Comparing Total Shoulder Arthroplasty with Reverse Shoulder Arthroplasty for osteoarthritis of the shoulder
Official title: TSA vs RSA in Glenohumeral Osteoarthritis
Study Evaluating Reverse Versus Anatomic Shoulder Arthroplasty Techniques in the Treatment of Osteoarthritis: Protocol
Interventions
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.
Canadian Sites (4)
University of Alberta
Edmonton, Alberta, Canada
Pan Am Clinic Foundation
Winnipeg, Manitoba, Canada
Kingston General Hospital (Site-Watkins 3)
Kingston, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
Exclusion
- −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 formInformed consentThe process of being told what taking part involves, then choosing freely.Read more →/process
- −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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Total Shoulder Arthroplasty, Reverse Shoulder Arthroplasty.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 65 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 108 people.
The study is currently expected to finish around December 2032.
The main measurement is taken over: 24-Months and 5-Years Post-Operative.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Western Ontario Osteoarthritis of the Shoulder Index (WOOS) — measured over 24-Months and 5-Years Post-Operative.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04228419 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Total Shoulder ArthroplastyProcedure
Replacement of the shoulder joint (ball and socket, or humeral head and glenoid) using prosthetic components.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Reverse Shoulder ArthroplastyProcedure
Replacement of the shoulder joint like the TSA, however the orientation of the ball and socket is reversed.
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 65 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 24-Months and 5-Years Post-Operative.
The study as a whole is currently expected to finish around 2032-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 108 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Edmonton, Alberta, Canada; Winnipeg, Manitoba, Canada; Kingston, Ontario, Canada; Ottawa, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.