondary	Constant Score	The Constant Score reflects an overall clinical functional assessment. This instrument is based on a 100-point scoring system. Subjective findings (pain, activities of daily living, and working in different positions) make up a total of 35 points. Objective measurements make up the remaining 65 points.The test is divided into four sub-categories: (1) pain is measured using 4 likert levels (15 points maximum), where a higher score indicates a better outcome; activities of daily living are measured using a likert scale, where a higher number indicates better outcomes (20 points maximum); mobility is measured by an assessor, and rated using a likert scale where a higher score indicates better outcomes (40 points maximum); finally, strength is measured by an assessor where 1 point is given per 0.5kg of force (maximum 25 points), a higher score indicates better outcomes. All categories are added together, and a total score out of 100 is given (higher score indicates better outcome).	24-Months and 5-Years Post-Operative
Secondary	Adverse Events (AE) and Serious Adverse Events (SAE)	Rates of study adverse events or serious adverse events (e.g. number of reoperations) will be monitored and recorded and compared between study groups. A higher rate of adverse events indicates a worse outcome.	24-Months and 5-Years Post-Operative
Secondary	Health Care Utilization	Health care utilization will be monitored and recorded using a questionnaire. These questions will include healthcare the patient accessed, cost of care, and medications taken during treatment. From this information, a cost-effectiveness analysis will be completed, which will adhere to the best practices for conducting and reporting of health economic evaluations.	24-Months and 5-Years Post-Operative