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

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.

Study Overview

• Status: Recruiting
• Conditions: Femur Fracture, Childhood

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Jean-Sébastien RAUL, MD, PhD; Phone Number: 33 3 69 55 10 34; Email: jean-sebastien.raul@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Service de Médecine Légale et Toxicologie - CHU de Strasbourg - France
    • Contact: Jean-Sébastien RAUL, MD, PhD; Phone Number: 33 3 69 55 10 34; Email: jean-sebastien.raul@chru-strasbourg.fr
    • Principal Investigator: Jean-Sébastien RAUL, MD, PhD
    • Sub-Investigator: Alexis WALCH, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 months (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Minor patient who died before the age of 3 years

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To retrospectively characterize the variations in femur morphology during growth in a target pediatric population aged 0 to 3 years	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	Files analysed retrospectively from January 01, 2015 to February 29, 2020 will be examined

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Femur Fracture, Childhood
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures
• Other Study ID Numbers: 7714

Drug and device information, study documents

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