<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/NCT03805490</url>
  </required_header>
  <id_info>
    <org_study_id>FJS2015</org_study_id>
    <nct_id>NCT03805490</nct_id>
  </id_info>
  <brief_title>Translation, Cross Cultural Adaptation and Validation of the Italian Version of the Forgotten Joint Score in Total Knee Arthroplasty</brief_title>
  <acronym>FJS2015</acronym>
  <official_title>Italian Validation of the Forgotten Joint Score(Fjs 2015)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Ortopedico Galeazzi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Ortopedico Galeazzi</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>
      This is an observational, prospective study that has the primary goal of validating the&#xD;
      Forgotten Joint Score (FJS)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational, prospective study that has the primary goal of validating the&#xD;
      Forgotten Joint Score (FJS) as described by Behrend and Giesinger in 2012. Patients will be&#xD;
      given two self-assessment questionnaires (WOMAC and FJS) to perform internal consistency&#xD;
      analysis, reliability and comparability of results in a population of people undergoing total&#xD;
      knee replacement prosthetic surgery.&#xD;
&#xD;
      Comparison of data will be done for each patient by evaluating the evolution of the&#xD;
      postoperative period, comparing the results obtained with a well known validated score&#xD;
      (WOMAC).&#xD;
&#xD;
      Questionnaires will be given pre-operatively, at 6 month ± 2 weeks, and 12 month ± 1 weeks&#xD;
      after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 13, 2015</start_date>
  <completion_date type="Anticipated">December 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 15, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validating the Forgotten Joint Score.</measure>
    <time_frame>18 month</time_frame>
    <description>Patients will be given self-assessment questionnaires Forgotten Joint Score (FJS) to perform internal consistency analysis, reliability and comparability of results in a population of people undergoing total knee replacement prosthetic surgery.&#xD;
FJS: minimum score 0 (worse outcome); maximum 100 (better outcome)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>18 months</time_frame>
    <description>weight and height will be combined to calculate the BMI in kg/m^2</description>
  </secondary_outcome>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Arthroplasty</condition>
  <condition>Surveys and Questionnaires</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of both gender, aged between 55 and 85 years old, Italian mother-tongue with&#xD;
        unilateral gonarthrosis who need total knee prosthesis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females&#xD;
&#xD;
          -  Age range between 55 and 85 years&#xD;
&#xD;
          -  Italian mother-tongue&#xD;
&#xD;
          -  Patients with unilateral gonarthrosis who need total knee prosthesis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with orthopedic pathologies of other origin&#xD;
&#xD;
          -  Patients with history of previous articular prosthetic replacement surgery on joints&#xD;
             of the lower limb.&#xD;
&#xD;
          -  Patients with history of previous major cardiovascular events&#xD;
&#xD;
          -  Patients who need aids for walking&#xD;
&#xD;
          -  Patients claiming that they can not submit to follow-up and therefore can not complete&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Valerio Pascale</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Istituto Ortopedico Galeazzi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IRCCS Istituto Ortopedico Galeazzi</name>
      <address>
        <city>Milan</city>
        <state>MI</state>
        <zip>20161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 28, 2017</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03805490
org study id: FJS2015
nct id: NCT03805490
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an observational, prospective study that has the primary goal of validating the
      Forgotten Joint Score (FJS)
This is an observational, prospective study that has the primary goal of validating the
      Forgotten Joint Score (FJS) as described by Behrend and Giesinger in 2012. Patients will be
      given two self-assessment questionnaires (WOMAC and FJS) to perform internal consistency
      analysis, reliability and comparability of results in a population of people undergoing total
      knee replacement prosthetic surgery.

      Comparison of data will be done for each patient by evaluating the evolution of the
      postoperative period, comparing the results obtained with a well known validated score
      (WOMAC).

      Questionnaires will be given pre-operatively, at 6 month ± 2 weeks, and 12 month ± 1 weeks
      after surgery.
observational model: Other
time perspective: Prospective
measure: Validating the Forgotten Joint Score.
time frame: 18 month
description: Patients will be given self-assessment questionnaires Forgotten Joint Score (FJS) to perform internal consistency analysis, reliability and comparability of results in a population of people undergoing total knee replacement prosthetic surgery.
FJS: minimum score 0 (worse outcome); maximum 100 (better outcome)
measure: BMI
time frame: 18 months
description: weight and height will be combined to calculate the BMI in kg/m^2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: 85 Years
healthy volunteers: No
last name: Valerio Pascale
role: Principal Investigator
affiliation: IRCCS Istituto Ortopedico Galeazzi
facility: 
country: Italy
responsible party type: Sponsor