NCT05928065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

June 23, 2023

Last Update Submit

June 23, 2023

Conditions

Bone Fracture

Keywords

bone traumaboneUltrasoundfractureradiography

Outcome Measures

Primary Outcomes (1)

  • Analysis concordance between the ultrasound and radiographic method for the diagnosis of long bone fractures.

    Analysis datas collected.

    Year: 1

Secondary Outcomes (1)

  • Analysis diagnostic performance between the ultrasound and radiographic method

    Year: 1

Study Arms (1)

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

Interventions

Collection of datasOTHER

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.

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

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Opened fracture, deforming trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Aymeric CANTAIS, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 3, 2023

Study Start

September 1, 2021

Primary Completion

March 9, 2022

Study Completion

March 9, 2022

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)