Radiological Dating of Child Fractures Before One Year | NCT06645561

Studies
Radiological Dating of Child Fractures Before One Year

NCT06645561

Sponsor

Fondation Lenval

Status

Completed

Last Update Posted

Oct 17, 2024Actual

Enrollment

99Actual

Phase

Not provided

Conditions

Fractures

Interventions

X-ray

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2, 2023Actual

Primary Completion Date

Oct 2, 2023Actual

Completion Date

Oct 2, 2023Actual

First Submitted Date

Oct 15, 2024

First Submission Date that Met QC Criteria

Oct 15, 2024

First Posted Date

Oct 17, 2024Actual

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 15, 2024

Last Update Posted Date

Oct 17, 2024Actual

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

The aim of this study was to use, in a precise manner, defined radiographic semiological criteria to determine an analytical methodology to facilitate the dating of long bone fractures of infants under one year of age. A total of 99 radiographs of infants under one year of age with long bone fractures of known date were studied. Four dating groups were established on the basis of data in the literature, with the aim of developing predictive models based on well-defined semiological criteria, in order to construct a simplified dating decision tree.

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

99Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infants under one year			Procedure: X-ray

Interventions

Name	Type	Description	Arm Group Labels	Other Names
X-ray	Procedure	defined radiographic semiological criteria to determine an analytical methodology to facilitate the dating of long bone fractures of infants under one year of age

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dating fracture	in days	between 2011 and 2023

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

had X-rays taken at the University Paediatric Hospital for the diagnosis and/or follow-up of a fracture of the long bones of the limbs (tibia, femur, fibula, radius, humerus and/or ulna)

Exclusion Criteria:

child maltreatment,
chronic illnesses

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

1 Year

Standard Ages

Child

Study Population

A total of 99 radiographs of infants under one year of age with long bone fractures of known date were studied.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Lenval		Nice		06200	France

ID	Term
D050723	Fractures, Bone

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D014965	X-Rays

Ancestor Terms

ID	Term
D060733	Electromagnetic Radiation
D055590	Electromagnetic Phenomena
D060328	Magnetic Phenomena
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided