- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06645561
Radiological Dating of Child Fractures Before One Year
October 15, 2024 updated by: Fondation Lenval
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
99
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nice, France, 06200
- Fondation Lenval
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Infants under one year
|
defined radiographic semiological criteria to determine an analytical methodology to facilitate the dating of long bone fractures of infants under one year of age
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dating fracture
Time Frame: between 2011 and 2023
|
in days
|
between 2011 and 2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 2, 2023
Primary Completion (Actual)
October 2, 2023
Study Completion (Actual)
October 2, 2023
Study Registration Dates
First Submitted
October 15, 2024
First Submitted That Met QC Criteria
October 15, 2024
First Posted (Actual)
October 17, 2024
Study Record Updates
Last Update Posted (Actual)
October 17, 2024
Last Update Submitted That Met QC Criteria
October 15, 2024
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-HPNCL-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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