Radiologist-Integrated Finite Element Framework for Acromial Stress in Reverse Shoulder Arthroplasty
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-80
SponsorUniversity of Molise
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Revision RSA or history of prior shoulder prosthetic complications
Uncorrectable imaging artefacts
Post-RSA follow-up shorter than 6 months
Trial population
Consecutive elective RSA candidates at a single orthopaedic centre
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Regional von Mises stress within acromial Levy zones
95th percentile of von Mises stress extracted from patient-specific finite element models within anatomically defined Levy classification zones of the acromion
Time frame
6 months post-surgerySponsors and contacts
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Source ClinicalTrials.gov
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