<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/NCT03307109</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0419</org_study_id>
    <nct_id>NCT03307109</nct_id>
  </id_info>
  <brief_title>Quality of Life in Patients Having a Prosthetic Joint Infection</brief_title>
  <acronym>QuaVIPA</acronym>
  <official_title>Quality of Life in Patients Having a Prosthetic Joint Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Bone and joint infections (BJI) are rare serious pathology which can lead to a very heavy&#xD;
      handicap and sometimes to the life threatening. These are devastating diseases whose&#xD;
      diagnosis is difficult. They are known to be associated with high mortality rates (5%) and&#xD;
      significant morbidities responsible for functional sequelae (40% of patients) with an&#xD;
      individual cost (prolonged hospitalization, altered quality of life) and societal (work&#xD;
      stoppage, partial or total disability, temporary or permanent) extremely high.&#xD;
&#xD;
      These bone and joint infections have a significant impact on the quality of life of those&#xD;
      affected who, in addition to their infection, are reduced in their autonomy and often need to&#xD;
      be taken care of outside their home, sometimes away from home.&#xD;
&#xD;
      To the knowledge of investigators, there are few studies on the measurement of quality of&#xD;
      life in patients with osteoarticular infection.&#xD;
&#xD;
      The aim of this study is to implement the EQ-5D-3L validated quality of life questionnaire&#xD;
      and the EVA scale (created by EuroQol Group) for each patient with a prosthetic joint&#xD;
      infection (IPA) on prosthesis during their medical care in the department of Infectious and&#xD;
      Tropical Diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 17, 2017</start_date>
  <completion_date type="Anticipated">October 2025</completion_date>
  <primary_completion_date type="Anticipated">October 2023</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>Questionnaire EQ-5D-3L</measure>
    <time_frame>12 to 24 months</time_frame>
    <description>EQ5D is one of the most widely used health states descriptive system and has a valuation in France.&#xD;
EQ-5D questionnaires have 5 dimensions: &quot;Mobility&quot;, &quot;Human Autonomy,&quot; &quot;Current Activities&quot;, &quot;Pain / Discomfort&quot;, &quot;Anxiety / Depression&quot; and all dimensions are described by 3 problem levels corresponding to patient response choices.&#xD;
A quality of life score is obtained according to the answers to the questionnaires.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Analog Visual Scale</measure>
    <time_frame>12 to 24 months</time_frame>
    <description>Use of a Analog Visual Scale to measure the quality of life</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire EQ-5D-5L</measure>
    <time_frame>12 to 24 months</time_frame>
    <description>In the EQ-5D-5L the 5 dimensions are described by 5 problem levels corresponding to patient response choices.&#xD;
A quality of life score is obtained according to the answers to the questionnaires. In France, only the EQ-5D-3L has been validated, not yet the EQ-5D-5L which has only been translated.&#xD;
In this study investigators want compare the score obtained to the questionnaires EQ5D-5L and EQ-5D-3L to determine if EQ-5D-5L is more adapted to patients having prosthetic joint infection.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Quality of Life</condition>
  <condition>Prosthetic Joint Infection</condition>
  <arm_group>
    <arm_group_label>Patients having prosthetic joint infection</arm_group_label>
    <description>The primary aim is to measure the evolution of quality of life in patients having prosthetic joint infection during their medical care and possibly psychologic assistance in the Infectious and Tropical Diseases Department of Croix-Rousse Hospital.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality of life</intervention_name>
    <description>Patients will complete two EQ-5D-5L and EQ-5D-3L quality of life questionnaires and will complete an analog visual scale during each of their follow-up visits to the Infectious and Tropical Diseases Department of Croix-Rousse hospital. No visits will be added to complete the questionnaires.</description>
    <arm_group_label>Patients having prosthetic joint infection</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients having an prosthetic joint infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient having prosthetic joint infection&#xD;
&#xD;
          -  Patient who did not object to participate in the study&#xD;
&#xD;
          -  Patients over 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with additional psychological or psychiatric support outside the service.&#xD;
&#xD;
          -  Patient benefiting from a system of legal protection (safeguard of justice,&#xD;
             guardianship, curatorship)&#xD;
&#xD;
          -  Patient participating in another study on measuring quality of life&#xD;
&#xD;
          -  Patients with cognitive impairment to understand the questionnaire&#xD;
&#xD;
          -  Impossibility of giving the patient informed information&#xD;
&#xD;
          -  Patients with no infection diseases follow up at the CROIX ROUSSE hospital&#xD;
&#xD;
          -  Patients with amputation as initial surgery for infection management&#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_contact>
    <last_name>Tristan FERRY, MD, PhD</last_name>
    <phone>04 72 07 11 07</phone>
    <phone_ext>+33</phone_ext>
    <email>tristan.ferry@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Eugénie MABRUT</last_name>
    <phone>04 26 73 29 38</phone>
    <phone_ext>+33</phone_ext>
    <email>eugenie.mabrut@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre de reference des infections ostéo-articulaires de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tristan FERRY, MD, PhD</last_name>
      <phone>04 72 07 11 07</phone>
      <phone_ext>+33</phone_ext>
      <email>tristan.ferry@chu-lyon.fr</email>
    </contact>
    <contact_backup>
      <last_name>Eugénie MABRUT</last_name>
      <phone>04 26 73 29 38</phone>
      <phone_ext>+33</phone_ext>
      <email>eugenie.mabrut@chu-lyon.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Tristan FERRY, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sebastien LUSTIG, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>March 31, 2023</last_update_submitted>
  <last_update_submitted_qc>March 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2023</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Arthritis, Infectious</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03307109
org study id: 69HCL17_0419
nct id: NCT03307109
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Bone and joint infections (BJI) are rare serious pathology which can lead to a very heavy
      handicap and sometimes to the life threatening. These are devastating diseases whose
      diagnosis is difficult. They are known to be associated with high mortality rates (5%) and
      significant morbidities responsible for functional sequelae (40% of patients) with an
      individual cost (prolonged hospitalization, altered quality of life) and societal (work
      stoppage, partial or total disability, temporary or permanent) extremely high.

