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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Completed

CT.gov ID

NCT05928065

Collaborator

(none)

186

Enrollment

Location

6.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bone Fracture	Other: Collection of datas

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

186 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Actual Primary Completion Date :

Mar 9, 2022

Actual Study Completion Date :

Mar 9, 2022

Arms and Interventions

Arm	Intervention/Treatment
Children with low kinetic, non-deforming, non-open long bone trauma Children with low kinetic, non-deforming, non-open long bone trauma will be included. Collection of datas of medical record.	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.

Arm

Intervention/Treatment

Children with low kinetic, non-deforming, non-open long bone trauma

Children with low kinetic, non-deforming, non-open long bone trauma will be included. Collection of datas of medical record.

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.

Outcome Measures

Primary Outcome Measures

Analysis concordance between the ultrasound and radiographic method for the diagnosis of long bone fractures. [Year: 1]
Analysis datas collected.

Secondary Outcome Measures

Analysis diagnostic performance between the ultrasound and radiographic method [Year: 1]
Analysis datas collected.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children with low kinetic, non-deforming, non-open long bone trauma

Exclusion Criteria:

Opened fracture, deforming trauma

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Saint-Etienne	Saint-Étienne		France

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator: Aymeric CANTAIS, MD, CHU Saint-Etienne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT05928065

Other Study ID Numbers:

IRBN1422021/CHUSTE

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 3, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

Additional relevant MeSH terms:

Emergencies

Fractures, Bone

Study Results

No Results Posted as of Jul 3, 2023