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/NCT06003374</url>
    </required_header>
    <id_info>
      <org_study_id>US in pediateric septic hip.</org_study_id>
      <nct_id>NCT06003374</nct_id>
    </id_info>
    <brief_title>Extended Hip Ultrasound as Anew Protocol for Septic Hip in Children</brief_title>
    <official_title>Extended Hip Ultrasound as Anew Protocol for Septic Hip in Children</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>
        To establish a new protocol in order to increase ultrasound diagnostic accuracy of pediatrics&#xD;
        presented with signs of septic hip .&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Septic arthritis is a severe life and function threatening condition with a 1-year mortality&#xD;
        rate of up to 10% and residual functional impairments in 30% to 50% of cases . Pediatric&#xD;
        Septic Hip Arthritis is an intra-articular infection in children that peaks in the first few&#xD;
        years of life. The incidence of septic arthritis is low, with about 4-5 per 100000 child&#xD;
        annually with about 50% of cases occur in children younger than 2 years of age with gender&#xD;
        affection in male &gt; female (2:1 ratio). The hip joint involved in about 35% of all cases of&#xD;
        septic arthritis. Imaging studies contribute crucially to the optimal management of septic&#xD;
        arthritis, thereby diminishing the risk of permanent functional loss .At present; magnetic&#xD;
        resonance imaging (MRI) is the most informative method. Thus, MRI assesses the severity of&#xD;
        the synovitis and can detect a joint effusion, bone and/or cartilage destruction, an abscess,&#xD;
        and/or bone edema. MRI had 75% specificity and nearly 100% sensitivity for diagnosing&#xD;
        concomitant abscess formation, cellulitis, or myositis . Disadvantages of MRI are high cost&#xD;
        and limited availability on an emergency basis in some settings , Ultrasonography of the bone&#xD;
        and joints has been developing at a fast pace in recent years. Ultrasonography is currently&#xD;
        used in the management of septic arthritis to confirm the presence of a joint effusion and to&#xD;
        guide the joint aspiration or synovial biopsy, particularly when the effusion is small or the&#xD;
        joint deep (e.g., hip). Ultrasonography has high sensitivity and specificity for joint&#xD;
        effusions .The difficulty of applying hip MRI in pediatric age group patients especially&#xD;
        neonates make challenge in the proper management of acute septic hip arthritis .the study aim&#xD;
        to apply a new protocol in diagnosis of septic hip in children by doing extended hip&#xD;
        ultrasound included psoas and quadriceps muscles.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">January 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>To describe the ultrasound abnormalities seen in Patients with septic hip arthritis.</measure>
      <time_frame>Baseline</time_frame>
      <description>To evaluate:&#xD;
  Synovial membrane thickness .&#xD;
  Synovial membrane vascularity.&#xD;
  Presence of a joint effusion.&#xD;
  Presence of a joint loculation.&#xD;
  Presence of a joint erosions.</description>
    </primary_outcome>
    <enrollment type="Anticipated">46</enrollment>
    <condition>Septic Arthritis</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Ultrasound</intervention_name>
      <description>At international protocol U/S examination is performed from an anterior approach, with the transducer in a sagittal plane parallel to the femoral neck. The patients are positioned supine with the hips in neutral position. Also a coronal view is performed from the lateral approach. Establish a new protocol in the MSK unit to perform hip US,&#xD;
  adductor view: flexion, abduction and lateral rotation of the hip joint with viewing the hip via adductor muscle group.&#xD;
  gluteal view: posterior approach of the hip joint via gluteal region with the patient lying on the contralateral examined hip.&#xD;
  Psoas and thigh views: US examination of psoas and quadriceps muscles to exclude the presence of absecess .&#xD;
  -finally US guided aspiration under complete a septic condition.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Neonates, infants and children presented with suspected septic hip arthritis.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Neonates, infants and children presented with suspected septic hip arthritis.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  DDH&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Week</minimum_age>
      <maximum_age>15 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Dalia khaled Mostafa, Master</last_name>
      <phone>01096638658</phone>
      <email>daliakhaled46@gmail.com</email>
    </overall_contact>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>December 17, 2022</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Dalia Khaled Mostafa Mohamed</investigator_full_name>
      <investigator_title>Resident doctor at diagnostic radiology department at assuit univerity</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Arthritis, Infectious</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06003374
  org study id: US in pediateric septic hip.
  nct id: NCT06003374
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To establish a new protocol in order to increase ultrasound diagnostic accuracy of pediatrics
        presented with signs of septic hip .
  Septic arthritis is a severe life and function threatening condition with a 1-year mortality
        rate of up to 10% and residual functional impairments in 30% to 50% of cases . Pediatric
        Septic Hip Arthritis is an intra-articular infection in children that peaks in the first few
        years of life. The incidence of septic arthritis is low, with about 4-5 per 100000 child
        annually with about 50% of cases occur in children younger than 2 years of age with gender
        affection in male > female (2:1 ratio). The hip joint involved in about 35% of all cases of
        septic arthritis. Imaging studies contribute crucially to the optimal management of septic
        arthritis, thereby diminishing the risk of permanent functional loss .At present; magnetic
        resonance imaging (MRI) is the most informative method. Thus, MRI assesses the severity of
        the synovitis and can detect a joint effusion, bone and/or cartilage destruction, an abscess,
        and/or bone edema. MRI had 75% specificity and nearly 100% sensitivity for diagnosing
        concomitant abscess formation, cellulitis, or myositis . Disadvantages of MRI are high cost
        and limited availability on an emergency basis in some settings , Ultrasonography of the bone
        and joints has been developing at a fast pace in recent years. Ultrasonography is currently
        used in the management of septic arthritis to confirm the presence of a joint effusion and to
        guide the joint aspiration or synovial biopsy, particularly when the effusion is small or the
        joint deep (e.g., hip). Ultrasonography has high sensitivity and specificity for joint
        effusions .The difficulty of applying hip MRI in pediatric age group patients especially
        neonates make challenge in the proper management of acute septic hip arthritis .the study aim
        to apply a new protocol in diagnosis of septic hip in children by doing extended hip
        ultrasound included psoas and quadriceps muscles.
  observational model: Cohort
  time perspective: Prospective
  measure: To describe the ultrasound abnormalities seen in Patients with septic hip arthritis.
  time frame: Baseline
  description: To evaluate:
  Synovial membrane thickness .
  Synovial membrane vascularity.
  Presence of a joint effusion.
  Presence of a joint loculation.
  Presence of a joint erosions.
  intervention type: Device
  intervention name: Ultrasound
  description: At international protocol U/S examination is performed from an anterior approach, with the transducer in a sagittal plane parallel to the femoral neck. The patients are positioned supine with the hips in neutral position. Also a coronal view is performed from the lateral approach. Establish a new protocol in the MSK unit to perform hip US,
  adductor view: flexion, abduction and lateral rotation of the hip joint with viewing the hip via adductor muscle group.
  gluteal view: posterior approach of the hip joint via gluteal region with the patient lying on the contralateral examined hip.
  Psoas and thigh views: US examination of psoas and quadriceps muscles to exclude the presence of absecess .
  -finally US guided aspiration under complete a septic condition.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Week
  maximum age: 15 Years
  last name: Dalia khaled Mostafa, Master
  phone: 01096638658
  email: daliakhaled46@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Dalia Khaled Mostafa Mohamed
  investigator title: Resident doctor at diagnostic radiology department at assuit univerity
  mesh term: Arthritis, Infectious
  sharing ipd: Undecided