<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/NCT02196792</url>
  </required_header>
  <id_info>
    <org_study_id>project-ID S-20080151</org_study_id>
    <nct_id>NCT02196792</nct_id>
  </id_info>
  <brief_title>Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement</brief_title>
  <official_title>Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement - A Prospective Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to investigate head penetration, cup migration, and clinical&#xD;
      outcome in total hip replacements using a factorial design. Treatment groups are E-Poly&#xD;
      versus ArComXL liners, and 36 mm versus 32 mm head size.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>May 1, 2009</start_date>
  <completion_date type="Anticipated">May 1, 2030</completion_date>
  <primary_completion_date type="Actual">May 1, 2015</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean head penetration from baseline to 5 year follow-up</measure>
    <time_frame>From baseline to 5 years</time_frame>
    <description>Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean cup migration form baseline to 5 year follow-up</measure>
    <time_frame>From baseline to 5 years</time_frame>
    <description>Mean cup migration assessed using RSA from baseline to 5 year follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in clinical outcome score from baseline to 5 year follow-up</measure>
    <time_frame>From baseline to 5 years</time_frame>
    <description>Mean change in patient-reported hip function (Harris Hip Score), quality of life (EQ-5D and SF-36), and patient activity (UCLA Activity Score).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Osteoarthritis, Hip</condition>
  <condition>Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>E-Poly/32 mm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E-Poly/36 mm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ArComXL/32 mm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ArComXL/36 mm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>E-Poly liner</intervention_name>
    <description>E-Poly liner with a titanium cup</description>
    <arm_group_label>E-Poly/32 mm</arm_group_label>
    <arm_group_label>E-Poly/36 mm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ArComXL liner</intervention_name>
    <description>ArComXL liner with a titanium cup</description>
    <arm_group_label>ArComXL/32 mm</arm_group_label>
    <arm_group_label>ArComXL/36 mm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>32 mm femoral head</intervention_name>
    <description>Stem with a 32 mm CoCr femoral head</description>
    <arm_group_label>ArComXL/32 mm</arm_group_label>
    <arm_group_label>E-Poly/32 mm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>36 mm femoral head</intervention_name>
    <description>Stem with a 36 mm CoCr femoral head</description>
    <arm_group_label>ArComXL/36 mm</arm_group_label>
    <arm_group_label>E-Poly/36 mm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary idiopathic arthritis,&#xD;
&#xD;
          -  Eligible for uncemented total hip arthroplasty&#xD;
&#xD;
          -  40 to70 years of age,&#xD;
&#xD;
          -  Cup size of 54mm and above&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anteversion where non-standard stem can be used,&#xD;
&#xD;
          -  Dysplasia (Center-edge angle of Wiberg &lt; 20°),&#xD;
&#xD;
          -  Malignant condition&#xD;
&#xD;
          -  Prior radiotherapy&#xD;
&#xD;
          -  Physical or psychological condition that renders it impossible for the patient to take&#xD;
             part in our usual rehabilitation programme (as stated in the department's standard&#xD;
             operation procedure),&#xD;
&#xD;
          -  Complications during surgery (requiring screws in shell or femoral cerclage)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph Abdalla N. El-Sahoury, BSc.med</last_name>
    <role>Principal Investigator</role>
    <affiliation>OUH Den Ortopædkirurgiske Forskningsenhed</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ming Ding, Professor MD</last_name>
    <role>Study Director</role>
    <affiliation>Odense University Hospital, University of Southern Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Joseph Abdalla Nommesen El-Sahoury</name>
      <address>
        <city>Odense C</city>
        <state>Syddanmark</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>June 17, 2022</last_update_submitted>
  <last_update_submitted_qc>June 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Joseph Abdalla Nommesen El-Sahoury</investigator_full_name>
    <investigator_title>Research assistant</investigator_title>
  </responsible_party>
  <keyword>Joint Diseases</keyword>
  <keyword>Musculoskeletal Diseases</keyword>
  <keyword>radiostereometric analysis</keyword>
  <keyword>Total hip arthroplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 19, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT02196792/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02196792
org study id: project-ID S-20080151
nct id: NCT02196792
lead sponsor: 
collaborator: 
has dmc: No
The objective of the study is to investigate head penetration, cup migration, and clinical
      outcome in total hip replacements using a factorial design. Treatment groups are E-Poly
      versus ArComXL liners, and 36 mm versus 32 mm head size.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean head penetration from baseline to 5 year follow-up
time frame: From baseline to 5 years
description: Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up
measure: Mean cup migration form baseline to 5 year follow-up
time frame: From baseline to 5 years
description: Mean cup migration assessed using RSA from baseline to 5 year follow-up
measure: Mean change in clinical outcome score from baseline to 5 year follow-up
time frame: From baseline to 5 years
description: Mean change in patient-reported hip function (Harris Hip Score), quality of life (EQ-5D and SF-36), and patient activity (UCLA Activity Score).
arm group label: E-Poly/32 mm
arm group type: Active Comparator
description: E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head.
arm group label: E-Poly/36 mm
arm group type: Active Comparator
description: E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
arm group label: ArComXL/32 mm
arm group type: Active Comparator
description: ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head.
arm group label: ArComXL/36 mm
arm group type: Active Comparator
description: ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head.
intervention type: Device
intervention name: E-Poly liner
description: E-Poly liner with a titanium cup
arm group label: E-Poly/32 mm
arm group label: E-Poly/36 mm
intervention type: Device
intervention name: ArComXL liner
description: ArComXL liner with a titanium cup
arm group label: ArComXL/32 mm
arm group label: ArComXL/36 mm
intervention type: Device
intervention name: 32 mm femoral head
description: Stem with a 32 mm CoCr femoral head
arm group label: ArComXL/32 mm
arm group label: E-Poly/32 mm
intervention type: Device
intervention name: 36 mm femoral head
description: Stem with a 36 mm CoCr femoral head
arm group label: ArComXL/36 mm
arm group label: E-Poly/36 mm
criteria: 
gender: All
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: No
last name: Joseph Abdalla N. El-Sahoury, BSc.med
role: Principal Investigator
affiliation: OUH Den Ortopædkirurgiske Forskningsenhed
last name: Ming Ding, Professor MD
role: Study Director
affiliation: Odense University Hospital, University of Southern Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Joseph Abdalla Nommesen El-Sahoury
investigator title: Research assistant
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Hip
sharing ipd: Undecided
provided document: 