Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06013852 |
| Other study ID # |
49RC23_0343 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2024 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
June 2024 |
| Source |
University Hospital, Angers |
| Contact |
Damien Combes, Dr |
| Phone |
+33 2 41 35 42 81 |
| Email |
damien.combe[@]chu-angers.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
After completing the X-ray requested, the senior emergency physician reads the X-ray (native
image only), gives his diagnosis (fracture yes/ no and localization) and reports if he
requests the specialist (orthopedist/ radiologist) or not and the reason why he asks for it
(urgent management, doubt about a fracture). After processing the radiography with the
"Boneview" software, the emergency physician makes a second reading taking into account the
analysis of artificial intelligence. It indicates its result and its decision in the same
way. Then, he performs the practical management of the patient: specialized call, exit,
urgent management.
During the systematic rereading of the radiographs made in the emergency department the night
before and night by the radiology intern, he makes a first reading of the native images and
gives the result (fracture yes/ no and localization). Then, he makes a second reading
assisted by "Boneview" and gives the result again.
A radiologist specialized in osteoarticular imaging will read the radiographs initially
native. He will note the result (fracture yes/ no and localization) then read the radiographs
annotated by the software. He will give the result again.
For the patient, there will be no additional imaging exams, but the x-ray will be read a
secondary time with artificial intelligence assistance. This pet reading causes a change in
patient management.
Indeed if a discrepancy is noted between the reading of the radiography by the internal
radiology or the conclusion of the emergency physician and the reading of the senior
radiologist specialized in osteoarticular imaging, the patient will be recalled and
reconvoked to the emergency department if necessary
