NCT05968092

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

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Status
unknown

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

First Submitted

Initial submission to the registry

July 7, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 1, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

August 7, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2024

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

July 7, 2023

Last Update Submit

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

Age7 Months - 14 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

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

Elbow Fractures

Condition Hierarchy (Ancestors)

Elbow InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Mohamed Gabeer, Lecturer

    Assiut University

    STUDY DIRECTOR
  • Hesham Mohammed, Lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Mariam Mosad, Master

CONTACT

Ahmed Mostafa, Professor

CONTACT

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