<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/NCT02976532</url>
  </required_header>
  <id_info>
    <org_study_id>NavDo2014</org_study_id>
    <nct_id>NCT02976532</nct_id>
  </id_info>
  <brief_title>Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking</brief_title>
  <official_title>Controlling Femoral Derotation Osteotomy With Electromagnetic Tracking - an in Vivo Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Heidelberg University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Heidelberg University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is designed to evaluate the use of electromagnetic tracking in femoral derotation&#xD;
      osteotomies. The goal is to raise the precision of the surgical procedure in order to improve&#xD;
      the outcome in short- and long term. The electromagnetic tracking system is evaluated against&#xD;
      a base line CT scan serving as reference standard.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Internal rotation gait is a common deformity in children, especially in those with spastic&#xD;
      diplegia. The treatment includes soft tissue and bony correction. Especially the bony&#xD;
      procedures e.g. femoral derotation osteotomies have proven to be effective both in short term&#xD;
      and long term evaluation. Nonetheless there is still a relevant number of patients that&#xD;
      suffer from over- or under-correction and recurrence over time. The reasons are diverse and&#xD;
      include false measurement of the derotation in OR.&#xD;
&#xD;
      The study now evaluates electromagnetic tracking for femoral derotation to improve these&#xD;
      results.&#xD;
&#xD;
      The patients are recruited from the outpatients department and included if they meet the&#xD;
      criteria.&#xD;
&#xD;
      A baseline rotational CT scan and a 3-D-gait analysis are performed and the derotation&#xD;
      measured with the EMT system in OR. The results of the measurement is invisible and unknown&#xD;
      to the surgeon as the system unit is controlled by a technician.&#xD;
&#xD;
      The surgical procedure follows standard rules and does not need alterations because of the&#xD;
      study.&#xD;
&#xD;
      After the operation a second rotational CT scan is performed and the derotation precisely&#xD;
      evaluated by two raters and later compared to the results of the electromagnetic tracking&#xD;
      system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between CT reference measurement and EMT measurement of femoral derotation osteotomies in degrees</measure>
    <time_frame>After the postoperative CT Scan (maximum of three month after surgery)</time_frame>
    <description>The study evaluates the result of the derotation measurement by the EMT system against the derotation in degrees that is measured with the difference between the pre- and the post-operative CT scan (meaning: EMT measurement intra-operative versus difference in femoral rotation in the CT scan between pre- and post-operative CT). The outcome is given in degrees.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Interna Rotation Gait</condition>
  <condition>Cerebral Palsy</condition>
  <condition>Malrotation; Bone</condition>
  <condition>In-toing</condition>
  <arm_group>
    <arm_group_label>EMT Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The study is performed with a single arm, as the system is an additional tool for derotation measurement and the surgical procedure itself and its technique is not changed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electromagnetic tracking unit in femoral derotation surgery</intervention_name>
    <description>Use of the electromagnetic tracking system during the surgical procedure in addition to the normal measurement with goniometer, the different devices listed are combined to form the EMT system unit</description>
    <arm_group_label>EMT Arm</arm_group_label>
    <other_name>A self developed software interface</other_name>
    <other_name>EMT pointer device (FlexPointer E01 2002, fiagon GmbH, Berlin, Germany) for surface sampling</other_name>
    <other_name>EMT sensors embedded in a clamp shell (PointerShell E01 2902, fiagon GmbH, Berlin, Germany)</other_name>
    <other_name>A field generator (AURORA v.2, Northern Digital, Waterloo, Canada)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  functionally impairing internal rotation gait and indication for supracondylar&#xD;
             derotation osteotomy (Evidence of falling because of internal rotation gait,&#xD;
             abnormally increased femoral anteversion, confirmation of internal rotation gait in&#xD;
             gait kinematics of hip rotation and foot progression angle and a mid point shift in&#xD;
             the clinical examination).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe mental retardation and inability to undertake the CT scan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Dreher, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>MD</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Thomas Dreher, Dr.</last_name>
    <email>thomas.dreher@med.uni-heidelberg.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andreas Geisbüsch, Dr.</last_name>
    <email>andreas.geisbuesch@med.uni-heidelberg.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Orthopaedic Department, University of Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <zip>69118</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Dreher, Dr.</last_name>
      <email>thomas.dreher@med.uni-heidelberg.de</email>
    </contact>
    <contact_backup>
      <last_name>Andreas Geisbüsch, Dr.</last_name>
      <email>andreas.geisbuesch@med.uni-heidelberg.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Geisbusch A, Auer C, Dickhaus H, Niklasch M, Dreher T. Electromagnetic bone segment tracking to control femoral derotation osteotomy-A saw bone study. J Orthop Res. 2017 May;35(5):1106-1112. doi: 10.1002/jor.23348. Epub 2016 Jul 4.</citation>
    <PMID>27325569</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 28, 2016</last_update_submitted>
  <last_update_submitted_qc>November 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Heidelberg University</investigator_affiliation>
    <investigator_full_name>Thomas Dreher</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Electromagnetic tracking</keyword>
  <keyword>Internal rotation gait</keyword>
  <keyword>Femoral derotation osteotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebral Palsy</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/NCT02976532
org study id: NavDo2014
nct id: NCT02976532
lead sponsor: 
has dmc: No
The study is designed to evaluate the use of electromagnetic tracking in femoral derotation
      osteotomies. The goal is to raise the precision of the surgical procedure in order to improve
      the outcome in short- and long term. The electromagnetic tracking system is evaluated against
      a base line CT scan serving as reference standard.
Internal rotation gait is a common deformity in children, especially in those with spastic
      diplegia. The treatment includes soft tissue and bony correction. Especially the bony
      procedures e.g. femoral derotation osteotomies have proven to be effective both in short term
      and long term evaluation. Nonetheless there is still a relevant number of patients that
      suffer from over- or under-correction and recurrence over time. The reasons are diverse and
      include false measurement of the derotation in OR.

