<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/NCT02196415</url>
  </required_header>
  <id_info>
    <org_study_id>KEK-ZH-Nr. 2013-0459</org_study_id>
    <nct_id>NCT02196415</nct_id>
  </id_info>
  <brief_title>Three-Dimensional Hindfoot Alignment Measurements Based On Biplanar Radiographs: Prospective Clinical Feasibility Study</brief_title>
  <official_title>Three-Dimensional Hindfoot Alignment Measurements Based On Biplanar Radiographs: Prospective Clinical Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Balgrist University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Balgrist University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      -  The measurement of hindfoot alignment is a technical challenge.&#xD;
&#xD;
        -  Today, hindfoot alignment is typically measured on hindfoot alignment view radiographs&#xD;
           or long axial view radiographs. Measurements on both types of radiographs are hampered&#xD;
           by technical shortcomings such as minimal rotational misplacement of the foot at the&#xD;
           time of image acquisition. In previous publications our study groups demonstrated&#xD;
           substantial measurement errors due to these shortcomings as well as bad interreader&#xD;
           agreement.&#xD;
&#xD;
        -  Hindfoot alignment measurement is feasible on MR images but hampered by the&#xD;
           non-weight-bearing position of the patient and therefore not suited for pre-treatment&#xD;
           evaluation.&#xD;
&#xD;
        -  In an ex vivo study using plastic phantoms of a foot our research group could&#xD;
           demonstrate superior interreader agreement and complete correction for foot misplacement&#xD;
           at the time of image acquisition using a 3D secondary measurement technique based on&#xD;
           biplanar low dose radiographs.&#xD;
&#xD;
        -  Image acquisition using biplanar low dose radiographs is associated with a substantial&#xD;
           reduction (about 1/7) of radiation dose applied to the patient compared to standard&#xD;
           radiographs.&#xD;
&#xD;
        -  Therefore the question arises if these excellent ex vivo results can be confirmed in a&#xD;
           prospective clinical study.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. Evaluation of technical feasibility of 3D hindfoot alignment measurements based on&#xD;
           biplanar radiographs.&#xD;
&#xD;
        2. Reproduction of superior interreader agreement of measurements based on biplanar&#xD;
           radiographs compared to measurements on conventional radiographs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Additional information to the brief summary:&#xD;
&#xD;
      Outcome(s): Hindfoot alignment measurement on standard radiographs and biplanar radiographs.&#xD;
      The hindfoot angle is measured between the tibial axis and the calcaneal axis in degrees.&#xD;
      Measurement results on plain films and based on 3D reconstructions will be compared.&#xD;
&#xD;
      Inclusion/Exclusion criteria:&#xD;
&#xD;
        -  Inclusion: All patients referred for hindfoot alignment radiographs. These are all&#xD;
           adults having suffered severe trauma or suffering from osteoarthrosis of the ankle&#xD;
           joint. No inclusion of vulnerable participants.&#xD;
&#xD;
        -  Exclusion criteria: Prior surgery, prior fracture, children and adolescents younger than&#xD;
           the age of 20 years, known pregnancy.&#xD;
&#xD;
      Measurements and Procedures: Measurement of hindfoot alignment based on conventional&#xD;
      radiographs and based on biplanar radiographs by two independent radiologists. Comparison of&#xD;
      measurement results (paired-t-test, Wilcoxon signed-rank test) and calculation of interreader&#xD;
      agreement (Intraclass correlation coefficient).&#xD;
&#xD;
      Study Product / Intervention: EOS low-dose biplanar x-ray scanner, EOS imaging, Paris, France&#xD;
      One scan of the ankle joint to obtain an antero-posterior and lateral view.&#xD;
&#xD;
      Control Intervention: Conventional x-rays of the ankle joint (a.p., lateral, long axial or&#xD;
      hindfoot alignment view) as referred from the clinician for treatment planning.&#xD;
&#xD;
      Number of Participants: 50 adults Based on a power analysis we think that this number of&#xD;
      patients will enable reliable results. Because we do not know how big the differences between&#xD;
      the measurements on standard radiographs and measurements on biplanar radiographs will be it&#xD;
      is very difficult to perform a reasonable power analysis. In prior studies comparing torsion&#xD;
      measurements on biplanar radiographs with CT measurements we were able to produce reliable&#xD;
      results with the same number of patients.&#xD;
&#xD;
      Study Schedule:&#xD;
&#xD;
      First-Participant-In: June 2014 Last-Participant-Out: May 2015&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Biplanar radiography and 3D reconstruction of hindfoot</measure>
    <time_frame>The measurement is performed immediately after image acquisition.</time_frame>
    <description>Hindfoot alignment is measured between the tibial axis and the calcaneal axis in degrees.&#xD;
Measurement on standard radiographs and biplanar radiographs are then compared.</description>
  </primary_outcome>
  <enrollment type="Actual">50</enrollment>
  <condition>Congenital Medial Deviation</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Biplanar Radiography</intervention_name>
    <description>standard biplanar radiography of the foot</description>
    <other_name>EOS low-dose biplanar radiography scanner</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with clinically suspected hindfoot malalignment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients referred for hindfoot alignment radiographs. These are all adults having&#xD;
             suffered severe trauma or suffering from osteoarthrosis of the ankle joint. No&#xD;
             inclusion of vulnerable participants.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior surgery, prior fracture, children and adolescents younger than the age of 20&#xD;
             years, known pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Florian M Buck, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Balgrist University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radiology Department, Balgrist University Clinic</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8008</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>September 30, 2018</last_update_submitted>
  <last_update_submitted_qc>September 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hindfoot Alignment</keyword>
  <keyword>Rearfoot</keyword>
  <keyword>Malalignment</keyword>
  <keyword>biplanar radiography</keyword>
  <keyword>3D measurement</keyword>
  <!-- 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/NCT02196415
org study id: KEK-ZH-Nr. 2013-0459
nct id: NCT02196415
lead sponsor: 
has dmc: No
-  The measurement of hindfoot alignment is a technical challenge.

