<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/NCT02251535</url>
  </required_header>
  <id_info>
    <org_study_id>DePuy ECO257107</org_study_id>
    <nct_id>NCT02251535</nct_id>
  </id_info>
  <brief_title>In-vivo Comparison of Different Levels of Femoral Rollback in a Primary Total Knee Arthroplasty</brief_title>
  <acronym>DePuyAttune</acronym>
  <official_title>Retrospective Non-randomized In-vivo Comparison of Different Levels of Femoral Rollback in the ATTUNE Total Knee Arthroplasiy System on the Basis of Fluoroscopic and Marker-based Motion Capture Evaluation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Carsten Perka</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Julius Wolff Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Retrospective non-randomized in-vivo comparison of different levels of femoral rollback in&#xD;
      the ATTUNE total knee arthroplasiy system (rotating platform CR high level roll back vs.&#xD;
      rotating platform CR low level roll back) on the basis of fluoroscopic and marker-based&#xD;
      motion capture evaluation. How do different levels of intra-operatively observed femoral&#xD;
      rollback correlate to postoperative kinematics under weight bearing conditions? Does the&#xD;
      modified design of the Attune Knee System influence the extent of the femoral rollback&#xD;
      compared to the PFC Sigma Knee System? Does the femoral rollback maintain over a period of 12&#xD;
      months follow up or is it reduced by, for example, remodelling of the posterior cruciate&#xD;
      ligament?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative knee pain is one of the most challenging problems following total knee&#xD;
      arthroplasty. Of all the possible complications, the patella-femoral joint is an important&#xD;
      cause of postoperative knee pain and prosthetic failure. Nägerl et al. observed that the&#xD;
      tibia slides along the femoral surface when the knee is flexed [Nagerlet al., 2009]. Beside&#xD;
      the stabilization of the flexion gap, the main task of the posterior cruciate ligament is to&#xD;
      initiate the femoral rollback to reduce the patellofemoral pressure. Vice versa, Heyse et al.&#xD;
      could show that the patello-femoral pressure rises with the nsuffictency of the posterior&#xD;
      cruciate ligament [Heyse et al., 2010]. Pandit et al. measured the physiological rollback in&#xD;
      healthy knees and following implantation of currently available TKA. They could show that&#xD;
      bonventional TKA are not able to restore the rollback in the natural tibio-femoral joint&#xD;
      [Pandit et al., 2005]. Thus it would be important to see if the knee stability in joint&#xD;
      replacement reaches the one found in intact or reconstructed knees after surgery. To mimic&#xD;
      the femoral rollback a new prosthesis has recently been developed and is about to be&#xD;
      introduced to be a new option for total knee arthroplasty. The &quot;Attune Knee System&quot; (DePuy,&#xD;
      Warsaw, USA) also has a reduced femoral flange to reduce the patella-femoral contact&#xD;
      pressure. The increased rotational stability, the reduced femoral flange and the femoral&#xD;
      rollback of the &quot;Attune Knee System&quot; are intended to decrease postoperative knee pain.&#xD;
      Different levels of femoral rollback were observed intra-operatively between the Attune and&#xD;
      PFC Sigma system. Yoshiya et al. could show the relation between the posterior cruciate&#xD;
      ligament with the femoral rollback [Yoshiya et al. 2005]. Therefore, one can hypothesize that&#xD;
      different implant designs in combination with the tension of the PCL produce different&#xD;
      extents of femoral rollback, ln order to test in-vivo knee kinematics in patients during&#xD;
      active movements, we use motion capture, together with combinations of advanced techniques&#xD;
      for assessing skeletal kinematics (including sARA [Ehrig et a1.2007], SCoRE [Ehrig et&#xD;
      al.2011] &amp; ocsr [Taytor et at. 2005]), a novet non-invasive approach to evaluate dynamic&#xD;
      tibio-femoral motion. The combination of these approaches is now able to provide the accuracy&#xD;
      and sensitivity required to analyze movement patterns in a rapid, robust and therefore&#xD;
      clinically viable manner. ln order to do so, highly advanced equipment is needed which is&#xD;
      available in our laboratory in the Julius Wolff lnstitute. Here, we use an infra-red optical&#xD;
      motion capture system (10 T20S cameras, Vicon, Oxford, UK; system accuracy \-0.3-0.5 mm),&#xD;
      tracked at120Hz, as well as 2 force plates (AMTI 0R6, Watertown, MA, USA) in order to assess&#xD;
      the external forces while performing active movements. With this methodology we are then able&#xD;
      to measure the kinematics as well as kinetics in the knee joint [Boeth et al., 2013],&#xD;
      especially different levels of femoral rollback in patients with ATTUNE implants, during&#xD;
      activities of daily living including walking, jogging, stair ascending/descending, rise a&#xD;
      chair, sit down. Furthermore lunge can also be performed with single plane fluoroscopy (BV&#xD;
      Pulsera, Philips) with a frequency of 30 Hz. During these measurements, the different extents&#xD;
      of femoral rollback in deep flexion (at 105'-125') under weight bearing condiiions will be&#xD;
      assessed and compared to the Sigma PFC system. The contact point between the femoral&#xD;
      component and the polyethylene inlay will be recorded and compared to standardized&#xD;
      postoperative radiographs. Clear specification should be given to the subject in order to&#xD;
      avoid unnecessary radiation, for this, at least 3 repetitions without radiation should be&#xD;
      performed to guarantee a complete subject's understanding of the procedure. The final&#xD;
      position of the foot on the sieps is marked to guarantee a standardization of the procedure.&#xD;
      The height of the c-arm of the device is adjusted to the specific shank's height of the&#xD;
      subject. During the analysis of the fluoroscopic assessment, model-based RSA software (MEDIS,&#xD;
      Leiden, The Netherlands) is used to register CAD models of the meiallic implants to the&#xD;
      fluoroscopic images, a registration accuracy of 0.6mm and 0.4' has been reported [Moewis&#xD;
      elal.2012].&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">September 2015</completion_date>
  <primary_completion_date type="Anticipated">April 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>tibio-femoral anterior-posterior translation</measure>
    <time_frame>at 12 months post operative</time_frame>
    <description>We intend to collect tibio-femoral anterior-posterior translation during active movement in order to analyse the different extent of femoral rollback (fluoroscopy and gait analysis including lunge activity) at 12 months post operative. Therefore, the femoral rollback will be classified to high level (l) and low level (ll) according to intraoperatively documented findings and postoperative radiographs.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 12 months post operative</time_frame>
    <description>We intend to collect the following secondary objective data pre operatively and '12 months post operative:&#xD;
- PKIP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 12 months post operative</time_frame>
    <description>We intend to collect the following secondary objective data pre operatively and '12 months post operative:&#xD;
- KOOS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 12 months post operative</time_frame>
    <description>We intend to collect the following secondary objective data pre operatively and '12 months post operative:&#xD;
- WOMAC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>at 12 months post operative</time_frame>
    <description>We intend to collect the following secondary objective data pre operatively and '12 months post operative:&#xD;
- SF 36</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Gonarthrosis</condition>
  <arm_group>
    <arm_group_label>test group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Retrospective test group 1 (n=10, ATTUNE® Knee System, rotating platform, cruciate retaining) with intraoperative high level rollback</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Retrospective test group 2 (n=10, ATTUNE® Knee System, rotating platform, cruciate retaining)with intraoperative low level rollback</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Control group (n=10, PFC® SIGMA® Knee System, rotatinq platform, cruciate retaininq)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ATTUNE® Knee System</intervention_name>
    <arm_group_label>test group 1</arm_group_label>
    <arm_group_label>test group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PFC® SIGMA® Knee System</intervention_name>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Gender: Both, male and female&#xD;
&#xD;
          2. MinimumAge: 18 Years&#xD;
&#xD;
          3. Osteoarthritis Kellgren Grad lll or lV&#xD;
&#xD;
          4. Mechanical leg axis between 10'valgus and 10' varus&#xD;
&#xD;
          5. Tibial slope between 0' and 10'&#xD;
&#xD;
          6. BMI&lt; 40, participation consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Multidirectional instability of the knee&#xD;
&#xD;
          2. connective tissue diseases (Marfan syndrome, Ehlers-Danlos syndrome, scleroderma)&#xD;
&#xD;
          3. Nervous system diseases (Parkinson, multiple sclerosis, Peripheral neuropathy)&#xD;
&#xD;
          4. 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_contact>
    <last_name>Georg N. Duda, Prof.</last_name>
    <phone>+49 30 450 559 079</phone>
    <email>georg.duda@charite.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anne Zergiebel</last_name>
    <phone>+49 30 450 515 235</phone>
    <email>anne.zergiebel@charite.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Charité University Medicine Berlin Center for Musculoskeletal Surgery Department of Orthopaedics</name>
      <address>
        <city>Berlin</city>
        <zip>10117</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://cmsc.charite.de/</url>
    <description>Center for Musculoskeletal Surgery</description>
  </link>
  <link>
    <url>http://jwi.charite.de/en/</url>
    <description>Julius Wolff Institute for Biomechanics and Musculoskeletal Regeneration</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Carsten Perka</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>kinematic analysis</keyword>
  <keyword>femoral rollback</keyword>
  <keyword>mobile bearing</keyword>
  <keyword>cruciate retaining Primary Total Knee Arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Knee</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/NCT02251535
org study id: DePuy ECO257107
nct id: NCT02251535
lead sponsor: 
collaborator: 
has dmc: No
Retrospective non-randomized in-vivo comparison of different levels of femoral rollback in
      the ATTUNE total knee arthroplasiy system (rotating platform CR high level roll back vs.
      rotating platform CR low level roll back) on the basis of fluoroscopic and marker-based
      motion capture evaluation. How do different levels of intra-operatively observed femoral
      rollback correlate to postoperative kinematics under weight bearing conditions? Does the
      modified design of the Attune Knee System influence the extent of the femoral rollback
      compared to the PFC Sigma Knee System? Does the femoral rollback maintain over a period of 12
      months follow up or is it reduced by, for example, remodelling of the posterior cruciate
      ligament?
Postoperative knee pain is one of the most challenging problems following total knee
      arthroplasty. Of all the possible complications, the patella-femoral joint is an important
      cause of postoperative knee pain and prosthetic failure. Nägerl et al. observed that the
      tibia slides along the femoral surface when the knee is flexed [Nagerlet al., 2009]. Beside
      the stabilization of the flexion gap, the main task of the posterior cruciate ligament is to
      initiate the femoral rollback to reduce the patellofemoral pressure. Vice versa, Heyse et al.
      could show that the patello-femoral pressure rises with the nsuffictency of the posterior
      cruciate ligament [Heyse et al., 2010]. Pandit et al. measured the physiological rollback in
      healthy knees and following implantation of currently available TKA. They could show that
      bonventional TKA are not able to restore the rollback in the natural tibio-femoral joint
      [Pandit et al., 2005]. Thus it would be important to see if the knee stability in joint
      replacement reaches the one found in intact or reconstructed knees after surgery. To mimic
      the femoral rollback a new prosthesis has recently been developed and is about to be
      introduced to be a new option for total knee arthroplasty. The "Attune Knee System" (DePuy,
      Warsaw, USA) also has a reduced femoral flange to reduce the patella-femoral contact
      pressure. The increased rotational stability, the reduced femoral flange and the femoral
      rollback of the "Attune Knee System" are intended to decrease postoperative knee pain.
      Different levels of femoral rollback were observed intra-operatively between the Attune and
      PFC Sigma system. Yoshiya et al. could show the relation between the posterior cruciate
      ligament with the femoral rollback [Yoshiya et al. 2005]. Therefore, one can hypothesize that
      different implant designs in combination with the tension of the PCL produce different
      extents of femoral rollback, ln order to test in-vivo knee kinematics in patients during
      active movements, we use motion capture, together with combinations of advanced techniques
      for assessing skeletal kinematics (including sARA [Ehrig et a1.2007], SCoRE [Ehrig et
      al.2011] & ocsr [Taytor et at. 2005]), a novet non-invasive approach to evaluate dynamic
      tibio-femoral motion. The combination of these approaches is now able to provide the accuracy
      and sensitivity required to analyze movement patterns in a rapid, robust and therefore
      clinically viable manner. ln order to do so, highly advanced equipment is needed which is
      available in our laboratory in the Julius Wolff lnstitute. Here, we use an infra-red optical
      motion capture system (10 T20S cameras, Vicon, Oxford, UK; system accuracy \-0.3-0.5 mm),
      tracked at120Hz, as well as 2 force plates (AMTI 0R6, Watertown, MA, USA) in order to assess
      the external forces while performing active movements. With this methodology we are then able
      to measure the kinematics as well as kinetics in the knee joint [Boeth et al., 2013],
      especially different levels of femoral rollback in patients with ATTUNE implants, during
      activities of daily living including walking, jogging, stair ascending/descending, rise a
      chair, sit down. Furthermore lunge can also be performed with single plane fluoroscopy (BV
      Pulsera, Philips) with a frequency of 30 Hz. During these measurements, the different extents
      of femoral rollback in deep flexion (at 105'-125') under weight bearing condiiions will be
      assessed and compared to the Sigma PFC system. The contact point between the femoral
      component and the polyethylene inlay will be recorded and compared to standardized
      postoperative radiographs. Clear specification should be given to the subject in order to
      avoid unnecessary radiation, for this, at least 3 repetitions without radiation should be
      performed to guarantee a complete subject's understanding of the procedure. The final
      position of the foot on the sieps is marked to guarantee a standardization of the procedure.
      The height of the c-arm of the device is adjusted to the specific shank's height of the
      subject. During the analysis of the fluoroscopic assessment, model-based RSA software (MEDIS,
      Leiden, The Netherlands) is used to register CAD models of the meiallic implants to the
      fluoroscopic images, a registration accuracy of 0.6mm and 0.4' has been reported [Moewis
      elal.2012].
allocation: Non-Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: tibio-femoral anterior-posterior translation
time frame: at 12 months post operative
description: We intend to collect tibio-femoral anterior-posterior translation during active movement in order to analyse the different extent of femoral rollback (fluoroscopy and gait analysis including lunge activity) at 12 months post operative. Therefore, the femoral rollback will be classified to high level (l) and low level (ll) according to intraoperatively documented findings and postoperative radiographs.
measure: quality of life
time frame: at 12 months post operative
description: We intend to collect the following secondary objective data pre operatively and '12 months post operative:
- PKIP
measure: quality of life
time frame: at 12 months post operative
description: We intend to collect the following secondary objective data pre operatively and '12 months post operative:
- KOOS
measure: quality of life
time frame: at 12 months post operative
description: We intend to collect the following secondary objective data pre operatively and '12 months post operative:
- WOMAC
measure: quality of life
time frame: at 12 months post operative
description: We intend to collect the following secondary objective data pre operatively and '12 months post operative:
- SF 36
arm group label: test group 1
arm group type: Experimental
description: Retrospective test group 1 (n=10, ATTUNE® Knee System, rotating platform, cruciate retaining) with intraoperative high level rollback
arm group label: test group 2
arm group type: Experimental
description: Retrospective test group 2 (n=10, ATTUNE® Knee System, rotating platform, cruciate retaining)with intraoperative low level rollback
arm group label: control group
arm group type: Experimental
description: Control group (n=10, PFC® SIGMA® Knee System, rotatinq platform, cruciate retaininq)
intervention type: Device
intervention name: ATTUNE® Knee System
arm group label: test group 1
arm group label: test group 2
intervention type: Device
intervention name: PFC® SIGMA® Knee System
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Georg N. Duda, Prof.
phone: +49 30 450 559 079
email: georg.duda@charite.de
last name: Anne Zergiebel
phone: +49 30 450 515 235
email: anne.zergiebel@charite.de
facility: 
status: Recruiting
country: Germany
url: http://cmsc.charite.de/
description: Center for Musculoskeletal Surgery
url: http://jwi.charite.de/en/
description: Julius Wolff Institute for Biomechanics and Musculoskeletal Regeneration
responsible party type: Sponsor-Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Prof. Dr. Carsten Perka
investigator title: Professor
mesh term: Osteoarthritis, Knee