Osteoarthritis ShoulderSERVASA15NCT05487274
TSA v RSA in Osteoarthritic Shoulders With Greater Than 15 Degrees of Retroversion
A study testing Total Shoulder Arthroplasty + augmented glenoid component and Reverse Shoulder Arthroplasty in people with Osteoarthritis Shoulder, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
This study will compare total shoulder arthroplasty (TSA) with an augmented glenoid component and reverse shoulder arthroplasty (RSA) procedures, in participants with advanced glenohumeral osteoarthritis aged 65 years and older, who also present with greater than 15 degrees of glenoid retroversion, in the context of a… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis Shoulder
- What is being tested?
- Total Shoulder Arthroplasty + augmented glenoid component 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
- 1 siteCanada
- Study dates
- 9 Aug 2022to 31 Dec 2029
- 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
- Diagnosis of idiopathic shoulder OA.
- Patients who have failed standard non-surgical management of their shoulder OA 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 at least 6 months. Medical management will be defined as: a) The use of drugs including analgesics and nonsteroidal anti-inflammatory drugs, b) Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.), c) Activity modification
- Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss
- Patients with a glenoid deficiency and >15 degrees of glenoid retroversion up to a maximum of 26 degrees of glenoid retroversion (i.e. -15.1, -17, -20…etc.)
- 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 12Show 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
- Rheumatoid arthritis in the affected shoulder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H8L6
Katie McIlquham, 613-737-8899 ext. 79839, kmcilquham@ohri.ca
Peter Lapner, MD FRCSC
About this study
Official title: Study Evaluating Reverse Versus Anatomic Total Shoulder Arthroplasty in Shoulders With Greater Than 15 Degrees of Retroversion in the Treatment of Osteoarthritis: Protocol
This study will compare total shoulder arthroplasty (TSA) with an augmented glenoid component and reverse shoulder arthroplasty (RSA) procedures, in participants with advanced glenohumeral osteoarthritis aged 65 years and older, who also present with greater than 15 degrees of glenoid retroversion, in the context of a prospective, randomized controlled trial to determine the optimal treatment in this patient population.
Read the detailed description
Osteoarthritis (OA) of the shoulder or glenohumeral joint, 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 our aging population. Total shoulder arthroplasty (TSA) or Reverse shoulder arthroplasty (RSA) are common surgical procedures used to treat patients with glenohumeral OA. TSA involves replacing the worn-out ball and socket glenohumeral joint with prosthetic components. TSA is performed today with high success rates, however, complication rates associated with TSA remain prevalent, particularly when the OA is associated with bone erosion on the glenoid (socket). An additional surgical technique using an "augmented glenoid component" has been developed to address this issue of missing bone. This technique attempts to realign and restore balance to the shoulder joint using artificial components and is also being performed as standard of care.
RSA is an alternative surgical procedure 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 in older population and those with a more advanced level of OA degeneration. Previous studies have been limited to case series with small sample sizes and respective designs.
This research will provide surgeons with new information regarding the best treatment for this patient population.
This randomized controlled trial (RCT) will compare TSA + augmented glenoid component and RSA procedures to determine which approach produces better functional outcomes and quality of life in those with advanced OA who are in older patient population (65 years and older).
Primary Objective: Determine the difference in disease specific quality of life between patients diagnosed with glenohumeral OA who present with greater than 15 degrees (-15.1, -17, -20…etc.) of glenoid retroversion and undergo either a TSA + augmented glenoid component or RSA as measured by the 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 glenohumeral OA who present with greater than 15 degrees of glenoid retroversion, and undergo a either a TSA + augmented glenoid component or RSA as measured by the Constant score, the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES), EuroQol Group EQ-5D-5L, pain Visual Analog Scale (VAS), and Subjective Shoulder Value (SSV) scores at 24-months and 5-years post-operative, as well as adverse events, and health care utilization.
ii) 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: Glenohumeral 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 Shoulder
- Being tested
- Total Shoulder Arthroplasty + augmented glenoid component, Reverse Shoulder Arthroplasty
- Keywords
- Shoulder 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 Arthroplasty + augmented glenoid componentProcedure or surgery
Replacement of the shoulder joint (ball and socket, or humeral head and glenoid) using prosthetic components. A prosthetic component is also implanted to correct for the amount of bone loss in the shoulder and restore stability.
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) + augmented glenoid component | Active comparator | TSA procedure involves replacing the worn-out ball and socket joint with prosthetic components. An additional surgical technique, "augmented glenoid component" implantation is performed when there is missing bone in the shoulder and is currently being done as standard of care. This technique is used particularly when a large amount of instability within the shoulder joint is present. This technique attempts to realign and restore balance to the shoulder joint using artificial components. Receives: Procedure: Total Shoulder Arthroplasty + augmented glenoid component |
| 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 Post-Operative
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: 5-Years Post-Operative
Secondary outcomes (14)
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 Post-Operative
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: 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 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: 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 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: 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 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: 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 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: 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 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: 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: 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: 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 posted4 Aug 2022
- Study start9 Aug 2022
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis 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
- Single blind
- Who is masked
- 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 FRCSC, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487274
- Sponsor's protocol ID
- 20220449-01H
- Acronym
- SERVASA15
- Status last verified
- Apr 2024
- First submitted
- 20 Jul 2022
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers unless requested and an agreement is in place. Only aggregate data will be made public (study results).
