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Optimization of the Diagnosis of Bone Fractures in Patients Treated in the Emergency Department by Using Artificial Intelligence for Reading Radiological Images in Comparison With Traditional Reading by the Emergency Doctor. (FracturIA)

Primary Purpose

Artificial Intelligence, Bone Fracture

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Artificial intelligence
Emergency physician
Sponsored by
Elsan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Artificial Intelligence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Major Subject Patient admitted to the emergency department for suspected peripheral fractures in the extremities of the upper limb and/or lower limb (wrist/hand and ankle/foot). Patient affiliated to or entitled to a social security system Patient having received written and informed information about the study and having signed a free and informed consent to participate in the study. Exclusion Criteria: Patient previously admitted to the emergency room for suspicion of fractures and not included in the study Patient admitted to the emergency room with suspicion of multiple fractures Refusal to participate in the study Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision and under judicial protection Pregnant, breastfeeding or parturient patient

Sites / Locations

  • Clinique Esquirol Saint HilaireRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Patient with emergency physician and AI for diagnosis

Patient with emergency physician only for diagnosis

Arm Description

Patient benefiting from imaging submitted to radiological reading by the emergency physician and the AI for diagnosis and treatment decision

Outcomes

Primary Outcome Measures

Patient readmission rate for failure to diagnose fracture during initial treatment.
This rate will be determined in each group (reading by the emergency doctor systematically doubled by the reading of the AI vs. simple reading by the emergency doctor) compared to centralized rereading.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2023
Last Updated
September 18, 2023
Sponsor
Elsan
Collaborators
Clinique Esquirol Saint Hilaire
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1. Study Identification

Unique Protocol Identification Number
NCT06051682
Brief Title
Optimization of the Diagnosis of Bone Fractures in Patients Treated in the Emergency Department by Using Artificial Intelligence for Reading Radiological Images in Comparison With Traditional Reading by the Emergency Doctor.
Acronym
FracturIA
Official Title
Optimization of the Diagnosis of Bone FRACtures in Patients Treated in the Emergency Department by Using Artificial Intelligence for Reading Radiological Images in Comparison With Traditional Reading by the Emergency Doctor.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
September 11, 2024 (Anticipated)
Study Completion Date
October 11, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elsan
Collaborators
Clinique Esquirol Saint Hilaire

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
As part of the management of a patient with suspected bone fractures, emergency physicians are required to make treatment decisions before obtaining the imaging reading report from the radiologist, who is generally not available only a few hours after the patient's admission, or even the following day. This situation of the emergency doctor, alone interpreting the radiological image, in a context of limited time due to the large flow of patients to be treated, leads to a significant risk of interpretation error. Unrecognized fractures represent one of the main causes of diagnostic errors in emergency departments. This comparative study consists of two cohorts of patients referred to the emergency department for suspected bone fracture. The first will be of interest to patients whose radiological images will be interpreted by the reading of the emergency doctor systematically doubled by the reading of the artificial intelligence. The other will interest a group of patients cared for by the simple reading of the emergency doctor. All of the images from both groups of patients will be re-read by the establishment's group of radiologists no later than 24 hours following the patient's treatment. A centralized review will be provided by two expert radiologists. Also, patients in both groups will be systematically recalled in the event of detection of an unknown fracture for hospitalization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Artificial Intelligence, Bone Fracture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with emergency physician and AI for diagnosis
Arm Type
Experimental
Arm Description
Patient benefiting from imaging submitted to radiological reading by the emergency physician and the AI for diagnosis and treatment decision
Arm Title
Patient with emergency physician only for diagnosis
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Artificial intelligence
Intervention Description
Artificial intelligence software : Boneview. It analyzes the x-rays, gives an assessment of the presence of fractures at the examination level and locates the fractures on each image by presenting them to the practitioner directly on their screen, without any other logistical constraints for the doctor.
Intervention Type
Procedure
Intervention Name(s)
Emergency physician
Intervention Description
the emergency physician analyzes the x-rays
Primary Outcome Measure Information:
Title
Patient readmission rate for failure to diagnose fracture during initial treatment.
Description
This rate will be determined in each group (reading by the emergency doctor systematically doubled by the reading of the AI vs. simple reading by the emergency doctor) compared to centralized rereading.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major Subject Patient admitted to the emergency department for suspected peripheral fractures in the extremities of the upper limb and/or lower limb (wrist/hand and ankle/foot). Patient affiliated to or entitled to a social security system Patient having received written and informed information about the study and having signed a free and informed consent to participate in the study. Exclusion Criteria: Patient previously admitted to the emergency room for suspicion of fractures and not included in the study Patient admitted to the emergency room with suspicion of multiple fractures Refusal to participate in the study Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision and under judicial protection Pregnant, breastfeeding or parturient patient
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martial MATINGOU, Dr
Phone
0662653598
Email
martial.matingou@orange.fr
Facility Information:
Facility Name
Clinique Esquirol Saint Hilaire
City
Agen
ZIP/Postal Code
47000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martial MATINGOU, MD
Phone
0662653598
Email
martial.matingou@orange.fr

12. IPD Sharing Statement

Learn more about this trial

Optimization of the Diagnosis of Bone Fractures in Patients Treated in the Emergency Department by Using Artificial Intelligence for Reading Radiological Images in Comparison With Traditional Reading by the Emergency Doctor.

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