ClinicalTrials.gg
Status unknownNCT05538403Updated Sep 13, 2022

AI Performance for the Detection of Bone Fractures in Children

An observational study in Fracture, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged 0 Years to 2 Years. Per ClinicalTrials.gov, last updated 2022-09-13.

Sponsored by University Hospital, Montpellier · Observational

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
210
Ages
0 Years to 2 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fracture

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Keywords

  • Aged
  • Radiography
  • Paediatric imaging
  • Artificial intelligence
  • child abuse
03

In context

Fractures, Bone

2,272 studies on the registry are indexed under Fractures, Bone; 321 are open to participants now.

This study's planned enrollment of 210 is above the median of 100 across 677 observational studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 227 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 2 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children aged less than 2 years old in suspected child abuse setting

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  • Radiograph not interpretable ( poor quality)
  • AI not applicable
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
210 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Percentage of fracture detected by AI on radiographs

    Percentage of fracture detected by AI on radiographs

    Time frame: 1 day

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2022 (actual). Primary completion is estimated for Nov 2022, 6 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 9, 2022
First posted
Sep 13, 2022
StartActual
May 1, 2022
Primary completionEst.
Nov 1, 2022
CompletionEst.
Dec 30, 2022
Last update
Sep 13, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05538403
Responsible party
Sponsor
First posted
Sep 13, 2022
Start date
May 1, 2022
Primary completion
Nov 1, 2022 (estimated)
Completion
Dec 30, 2022 (estimated)
Last update
Sep 13, 2022

Study contacts

Ingrid Millet, PUPH
Contact
i-millet@chu-montpellier.fr
678887174 ext. 33
Ingrid Millet, PUPH
study director · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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