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating Reverse Versus Anatomic Total Shoulder Arthroplasty in Shoulders With Greater Than 15 Degrees of Retroversion in the Treatment of Osteoarthritis: Protocol
- ClinicalTrials.gov ID
- NCT05487274
- Acronym / sponsor ID
- SERVASA15 / 20220449-01H
- Conditions
- Osteoarthritis Shoulder
- Keywords
- Shoulder 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 Aug 2022 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Aug 2022 (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) with an augmented glenoid component and reverse shoulder arthroplasty (RSA) procedures, in participants with advanced glenohumeral osteoarthritis aged 65 years and older, who also present with greater than 15 degrees of glenoid retroversion, in the context of a prospective, randomized controlled trial to determine the optimal treatment in this patient population.
Detailed description
Osteoarthritis (OA) of the shoulder or glenohumeral joint, 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 our aging population. Total shoulder arthroplasty (TSA) or Reverse shoulder arthroplasty (RSA) are common surgical procedures used to treat patients with glenohumeral OA. TSA involves replacing the worn-out ball and socket glenohumeral joint with prosthetic components. TSA is performed today with high success rates, however, complication rates associated with TSA remain prevalent, particularly when the OA is associated with bone erosion on the glenoid (socket). An additional surgical technique using an "augmented glenoid component" has been developed to address this issue of missing bone. This technique attempts to realign and restore balance to the shoulder joint using artificial components and is also being performed as standard of care.
RSA is an alternative surgical procedure 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 in older population and those with a more advanced level of OA degeneration. Previous studies have been limited to case series with small sample sizes and respective designs.
This research will provide surgeons with new information regarding the best treatment for this patient population.
This randomized controlled trial (RCT) will compare TSA + augmented glenoid component and RSA procedures to determine which approach produces better functional outcomes and quality of life in those with advanced OA who are in older patient population (65 years and older).
Primary Objective: Determine the difference in disease specific quality of life between patients diagnosed with glenohumeral OA who present with greater than 15 degrees (-15.1, -17, -20…etc.) of glenoid retroversion and undergo either a TSA + augmented glenoid component or RSA as measured by the 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 glenohumeral OA who present with greater than 15 degrees of glenoid retroversion, and undergo a either a TSA + augmented glenoid component or RSA as measured by the Constant score, the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES), EuroQol Group EQ-5D-5L, pain Visual Analog Scale (VAS), and Subjective Shoulder Value (SSV) scores at 24-months and 5-years post-operative, as well as adverse events, and health care utilization.
ii) 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: Glenohumeral 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
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Shoulder Arthroplasty (anatomic) + augmented glenoid component | Active comparator | Procedure: Total Shoulder Arthroplasty + augmented glenoid componentTSA procedure involves replacing the worn-out ball and socket joint with prosthetic components. An additional surgical technique, "augmented glenoid component" implantation is performed when there is missing bone in the shoulder and is currently being done as standard of care. This technique is used particularly when a large amount of instability within the shoulder joint is present. This technique attempts to realign and restore balance to the shoulder joint using artificial 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 (5 listed)
- Diagnosis of idiopathic shoulder OA.
- Patients who have failed standard non-surgical management of their shoulder OA 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 at least 6 months. Medical management will be defined as: a) The use of drugs including analgesics and nonsteroidal anti-inflammatory drugs, b) Physiotherapy consisting of stretching, strengthening and local modalities (ultrasound, cryotherapy, etc.), c) Activity modification
- Imaging, and intra-operative findings confirming advanced glenohumeral cartilage loss
- Patients with a glenoid deficiency and >15 degrees of glenoid retroversion up to a maximum of 26 degrees of glenoid retroversion (i.e. -15.1, -17, -20…etc.)
- 65 years of age and older
Key exclusion criteria (12 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 Arthroplasty + augmented glenoid componentReplacement of the shoulder joint (ball and socket, or humeral head and glenoid) using prosthetic components. A prosthetic component is also implanted to correct for the amount of bone loss in the shoulder and restore stability. | Procedure or surgery | Total Shoulder Arthroplasty (anatomic) + augmented glenoid component |
| 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 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.
Western Ontario Osteoarthritis of the Shoulder Index (WOOS)
Time frame: 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.
14 secondary outcomes
Standard CT Scans
Time frame: 24-Months Post-Operative
Standard CT Scans
Time frame: 5-Years Post-Operative
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)
Time frame: 24-Months Post-Operative
American Shoulder and Elbow Surgeons Standardized Shoulder Assessment form (ASES)
Time frame: 5-Years Post-Operative
Pain Level
Time frame: 24-Months Post-Operative
Pain Level
Time frame: 5-Years Post-Operative
Subjective Shoulder Value
Time frame: 24-Months Post-Operative
Subjective Shoulder Value
Time frame: 5-Years Post-Operative
EuroQol EQ-5D-5L
Time frame: 24-Months Post-Operative
EuroQol EQ-5D-5L
Time frame: 5-Years Post-Operative
Constant Score
Time frame: 24-Months Post-Operative
Constant Score
Time frame: 5-Years Post-Operative
Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: 5-Years Post-Operative
Health Care Utilization
Time frame: 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 30 Apr 2024.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers unless requested and an agreement is in place. Only aggregate data will be made public (study results).
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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 FRCSC principal investigator
The Ottawa Hospital
1 site 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 + augmented glenoid component and Reverse Shoulder Arthroplasty in people with Osteoarthritis Shoulder, run by Ottawa Hospital Research Institute at 1 site 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 5 inclusion and 12 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Katie McIlquham (613-737-8899 ext. 79839, kmcilquham@ohri.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 Post-Operative). The study lists 2 primary outcomes in all. 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 30 Apr 2024.