xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05968092</url>
    </required_header>
    <id_info>
      <org_study_id>US and X Ray in elbow</org_study_id>
      <nct_id>NCT05968092</nct_id>
    </id_info>
    <brief_title>Role of US vs X Ray in Detection of Pediatric Elbow Fractures.</brief_title>
    <official_title>Role of US vs X Ray in Detection of Pediatric Elbow Fractures.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this prospective study is to evaluate and compare the accuracy of elbow&#xD;
        ultrasonography with X Ray radiography for the diagnosis of elbow fractures in children&#xD;
        following trauma in order to detect the validity of US in diagnosis of fractures as a&#xD;
        dependent tool.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Acute bone fractures in children are common and account for 10-25% of total injuries in early&#xD;
        ages with considerable effects on activity restriction and subsequent high socioeconomical&#xD;
        impact. In these cases, the elbow is a common site of pediatric fractures (account for up to&#xD;
        15% of all fractures) referring to the emergency department, and diagnostic testing with&#xD;
        X-ray, including standard 2-way anteroposterior and lateral views, are required primarily for&#xD;
        the evaluation of elbow injuries. In the setting of elbow trauma, the posterior fat pad sign&#xD;
        on lateral radiographs is highly sensitive for fracture . However, radiological assessment of&#xD;
        the elbow may be challenging in early ages due to the non-ossifed epiphysis and often&#xD;
        non-exact two- plane radiographs in uncooperative children. Because of the higher sensitivity&#xD;
        of growing bones to ionizing radiation, and dose-dependent radiation exposure is both CT&#xD;
        scans and X-ray, every imaging should be minimized in children. Therefore, alternative&#xD;
        imaging methods, such as US, have become a current issue to reduce exposure to radiation .&#xD;
        Ultrasound is radiation-free, it is a real-time bedside assessment, it can be immediately&#xD;
        performed and is easily accessible, and it is fast and reliable ,Ultrasonography can detect&#xD;
        cortical disruption and irregularity, which directly indicates fractures. However, an&#xD;
        elevated posterior fat pad can be easily identified by US, indirectly indicates intracapsular&#xD;
        fractures . Ultrasonography is superior to radiography in detecting posterior fat pad&#xD;
        elevation. Elbow joint effusion is a classic finding after trauma.&#xD;
  &#xD;
        It is not always associated with a cortical fracture, whereas lipohaemarthrosis,&#xD;
        corresponding to the presence of blood and lipid material in the posterior fat pad, indicates&#xD;
        an intraarticular elbow fracture, too.&#xD;
  &#xD;
        Lipohemarthrosis, as well as an elevated posterior fat pad, can easily be identifed on&#xD;
        ultrasound.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 7, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 7, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Month</target_duration>
    <primary_outcome>
      <measure>Evaluate the accuracy of elbow ultrasonography for the diagnosis of elbow fractures in children following trauma.</measure>
      <time_frame>Base line</time_frame>
      <description>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.&#xD;
  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.</description>
    </primary_outcome>
    <enrollment type="Anticipated">52</enrollment>
    <condition>Elbow Fractures</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Ultrasonography examination is done by a 5-10 MHz linear probe. Immediately after it ,&#xD;
          sonographic fndings are recorded the on data collection forms and after that standard&#xD;
          two-view radiographic imaging (AP and lateral elbow X-ray) of the elbow is performed and&#xD;
          compared with US results. For performing elbow ultrasonography, patients took a sitting&#xD;
          position in front of the examiner. In this position, the elbow flexed to 90 degrees , then&#xD;
          the transducer was placed over the posterior-midline aspect of the distal humerus. Both&#xD;
          transverse and longitudinal views of the elbow are obtained, and still, pictures and video&#xD;
          clips are recorded in each orientation.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The patients' age between 7 month and 14 years with a suspected elbow fracture.&#xD;
  &#xD;
            -  Patients who less than 7 days after the injury of elbow.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a an open injury in elbow.&#xD;
  &#xD;
            -  Patients with suspected vascular injury.&#xD;
  &#xD;
            -  Patients with unstable vital signs .&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Months</minimum_age>
      <maximum_age>14 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Mohamed Gabeer, Lecturer</last_name>
      <role>Study Director</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hesham Mohammed, Lecturer</last_name>
      <role>Study Director</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Mariam Mosad, Master</last_name>
      <phone>01272629579</phone>
      <email>mariammosad475@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ahmed Mostafa, Professor</last_name>
      <phone>01000024182</phone>
      <email>moustafamanar@gmail.com</email>
    </overall_contact_backup>
    <reference>
      <citation>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.</citation>
      <PMID>33763708</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Mariam Mosad Shenouda</investigator_full_name>
      <investigator_title>Resident doctor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Elbow Fractures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05968092
  org study id: US and X Ray in elbow
  nct id: NCT05968092
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Case-Crossover
  time perspective: Prospective
  measure: Evaluate the accuracy of elbow ultrasonography for the diagnosis of elbow fractures in children following trauma.
  time frame: Base line
  description: 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.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 7 Months
  maximum age: 14 Years
  last name: Mohamed Gabeer, Lecturer
  role: Study Director
  affiliation: Assiut University
  last name: Hesham Mohammed, Lecturer
  role: Study Director
  affiliation: Assiut University
  last name: Mariam Mosad, Master
  phone: 01272629579
  email: mariammosad475@gmail.com
  last name: Ahmed Mostafa, Professor
  phone: 01000024182
  email: moustafamanar@gmail.com
  citation: 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: 33763708
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Mariam Mosad Shenouda
  investigator title: Resident doctor
  mesh term: Fractures, Bone
  mesh term: Elbow Fractures
  sharing ipd: No