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NCT05538403 Clinical Trial

AI Performance for the Detection of Bone Fractures in Children

Fracture Clinical Trial

Official title:
Assessment of AI Performance for the Detection of Bone Fractures in Children Aged Less Than 2 Years Old in Suspected Child Abuse Setting.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05538403
Other study ID # RECHMPL22_0224
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date December 30, 2022

Study information
Verified date September 2022
Source University Hospital, Montpellier
Contact Ingrid Millet, PUPH
Phone 678887174
Email i-millet@chu-montpellier.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The artificial intelligence (AI) software BoneView (GLEAMER Company, Paris, France) has been designed, tested and validated to detect and locate recent or semi-recent fractures on standard radiographs. The objective will be to assess the AI performance for the detection of bone fractures in children aged less than 2 years old in suspected child abuse setting. These patients benefit from a whole body radiography with a double blind reading by a "generalist" radiologist and a radiologist with expertise in child abuse. This readings will be compared with the AI results. Hypothesis is that AI is effective for child fractures detection and could be of help especially for radiologists who are not experts in child abuse.

Recruitment information / eligibility
Status Recruiting
Enrollment 210
Est. completion date December 30, 2022
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group 0 Years to 2 Years
Eligibility Inclusion criteria: - aged less than 2 years old - whole body radiography performed for suspected child abuse setting - report available with a double blind reading (generalist radiologist and radiologist with expertise in child abuse) Exclusion criteria: - Radiograph not interpretable ( poor quality) - AI not applicable

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France University hospital Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of fracture detected by AI on radiographs Percentage of fracture detected by AI on radiographs 1 day
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