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/NCT05966220</url>
    </required_header>
    <id_info>
      <org_study_id>2021-01</org_study_id>
      <nct_id>NCT05966220</nct_id>
    </id_info>
    <brief_title>Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices.</brief_title>
    <acronym>HipFHOrtho</acronym>
    <official_title>Post Market Clinical Follow-up of Hip Surgery Using FH ORTHO Company Medical Devices (FH ORTHO Company Hip Observatory).</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>FH ORTHO</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>FH ORTHO</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>
        The objective of this observatory is to generate additional real life clinical data in&#xD;
        accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study&#xD;
        carried out following the European Conformity (CE) marking of a device and intended to answer&#xD;
        specific questions relating to clinical safety or performance (i.e. residual risks) of a&#xD;
        device when used in accordance with its approved labelling).&#xD;
  &#xD;
        The difficulty of such an observatory is to be able to collect data on the different versions&#xD;
        of the devices, on the different possible combinations of implants of an arthroplasty. The&#xD;
        observatory must also be able to cover devices used in surgery to repair osteoarticular&#xD;
        trauma.&#xD;
  &#xD;
        The observatory will be based on the principle of a &quot;dynamic&quot; cohort during the inclusion&#xD;
        period, i.e. with possible inclusions to replace the premature exits.&#xD;
  &#xD;
        Technical solutions will be implemented to facilitate data collection from surgeons&#xD;
        (electronic Case Report Form (eCRF) and from patients (Electronic Patient Reported Outcome&#xD;
        (ePRO) on phone/tablet/computer).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2038</completion_date>
    <primary_completion_date type="Anticipated">October 2038</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Survival rate (revision) of the medical device over the long term (maximum 15 years).</measure>
      <time_frame>maximum 15 years.</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">800</enrollment>
    <condition>Hip Surgery</condition>
    <arm_group>
      <arm_group_label>Total hip arthroplasty (THA) and Revision THA</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients will be monitored for up to 15 years postoperatively.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Traumatology: femoral neck Total hip arthroplasty or hemiarthroplasty</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients will be monitored for up to 10 years postoperatively.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Hip surgery with FH Ortho devices</intervention_name>
      <description>This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone hip joint replacement or repair following hip trauma.&#xD;
  In this type of intervention, one or more medical devices distributed by FH ORTHO Company may be used by surgeons.</description>
      <arm_group_label>Total hip arthroplasty (THA) and Revision THA</arm_group_label>
      <arm_group_label>Traumatology: femoral neck Total hip arthroplasty or hemiarthroplasty</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Any patient undergoing or having undergone implantation of medical devices distributed&#xD;
               by FH ORTHO Company for hip arthroplasty and traumatology, used in accordance with&#xD;
               their approved Instruction For Use, in one of the centers participating in the&#xD;
               Observatory.&#xD;
  &#xD;
            2. Patient is at least 18 years of age.&#xD;
  &#xD;
            3. Patient agreeing to participate after having been informed orally and in writing (with&#xD;
               written consent if required locally).&#xD;
  &#xD;
            4. In some countries, such as France, the patient will have to be socially insured to be&#xD;
               included in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. An infection, or latent infection.&#xD;
  &#xD;
            2. A mental or neuromuscular disorder that would create an unacceptable risk of&#xD;
               prosthetic instability, failure of prosthetic fixation, or post-operative&#xD;
               complications (except for the HIP&amp;GO Double mobility cemented cup and, if applicable,&#xD;
               the associated stems and heads when assembled together).&#xD;
  &#xD;
            3. Known Insufficient bone quality and/or bone stock.&#xD;
  &#xD;
            4. Known allergy to any component of the material listed on the product label.&#xD;
  &#xD;
            5. Metabolic diseases that could compromise bone regrowth.&#xD;
  &#xD;
            6. Metabolic and/or vascular treatment or disease that may compromise bone healing or&#xD;
               consolidation.&#xD;
  &#xD;
            7. Drug dependency.&#xD;
  &#xD;
            8. Uncooperative patient unable to follow recommendations.&#xD;
  &#xD;
            9. Protected adult&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05966220
  org study id: 2021-01
  nct id: NCT05966220
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this observatory is to generate additional real life clinical data in
        accordance with local regulation (i.e. Post-Market Clinical Follow-up (PMCF) study, a study
        carried out following the European Conformity (CE) marking of a device and intended to answer
        specific questions relating to clinical safety or performance (i.e. residual risks) of a
        device when used in accordance with its approved labelling).
  
        The difficulty of such an observatory is to be able to collect data on the different versions
        of the devices, on the different possible combinations of implants of an arthroplasty. The
        observatory must also be able to cover devices used in surgery to repair osteoarticular
        trauma.
  
        The observatory will be based on the principle of a "dynamic" cohort during the inclusion
        period, i.e. with possible inclusions to replace the premature exits.
  
        Technical solutions will be implemented to facilitate data collection from surgeons
        (electronic Case Report Form (eCRF) and from patients (Electronic Patient Reported Outcome
        (ePRO) on phone/tablet/computer).
  allocation: Non-Randomized
  intervention model: Single Group Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Survival rate (revision) of the medical device over the long term (maximum 15 years).
  time frame: maximum 15 years.
  arm group label: Total hip arthroplasty (THA) and Revision THA
  arm group type: Other
  description: Patients will be monitored for up to 15 years postoperatively.
  arm group label: Traumatology: femoral neck Total hip arthroplasty or hemiarthroplasty
  arm group type: Other
  description: Patients will be monitored for up to 10 years postoperatively.
  intervention type: Device
  intervention name: Hip surgery with FH Ortho devices
  description: This study is a real-life observatory designed to collect long-term clinical data on patients who have undergone hip joint replacement or repair following hip trauma.
  In this type of intervention, one or more medical devices distributed by FH ORTHO Company may be used by surgeons.
  arm group label: Total hip arthroplasty (THA) and Revision THA
  arm group label: Traumatology: femoral neck Total hip arthroplasty or hemiarthroplasty
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  sharing ipd: No