<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/NCT03041857</url>
  </required_header>
  <id_info>
    <org_study_id>MedactaGMKSphere</org_study_id>
    <nct_id>NCT03041857</nct_id>
  </id_info>
  <brief_title>Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy</brief_title>
  <official_title>Understanding GMK Sphere Implant Tibiofemoral Kinematics by Means of Dynamic Videofluoroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Renate List</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kantonsspital Winterthur KSW</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Balgrist University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Institute for Biomechanics, ETH Zürich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this research project is to perform a comparative study on the in vivo&#xD;
      kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed&#xD;
      Bearing TKA as well as to the GMK UC Mobile Bearing during level walking, stair descent and&#xD;
      downhill walking by means of videofluoroscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total arthroplasty of the knee (TKA) aims to relieve patient pain and improve functionality&#xD;
      of the joint. To maintain sufficient range of motion, but also not overload the surrounding&#xD;
      soft tissue structures, reproduction of tibio-femoral kinematics of the healthy knee is&#xD;
      thought to be beneficial. In previous studies, it has been shown that the medial condyle,&#xD;
      described by the centre of the medial condylar sphere, does not move anterioposteriorly&#xD;
      during progressing joint flexion, whereas the lateral condyle has been observed to translate&#xD;
      in a posterior direction producing tibial internal rotation with flexion (Freeman and&#xD;
      Pinskerova 2003, Pinskerova, Johal et al. 2004, Freeman and Pinskerova 2005). The GMK Sphere&#xD;
      prosthesis is specifically designed to mimic the healthy kinematics with providing a medial&#xD;
      pivot.&#xD;
&#xD;
      The objective of this research project is to perform a comparative study on the in vivo&#xD;
      kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed&#xD;
      Bearing TKA as well as to the GMK UC Fixed Bearing. The study includes the simultaneous&#xD;
      assessment of the 3D kinematics of the TKA by means of an automated moving fluoroscope and&#xD;
      subsequent 2D/3D registration based on CAD models of the TKA, whole leg kinematics by means&#xD;
      of skin markers and ground reaction forces during level walking, stair descent and downhill&#xD;
      walking a 10° inclined slope. Precisely, the aim is to assess tibio-femoral kinematics in&#xD;
      8-10 TKA subjects implanted one or more years previously with the GMK Sphere prosthesis. In&#xD;
      addition, 8-10 conventional GMK PS Fixed Bearing TKA subjects, as well as 8-10 GMK UC Mobile&#xD;
      Bearing TKA subjects will be measured to provide a comparison against the GMK Sphere&#xD;
      prosthesis kinematics.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2013</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of the three-dimensional kinematics of the GMK Sphere Fixed Bearing TKA to the kinematics of the GMK Primary PS fixed bearing and GMK Primary UC Mobile Bearing TKA.</measure>
    <time_frame>3 hours</time_frame>
    <description>With video-fluoroscopic assessment it is possible to directly measure the kinematics of the tibial and the femoral components in vivo during daily activities, such as level walking, downhill walking and stair descent. Thus, for the first time the present study provides in vivo assessed data of the 3D motion of the GMK Sphere System during daily activities. The knowledge of the in vivo kinematic behaviour of the GMK Sphere System compared to conventional GMK PS Fixed Bearing and GMK UC Mobile Bearing TKA leads to an improved understanding of the design principle. Observation of the kinematics in terms of range of motion, patterns of anterior-posterior motion of medial and lateral condyle points (&quot;posterior femoral rollback&quot;) and tibio-femoral internal/external rotation.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <condition>Tibiofemoral Kinematics</condition>
  <arm_group>
    <arm_group_label>GMK Sphere</arm_group_label>
    <description>Subjects with a unilateral Medacta GMK Sphere TKA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GMK PS</arm_group_label>
    <description>Subjects with a unilateral Medacta GMK Primary PS Fixed Bearing TKA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GMK UC</arm_group_label>
    <description>Subjects with a unilateral Medacta GMK Primary UC Fixed Bearing TKA</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Observational use of fluoroscopy</intervention_name>
    <arm_group_label>GMK PS</arm_group_label>
    <arm_group_label>GMK Sphere</arm_group_label>
    <arm_group_label>GMK UC</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants fulfilling all of the following inclusion criteria are eligible for the study.&#xD;
        The presence of any one of the following exclusion criteria will lead to the exclusion of&#xD;
        the participant.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female or male&#xD;
&#xD;
          -  Age: 40 to 100 years&#xD;
&#xD;
          -  Unilateral TKA&#xD;
&#xD;
          -  ≥ 1 years postoperatively&#xD;
&#xD;
          -  BMI ≤ 33&#xD;
&#xD;
          -  Good outcome, WOMAC between 0 to 28 (0-14 (Excellent), 15-28 (Good)) No pain subjects,&#xD;
             VAS ≤ 2&#xD;
&#xD;
          -  Good health condition, adequate for test procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other actual significant problem on lower extremities&#xD;
&#xD;
          -  Any other arthroplasty at the lower extremities&#xD;
&#xD;
          -  Subject incapable to understand and sign informed consent&#xD;
&#xD;
          -  Pregnancy at time of testing&#xD;
&#xD;
          -  Incapable of performing the motion tasks&#xD;
&#xD;
          -  Misaligned TKA (≥ ± 3° from mechanical axis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Renate List, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Biomechanics, ETH Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute for Biomechanics, ETH Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8093</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>March 4, 2016</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Institute for Biomechanics, ETH Zürich</investigator_affiliation>
    <investigator_full_name>Dr. Renate List</investigator_full_name>
    <investigator_title>Doctor of Sciences (Dr. sc. ETH)</investigator_title>
  </responsible_party>
  <keyword>Videofluoroscopy</keyword>
  <keyword>GMK Sphere</keyword>
  <keyword>GMK PS Fixed Bearing</keyword>
  <keyword>GMK UC Mobile Bearing</keyword>
  <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/NCT03041857
org study id: MedactaGMKSphere
nct id: NCT03041857
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The objective of this research project is to perform a comparative study on the in vivo
      kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed
      Bearing TKA as well as to the GMK UC Mobile Bearing during level walking, stair descent and
      downhill walking by means of videofluoroscopy.
Total arthroplasty of the knee (TKA) aims to relieve patient pain and improve functionality
      of the joint. To maintain sufficient range of motion, but also not overload the surrounding
      soft tissue structures, reproduction of tibio-femoral kinematics of the healthy knee is
      thought to be beneficial. In previous studies, it has been shown that the medial condyle,
      described by the centre of the medial condylar sphere, does not move anterioposteriorly
      during progressing joint flexion, whereas the lateral condyle has been observed to translate
      in a posterior direction producing tibial internal rotation with flexion (Freeman and
      Pinskerova 2003, Pinskerova, Johal et al. 2004, Freeman and Pinskerova 2005). The GMK Sphere
      prosthesis is specifically designed to mimic the healthy kinematics with providing a medial
      pivot.

      The objective of this research project is to perform a comparative study on the in vivo
      kinematics of the GMK Sphere prosthesis in comparison to the conventional GMK PS Fixed
      Bearing TKA as well as to the GMK UC Fixed Bearing. The study includes the simultaneous
      assessment of the 3D kinematics of the TKA by means of an automated moving fluoroscope and
      subsequent 2D/3D registration based on CAD models of the TKA, whole leg kinematics by means
      of skin markers and ground reaction forces during level walking, stair descent and downhill
      walking a 10° inclined slope. Precisely, the aim is to assess tibio-femoral kinematics in
      8-10 TKA subjects implanted one or more years previously with the GMK Sphere prosthesis. In
      addition, 8-10 conventional GMK PS Fixed Bearing TKA subjects, as well as 8-10 GMK UC Mobile
      Bearing TKA subjects will be measured to provide a comparison against the GMK Sphere
      prosthesis kinematics.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Comparison of the three-dimensional kinematics of the GMK Sphere Fixed Bearing TKA to the kinematics of the GMK Primary PS fixed bearing and GMK Primary UC Mobile Bearing TKA.
time frame: 3 hours
description: With video-fluoroscopic assessment it is possible to directly measure the kinematics of the tibial and the femoral components in vivo during daily activities, such as level walking, downhill walking and stair descent. Thus, for the first time the present study provides in vivo assessed data of the 3D motion of the GMK Sphere System during daily activities. The knowledge of the in vivo kinematic behaviour of the GMK Sphere System compared to conventional GMK PS Fixed Bearing and GMK UC Mobile Bearing TKA leads to an improved understanding of the design principle. Observation of the kinematics in terms of range of motion, patterns of anterior-posterior motion of medial and lateral condyle points ("posterior femoral rollback") and tibio-femoral internal/external rotation.
arm group label: GMK Sphere
description: Subjects with a unilateral Medacta GMK Sphere TKA
arm group label: GMK PS
description: Subjects with a unilateral Medacta GMK Primary PS Fixed Bearing TKA
arm group label: GMK UC
description: Subjects with a unilateral Medacta GMK Primary UC Fixed Bearing TKA
intervention type: Radiation
intervention name: Observational use of fluoroscopy
arm group label: GMK PS
arm group label: GMK Sphere
arm group label: GMK UC
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 100 Years
healthy volunteers: No
last name: Renate List, Dr.
role: Principal Investigator
affiliation: Institute for Biomechanics, ETH Zurich
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Institute for Biomechanics, ETH Zürich
investigator full name: Dr. Renate List
investigator title: Doctor of Sciences (Dr. sc. ETH)
sharing ipd: No