Bone FractureNCT05928065
Ultrasound Analysis of Suspected Long Bone Fractures in the Emergency Department - Diagnostic Performance Compared to Radiography.
An observational study of Bone Fracture, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Bone Fracture
- What is being tested?
- Collection of datas
- How many people
- 186 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2021to 9 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged between 0 to 18 with low kinetic, non-deforming, non-open long bone trauma will be included.
Who may be able to join
- Children with low kinetic, non-deforming, non-open long bone trauma
Who cannot join
- Opened fracture, deforming trauma
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bone Fracture
- Being tested
- Collection of datas
- Keywords
- bone trauma, bone, Ultrasound, fracture, radiography
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Collection of datas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis concordance between the ultrasound and radiographic method for the diagnosis of long bone fractures.
Analysis datas collected.
Measured: Year: 1
Secondary outcomes (1)
Analysis diagnostic performance between the ultrasound and radiographic method
Analysis datas collected.
Measured: Year: 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Sep 2021
- Primary completion9 Mar 2022
- Study completion9 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone FractureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aymeric CANTAIS, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928065
- Sponsor's protocol ID
- IRBN1422021/CHUSTE
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Analysis of Suspected Long Bone Fractures in the Emergency Department - Diagnostic Performance Compared to Radiography.
- ClinicalTrials.gov ID
- NCT05928065
- Acronym / sponsor ID
- IRBN1422021/CHUSTE
- Conditions
- Bone Fracture
- Keywords
- bone trauma, bone, Ultrasound, fracture, radiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 9 Mar 2022 (actual)
- Study completion
- 9 Mar 2022 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with low kinetic, non-deforming, non-open long bone trauma | – | Other: Collection of datasChildren with low kinetic, non-deforming, non-open long bone trauma will be included. Collection of datas of medical record. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged between 0 to 18 with low kinetic, non-deforming, non-open long bone trauma will be included.
Key inclusion criteria (1 listed)
- Children with low kinetic, non-deforming, non-open long bone trauma
Key exclusion criteria (1 listed)
- Opened fracture, deforming trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of datasCollection of datas: datas of physical examination (swelling, hematoma, edema), benign trauma (non deforming and closed fractures), ultrasound and radiographic images and evaluation of pain. | Other | Children with low kinetic, non-deforming, non-open long bone trauma |
Primary outcome
Analysis concordance between the ultrasound and radiographic method for the diagnosis of long bone fractures.
Time frame: Year: 1
Analysis datas collected.
1 secondary outcome
Analysis diagnostic performance between the ultrasound and radiographic method
Time frame: Year: 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aymeric CANTAIS, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Fracture, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis concordance between the ultrasound and radiographic method for the diagnosis of long bone fractures. (time frame: Year: 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.