TSA Versus RSA in Patients >75 (NCT04827277) | Clinical Trial Compass
UnknownNot Applicable
TSA Versus RSA in Patients >75
United States108 participantsStarted 2021-04-15
Plain-language summary
Total shoulder arthroplasty (TSA) has proven to be a predictable and successful operation for the treatment of symptomatic glenohumeral osteoarthritis (GHOA) with an intact rotator cuff. Results after TSA have not been as good in cases with rotator cuff dysfunction, however. Early glenoid loosening, shoulder pain and the need for revision surgery has been all associated with rotator cuff deficiency. Even in cases without tears, fatty infiltration of the rotator cuff has been associated with inferior outcomes in TSA.
Advanced age has been shown to be associated with increased fatty infiltration of the rotator cuff in shoulders with primary osteoarthritis. Because of this, one may propose that surgeons should avoid the potential complications with TSA and perform RSA for patients with advanced age. It is thus the purpose of this study to evaluate the patient reported outcomes (PROs) of total shoulder arthroplasty (TSA) compared with reverse shoulder arthroplasty (RSA) in patients \>75 years of age
Who can participate
Age range
75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* All patients (75 years of age) at the time of surgery
* Patient is willing to participate by complying with pre and postoperative visit requirements
* Patient is willing to consent for enrollment
* Patient has advanced imaging (CT or MRI) that demonstrates an intact rotator cuff
Exclusion Criteria:
* Patients under the age of 75
* Need for any structural graft for repair of the shoulder during surgery
* Current infection of the proximal humerus or scapula
* Proximal humerus fracture
* Inadequate or malformed bone that precludes adequate support for prosthesis (B2, B3, C Glenoid morphology)
* Neuromuscular disorder that does not allow control of the shoulder joint
* Significant injury to the brachial plexus
* Diagnosis of inflammatory arthropathy
* Preoperative diagnosis of full thickness rotator cuff tear
* \>Goutallier Stage 1 rotator cuff atrophy
* Prior shoulder arthroplasty
* Non-functioning deltoid muscle
* Patients who are known drug or alcohol abuser, or have a psychological disorder as defined by the DSM4 that could affect follow-up care
* Patient is a prisoner
* Patients who are currently involved in any personal injury litigation, or worker's compensation claims.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.