Modal Anatomy of the Ethmoid Bone (AME)

Constitution d'un modèle 3D d'Anatomie Modale de L'Ethmoide Par intégration de Multiples Instances d'Acquisition

The creation of a 3D model of modal anatomy of the ethmoid could, like other parts of the body, improve anatomical, radiological and perhaps even surgical learning. Anatomical variations might constitute a "background noise" of the modal anatomy, which can be attenuated by multiplying the instances of acquisitions. The objective of this work is to establish modal anatomy of the ethmoid by the analysis of a large number of CT-scan acquisitions carried out in individuals with no acquired sinus pathology.

Study Overview

• Status: Unknown
• Conditions: Anatomic Abnormality
• Intervention / Treatment: Other: No intervention

Detailed Description

Non-interventional descriptive research.

Sinus CTscans (period 2016-2019) will be reviewed from the PACS database of the CHRU of Nancy and selected in individuals without sinus pathology. All CT-scans will be fully anonymized. 26 landmarks will be pointed out to enable :

1. prior images alignment (centering on the median line, realignment rotations then resizing)
2. a mean and median calculation, allowing to establish a mean and median ethmoid model
3. calculation of standard deviations for each voxel The structures obtained in this way (bone, tissue or aerial) will be described anatomically.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who had a sinus CT-scan during the 2016-2019 period.

Description

Retrospective analysis of sinus CT scans images from individuals (period 2016-2019)

Inclusion Criteria:

All individuals (>18 years all) with a sinus CT scan available in the CHRU database

Exclusion Criteria:

inflammatory sinus disease (eg. nasal polyposis, aspergilloma, ...) evolutive sinus tumor anatomical abnormality (e.g. post traumatic, prior sinus surgery, embryologic abnormality...)

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CT scans; No intervention Data of voxels will be integrated to the final model	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Descriptive study of the anatomy of the final 3D model	Descriptive study The study aims to produce the "modal" (generic) model from all the individual sub-models. The structures obtained will be described anatomically by ENT experts: the created model will be described in comparison with anatomical data from literature: constant structures (e.g. middle turbinate, inferior turbinate, or orbital wall) will be listed and described (sites of insertion, direction, form), while variations in anatomical structures will be described through the variance (variances of voxels, pooled for each anatomical sub-site) (e.g. anterior ethmoid, sphenoid...). The heat map of voxels' variances will be superposed on the final model. No scale/physiological parameter/questionnaire can be used for anatomical description of a single model. Therefore we don't really understand your remark "Please further specify the measurement that will be used (e.g., descriptive name of scale, physiological parameter, questionnaire) to assess this outcome measure."	Through completion of the study: 1 month (The model will be available only at the end of the study, after implementation of all CT-scans)

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2021
• Primary Completion (Anticipated): August 30, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: April 25, 2021
• First Posted (Actual): April 29, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 19, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 2020PI160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No