Osteoarthritis of the ShoulderSERVASANCT04228419
TSA vs RSA in Glenohumeral Osteoarthritis
A study testing Total Shoulder Arthroplasty and Reverse Shoulder Arthroplasty in people with Osteoarthritis of the Shoulder, run by Ottawa Hospital Research Institute at 4 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis of the Shoulder
- What is being tested?
- Total Shoulder Arthroplasty and Reverse Shoulder Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 4 sitesCanada
- Study dates
- 9 Mar 2020to 31 Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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:
- 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 glenohumeral cartilage loss
- Patients may present with a glenoid deficiency and </=15 degrees of retroversion
- 65 years of age and older
Who cannot join
- Active joint or systemic infection
- Rotator cuff arthropathy
- Significant muscle paralysis
- Charcot's arthropathy
- Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
- Unable to understand the consent form/process
Show all 11Show fewer
- Pregnancy
- Psychiatric illness that precludes informed consent
- Unwilling to be followed for the duration of the study
- Retroversion cannot be surgically corrected to within 10 degrees of neutral
- History of previous shoulder surgery on affected side
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Not yet recruiting
University of Alberta
Edmonton, Alberta, T6G2G3
Martin Bouliane, MD, 780-434-4859
Martin Bouliane, MD
- Recruiting
Kingston General Hospital (Site-Watkins 3)
Kingston, Ontario, K7L 2V7
Fiona Howells, 613-549-6666 ext. 4348, fiona.howells@queensu.ca
Ryan Bicknell, MD
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H8L6
Peter Lapner, MD, 6137378899 ext. 78377
Peter Lapner, MD
- Not yet recruiting
Pan Am Clinic Foundation
Winnipeg, Manitoba, R3M3E4
Sheila McRae, 204-925-7469
Jason Old, MD
About this study
Official title: Study Evaluating Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis: Protocol
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.
Read the 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.
- Conditions
- Osteoarthritis of the Shoulder
- Being tested
- Total Shoulder Arthroplasty, Reverse Shoulder Arthroplasty
- Keywords
- arthroplasty, glenohumeral osteoarthritis, idiopathic osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Shoulder ArthroplastyProcedure or surgery
Replacement of the shoulder joint (ball and socket, or humeral head and glenoid) using prosthetic components.
Reverse Shoulder ArthroplastyProcedure or surgery
Replacement of the shoulder joint like the TSA, however the orientation of the ball and socket is reversed.
| Study group | Role | What they receive |
|---|---|---|
| Total Shoulder Arthroplasty (anatomic) | Active comparator | TSA procedure involves replacing the worn-out ball and socket joint with prosthetic components. Receives: Procedure: Total Shoulder Arthroplasty |
| Reverse Shoulder Arthroplasty | Active comparator | RSA procedure is similar to a TSA, however the orientation of the ball and socket joint is placed in the reverse position Receives: Procedure: Reverse Shoulder Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24-Months and 5-Years Post-Operative
Secondary outcomes (8)
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.
Measured: 24-Months and 5-Years Post-Operative
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.
Measured: 24-Months and 5-Years Post-Operative
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.
Measured: 24-Months and 5-Years Post-Operative
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.
Measured: 24-Months and 5-Years Post-Operative
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.
Measured: 24-Months and 5-Years Post-Operative
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).
Measured: 24-Months and 5-Years Post-Operative
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.
Measured: 24-Months and 5-Years Post-Operative
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.
Measured: 24-Months and 5-Years Post-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start9 Mar 2020
- Primary completion1 Jan 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the ShoulderStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Lapner, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228419
- Sponsor's protocol ID
- 20190674-01H
- Acronym
- SERVASA
- Status last verified
- Mar 2025
- First submitted
- 17 Dec 2019
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers, who are not participating in the study.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis: Protocol
- ClinicalTrials.gov ID
- NCT04228419
- Acronym / sponsor ID
- SERVASA / 20190674-01H
- Conditions
- Osteoarthritis of the Shoulder
- Keywords
- arthroplasty, glenohumeral osteoarthritis, idiopathic osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Shoulder Arthroplasty (anatomic) | Active comparator | Procedure: Total Shoulder ArthroplastyTSA procedure involves replacing the worn-out ball and socket joint with prosthetic components. |
| Reverse Shoulder Arthroplasty | Active comparator | Procedure: Reverse Shoulder ArthroplastyRSA procedure is similar to a TSA, however the orientation of the ball and socket joint is placed in the reverse position |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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:
- Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss
- Patients may present with a glenoid deficiency and </=15 degrees of retroversion
- 65 years of age and older
Key exclusion criteria (11 listed)
- Active joint or systemic infection
- Rotator cuff arthropathy
- Significant muscle paralysis
- Charcot's arthropathy
- Major medical illness (life expectancy less than 1 year or unacceptably high operative risk)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Shoulder ArthroplastyReplacement of the shoulder joint (ball and socket, or humeral head and glenoid) using prosthetic components. | Procedure or surgery | Total Shoulder Arthroplasty (anatomic) |
| Reverse Shoulder ArthroplastyReplacement of the shoulder joint like the TSA, however the orientation of the ball and socket is reversed. | Procedure or surgery | Reverse Shoulder Arthroplasty |
Primary outcome
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Time frame: 24-Months and 5-Years Post-Operative
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.
8 secondary outcomes
Standard CT Scans
Time frame: 24-Months and 5-Years Post-Operative
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)
Time frame: 24-Months and 5-Years Post-Operative
Pain Level
Time frame: 24-Months and 5-Years Post-Operative
Subjective Shoulder Value
Time frame: 24-Months and 5-Years Post-Operative
EuroQol EQ-5D-5L
Time frame: 24-Months and 5-Years Post-Operative
Constant Score
Time frame: 24-Months and 5-Years Post-Operative
Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: 24-Months and 5-Years Post-Operative
Health Care Utilization
Time frame: 24-Months and 5-Years Post-Operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers, who are not participating in the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Lapner, MD principal investigator
The Ottawa Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Shoulder Arthroplasty and Reverse Shoulder Arthroplasty in people with Osteoarthritis of the Shoulder, run by Ottawa Hospital Research Institute at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Lapner Lapner, MD (613-737-8899 ext. 78377, plapner@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario Osteoarthritis of the Shoulder Index (WOOS) (time frame: 24-Months and 5-Years Post-Operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.