Role of US vs X Ray in Detection of Pediatric Elbow Fractures.
1 other identifier
observational
52
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedStudy Start
First participant enrolled
August 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedAugust 1, 2023
July 1, 2023
1 year
July 7, 2023
July 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Base line
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Patients with a an open injury in elbow.
- Patients with suspected vascular injury.
- Patients with unstable vital signs .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 33763708BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mohamed Gabeer, Lecturer
Assiut University
- STUDY DIRECTOR
Hesham Mohammed, Lecturer
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CROSSOVER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Month
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident doctor
Study Record Dates
First Submitted
July 7, 2023
First Posted
August 1, 2023
Study Start
August 7, 2023
Primary Completion
August 7, 2024
Study Completion
September 1, 2024
Last Updated
August 1, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share