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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04304742
Other study ID # RECHMPL20_0126
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date October 30, 2021

Study information

Verified date April 2022
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In France, femoral neck fracture is mainly detected with interpretation of pelvis/hip X-ray imaging (French Health Authority recommandation). However, up to 10% of fractures are not identified or misdiagnosed, especially in patients admitted to the emergency department. Indeed, radiologists may be subject to excessive work, wich cause the risk of inaccurate on X-rays diagnosis. The Artificial intelligence (AI) begins study the detection of fratures on medical imaging. In this retropective study, this technology developed by GLEAMER company is tested to evaluate the detection rate of hip fracture and specifically femoral neck fracture, compared to the radiologist diagnostic, in eldery patients admitted in emergency department. AI could optimize the diagnostic performance of radiologists (increase of confidence level) and improve the efficiency of suspected fractures sorting from emergency department.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date October 30, 2021
Est. primary completion date April 1, 2021
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion criteria: - Patients aged 60 and older - Minor trauma - Admitted in emergency department for painful hip/fonctional impotence after minor trauma - Takes at least a hip radiography Exclusion criteria: - Painful before the minor trauma - Important trauma

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
hip standard radiography/ CT scan/ MRI
hip standard radiography/ CT scan/ MRI

Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detection rate of femoral neck fracture Detection rate of femoral neck fracture 1 day
Secondary Detection rate of other hip fracture Detection rate of other hip fracture 1 day