Boneview-ED - Impact of Artificial Intelligence Detecting Fractures in the Emergence Department : a Pragmatic Prospective Study

NCT06013852 | Recruiting

• 1 other identifier: 49RC23_0343
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 1

Brief Summary

Traumatic emergencies are the primary reason for consultation in emergency departments and standard radiography is the primary imaging exam for osteoarticular trauma. However, with the increase in the number of patients admitted to emergency departments and thus the increased workload for emergency room attendants, Interpretation of radiographs in trauma emergencies is made more difficult, resulting in a high risk of misinterpretation. The growing presence of artificial intelligence in the medical field, notably through the involvement of diagnostic software on imageries, makes its use more relevant in the aid of the replay of osteoarticular imageries. A recent meta-analysis of 32 studies evaluating the performance of artificial intelligence in fracture detection found comparable performance between experienced radiologists and AI-based diagnosis. However, these were mainly retrospective studies, and thus more distant from the reality of its use in a care stream such as emergencies. The objective of this study is therefore to prospectively validate the use of artificial intelligence software during its implementation in an emergency department for patients admitted for a suspicion of osteoarticular trauma.

Conditions

Fractures, Bone

Outcome Measures

Primary Outcomes (1)

• Change in ER support between X-ray reading without and with artificial intelligence

  Compare ER support decisions without and with fracture diagnostic software

  1 year

Study Arms (1)

Unique arm

OTHER

Without and with Boneview software use for all included patients

Diagnostic Test: processing the radiography with the "Boneview" software

Interventions

processing the radiography with the "Boneview" software DIAGNOSTIC_TEST

all X-Rays will be analysed with and without the software

Unique arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major patient
• Admitted to the emergency department after trauma less than 48 hours
• Patient with an indication on an x-ray of the limbs or/and pelvis
• Express patient consent
• Affiliated patient or social security beneficiary

You may not qualify if:

• Polytraumatized patient
• X-ray of the corso-lumbar spine, skull, cervical spine (all parts of the body not affected by the intended use of the software)
• Pregnant, lactating or parturient patient

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Dr Damien COMBES

Angers, Maine Et Loire, 49933, France

RECRUITING

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Damien Combes, Dr

  University hospital of Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Damien Combes, Dr

CONTACT

(0)2 41 35 42 81; damien.combe@chu-angers.fr

Marie Bost

CONTACT

(0)2 41 35 31 99; mabost@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: July 22, 2024
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)