      The study now evaluates electromagnetic tracking for femoral derotation to improve these
      results.

      The patients are recruited from the outpatients department and included if they meet the
      criteria.

      A baseline rotational CT scan and a 3-D-gait analysis are performed and the derotation
      measured with the EMT system in OR. The results of the measurement is invisible and unknown
      to the surgeon as the system unit is controlled by a technician.

      The surgical procedure follows standard rules and does not need alterations because of the
      study.

      After the operation a second rotational CT scan is performed and the derotation precisely
      evaluated by two raters and later compared to the results of the electromagnetic tracking
      system.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Difference between CT reference measurement and EMT measurement of femoral derotation osteotomies in degrees
time frame: After the postoperative CT Scan (maximum of three month after surgery)
description: The study evaluates the result of the derotation measurement by the EMT system against the derotation in degrees that is measured with the difference between the pre- and the post-operative CT scan (meaning: EMT measurement intra-operative versus difference in femoral rotation in the CT scan between pre- and post-operative CT). The outcome is given in degrees.
arm group label: EMT Arm
arm group type: Other
description: The study is performed with a single arm, as the system is an additional tool for derotation measurement and the surgical procedure itself and its technique is not changed.
intervention type: Other
intervention name: Electromagnetic tracking unit in femoral derotation surgery
description: Use of the electromagnetic tracking system during the surgical procedure in addition to the normal measurement with goniometer, the different devices listed are combined to form the EMT system unit
arm group label: EMT Arm
other name: A self developed software interface
other name: EMT pointer device (FlexPointer E01 2002, fiagon GmbH, Berlin, Germany) for surface sampling
other name: EMT sensors embedded in a clamp shell (PointerShell E01 2902, fiagon GmbH, Berlin, Germany)
other name: A field generator (AURORA v.2, Northern Digital, Waterloo, Canada)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Thomas Dreher, Dr.
role: Principal Investigator
affiliation: MD
last name: Thomas Dreher, Dr.
email: thomas.dreher@med.uni-heidelberg.de
last name: Andreas Geisbüsch, Dr.
email: andreas.geisbuesch@med.uni-heidelberg.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
citation: Geisbusch A, Auer C, Dickhaus H, Niklasch M, Dreher T. Electromagnetic bone segment tracking to control femoral derotation osteotomy-A saw bone study. J Orthop Res. 2017 May;35(5):1106-1112. doi: 10.1002/jor.23348. Epub 2016 Jul 4.
PMID: 27325569
responsible party type: Principal Investigator
investigator affiliation: Heidelberg University
investigator full name: Thomas Dreher
investigator title: Principal Investigator
mesh term: Cerebral Palsy
sharing ipd: No