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

June 23, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children aged between 0 to 18 with low kinetic, non-deforming, non-open long bone trauma will be included.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Opened fracture, deforming trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis concordance between the ultrasound and radiographic method for the diagnosis of long bone fractures.
Time Frame: Year: 1
Analysis datas collected.
Year: 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis diagnostic performance between the ultrasound and radiographic method
Time Frame: Year: 1
Analysis datas collected.
Year: 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

March 9, 2022

Study Completion (Actual)

March 9, 2022

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

June 23, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBN1422021/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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