Elbow FracturesNCT05968092
Role of US vs X Ray in Detection of Pediatric Elbow Fractures.
An observational study of Elbow Fractures, run by Assiut University.
Trial summary
The purpose of this prospective study is to evaluate and compare the accuracy of elbow ultrasonography with X Ray radiography for the diagnosis of elbow fractures in children following trauma in order to detect the validity of US in diagnosis of fractures as a dependent tool. Read more about this study
- Who is it for?
- Ages 7 months to 14 years
- Conditions the study is for
- Elbow Fractures
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 7 Aug 2023to 1 Sep 2024
- How long will I take part?
- 1 Month
- 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 7 months to 14 years
- All sexes
- Child
Study population: Ultrasonography examination is done by a 5-10 MHz linear probe. Immediately after it , sonographic fndings are recorded the on data collection forms and after that standard two-view radiographic imaging (AP and lateral elbow X-ray) of the elbow is performed and compared with US results. For performing elbow ultrasonography, patients took a sitting position in front of the examiner. In this position, the elbow flexed to 90 degrees , then the transducer was placed over the posterior-midline aspect of the distal humerus. Both transverse and longitudinal views of the elbow are obtained, and still, pictures and video clips are recorded in each orientation.
Who may be able to join
- The patients' age between 7 month and 14 years with a suspected elbow fracture.
- Patients who less than 7 days after the injury of elbow.
Who cannot join
- Patients with a an open injury in elbow.
- Patients with suspected vascular injury.
- Patients with unstable vital signs .
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this prospective study is to evaluate and compare the accuracy of elbow ultrasonography with X Ray radiography for the diagnosis of elbow fractures in children following trauma in order to detect the validity of US in diagnosis of fractures as a dependent tool.
Read the detailed description
Acute bone fractures in children are common and account for 10-25% of total injuries in early ages with considerable effects on activity restriction and subsequent high socioeconomical impact. In these cases, the elbow is a common site of pediatric fractures (account for up to 15% of all fractures) referring to the emergency department, and diagnostic testing with X-ray, including standard 2-way anteroposterior and lateral views, are required primarily for the evaluation of elbow injuries. In the setting of elbow trauma, the posterior fat pad sign on lateral radiographs is highly sensitive for fracture . However, radiological assessment of the elbow may be challenging in early ages due to the non-ossifed epiphysis and often non-exact two- plane radiographs in uncooperative children. Because of the higher sensitivity of growing bones to ionizing radiation, and dose-dependent radiation exposure is both CT scans and X-ray, every imaging should be minimized in children. Therefore, alternative imaging methods, such as US, have become a current issue to reduce exposure to radiation . Ultrasound is radiation-free, it is a real-time bedside assessment, it can be immediately performed and is easily accessible, and it is fast and reliable ,Ultrasonography can detect cortical disruption and irregularity, which directly indicates fractures. However, an elevated posterior fat pad can be easily identified by US, indirectly indicates intracapsular fractures . Ultrasonography is superior to radiography in detecting posterior fat pad elevation. Elbow joint effusion is a classic finding after trauma.
It is not always associated with a cortical fracture, whereas lipohaemarthrosis, corresponding to the presence of blood and lipid material in the posterior fat pad, indicates an intraarticular elbow fracture, too.
Lipohemarthrosis, as well as an elevated posterior fat pad, can easily be identifed on ultrasound.
- Conditions
- Elbow Fractures
- Medical subject headings
- Elbow Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the accuracy of elbow ultrasonography for the diagnosis of elbow fractures in children following trauma.
Ultrasonography examination is done by a 5-10 MHz linear probe , searching for fracture sonographic fndings such as fracture line (it's site and size in cm), lipohaemarthrosis, subcutaneous edema, intramuscular haematoma, subperiosteal haematoma and posterior fat pad.
For performing elbow ultrasonography, patients took a sitting position in front of the examiner. In this position, the elbow flexed to 90 degrees , then the transducer was placed over the posterior-midline aspect of the distal humerus. Both transverse and longitudinal views of the elbow are obtained, and still, pictures and video clips are recorded in each orientation.
Measured: Base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start7 Aug 2023 (estimated)
- Primary completion7 Aug 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elbow FracturesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mosad Shenouda, Assiut University
- Investigators
- Mohamed Gabeer, Lecturer, Study director, Assiut UniversityHesham Mohammed, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968092
- Sponsor's protocol ID
- US and X Ray in elbow
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azizkhani R, Hosseini Yazdi Z, Heydari F. Diagnostic accuracy of ultrasonography for diagnosis of elbow fractures in children. Eur J Trauma Emerg Surg. 2022 Oct;48(5):3777-3784. doi: 10.1007/s00068-021-01648-6. Epub 2021 Mar 24.
