<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/NCT02983929</url>
  </required_header>
  <id_info>
    <org_study_id>MK1</org_study_id>
    <nct_id>NCT02983929</nct_id>
  </id_info>
  <brief_title>Short-Term Follow-up Indicator for Total Knee Arthroplasty and Body Mass Index</brief_title>
  <official_title>Impact of Elevated Body Mass Index on Short-term Follow-up Indicators for Total Knee Arthroplasty : a Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Durécu Lavoisier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Durécu Lavoisier</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to determine the influence of obesity on the short term&#xD;
      follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee&#xD;
      arthroplasty. It is a retrospective, comparative study&#xD;
&#xD;
      The secondary purposes are to explore the links between length of stay and short-term&#xD;
      follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee&#xD;
      arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2007</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <target_duration>2 Months</target_duration>
  <primary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>2 Month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Range Of Motion of the Knee</measure>
    <time_frame>2 Month</time_frame>
    <description>The investigators will report the initial, final flexion and extension and calculate the total gain of flexion and extension of the knee for each participant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Age</measure>
    <time_frame>2 Month</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mansat Score</measure>
    <time_frame>2 Month</time_frame>
    <description>This score is a composite score recommended by the French Authority of Health.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>2 month</time_frame>
    <description>The investigators will report the length of stay in the rehabilitation clinic for each participant.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">244</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <condition>Body Mass Index</condition>
  <condition>Rehabilitation</condition>
  <arm_group>
    <arm_group_label>BMI &lt;30 kg.m-2</arm_group_label>
    <description>Patients with a BMI inferior to the obesity limit defined by the World Health Organization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMI &gt;30 kg.m-2</arm_group_label>
    <description>Patients with a BMI superior to the obesity limit defined by the World Health Organization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rehabilitation after total knee arthroplasty</intervention_name>
    <description>All the included patients followed a rehabilitation program in the Polyvalent Geriatric Rehabilitation Clinic after total knee arthroplasty.</description>
    <arm_group_label>BMI &lt;30 kg.m-2</arm_group_label>
    <arm_group_label>BMI &gt;30 kg.m-2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Men and Women admitted after total knee arthroplasty in Polyvalent Geriatric Rehabilitation&#xD;
        Clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient admitted after total knee arthroplasty in Polyvalent Geriatric Rehabilitation&#xD;
             Clinic during the january 2007/October 2016 period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncompleted case file or case file anterior to 2007 ;&#xD;
&#xD;
          -  Inter-current orthopedic complication ;&#xD;
&#xD;
          -  Evolutive or inter-current pathology written in the case-file (neurologic affection,&#xD;
             etc...).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Durécu Lavoisier</investigator_affiliation>
    <investigator_full_name>Timothée Gillot</investigator_full_name>
    <investigator_title>Physical therapist, Msc.</investigator_title>
  </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/NCT02983929
org study id: MK1
nct id: NCT02983929
lead sponsor: 
has dmc: No
The main purpose of this study is to determine the influence of obesity on the short term
      follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee
      arthroplasty. It is a retrospective, comparative study

      The secondary purposes are to explore the links between length of stay and short-term
      follow-up indicators of a polyvalent geriatric rehabilitation clinic after total knee
      arthroplasty.
measure: Body Mass Index
time frame: 2 Month
measure: Range Of Motion of the Knee
time frame: 2 Month
description: The investigators will report the initial, final flexion and extension and calculate the total gain of flexion and extension of the knee for each participant.
measure: Age
time frame: 2 Month
measure: Mansat Score
time frame: 2 Month
description: This score is a composite score recommended by the French Authority of Health.
measure: Length of stay
time frame: 2 month
description: The investigators will report the length of stay in the rehabilitation clinic for each participant.
arm group label: BMI <30 kg.m-2
description: Patients with a BMI inferior to the obesity limit defined by the World Health Organization.
arm group label: BMI >30 kg.m-2
description: Patients with a BMI superior to the obesity limit defined by the World Health Organization.
intervention type: Procedure
intervention name: Rehabilitation after total knee arthroplasty
description: All the included patients followed a rehabilitation program in the Polyvalent Geriatric Rehabilitation Clinic after total knee arthroplasty.
arm group label: BMI <30 kg.m-2
arm group label: BMI >30 kg.m-2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Durécu Lavoisier
investigator full name: Timothée Gillot
investigator title: Physical therapist, Msc.