      These bone and joint infections have a significant impact on the quality of life of those
      affected who, in addition to their infection, are reduced in their autonomy and often need to
      be taken care of outside their home, sometimes away from home.

      To the knowledge of investigators, there are few studies on the measurement of quality of
      life in patients with osteoarticular infection.

      The aim of this study is to implement the EQ-5D-3L validated quality of life questionnaire
      and the EVA scale (created by EuroQol Group) for each patient with a prosthetic joint
      infection (IPA) on prosthesis during their medical care in the department of Infectious and
      Tropical Diseases.
observational model: Cohort
time perspective: Prospective
measure: Questionnaire EQ-5D-3L
time frame: 12 to 24 months
description: EQ5D is one of the most widely used health states descriptive system and has a valuation in France.
EQ-5D questionnaires have 5 dimensions: "Mobility", "Human Autonomy," "Current Activities", "Pain / Discomfort", "Anxiety / Depression" and all dimensions are described by 3 problem levels corresponding to patient response choices.
A quality of life score is obtained according to the answers to the questionnaires.
measure: Analog Visual Scale
time frame: 12 to 24 months
description: Use of a Analog Visual Scale to measure the quality of life
measure: Questionnaire EQ-5D-5L
time frame: 12 to 24 months
description: In the EQ-5D-5L the 5 dimensions are described by 5 problem levels corresponding to patient response choices.
A quality of life score is obtained according to the answers to the questionnaires. In France, only the EQ-5D-3L has been validated, not yet the EQ-5D-5L which has only been translated.
In this study investigators want compare the score obtained to the questionnaires EQ5D-5L and EQ-5D-3L to determine if EQ-5D-5L is more adapted to patients having prosthetic joint infection.
arm group label: Patients having prosthetic joint infection
description: The primary aim is to measure the evolution of quality of life in patients having prosthetic joint infection during their medical care and possibly psychologic assistance in the Infectious and Tropical Diseases Department of Croix-Rousse Hospital.
intervention type: Other
intervention name: Quality of life
description: Patients will complete two EQ-5D-5L and EQ-5D-3L quality of life questionnaires and will complete an analog visual scale during each of their follow-up visits to the Infectious and Tropical Diseases Department of Croix-Rousse hospital. No visits will be added to complete the questionnaires.
arm group label: Patients having prosthetic joint infection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tristan FERRY, MD, PhD
phone: 04 72 07 11 07
phone ext: +33
email: tristan.ferry@chu-lyon.fr
last name: Eugénie MABRUT
phone: 04 26 73 29 38
phone ext: +33
email: eugenie.mabrut@chu-lyon.fr
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Arthritis, Infectious
sharing ipd: No