PubMed 33763708
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of US vs X Ray in Detection of Pediatric Elbow Fractures.
- ClinicalTrials.gov ID
- NCT05968092
- Acronym / sponsor ID
- US and X Ray in elbow
- Conditions
- Elbow Fractures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 7 Aug 2023 (estimated)
- Primary completion
- 7 Aug 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 1 Aug 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.
The purpose of this prospective study is to evaluate and compare the accuracy of elbow ultrasonography with X Ray radiography for the diagnosis of elbow fractures in children following trauma in order to detect the validity of US in diagnosis of fractures as a dependent tool.
Detailed description
Acute bone fractures in children are common and account for 10-25% of total injuries in early ages with considerable effects on activity restriction and subsequent high socioeconomical impact. In these cases, the elbow is a common site of pediatric fractures (account for up to 15% of all fractures) referring to the emergency department, and diagnostic testing with X-ray, including standard 2-way anteroposterior and lateral views, are required primarily for the evaluation of elbow injuries. In the setting of elbow trauma, the posterior fat pad sign on lateral radiographs is highly sensitive for fracture . However, radiological assessment of the elbow may be challenging in early ages due to the non-ossifed epiphysis and often non-exact two- plane radiographs in uncooperative children. Because of the higher sensitivity of growing bones to ionizing radiation, and dose-dependent radiation exposure is both CT scans and X-ray, every imaging should be minimized in children. Therefore, alternative imaging methods, such as US, have become a current issue to reduce exposure to radiation . Ultrasound is radiation-free, it is a real-time bedside assessment, it can be immediately performed and is easily accessible, and it is fast and reliable ,Ultrasonography can detect cortical disruption and irregularity, which directly indicates fractures. However, an elevated posterior fat pad can be easily identified by US, indirectly indicates intracapsular fractures . Ultrasonography is superior to radiography in detecting posterior fat pad elevation. Elbow joint effusion is a classic finding after trauma.
It is not always associated with a cortical fracture, whereas lipohaemarthrosis, corresponding to the presence of blood and lipid material in the posterior fat pad, indicates an intraarticular elbow fracture, too.
Lipohemarthrosis, as well as an elevated posterior fat pad, can easily be identifed on ultrasound.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 7 months to 14 years
- Sex
- All
- Age groups
- Child
- Study population
- Ultrasonography examination is done by a 5-10 MHz linear probe. Immediately after it , sonographic fndings are recorded the on data collection forms and after that standard two-view radiographic imaging (AP and lateral elbow X-ray) of the elbow is performed and compared with US results. For performing elbow ultrasonography, patients took a sitting position in front of the examiner. In this position, the elbow flexed to 90 degrees , then the transducer was placed over the posterior-midline aspect of the distal humerus. Both transverse and longitudinal views of the elbow are obtained, and still, pictures and video clips are recorded in each orientation.
Key inclusion criteria (2 listed)
- The patients' age between 7 month and 14 years with a suspected elbow fracture.
- Patients who less than 7 days after the injury of elbow.
Key exclusion criteria (3 listed)
- Patients with a an open injury in elbow.
- Patients with suspected vascular injury.
- Patients with unstable vital signs .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the accuracy of elbow ultrasonography for the diagnosis of elbow fractures in children following trauma.
Time frame: Base line
Ultrasonography examination is done by a 5-10 MHz linear probe , searching for fracture sonographic fndings such as fracture line (it's site and size in cm), lipohaemarthrosis, subcutaneous edema, intramuscular haematoma, subperiosteal haematoma and posterior fat pad. For performing elbow ultrasonography, patients took a sitting position in front of the examiner. In this position, the elbow flexed to 90 degrees , then the transducer was placed over the posterior-midline aspect of the distal humerus. Both transverse and longitudinal views of the elbow are obtained, and still, pictures and video clips are recorded in each orientation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Background: PubMed 33763708Azizkhani R, Hosseini Yazdi Z, Heydari F. Diagnostic accuracy of ultrasonography for diagnosis of elbow fractures in children. Eur J Trauma Emerg Surg. 2022 Oct;48(5):3777-3784. doi: 10.1007/s00068-021-01648-6. Epub 2021 Mar 24.
- 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.
Mohamed Gabeer, Lecturer study director
Assiut University
Hesham Mohammed, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Elbow Fractures, run by Assiut University.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam Mosad, Master (01272629579, mariammosad475@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the accuracy of elbow ultrasonography for the diagnosis of elbow fractures in children following trauma. (time frame: Base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05968092, which also lists 1 linked publication.
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 1 Aug 2023.