<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/NCT02254980</url>
  </required_header>
  <id_info>
    <org_study_id>E1-H</org_study_id>
    <nct_id>NCT02254980</nct_id>
  </id_info>
  <brief_title>Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty</brief_title>
  <acronym>E1-hip</acronym>
  <official_title>Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup Compared to Standard Cemented Cup in Total Hip Arthroplasty. A Randomized, Single-blinded, Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Danderyd Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zimmer Biomet</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Danderyd Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have&#xD;
      superior wear resistance and improved mechanical properties as compared to that of standard&#xD;
      highly cross-linked PE. There are as of yet no published studies with vitamin-E diffused PE&#xD;
      although several trials are ongoing. All of these trials use uncemented acetabular cups&#xD;
      intended for biological fixation. In many countries the standard fixation method for the&#xD;
      acetabular component is bone-cement. The Vitamin-E used in implants is alfa-tocopherol, a&#xD;
      lipid-soluble antioxidant with oily consistency; theoretically affecting cemented fixation&#xD;
      when used in acetabular components. The aim of the study is to compare migration, linear wear&#xD;
      and clinical results between two types of cemented acetabular cups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">October 2026</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cup migration</measure>
    <time_frame>2 years</time_frame>
    <description>The primary outcome measure is migration of the cup at 2 years measured with radiostereometry (RSA) as proximal migration.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Linear wear</measure>
    <time_frame>2 years</time_frame>
    <description>Linear head penetration measured with RSA at 2 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Linear wear</measure>
    <time_frame>4 years</time_frame>
    <description>Linear head penetration measured with RSA at 4 years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Osteolysis</measure>
    <time_frame>10 years</time_frame>
    <description>Development of radiolucent lines between bone and cement around the cup.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Osteolysis</measure>
    <time_frame>2 years</time_frame>
    <description>Development of radiolucent lines between bone and cement around the cup.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional outcome</measure>
    <time_frame>2 years</time_frame>
    <description>Hip function measured with Harris hip score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>10 years</time_frame>
    <description>All hip-related complications and revision of implants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cup migration total</measure>
    <time_frame>2 years</time_frame>
    <description>Migration of the cup at 2 years measured with radiostereometry (RSA) as maximum total point motion (MTPM).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Total Hip Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Vitamin-E group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vitamin-E diffused polyethylene</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard polyethylene</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vitamin-E diffused polyethylene acetabular component</intervention_name>
    <description>Patients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E</description>
    <arm_group_label>Vitamin-E group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard polyethylene acetabular component</intervention_name>
    <description>Patients will undergo total hip arthroplasty using a standard cemented acetabular component</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary osteoarthritis of the hip&#xD;
&#xD;
          -  Willingness and ability to follow study-protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inflammatory arthritis or secondary osteoarthritis.&#xD;
&#xD;
          -  Type C (stove pipe) femur&#xD;
&#xD;
          -  Abnormal femoral or pelvic anatomy after hip dysplasia, not suitable for implantation&#xD;
             of components&#xD;
&#xD;
          -  Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery&#xD;
&#xD;
          -  Ongoing oestrogen treatment&#xD;
&#xD;
          -  Not suited for the study for other reason (surgeons preference)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Orthopaedic department, Danderyd Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>18288</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>February 6, 2019</last_update_submitted>
  <last_update_submitted_qc>February 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Danderyd Hospital</investigator_affiliation>
    <investigator_full_name>Olof Skoldenberg</investigator_full_name>
    <investigator_title>Consultant orthopedic surgeon</investigator_title>
  </responsible_party>
  <keyword>Total hip arthroplasty</keyword>
  <keyword>Cemented acetabular cup</keyword>
  <keyword>Vitamin-E</keyword>
  <keyword>Radiostereometry</keyword>
  <keyword>Fixation of cemented acetabular component in total hip arthroplasty</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin E</mesh_term>
  </intervention_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/NCT02254980
org study id: E1-H
nct id: NCT02254980
lead sponsor: 
collaborator: 
has dmc: No
In vitro, Vitamin-E diffused, highly cross-linked polyethylene (PE) have been shown to have
      superior wear resistance and improved mechanical properties as compared to that of standard
      highly cross-linked PE. There are as of yet no published studies with vitamin-E diffused PE
      although several trials are ongoing. All of these trials use uncemented acetabular cups
      intended for biological fixation. In many countries the standard fixation method for the
      acetabular component is bone-cement. The Vitamin-E used in implants is alfa-tocopherol, a
      lipid-soluble antioxidant with oily consistency; theoretically affecting cemented fixation
      when used in acetabular components. The aim of the study is to compare migration, linear wear
      and clinical results between two types of cemented acetabular cups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Cup migration
time frame: 2 years
description: The primary outcome measure is migration of the cup at 2 years measured with radiostereometry (RSA) as proximal migration.
measure: Linear wear
time frame: 2 years
description: Linear head penetration measured with RSA at 2 years
measure: Linear wear
time frame: 4 years
description: Linear head penetration measured with RSA at 4 years
measure: Osteolysis
time frame: 10 years
description: Development of radiolucent lines between bone and cement around the cup.
measure: Osteolysis
time frame: 2 years
description: Development of radiolucent lines between bone and cement around the cup.
measure: Functional outcome
time frame: 2 years
description: Hip function measured with Harris hip score
measure: Complication rate
time frame: 10 years
description: All hip-related complications and revision of implants
measure: Cup migration total
time frame: 2 years
description: Migration of the cup at 2 years measured with radiostereometry (RSA) as maximum total point motion (MTPM).
arm group label: Vitamin-E group
arm group type: Experimental
description: Vitamin-E diffused polyethylene
arm group label: Control group
arm group type: Active Comparator
description: Standard polyethylene
intervention type: Device
intervention name: Vitamin-E diffused polyethylene acetabular component
description: Patients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E
arm group label: Vitamin-E group
intervention type: Device
intervention name: Standard polyethylene acetabular component
description: Patients will undergo total hip arthroplasty using a standard cemented acetabular component
arm group label: Control group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Danderyd Hospital
investigator full name: Olof Skoldenberg
investigator title: Consultant orthopedic surgeon
mesh term: Vitamin E