NCT06645561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 15, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
Last Updated

October 17, 2024

Status Verified

February 1, 2023

Enrollment Period

8 months

First QC Date

October 15, 2024

Last Update Submit

October 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dating fracture

    in days

    between 2011 and 2023

Study Arms (1)

Infants under one year

Procedure: X-ray

Interventions

X-rayPROCEDURE

defined radiographic semiological criteria to determine an analytical methodology to facilitate the dating of long bone fractures of infants under one year of age

Infants under one year

Eligibility Criteria

Age0 Years - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

  • child maltreatment,
  • chronic illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Lenval

Nice, 06200, France

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 17, 2024

Study Start

February 2, 2023

Primary Completion

October 2, 2023

Study Completion

October 2, 2023

Last Updated

October 17, 2024

Record last verified: 2023-02

Locations