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

Assessment of the Contribution of an Artificial Intelligence Tool to Help the Diagnosis of Limb Fractures in Pediatric Emergencies : an Interventional, Prospective, Single-center Study

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

Study Overview

• Status: Completed
• Conditions: Fractures, Bone
• Intervention / Treatment: Diagnostic test: radiograph interpretation without the support of the RAYVOLVE app; Diagnostic test: radiograph interpretation with the support of the RAYVOLVE app

Detailed Description

Limb fracture is a common pathology in children with trauma. It represents the first complaint in traumatology among children in developed countries.

Failure to diagnose a fracture on an X-ray can have severe consequences in pediatric patients, with growing bones, that can lead to delayed treatment, pain and poor functional recovery (with risk of bone deformity and bad consolidation).

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 both residents and pediatricians before the radiologists proofread (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 clinician exposed to this condition.

Artificial intelligence (AI) in medicine is booming and has already proven its worth, in terms of prevention, monitoring and diagnosis.

AZMED has created RAYVOLVE®, a deep learning algorithm to help physicians in diagnosing fractures. The RAYVOLVE® tool connects to the PACS (Picture Archiving and Communication System) of any hospital and indicates, using a frame, the location of a potential fracture.

The tool has not yet been validated in pediatric patients.

The purpose of this research project is to evaluate the contribution of this artificial intelligence-based tool in the diagnosis of limb fracture in pediatric population.

The investigators will study the concordance in diagnosing limb fracture between the junior emergency physicians using the RAYVOLVE® application and senior radiologists, as the gold standard.

• Study Type: Interventional
• Enrollment (Actual): 1200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France, 06200
    • Hôpitaux Pédiatriques de Nice CHU-Lenval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children under 18
• Showing signs that may suggest a limb fracture and justifying the realization of an X-ray (trauma with pain, deformation, edema, wound)
• Written informed consent from one of the two parents or the holder of parental authority signed
• Beneficiaries or members of a Health Insurance scheme

Exclusion Criteria:

• A sign (s) of vital distress
• Any other reason than that of a suspected limb fracture
• A diagnosis of a limb fracture before its management in the emergency room (x-ray made in pre-hospital)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: radiograph interpretation without the support of the RAYVOLVE app	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.
Experimental: radiograph interpretation with the support of the RAYVOLVE app	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis fracture with Rayvolve app compare to gold standard	Assess the statistical concordance between residents using the RAYVOLVE application tool and senior radiologists in diagnosing fractures of the extremities, as gold standard. Criteria: binary: fracture Yes/No	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis fracture with Rayvolve app compare to diagnosis done by physicians	Assess the statistical concordance between residents using the RAYVOLVE application tool and pediatric emergency physicians in diagnosing fractures of the extremities Criteria: binary: fracture Yes/No	at inclusion
Diagnosis fracture without Rayvolve app compare to diagnosis done by physicians	Assess the statistical concordance between residents not using the RAYVOLVE application tool and pediatric emergency physicians in diagnosing fractures of the extremities Criteria: binary: presence or no fracture	at inclusion
collection of patient data to define risk factors associated with the discrepancy between residents using the RAYVOLVE application tool and senior radiologists not using the application	collection patient data such as patient's age, fracture location, fracture type, number of fractures, day and time of diagnosis. The goal is to define potential risk factors to explain diagnostic differences between residents and primary radiologists	at inclusion
satisfaction of the residents using the application assessed by Likert scale	measure of satisfaction by an in-house Likert scale: consisting of 4 questions with multiple choice answers on the use and ergonomics of the application. The answers range from not at all satisfied to very satisfied.	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Fondation Lenval

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Actual): February 17, 2024
• Study Completion (Actual): February 17, 2024

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 21-HPNCL-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No