<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/NCT01684631</url>
  </required_header>
  <id_info>
    <org_study_id>27062008</org_study_id>
    <nct_id>NCT01684631</nct_id>
  </id_info>
  <brief_title>Evaluation of Implant Survival in Patients With a Pinnacle Ultamet Device in Conventional Total Hip Joint Replacement</brief_title>
  <official_title>Prospective, Multicentric, Observational Cohort Study for the Evaluation of Implant Survival in Patients With a Metal-on-Metal Pinnacle(R) Ultamet(TM) Device in Conventional Total Hip Joint Replacement.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DePuy International</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DePuy International</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective is to evaluate the implant survival rate for patients implanted with a&#xD;
      PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the&#xD;
      treatment of a severe hip disease and true femoral cervical fracture.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">November 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>Implant Survival Rate</measure>
    <time_frame>up to 5 years</time_frame>
    <description>Implant Survival Rate as the duration of PINNACLE® ULTAMET™ implantation for the follow-up duration, free of revision surgery, whatever the cause.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Harris Hip Score</measure>
    <time_frame>pre-operative, 1, 2, 3, 5 years</time_frame>
    <description>Measure of hip function using the Harris Hip Score</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cobalt and Chromium serum concentration</measure>
    <time_frame>3 to 6 Months, 1, 2, 3, 5 years</time_frame>
    <description>Descriptive analysis of patient serum concentration of Cobalt and Chromium</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Event Frequency</measure>
    <time_frame>Per-operative, 3 to 6 Months, 1, 2, 3, 5 years</time_frame>
    <description>Descriptive Analysis of Adverse Event Frequency for the duration of the study.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">107</enrollment>
  <condition>Arthropathy of Hip</condition>
  <arm_group>
    <arm_group_label>Hip arthroplasty</arm_group_label>
    <description>Patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease or true femoral cervical fracture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Total Hip arthroplasty</intervention_name>
    <arm_group_label>Hip arthroplasty</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients susceptible to receive a PINNACLE® ULTAMET™ implant&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients susceptible to receive a PINNACLE® ULTAMET™ implant as per routine practice&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal to participate to the data collection&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Patients age is less than 18 years old&#xD;
&#xD;
          -  The planned intervention is a revision of a previous intervention on the studied hip&#xD;
             joint&#xD;
&#xD;
          -  Previous metal implant, except for pure titanium or titanium alloys&#xD;
&#xD;
          -  Exposure to cobalt and chromium that could influence serum metal ions levels&#xD;
&#xD;
          -  Planned bilateral intervention&#xD;
&#xD;
          -  Patient residing outside France&#xD;
&#xD;
          -  Patient not implanted with a Pinnacle(R) ULTAMET(TM)&#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_official>
    <last_name>Jean-Marie Toupin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique Saint Hilaire Rouen, France 76000</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique Herbert</name>
      <address>
        <city>Aix-les-Bains</city>
        <zip>73100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Bonnefon</name>
      <address>
        <city>Ales</city>
        <zip>30104</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Georges Renon</name>
      <address>
        <city>Niort</city>
        <zip>79021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint Hilaire</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur</name>
      <address>
        <city>Royan</city>
        <zip>17200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Mutualiste Saint Etienne</name>
      <address>
        <city>Saint Etienne</city>
        <zip>42013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.</citation>
    <PMID>5783851</PMID>
  </reference>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>September 23, 2016</last_update_submitted>
  <last_update_submitted_qc>September 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2016</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>Joint Diseases</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/NCT01684631
org study id: 27062008
nct id: NCT01684631
lead sponsor: 
has dmc: No
The objective is to evaluate the implant survival rate for patients implanted with a
      PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the
      treatment of a severe hip disease and true femoral cervical fracture.
observational model: Cohort
time perspective: Prospective
measure: Implant Survival Rate
time frame: up to 5 years
description: Implant Survival Rate as the duration of PINNACLE® ULTAMET™ implantation for the follow-up duration, free of revision surgery, whatever the cause.
measure: Harris Hip Score
time frame: pre-operative, 1, 2, 3, 5 years
description: Measure of hip function using the Harris Hip Score
measure: Cobalt and Chromium serum concentration
time frame: 3 to 6 Months, 1, 2, 3, 5 years
description: Descriptive analysis of patient serum concentration of Cobalt and Chromium
measure: Adverse Event Frequency
time frame: Per-operative, 3 to 6 Months, 1, 2, 3, 5 years
description: Descriptive Analysis of Adverse Event Frequency for the duration of the study.
arm group label: Hip arthroplasty
description: Patients implanted with a PINNACLE® ULTAMET™ Metal-on-Metal implant for conventional total hip arthroplasty for the treatment of a severe hip disease or true femoral cervical fracture.
intervention type: Device
intervention name: Total Hip arthroplasty
arm group label: Hip arthroplasty
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Marie Toupin, MD
role: Principal Investigator
affiliation: Clinique Saint Hilaire Rouen, France 76000
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
citation: Harris WH. Traumatic arthritis of the hip after dislocation and acetabular fractures: treatment by mold arthroplasty. An end-result study using a new method of result evaluation. J Bone Joint Surg Am. 1969 Jun;51(4):737-55. No abstract available.
PMID: 5783851
responsible party type: Sponsor
mesh term: Joint Diseases