        -  Today, hindfoot alignment is typically measured on hindfoot alignment view radiographs
           or long axial view radiographs. Measurements on both types of radiographs are hampered
           by technical shortcomings such as minimal rotational misplacement of the foot at the
           time of image acquisition. In previous publications our study groups demonstrated
           substantial measurement errors due to these shortcomings as well as bad interreader
           agreement.

        -  Hindfoot alignment measurement is feasible on MR images but hampered by the
           non-weight-bearing position of the patient and therefore not suited for pre-treatment
           evaluation.

        -  In an ex vivo study using plastic phantoms of a foot our research group could
           demonstrate superior interreader agreement and complete correction for foot misplacement
           at the time of image acquisition using a 3D secondary measurement technique based on
           biplanar low dose radiographs.

        -  Image acquisition using biplanar low dose radiographs is associated with a substantial
           reduction (about 1/7) of radiation dose applied to the patient compared to standard
           radiographs.

        -  Therefore the question arises if these excellent ex vivo results can be confirmed in a
           prospective clinical study.

      Objectives:

        1. Evaluation of technical feasibility of 3D hindfoot alignment measurements based on
           biplanar radiographs.

        2. Reproduction of superior interreader agreement of measurements based on biplanar
           radiographs compared to measurements on conventional radiographs.
Additional information to the brief summary:

      Outcome(s): Hindfoot alignment measurement on standard radiographs and biplanar radiographs.
      The hindfoot angle is measured between the tibial axis and the calcaneal axis in degrees.
      Measurement results on plain films and based on 3D reconstructions will be compared.

      Inclusion/Exclusion criteria:

        -  Inclusion: All patients referred for hindfoot alignment radiographs. These are all
           adults having suffered severe trauma or suffering from osteoarthrosis of the ankle
           joint. No inclusion of vulnerable participants.

        -  Exclusion criteria: Prior surgery, prior fracture, children and adolescents younger than
           the age of 20 years, known pregnancy.

      Measurements and Procedures: Measurement of hindfoot alignment based on conventional
      radiographs and based on biplanar radiographs by two independent radiologists. Comparison of
      measurement results (paired-t-test, Wilcoxon signed-rank test) and calculation of interreader
      agreement (Intraclass correlation coefficient).

      Study Product / Intervention: EOS low-dose biplanar x-ray scanner, EOS imaging, Paris, France
      One scan of the ankle joint to obtain an antero-posterior and lateral view.

      Control Intervention: Conventional x-rays of the ankle joint (a.p., lateral, long axial or
      hindfoot alignment view) as referred from the clinician for treatment planning.

      Number of Participants: 50 adults Based on a power analysis we think that this number of
      patients will enable reliable results. Because we do not know how big the differences between
      the measurements on standard radiographs and measurements on biplanar radiographs will be it
      is very difficult to perform a reasonable power analysis. In prior studies comparing torsion
      measurements on biplanar radiographs with CT measurements we were able to produce reliable
      results with the same number of patients.

      Study Schedule:

      First-Participant-In: June 2014 Last-Participant-Out: May 2015
observational model: Case-Only
time perspective: Prospective
measure: Biplanar radiography and 3D reconstruction of hindfoot
time frame: The measurement is performed immediately after image acquisition.
description: Hindfoot alignment is measured between the tibial axis and the calcaneal axis in degrees.
Measurement on standard radiographs and biplanar radiographs are then compared.
intervention type: Device
intervention name: Biplanar Radiography
description: standard biplanar radiography of the foot
other name: EOS low-dose biplanar radiography scanner
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Florian M Buck, MD
role: Principal Investigator
affiliation: Balgrist University Hospital
facility: 
country: Switzerland
responsible party type: Sponsor