<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/NCT02230826</url>
  </required_header>
  <id_info>
    <org_study_id>1302-T-HIPLTO-RM</org_study_id>
    <nct_id>NCT02230826</nct_id>
  </id_info>
  <brief_title>Observational Study to Evaluate Long-Term Outcome in Hip Arthroplasty</brief_title>
  <official_title>Multicentric Observational PMCF Study to Evaluate Long-term Outcome, Performance and Safety of Implantable Devices in Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corin</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This long-term outcomes study is designed to collect safety and efficacy data on designated,&#xD;
      commercially available, hip arthroplasty products.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Outcome data collected from this study will be used for Post Market Surveillance (PMS) and&#xD;
      Clinical Evaluations on Corin hip devices and will support peer-reviewed publications on&#xD;
      products performance and safety at long term follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>May 2014</start_date>
  <completion_date type="Anticipated">December 2044</completion_date>
  <primary_completion_date type="Anticipated">December 2034</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>Evaluation of long-term outcome after hip arthroplasty with Corin implants.</measure>
    <time_frame>At 10 years</time_frame>
    <description>Implants revision rate at 10-year FU hip arthroplasty</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of long-term outcome after hip arthroplasty with Corin implants at 15 and 20-year FU.</measure>
    <time_frame>at 15- and 20-year</time_frame>
    <description>Implants revision rate at 15- and 20-year FU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of clinical performance of Corin hip implants</measure>
    <time_frame>starting intraoperatively up to 20-year FU</time_frame>
    <description>Change of Patient Reported Outcome Measures (PROMs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of Safety of Corin hip implants</measure>
    <time_frame>starting intraoperatively up to 20-year FU</time_frame>
    <description>Number, severity and causal relationship of procedure or implant-related Adverse Events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological evaluation of positioning and osteointegration of Corin hip implants.</measure>
    <time_frame>starting intraoperatively up to 20-year FU</time_frame>
    <description>Number, thickness and location of radiolucent lines, osteolysis and heterotopic ossifications reported via radiological evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of patient quality of life</measure>
    <time_frame>starting intraoperatively up to 20-year FU</time_frame>
    <description>Improvement of quality of life via EQ-5D-5L scores.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of patient satisfaction following surgery</measure>
    <time_frame>3 months ; 2.5-year; 6, 11, 15, 20-year visits</time_frame>
    <description>Improvement of patient's satisfaction</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>Hip Replacement</condition>
  <condition>Primary, Secondary or Post-traumatic Osteoarthrosis</condition>
  <condition>Femur Head Necrosis</condition>
  <condition>Congenital Dislocations</condition>
  <condition>Primary and Revision Surgery</condition>
  <arm_group>
    <arm_group_label>Patients with Hip arthroplasty</arm_group_label>
    <description>Patients with Hip implants.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Cohort of patients with a partial or total hip replacement (Corin implants)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man or woman &gt;18 years&#xD;
&#xD;
          -  Subjects with indication of arthroplasty surgery with Corin hip devices which are&#xD;
             under assessment as part of this PMCF study&#xD;
&#xD;
          -  Subjects who agreed for study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with existing tumour and/or particularly high surgical risk-&#xD;
&#xD;
          -  Subjects with anaesthetic risk class IV or higher&#xD;
&#xD;
          -  Subjects under guardianship and/or unable to follow procedures or matters related to&#xD;
             the study (examples: Illiterate, recent psychotic or mania disorders and / or&#xD;
             inability to comply with usual follow-up visits.)&#xD;
&#xD;
          -  Contraindications for arthroplasty with a Corin hip devices as per product IFU&#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>Goulven Rochcongar, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital, Caen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vanessa Grimaud</last_name>
    <email>vanessa.grimaud@coringroup.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Bordeaux - Groupe Hospitalier Pellegrin</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>clinique Oxford Cannes</name>
      <address>
        <city>Cannes</city>
        <zip>06400</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mathieu NICOLAS, MD</last_name>
    </contact>
    <investigator>
      <last_name>Mathieu NICOLAS, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH Dunkerque</name>
      <address>
        <city>Dunkerque</city>
        <zip>59385</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nicolas JAN, MD</last_name>
    </contact>
    <investigator>
      <last_name>Nicolas JAN, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Polyclinique Henin Beaumont</name>
      <address>
        <city>Hénin-Beaumont</city>
        <zip>62254</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre CHOLEWINSKI, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>Romain GALMICHE, MD</last_name>
    </contact_backup>
    <investigator>
      <last_name>Pierre CHOLEWINSKI, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Romain GALMICHE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Nice</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Régis BERNARD DE DOMPSURE, MD</last_name>
    </contact>
    <investigator>
      <last_name>Régis BERNARD DE DOMPSURE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jean-François GONZALEZ, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Régionnal d'Orléans - Site La Source</name>
      <address>
        <city>Orléans</city>
        <zip>45000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinique Arago</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dorick PASSERON, MD</last_name>
    </contact>
    <investigator>
      <last_name>Dorick PASSERON, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Croix Saint-Simon</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antoine MOUTON, MD</last_name>
    </contact>
    <investigator>
      <last_name>Antoine MOUTON, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Luc LHOTELLIER, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hopital privé Saint-Martin</name>
      <address>
        <city>Pessac</city>
        <zip>33600</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Provo</name>
      <address>
        <city>Roubaix</city>
        <zip>59100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>François GIRAUD, MD</last_name>
    </contact>
    <investigator>
      <last_name>François GIRAUD, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Polyclinique St Georges de Didonne</name>
      <address>
        <city>St Georges de Didonne</city>
        <zip>17110</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine LAUTRIDOU, MD</last_name>
    </contact>
    <investigator>
      <last_name>Christine LAUTRIDOU, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Médipôle Garonne</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Terminated</status>
  </location>
  <location>
    <facility>
      <name>Hôpital Jean Bernard</name>
      <address>
        <city>Valenciennes</city>
        <zip>59300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Charles BERTON, MD</last_name>
    </contact>
    <investigator>
      <last_name>Charles BERTON, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alexandre BLAIRON, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>March 14, 2023</last_update_submitted>
  <last_update_submitted_qc>March 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Arthroplasty</keyword>
  <keyword>Hip Replacement</keyword>
  <keyword>Acetabular cup</keyword>
  <keyword>Femoral stem</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Femur Head Necrosis</mesh_term>
    <mesh_term>Necrosis</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/NCT02230826
org study id: 1302-T-HIPLTO-RM
nct id: NCT02230826
lead sponsor: 
has dmc: No
This long-term outcomes study is designed to collect safety and efficacy data on designated,
      commercially available, hip arthroplasty products.
Outcome data collected from this study will be used for Post Market Surveillance (PMS) and
      Clinical Evaluations on Corin hip devices and will support peer-reviewed publications on
      products performance and safety at long term follow-up.
observational model: Cohort
time perspective: Prospective
measure: Evaluation of long-term outcome after hip arthroplasty with Corin implants.
time frame: At 10 years
description: Implants revision rate at 10-year FU hip arthroplasty
measure: Evaluation of long-term outcome after hip arthroplasty with Corin implants at 15 and 20-year FU.
time frame: at 15- and 20-year
description: Implants revision rate at 15- and 20-year FU.
measure: Evaluation of clinical performance of Corin hip implants
time frame: starting intraoperatively up to 20-year FU
description: Change of Patient Reported Outcome Measures (PROMs)
measure: Evaluation of Safety of Corin hip implants
time frame: starting intraoperatively up to 20-year FU
description: Number, severity and causal relationship of procedure or implant-related Adverse Events
measure: Radiological evaluation of positioning and osteointegration of Corin hip implants.
time frame: starting intraoperatively up to 20-year FU
description: Number, thickness and location of radiolucent lines, osteolysis and heterotopic ossifications reported via radiological evaluation
measure: Evaluation of patient quality of life
time frame: starting intraoperatively up to 20-year FU
description: Improvement of quality of life via EQ-5D-5L scores.
measure: Evaluation of patient satisfaction following surgery
time frame: 3 months ; 2.5-year; 6, 11, 15, 20-year visits
description: Improvement of patient's satisfaction
arm group label: Patients with Hip arthroplasty
description: Patients with Hip implants.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Goulven Rochcongar, MD
role: Study Chair
affiliation: University Hospital, Caen
last name: Vanessa Grimaud
email: vanessa.grimaud@coringroup.com
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Terminated
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Femur Head Necrosis
mesh term: Necrosis