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

NCT05187585 | Completed

• 1 other identifier: 21-HPNCL-06
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Diagnosis fracture with Rayvolve app compare to diagnosis done by physicians

  at inclusion

• Diagnosis fracture without Rayvolve app compare to diagnosis done by physicians

  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

  at inclusion

• satisfaction of the residents using the application assessed by Likert scale

  through study completion, an average of 6 months

Study Arms (2)

radiograph interpretation without the support of the RAYVOLVE app

SHAM COMPARATOR

Diagnostic Test: radiograph interpretation without the support of the RAYVOLVE app

radiograph interpretation with the support of the RAYVOLVE app

EXPERIMENTAL

Diagnostic Test: radiograph interpretation with the support of the RAYVOLVE app

Interventions

radiograph interpretation without the support of the RAYVOLVE app DIAGNOSTIC_TEST

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.

radiograph interpretation without the support of the RAYVOLVE app

radiograph interpretation with the support of the RAYVOLVE app DIAGNOSTIC_TEST

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

radiograph interpretation with the support of the RAYVOLVE app

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondation Lenval: lead

Study Sites (1)

Hopitaux Pediatriques de Nice Chu-Lenval

Nice, 06200, France

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 12, 2022
• Study Start: February 10, 2022
• Primary Completion: February 17, 2024
• Study Completion: February 17, 2024
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

FR (1)