Radiologist-Integrated Finite Element Framework for Acromial Stress in Reverse Shoulder Arthroplasty (NCT07545707) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Radiologist-Integrated Finite Element Framework for Acromial Stress in Reverse Shoulder Arthroplasty
Italy13 participantsStarted 2026-06-01
Plain-language summary
The current prospective single-center study is designed to examine an approach that utilizes both high-resolution CT and MRI scans, coupled with customized finite element modelling to analyze the stress placed on the acromion of patients who have undergone RSA surgery. The degree of rotator cuff deficiency will be assessed using Goutallier classification and quantified as Cuff Deficiency Index (CDI), which directly provides biomechanical information for calculating deltoid forces used in finite element analysis. Von Mises stresses will then be analyzed in anatomically defined acromial zones (Levy zones I-III).
Who can participate
Age range
60 Years – 80 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:
* Adult patients (60-80 years) with cuff tear arthropathy (Hamada grade 3 or above, Walch glenoid B/C) scheduled for primary unilateral reverse shoulder arthroplasty
* Availability of preoperative high-resolution CT (voxel 1 mm or less) and 1.5T/3T MRI
* Written informed consent for prospective use of anonymised data
Exclusion Criteria:
* Revision RSA or history of prior shoulder prosthetic complications
* Uncorrectable imaging artefacts
* Post-RSA follow-up shorter than 6 months
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.
What they're measuring
1
Regional von Mises stress within acromial Levy zones