xml: <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/NCT05969366</url>
    </required_header>
    <id_info>
      <org_study_id>2022PI032</org_study_id>
      <nct_id>NCT05969366</nct_id>
    </id_info>
    <brief_title>Early Clinical and Radiological Outcomes of Uncemented Fully Coated Stem With Patients of 85 Years and More, Complications and Risks Factor</brief_title>
    <official_title>Early Clinical and Radiological Outcomes of Uncemented Fully Coated Stem With Patients of 85 Years and More, Complications and Risks Factor</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Central Hospital, Nancy, France</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Central Hospital, Nancy, France</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Retrospective, single-centre study. Review of patients aged 85 and over who underwent total&#xD;
        hip replacement between June 2015 and February 2022.&#xD;
  &#xD;
        This is a femoral stem survival study with calculation of the complication rate in this&#xD;
        population.&#xD;
  &#xD;
        The study does not focus on total hip replacements in the context of trauma. The secondary&#xD;
        endpoint was the search for complication risk factors.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 2015</start_date>
    <completion_date type="Actual">July 2023</completion_date>
    <primary_completion_date type="Actual">April 2016</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>rate of complication</measure>
      <time_frame>minimum of 3 months follow up</time_frame>
      <description>survival study, any complications</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>risk factor of complications</measure>
      <time_frame>minimum of 3 months follow up</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">79</enrollment>
    <condition>Arthroplasty Complications</condition>
    <arm_group>
      <arm_group_label>patients 85 yearsold or orlder who hab total hip replacement with uncemented femoral stem</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Total hip arthroplasty</intervention_name>
      <arm_group_label>patients 85 yearsold or orlder who hab total hip replacement with uncemented femoral stem</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Any people of 85 years of more who received total hip arthroplasty with uncemented stem&#xD;
          fully hydroxyapatitis coated&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  receive total hip arthroplasty with uncemented stem fully hydroxyapatites coated&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  trauma context&#xD;
  &#xD;
            -  less than 3 month follow up&#xD;
  &#xD;
            -  Any surgery of the hip as medical history&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>85 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Centre Chirurgical Emile Gallé</name>
        <address>
          <city>Nancy</city>
          <zip>54000</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 23, 2023</study_first_submitted>
    <study_first_submitted_qc>July 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 23, 2023</last_update_submitted>
    <last_update_submitted_qc>July 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Central Hospital, Nancy, France</investigator_affiliation>
      <investigator_full_name>Olivier ROCHE</investigator_full_name>
      <investigator_title>Praticien Hospitalier</investigator_title>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05969366
  org study id: 2022PI032
  nct id: NCT05969366
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Retrospective, single-centre study. Review of patients aged 85 and over who underwent total
        hip replacement between June 2015 and February 2022.
  
        This is a femoral stem survival study with calculation of the complication rate in this
        population.
  
        The study does not focus on total hip replacements in the context of trauma. The secondary
        endpoint was the search for complication risk factors.
  observational model: Cohort
  time perspective: Retrospective
  measure: rate of complication
  time frame: minimum of 3 months follow up
  description: survival study, any complications
  measure: risk factor of complications
  time frame: minimum of 3 months follow up
  arm group label: patients 85 yearsold or orlder who hab total hip replacement with uncemented femoral stem
  intervention type: Procedure
  intervention name: Total hip arthroplasty
  arm group label: patients 85 yearsold or orlder who hab total hip replacement with uncemented femoral stem
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 85 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: France
  responsible party type: Principal Investigator
  investigator affiliation: Central Hospital, Nancy, France
  investigator full name: Olivier ROCHE
  investigator title: Praticien Hospitalier