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GFI: Study of the Geometry of the Immature Human Femur Before the Age of 3 Years From Data Measured on CT Scan

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05620394
Collaborator
(none)
150
Enrollment
1
Location
26.8
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Childhood fractures are the second most common presentation of abuse. The target population for screening for these injuries is children under the age of three who are unable to express themselves about the circumstances of the trauma, hence the need to develop a validated model to predict the outcome of trauma as well as the origin of a fracture.

Few morphological data are available in the literature for the femur concerning the period of rapid growth between 0 and 3 years of age.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Study of the Geometry of the Immature Human Femur Before the Age of 3 Years From Data Measured on CT Scan
    Actual Study Start Date :
    Oct 7, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. To retrospectively characterize the variations in femur morphology during growth in a target pediatric population aged 0 to 3 years [Files analysed retrospectively from January 01, 2015 to February 29, 2020 will be examined]

      To retrospectively characterize the variations in femur morphology during growth in a target pediatric population aged 0 to 3 years with the aim of later developing a numerical model to study fracture mechanisms for forensic applications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 3 Years
    Sexes Eligible for Study:
    All
    Inclusion criteria:

    • Minor patient who died before the age of 3 years

    • Whole body CT imaging performed post mortem on judicial requisition in the framework of a forensic procedure

    • Absence of refusal in the medical file by the holders of parental authority concerning the re-use of their child's data for the purposes of this research

    Exclusion criteria:

    • Refusal manifested in the medical record by parental authority holders regarding the reuse of their child's data for the purpose of this research,

    • Femur not fully assessable on imaging acquisition

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Médecine Légale et Toxicologie - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05620394
    Other Study ID Numbers:
    • 7714
    First Posted:
    Nov 17, 2022
    Last Update Posted:
    Nov 17, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Femur Fracture, Childhood
    Additional relevant MeSH terms:
    Femoral Fractures

    Study Results

    No Results Posted as of Nov 17, 2022