<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/NCT01666873</url>
  </required_header>
  <id_info>
    <org_study_id>2012/526</org_study_id>
    <nct_id>NCT01666873</nct_id>
  </id_info>
  <brief_title>Correlation Between Alignment of Lower Limb and Clinical Outcome After Total Knee Prosthesis.</brief_title>
  <official_title>Correlation Between Alignment of Lower Limb and Clinical Outcome After Total Knee Prosthesis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of the clinical results after total knee prosthesis, and correlation with the&#xD;
      alignment of the lower limb.&#xD;
&#xD;
      Radiological measurements by means of 3D technology will be performed. The clinical result&#xD;
      will be stipulated by means of standardized questionnaires (KOOS, KSS and Oxford knee&#xD;
      score-questionnaire).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">January 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical results after total knee prosthesis with standardized questionnaires after 6 months</measure>
    <time_frame>6 months after total knee prosthesis</time_frame>
    <description>Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical results after total knee prosthesis with standardized questionnaires after 12 months.</measure>
    <time_frame>12 months after total knee prosthesis</time_frame>
    <description>Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical results after total knee prosthesis with standardized questionnaires after 24 months.</measure>
    <time_frame>24 months after total knee prosthesis</time_frame>
    <description>Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alignment of lower limb, slope of lateral and medial tibial plateau, femoral slope.</measure>
    <time_frame>6 months after total knee prosthesis</time_frame>
    <description>imaging with 3D software (MIMICS)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">150</enrollment>
  <condition>Osteoarthritis of the Knee Joint</condition>
  <arm_group>
    <arm_group_label>total knee prosthesis</arm_group_label>
    <description>Patients that undergo a total knee prosthesis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>patients that undergo a total knee prosthesis</intervention_name>
    <arm_group_label>total knee prosthesis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        People who have osteoarthritis of the knee joint and receive a total knee prosthesis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with osteoarthritis of the knee joint, without severe bone deformation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Victor, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Ghent</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://www.uzgent.be</url>
    <description>Related Info</description>
  </link>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>December 28, 2022</last_update_submitted>
  <last_update_submitted_qc>December 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>osteoarthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT01666873
org study id: 2012/526
nct id: NCT01666873
lead sponsor: 
has dmc: No
Evaluation of the clinical results after total knee prosthesis, and correlation with the
      alignment of the lower limb.

      Radiological measurements by means of 3D technology will be performed. The clinical result
      will be stipulated by means of standardized questionnaires (KOOS, KSS and Oxford knee
      score-questionnaire).
observational model: Cohort
time perspective: Prospective
measure: Clinical results after total knee prosthesis with standardized questionnaires after 6 months
time frame: 6 months after total knee prosthesis
description: Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).
measure: Clinical results after total knee prosthesis with standardized questionnaires after 12 months.
time frame: 12 months after total knee prosthesis
description: Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).
measure: Clinical results after total knee prosthesis with standardized questionnaires after 24 months.
time frame: 24 months after total knee prosthesis
description: Standardized questionnaires (KOOS KSS en Oxford knee score-questionnaire).
measure: Alignment of lower limb, slope of lateral and medial tibial plateau, femoral slope.
time frame: 6 months after total knee prosthesis
description: imaging with 3D software (MIMICS)
arm group label: total knee prosthesis
description: Patients that undergo a total knee prosthesis.
intervention type: Procedure
intervention name: patients that undergo a total knee prosthesis
arm group label: total knee prosthesis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Jan Victor, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Ghent
facility: 
country: Belgium
url: http://www.uzgent.be
description: Related Info
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee