<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/NCT01713062</url>
  </required_header>
  <id_info>
    <org_study_id>AAG-G-H-1113</org_study_id>
    <nct_id>NCT01713062</nct_id>
  </id_info>
  <brief_title>Longterm-Evaluation of Vitelene® Against Standard</brief_title>
  <acronym>VITAS</acronym>
  <official_title>Randomised Prospective Multicenter Longterm-Evaluation of the Survival Rate of the Implant, Wear and Periprosthetic Osteolysis of Highly Cross-linked Polyethylene With and Without Addition of Vitamin E (UHMWPE-XE vs. UHMWPE-X)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aesculap AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aesculap AG</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this randomised prospective multicenter longterm study is to evaluate the&#xD;
      survival rate of the implant, wear and periprosthetic osteolysis of highly cross-linked&#xD;
      polyethylene with and without addition of Vitamin E (UHMWPE-XE vs. UHMWPE-X) in Total Hip&#xD;
      Arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 2012</start_date>
  <completion_date type="Anticipated">April 2030</completion_date>
  <primary_completion_date type="Actual">April 24, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Analysis and measurement of oxidation index of the Polyethylene Inlay after Revision</measure>
    <time_frame>Oxidation index is assessed in case of loosening and revision within 15 years</time_frame>
    <description>The Oxidation index is measured after explantation in case of loosening of the inlay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Manifest radiological osteolyses</measure>
    <time_frame>Measured radiologically after 1, 5, 10 and 15 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Traceable wear of polyethylene over 0.5 mm</measure>
    <time_frame>Measured radiologically after 1, 5, 10 and 15 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Outcome</measure>
    <time_frame>After 1, 5, 10 and 15 years</time_frame>
    <description>Clinical Outcome measured by Harris Hip Score (HHS), Hip disability and osteoarthritis outcome score(HOOS), University of California at Los Angeles Score (UCLA)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Osteoarthritis, Hip</condition>
  <condition>Arthritis</condition>
  <arm_group>
    <arm_group_label>Vitelene</arm_group_label>
    <description>Plasmacup DC® with Vitelene® inlay manufactured by UHMWPE-XE (Ultra High Molecular Weight Polyethylene highly cross-linked with 0.1% Vitamin E) in combination with one of four different Aesculap® stems (Bicontact®, TRJ®, Metha®, Excia®)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>XLPE</arm_group_label>
    <description>Plasmacup DC® with a standard polyethylene inlay manufactured by UHMWPE-X (Ultra High Molecular Weight Polyethylene highly cross-linked) in combination with one of four different Aesculap® stems (Bicontact®, TRJ®, Metha®, Excia®)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vitelene</intervention_name>
    <description>THA</description>
    <arm_group_label>Vitelene</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>XLPE</intervention_name>
    <description>THA</description>
    <arm_group_label>XLPE</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Minimum age: 18 years&#xD;
&#xD;
          -  Maximum age: 75 years&#xD;
&#xD;
          -  Indication of cementless THA&#xD;
&#xD;
          -  Approval of study participation and treatment according to study protocol&#xD;
&#xD;
          -  Physical and mental willingness of adhering to clinical and radiological follow up&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Patient is not able to join follow up&#xD;
&#xD;
          -  Increased risk of anaesthesia according to the &quot;American Society of Anesthesiology&quot;:&#xD;
             ASA IV&#xD;
&#xD;
          -  Tumor disease&#xD;
&#xD;
          -  Alcohol and drug dependency&#xD;
&#xD;
          -  Permanent cortisone therapy&#xD;
&#xD;
          -  Clinical relevant infections&#xD;
&#xD;
          -  Pregnancy and planned pregnancy&#xD;
&#xD;
          -  Previous interventions like adjustment-osteotomy, treatment of fractures or THA on&#xD;
             affected side&#xD;
&#xD;
          -  Acute fractures of the affected hip joint&#xD;
&#xD;
          -  Patients with bone quality, which doesn´t allow a cementless treatment&#xD;
&#xD;
          -  Requirements of clinical relevant deformities (condition after preoperation or bone&#xD;
             fracture, leg length discrepancy &gt; 30 mm, Offset-reduction about &gt; 30 mm)&#xD;
&#xD;
          -  Small acetabular treatments with 28 mm heads&#xD;
&#xD;
          -  Treatments without using ceramic heads&#xD;
&#xD;
          -  Treatments which require neck prolonging components&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcus Jäger, Prof. Dr. med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Essen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fachklinik für Orthopädie, Unfallchirurgie, WirbelsäulenchirurgieMarienhaus Klinikum St. Josef</name>
      <address>
        <city>Bendorf</city>
        <zip>56170</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Orthopädie und Unfallchirurgie</name>
      <address>
        <city>Bochum</city>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Dortmund gGmbH - Orthopädische Klinik</name>
      <address>
        <city>Dortmund</city>
        <zip>44137</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopädische Universitätsklinik Essen</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik und Poliklinik für Orthopädie</name>
      <address>
        <city>Halle</city>
        <zip>06097</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopädische Klinik der MHH im Annastift</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elisabeth Klinikum Olsberg</name>
      <address>
        <city>Olsberg</city>
        <zip>59939</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>October 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis, Hip</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/NCT01713062
org study id: AAG-G-H-1113
nct id: NCT01713062
lead sponsor: 
has dmc: No
The purpose of this randomised prospective multicenter longterm study is to evaluate the
      survival rate of the implant, wear and periprosthetic osteolysis of highly cross-linked
      polyethylene with and without addition of Vitamin E (UHMWPE-XE vs. UHMWPE-X) in Total Hip
      Arthroplasty.
observational model: Cohort
time perspective: Prospective
measure: Analysis and measurement of oxidation index of the Polyethylene Inlay after Revision
time frame: Oxidation index is assessed in case of loosening and revision within 15 years
description: The Oxidation index is measured after explantation in case of loosening of the inlay
measure: Manifest radiological osteolyses
time frame: Measured radiologically after 1, 5, 10 and 15 years
measure: Traceable wear of polyethylene over 0.5 mm
time frame: Measured radiologically after 1, 5, 10 and 15 years
measure: Clinical Outcome
time frame: After 1, 5, 10 and 15 years
description: Clinical Outcome measured by Harris Hip Score (HHS), Hip disability and osteoarthritis outcome score(HOOS), University of California at Los Angeles Score (UCLA)
arm group label: Vitelene
description: Plasmacup DC® with Vitelene® inlay manufactured by UHMWPE-XE (Ultra High Molecular Weight Polyethylene highly cross-linked with 0.1% Vitamin E) in combination with one of four different Aesculap® stems (Bicontact®, TRJ®, Metha®, Excia®)
arm group label: XLPE
description: Plasmacup DC® with a standard polyethylene inlay manufactured by UHMWPE-X (Ultra High Molecular Weight Polyethylene highly cross-linked) in combination with one of four different Aesculap® stems (Bicontact®, TRJ®, Metha®, Excia®)
intervention type: Device
intervention name: Vitelene
description: THA
arm group label: Vitelene
intervention type: Device
intervention name: XLPE
description: THA
arm group label: XLPE
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Marcus Jäger, Prof. Dr. med
role: Principal Investigator
affiliation: Universitätsklinikum Essen
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Osteoarthritis, Hip