Study of the Geometry of the Immature Human Femur Before... | NCT05620394

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

NCT05620394

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Oct 31, 2023Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Femur Fracture, Childhood

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 7, 2020Actual

Primary Completion Date

Dec 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Nov 9, 2022

First Submission Date that Met QC Criteria

Nov 9, 2022

First Posted Date

Nov 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2023

Last Update Posted Date

Oct 31, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Years

Standard Ages

Child

Study Population

Minor patient who died before the age of 3 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jean-Sébastien RAUL, MD, PhD	Contact	33 3 69 55 10 34		jean-sebastien.raul@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Médecine Légale et Toxicologie - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D005264	Femoral Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided