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Radiologist-Integrated Finite Element Framework for Acromial Stress in Reverse Shoulder Arthroplasty (NCT07545707)

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Summary

NCT07545707 is a prospective single-center observational study registered April 22, 2026, examining an approach using high-resolution CT and MRI scans combined with customized finite element modelling to analyze stress on the acromion of patients who have undergone reverse shoulder arthroplasty (RSA) surgery. The study will assess rotator cuff deficiency using Goutallier classification quantified as Cuff Deficiency Index (CDI) to calculate deltoid forces for finite element analysis. Von Mises stresses in specific acromion zones defined by Levy et al. will then be analyzed. The study focuses on patients with Rotator Cuff Injuries and Shoulder Fractures.

“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.”

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What changed

NCT07545707 registers a prospective observational clinical study examining the use of high-resolution CT and MRI scans combined with customized finite element modelling to analyze stress placed on the acromion of patients who have undergone reverse shoulder arthroplasty (RSA) surgery. The study design includes assessment of rotator cuff deficiency using Goutallier classification quantified as Cuff Deficiency Index (CDI), which provides biomechanical information for calculating deltoid forces used in finite element analysis. Von Mises stresses in specific acromion zones defined by Levy et al. will be analyzed. This is an informational registration entry in ClinicalTrials.gov database — it does not create compliance obligations or regulatory requirements. Healthcare providers and clinical researchers may use this registry entry to identify ongoing research in shoulder biomechanics and acromial stress analysis.

Archived snapshot

Apr 23, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

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

Observational NCT07545707 Kind: OBSERVATIONAL Apr 22, 2026

Abstract

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 in specific acromion zones defined by Levy et al. will then be analyzed.

Conditions: Rotator Cuff Injuries, Shoulder Fractures

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Classification

Agency
NIH
Published
April 22nd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical research Medical imaging Device performance monitoring
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Public Health

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