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NCT Number: NCT07545707

Radiologist-Integrated Finite Element Framework for Acromial Stress in Reverse Shoulder Arthroplasty

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).

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Key information

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Molise

Campobasso, CB, 86100, Italy

Location contact

Emanuele Zappia

CONTACT

[email protected]

About this study

Background and Rationale. Acromial stress fracture is a recognised complication following reverse shoulder arthroplasty (RSA), with a clinically relevant incidence reported in prospective cohorts. The mechanical link between RSA-induced load redistribution and acromial fracture localisation remains incompletely characterised, and no validated preoperative tool currently exists to stratify acromial fracture risk on a patient-specific basis. This study addresses that gap by integrating musculoskeletal radiology grading with subject-specific finite element (FE) modelling within a single prospective pipeline.

Study Design. A prospective single-centre observational cohort of consecutive elective RSA candidates will be enrolled. Each participant will undergo high-resolution preoperative imaging consisting of computed tomography (voxel ≤1 mm) for cortical bone reconstruction and 1.5T or 3T magnetic resonance imaging for soft-tissue and rotator cuff assessment.

Radiologist Grading and Cuff Deficiency Index. Rotator cuff integrity will be graded by a senior musculoskeletal radiologist using the Goutallier classification for fatty infiltration. From these grades, a continuous Cuff Deficiency Index (CDI) will be derived as a quantitative descriptor of cuff functional capacity. The CDI will be used as a direct biomechanical input to scale the deltoid force estimates applied to the FE model.

Finite Element Pipeline. Patient-specific finite element models will be constructed from the segmented imaging data. Cortical bone will be assigned heterogeneous Hounsfield-mapped material properties, deltoid muscle anatomy will be reconstructed from MRI, and physiological as well as RSA-specific loading scenarios will be simulated using FEBio. Mesh convergence and boundary-condition sensitivity will be verified for each subject.

Outcome Assessment. The primary outcome is the regional 95th-percentile von Mises stress within acromial regions of interest corresponding to Levy zones I-III, evaluated at six months post-surgery. Stress-based and morphometric parameters will be correlated with postoperative radiographic outcomes assessed at the same six-month follow-up.

Expected Contribution. By coupling radiologist-graded clinical input with patient-specific FE modelling, this study aims to establish the feasibility of a prospective framework for preoperative acromial stress assessment in RSA candidates.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Regional von Mises stress within acromial Levy zones

    Time frame: 6 months post-surgery

    95th percentile of von Mises stress extracted from patient-specific finite element models within anatomically defined Levy classification zones of the acromion

Study contacts

Contact information is provided by the study sponsor or research team.

Emanuele Zappia

CONTACT

[email protected]

00393393111619

Sponsors and collaborators

Lead sponsor

University of Molise

Other

Registry information

Official study title

From Clinical Grading to Mechanical Vulnerability: A Radiologist-Integrated Parametric Finite Element Study of Progressive Cuff Deficiency and Acromial Overload in Reverse Shoulder Arthroplasty

Acronym: RIFA-RSA

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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