Assessment of the Contribution of an Artificial Intelligence Tool to Help the Diagnosis of Limb Fractures in Pediatric Emergencies

NCT05187585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2025-04-01

No results posted yet for this study

Summary

Limb fracture is a common pathology in children. It represents the first complaint in traumatology among children in developed countries. Failure to diagnose a fracture can have severe consequences in pediatric patients with growing bones, that can lead to delayed treatment, pain and poor functional recovery.

X-ray is the first tool used by doctors to diagnose a fracture. However, the diagnosis of fracture in the emergency room can be challenging. Most images are interpreted and processed by emergency pediatricians before being reviewed by radiologists (most often the day after).

Previous studies have reported the rate of misdiagnosis in fracture by emergency physicians from 5% to 15%.

A tool to investigate in diagnosing limb fractures could be helpful for any emergency physicians exposed to this condition

Conditions

  • Fractures, Bone

Interventions

DIAGNOSTIC_TEST

radiograph interpretation without the support of the RAYVOLVE app

Phase 1 does not involve any intervention: residents, emergency physicians, and radiologists will interpret the x-rays without the support of the RAYVOLVE application. The emergency physician interprets the x-ray and manage the case as per protocol, all the x-rays will be reinterpreted by the radiologist only later, usually the day after. In case of missed fractures, the physician is notified of the error by the radiologist, and patients will be informed and recalled to the hospital to be reevaluated.

DIAGNOSTIC_TEST

radiograph interpretation with the support of the RAYVOLVE app

The residents interpret the X-ray with the RAYVOLVE application's support and indicate the presence or not of a fracture without sharing it with the senior emergency physician. A senior emergency physician manages the case as usual, and all the x-rays will be reinterpreted by the radiologist only later, usually the day after. In case of missed fractures, the physician is notified of the error by the radiologist, and patients will be informed and recalled to the hospital to be reevaluated

Sponsors & Collaborators

  • Fondation Lenval

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-10
Primary Completion
2024-02-17
Completion
2024-02-17

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05187585 on ClinicalTrials.gov