<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/NCT02261038</url>
  </required_header>
  <id_info>
    <org_study_id>Rad-2CT-3CT_001_MH</org_study_id>
    <secondary_id>332/13</secondary_id>
    <nct_id>NCT02261038</nct_id>
  </id_info>
  <brief_title>Comparison of the Femoral Prothesis-rotation in Conventional X-ray, in Axial CT Slices and 3D-reconstructed CT</brief_title>
  <official_title>Comparative Study pf the Femoral Prothesis-rotation in Conventional X-Ray, in Axial CT Slices and 3D-reconstructed CT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michael Tobias Hirschmann</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kantonsspital Baselland Bruderholz</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Femoral component rotation in total knee arthroplasty (TKA) has been considered an important&#xD;
      factor for outcome. However, measurement of femoral component rotation is difficult to&#xD;
      perform.&#xD;
&#xD;
      Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique),&#xD;
      axial CT slices and 3D reconstructed CT images.&#xD;
&#xD;
      It was the hypothesis that measurements on radiographs are comparable to measurement on CT&#xD;
      images.&#xD;
&#xD;
      Measurements of femoral TKA rotation will be measured three times by three different&#xD;
      observers and inter- and intraobserver reliability is calculated. The absolute values of each&#xD;
      measurement method is noted in degrees.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Femoral component rotation in total knee arthroplasty (TKA) has been considered an important&#xD;
      factor for outcome. However, measurement of femoral component rotation is difficult to&#xD;
      perform.&#xD;
&#xD;
      Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique),&#xD;
      axial CT slices and 3D reconstructed CT images.&#xD;
&#xD;
      It was the hypothesis that measurements on radiographs are comparable to measurement on CT&#xD;
      images.&#xD;
&#xD;
      In agreement with our standard diagnostic algorithm for patients with pain and problems after&#xD;
      TKA CT images as well as Kanekasu radiographs are performed. If the Kanekasu radiograph is&#xD;
      comparable reliable, it could be possible to use this radiograph instead.&#xD;
&#xD;
      Measurements of femoral TKA rotation will be measured three times by three different&#xD;
      observers and inter- and intraobserver reliability is calculated. The absolute values of each&#xD;
      measurement method is noted in degrees. The measurements are performed with two weeks&#xD;
      interval and the different observers are blinded to their previous and the measurements of&#xD;
      the others.&#xD;
&#xD;
      The absolute difference of femoral TKA rotation is calculated between and inter the groups&#xD;
      investigated.&#xD;
&#xD;
      Intra class correlation coefficients are calculated for inter- and intraobserver reliability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</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>Femoral TKA component rotation in degrees</measure>
    <time_frame>one year</time_frame>
    <description>Femoral TKA component rotation in degrees is assessed on radiographs (Kanekasu), axial CT and 3D reconstructed CT images. All three measurement by each three observers are compared to each other.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inter- and intraobserver reliability of TKA femoral component rotation</measure>
    <time_frame>one year</time_frame>
    <description>Inter- and intraobserver reliability of TKA femoral component rotation are calculated by intra class correlation coefficients (ICC) and compared between all three measurement methods.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Kanekasu radiographs</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>No drugs or devices are used in this study. Commonly available radiological techniques such as radiographs and CT are used. All patients undergo a CT of the knee and a special radiograph (Kanekasu technique).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Kanekasu radiographs</intervention_name>
    <description>No interventions are performed here. All patients undergo CT and special radiographs of the knee to assess femoral TKA rotation.</description>
    <arm_group_label>Kanekasu radiographs</arm_group_label>
    <other_name>Femoral component rotation</other_name>
    <other_name>total knee prothesis</other_name>
    <other_name>X-ray</other_name>
    <other_name>kanekasu-technic</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Total Knee prosthesis (primary)&#xD;
&#xD;
          -  &gt;55 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  lactating women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael T. Hirschmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Orthop. Surgery and Traumatology, Kantonsspital Baselland - Bruderholz, Unitverstity of Basel, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kantonsspital Baselland, Bruderholz</name>
      <address>
        <city>Bruderholz</city>
        <state>Baselland</state>
        <zip>4101</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>October 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>October 22, 2018</last_update_submitted>
  <last_update_submitted_qc>October 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kantonsspital Baselland Bruderholz</investigator_affiliation>
    <investigator_full_name>Michael Tobias Hirschmann</investigator_full_name>
    <investigator_title>PD Dr. med.</investigator_title>
  </responsible_party>
  <keyword>total knee arthroplasty</keyword>
  <keyword>total knee prothesis</keyword>
  <keyword>X-Ray</keyword>
  <keyword>Kanekasu radiographs</keyword>
  <keyword>femoral component rotation</keyword>
  <keyword>effects</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
  </condition_browse>
  <!-- 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/NCT02261038
org study id: Rad-2CT-3CT_001_MH
secondary id: 332/13
nct id: NCT02261038
lead sponsor: 
has dmc: Yes
Femoral component rotation in total knee arthroplasty (TKA) has been considered an important
      factor for outcome. However, measurement of femoral component rotation is difficult to
      perform.

      Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique),
      axial CT slices and 3D reconstructed CT images.

      It was the hypothesis that measurements on radiographs are comparable to measurement on CT
      images.

      Measurements of femoral TKA rotation will be measured three times by three different
      observers and inter- and intraobserver reliability is calculated. The absolute values of each
      measurement method is noted in degrees.
Femoral component rotation in total knee arthroplasty (TKA) has been considered an important
      factor for outcome. However, measurement of femoral component rotation is difficult to
      perform.

      Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique),
      axial CT slices and 3D reconstructed CT images.

      It was the hypothesis that measurements on radiographs are comparable to measurement on CT
      images.

      In agreement with our standard diagnostic algorithm for patients with pain and problems after
      TKA CT images as well as Kanekasu radiographs are performed. If the Kanekasu radiograph is
      comparable reliable, it could be possible to use this radiograph instead.

      Measurements of femoral TKA rotation will be measured three times by three different
      observers and inter- and intraobserver reliability is calculated. The absolute values of each
      measurement method is noted in degrees. The measurements are performed with two weeks
      interval and the different observers are blinded to their previous and the measurements of
      the others.

      The absolute difference of femoral TKA rotation is calculated between and inter the groups
      investigated.

      Intra class correlation coefficients are calculated for inter- and intraobserver reliability.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Femoral TKA component rotation in degrees
time frame: one year
description: Femoral TKA component rotation in degrees is assessed on radiographs (Kanekasu), axial CT and 3D reconstructed CT images. All three measurement by each three observers are compared to each other.
measure: Inter- and intraobserver reliability of TKA femoral component rotation
time frame: one year
description: Inter- and intraobserver reliability of TKA femoral component rotation are calculated by intra class correlation coefficients (ICC) and compared between all three measurement methods.
arm group label: Kanekasu radiographs
arm group type: Other
description: No drugs or devices are used in this study. Commonly available radiological techniques such as radiographs and CT are used. All patients undergo a CT of the knee and a special radiograph (Kanekasu technique).
intervention type: Other
intervention name: Kanekasu radiographs
description: No interventions are performed here. All patients undergo CT and special radiographs of the knee to assess femoral TKA rotation.
arm group label: Kanekasu radiographs
other name: Femoral component rotation
other name: total knee prothesis
other name: X-ray
other name: kanekasu-technic
criteria: 
gender: All
minimum age: 55 Years
maximum age: 95 Years
healthy volunteers: No
last name: Michael T. Hirschmann, MD
role: Principal Investigator
affiliation: Dept. of Orthop. Surgery and Traumatology, Kantonsspital Baselland - Bruderholz, Unitverstity of Basel, Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Kantonsspital Baselland Bruderholz
investigator full name: Michael Tobias Hirschmann
investigator title: PD Dr. med.
mesh term: Osteoarthritis