<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/NCT02262468</url>
  </required_header>
  <id_info>
    <org_study_id>IIS2012012</org_study_id>
    <nct_id>NCT02262468</nct_id>
  </id_info>
  <brief_title>Warwick Metal On Metal Study</brief_title>
  <official_title>Review of 750 36mm MOM Hip Replacements ( Pinnacle/Corail) With up to 6 Year Follow up</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>South Warwickshire NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DePuy International</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>South Warwickshire NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      assess results of metal on metal hip replacements carried out at warwick hospital&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Resurfacing and XL head hip replacements have not done as well as expected. The ASR implant&#xD;
      has been withdrawn. Recent publications and media appearances by Tony Nargol, an orthopaedic&#xD;
      surgeon, have suggested 36mm metal on metal replacements. I intend to report the results of&#xD;
      this series.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Oxford hip score</measure>
    <time_frame>6 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">750</enrollment>
  <condition>Metal Hip Replacement</condition>
  <arm_group>
    <arm_group_label>MOM total hip replacements</arm_group_label>
    <description>all patients with MOM 36mm hip replacements</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>x ray</intervention_name>
    <arm_group_label>MOM total hip replacements</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with 36mm metal on metal hips&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients with 36mm metal on metal hips&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 7, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 10, 2014</last_update_submitted>
  <last_update_submitted_qc>October 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>South Warwickshire NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>Stephen Young</investigator_full_name>
    <investigator_title>consultant orthopaedic surgeon</investigator_title>
  </responsible_party>
  <keyword>retrospective analysis</keyword>
  <!-- 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/NCT02262468
org study id: IIS2012012
nct id: NCT02262468
lead sponsor: 
collaborator: 
has dmc: No
assess results of metal on metal hip replacements carried out at warwick hospital
Resurfacing and XL head hip replacements have not done as well as expected. The ASR implant
      has been withdrawn. Recent publications and media appearances by Tony Nargol, an orthopaedic
      surgeon, have suggested 36mm metal on metal replacements. I intend to report the results of
      this series.
observational model: Cohort
time perspective: Retrospective
measure: Oxford hip score
time frame: 6 years
arm group label: MOM total hip replacements
description: all patients with MOM 36mm hip replacements
intervention type: Radiation
intervention name: x ray
arm group label: MOM total hip replacements
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: South Warwickshire NHS Foundation Trust
investigator full name: Stephen Young
investigator title: consultant orthopaedic surgeon