Clinical trial NCT04228419: TSA vs RSA in Glenohumeral Osteoarthritis
Official title: Study Evaluating Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis: Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis of the Shoulder
Keywords: arthroplasty
glenohumeral osteoarthritis
idiopathic osteoarthritis
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 108
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
timeFrame: 24-Months and 5-Years Post-Operative
Secondary outcomes:
measure: Standard CT Scans
timeFrame: 24-Months and 5-Years Post-Operative
measure: American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)
timeFrame: 24-Months and 5-Years Post-Operative
measure: Pain Level
timeFrame: 24-Months and 5-Years Post-Operative
measure: Subjective Shoulder Value
timeFrame: 24-Months and 5-Years Post-Operative
measure: EuroQol EQ-5D-5L
timeFrame: 24-Months and 5-Years Post-Operative
measure: Constant Score
timeFrame: 24-Months and 5-Years Post-Operative
measure: Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: 24-Months and 5-Years Post-Operative
measure: Health Care Utilization
timeFrame: 24-Months and 5-Years Post-Operative
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Winnipeg
country: Canada
facility: Pan Am Clinic Foundation
state: Manitoba
city: Kingston
country: Canada
facility: Kingston General Hospital (Site-Watkins 3)
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Peter Lapner, MD
role: PRINCIPAL_INVESTIGATOR
References: