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NCT05928065 Clinical Trial

Ultrasound Analysis of Suspected Long Bone Fractures in the Emergency Department - Diagnostic Performance Compared to Radiography.

Bone Fracture Clinical Trial

Official title:
Ultrasound Analysis of Suspected Long Bone Fractures in the Emergency Department - Diagnostic Performance Compared to Radiography.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05928065
Other study ID # IRBN1422021/CHUSTE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date March 9, 2022

Study information
Verified date June 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Ultrasound tool in bones trauma is underused in the emergency department of the University Hospital of Saint-Etienne. This prospective non randomized monocentric study will measure how much this non irradiant method of diagnostic is sensible and specific in long bones fractures, and will evaluate it advantages versus conventional X ray examination.

Description:

This study is based on physical examination (swelling, hematoma, edema) and concerns all long bones, including benign trauma (non deforming and closed fractures). The necessary time to make an ultrasound conclusion and the operator certitude degree will be measured.

Recruitment information / eligibility
Status Completed
Enrollment 186
Est. completion date March 9, 2022
Est. primary completion date March 9, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Children with low kinetic, non-deforming, non-open long bone trauma Exclusion Criteria: - Opened fracture, deforming trauma

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Collection of datas
Collection of datas: datas of physical examination (swelling, hematoma, edema), benign trauma (non deforming and closed fractures), ultrasound and radiographic images and evaluation of pain.

Locations
Country Name City State
France CHU Saint-Etienne Saint-Étienne

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Analysis concordance between the ultrasound and radiographic method for the diagnosis of long bone fractures. Analysis datas collected. Year: 1
Secondary Analysis diagnostic performance between the ultrasound and radiographic method Analysis datas collected. Year: 1
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