<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/NCT03749265</url>
  </required_header>
  <id_info>
    <org_study_id>EMC-0010-18</org_study_id>
    <nct_id>NCT03749265</nct_id>
  </id_info>
  <brief_title>Rate Of Residual Clubfoot Deformity With Correlation To Absence Of Peroneus Tertius Muscle</brief_title>
  <official_title>Rate Of Residual Clubfoot Deformity With Correlation To Absence Of Peroneus Tertius Muscle: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rate Of Residual Clubfoot Deformity With Correlation To Absence Of Peroneus Tertius Muscle ,&#xD;
      A Prospective Study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</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>Presence or Absence of peroneus tertius</measure>
    <time_frame>1 hour</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">75</enrollment>
  <condition>Clubfoot</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound test</intervention_name>
    <description>patients need to undergo an ultrasound test for detecting the presence or abscence of peroneus tertius tendon</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients aged 5-17 years , which were treated with the Ponseti technique for Clubfoot in&#xD;
        HaEmek medical center, and have sufficient data/follow-up about them in medical records&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged 5-17 years , which were treated with the Ponseti technique for Clubfoot&#xD;
             in HaEmek medical center, and have sufficient data/follow-up about them in medical&#xD;
             records /&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients aged&lt; 5 years&#xD;
&#xD;
          -  Neurological Clubfoot&#xD;
&#xD;
          -  patients with insufficient data in medical records&#xD;
&#xD;
          -  clubfoot caused by arthrogryposis , connective tissue diseases and congenital fibular&#xD;
             hemimelia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eytan Dujovni, senior</last_name>
    <role>Principal Investigator</role>
    <affiliation>haemek medical center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Eytan Dujovni, senior</last_name>
    <phone>+97254761-1961</phone>
    <email>eytan_du@clalit.org.il</email>
  </overall_contact>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 20, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>HaEmek Medical Center, Israel</investigator_affiliation>
    <investigator_full_name>Eytan Dujovny</investigator_full_name>
    <investigator_title>Senior doctor in orthopedics department</investigator_title>
  </responsible_party>
  <keyword>Peroneus Tertius Muscle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clubfoot</mesh_term>
    <mesh_term>Talipes</mesh_term>
    <mesh_term>Equinus Deformity</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03749265
org study id: EMC-0010-18
nct id: NCT03749265
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rate Of Residual Clubfoot Deformity With Correlation To Absence Of Peroneus Tertius Muscle ,
      A Prospective Study.
observational model: Cohort
time perspective: Prospective
measure: Presence or Absence of peroneus tertius
time frame: 1 hour
intervention type: Other
intervention name: Ultrasound test
description: patients need to undergo an ultrasound test for detecting the presence or abscence of peroneus tertius tendon
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 120 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eytan Dujovni, senior
role: Principal Investigator
affiliation: haemek medical center
last name: Eytan Dujovni, senior
phone: +97254761-1961
email: eytan_du@clalit.org.il
responsible party type: Principal Investigator
investigator affiliation: HaEmek Medical Center, Israel
investigator full name: Eytan Dujovny
investigator title: Senior doctor in orthopedics department
mesh term: Clubfoot
mesh term: Talipes
mesh term: Equinus Deformity
sharing ipd: No