<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/NCT01671917</url>
  </required_header>
  <id_info>
    <org_study_id>AOM 10042</org_study_id>
    <nct_id>NCT01671917</nct_id>
  </id_info>
  <brief_title>Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty</brief_title>
  <acronym>EDEX</acronym>
  <official_title>Evaluation of an Educational Program Associated With Exercises (EDEX) Before Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Paris 5 - Rene Descartes</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether a standardized education and exercise&#xD;
      program proposed before a total knee replacement for knee osteoarthritis is effective in&#xD;
      functional recovery after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Knee osteoarthritis leads to deficiencies in muscle strength, knee range of motion and&#xD;
      balance, and cardio respiratory deconditioning that contribute to alter abilities to perform&#xD;
      activities of daily living. It is the principal indication for total knee arthroplasty (TKA).&#xD;
      Patients' functional state and pain level are generally improved after TKA and the physical&#xD;
      and functional status pre-TKA are predictive of recovery after surgery. Decreasing length of&#xD;
      stay at surgery departments and promoting return at home after TKA are recommended. The&#xD;
      recommendations of the Health Authority in France (HAS) and the new law of finance for French&#xD;
      clinics contribute to shorter hospital stays and to restrain the conditions of admission to&#xD;
      Physical Medicine and Rehabilitation department after TKA.Exercise and education programs&#xD;
      conducted before TKA could help better prepare patients for surgery, improve functional&#xD;
      outcome and accelerate functional recovery after surgery thus reducing the length of stay in&#xD;
      orthopedic departments and facilitate return to home (directly or after a stay in PMR&#xD;
      departments). The type of program necessary to achieve those goals remains to be defined.A&#xD;
      systematic review of the literature associated with an analysis of practices about the&#xD;
      relevance of rehabilitation programs before TKA, concluded that the implementation of such&#xD;
      programs before TKA was likely to reduce the length of stay in surgery departments and&#xD;
      improve the rate of direct return to home after surgery but that high quality trials were&#xD;
      lacking. It also suggested that association of exercise programs with educational ones could&#xD;
      be more effective than exercise or education alone, particularly for fragile patients with&#xD;
      impaired functional capacity, co-morbidities and/or social problems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2012</start_date>
  <completion_date type="Actual">November 29, 2017</completion_date>
  <primary_completion_date type="Actual">September 22, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of patients able to quit independently the orthopedic department</measure>
    <time_frame>at day 4 post-surgery</time_frame>
    <description>Assessed by the ability to perform lying-sitting and sitting-standing transfers, walk 30 meters and go up and down one floor at day 4 (± 1 day) after the surgery. Each item will be scored on a 4-class scale (0, unable to perform and 3, able to perform independently). Ability to quite the orthopedic department will be defined as scoring 3 out of 3 for all 4 assessed items on the day of discharge from the orthopedic department.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in functional recovery</measure>
    <time_frame>6 months post-surgery</time_frame>
    <description>Assessed by the area under the curve of the function subscale of the WOMAC index within the first 6 months post-surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in mean knee pain in the previous 48 hrs</measure>
    <time_frame>6 months post-surgery</time_frame>
    <description>Assessed by a self-administered 11-point numeric rating scale (0, no pain and 100, maximal pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in mean knee pain in the previous 48 hrs</measure>
    <time_frame>12 months post-surgery</time_frame>
    <description>Assessed by a self-administered 11-point numeric rating scale (0, no pain and 100, maximal pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in mean function in the previous 48 hrs</measure>
    <time_frame>6 months post-surgery</time_frame>
    <description>Assessed by the self-administered WOMAC function subscale (0, best function and 100, worse function)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in mean function in the previous 48 hrs</measure>
    <time_frame>12 months post-surgery</time_frame>
    <description>Assessed by the self-administered WOMAC function subscale (0, best function and 100, worse function)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in mean quality of life</measure>
    <time_frame>6 months post-surgery</time_frame>
    <description>Assessed by the physical and mental components of the self-administered SF-12 questionnaire (0, worse quality of life and 100, best quality of life) and by the self-administered EQ-5D-3L questionnaire (11111, best quality of life and 33333, worse quality of life)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in mean quality of life</measure>
    <time_frame>12 months post-surgery</time_frame>
    <description>Assessed by the physical and mental components of the self-administered SF-12 questionnaire (0, worse quality of life and 100, best quality of life) and by the self-administered EQ-5D-3L questionnaire (11111, best quality of life and 33333, worse quality of life)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in the mean number of steps in the previous week</measure>
    <time_frame>6 months post-surgery</time_frame>
    <description>Assessed by the self-reported number of steps monitored by a podometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in the mean number of steps in the previous week</measure>
    <time_frame>12 months post-surgery</time_frame>
    <description>Assessed by the self-reported number of steps monitored by a podometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the treatment</measure>
    <time_frame>6 months post-surgery</time_frame>
    <description>Assessed by a self-administered 11-point numeric rating scale (0, not satisfied and 100, totally satisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the treatment</measure>
    <time_frame>12 months months post-surgery</time_frame>
    <description>Assessed by a self-administered 11-point numeric rating scale (0, not satisfied and 100, totally satisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>6 months post-surgery</time_frame>
    <description>Assessed by the cost-utility ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>12 months months post-surgery</time_frame>
    <description>Assessed by the cost-utility ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>12 months post-surgery</time_frame>
    <description>Assessed by self reporting using an open-ended question</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">262</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Educational and exercise program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational and exercise program</intervention_name>
    <description>4 (twice a week) group education sessions lasting 30 minutes plus an education booklet about knee replacement&#xD;
4 (twice a week) sessions of an exercise programme lasting 1 hour</description>
    <arm_group_label>Educational and exercise program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <description>Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.</description>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged 50 to 85 years&#xD;
&#xD;
          -  Patient suffering from knee osteoarthritis according to ACR for which a total knee&#xD;
             arthroplasty is scheduled&#xD;
&#xD;
          -  Preliminary medical examination whose results will be transmitted to the patient&#xD;
&#xD;
          -  Patient giving his informed consent to participate in the study&#xD;
&#xD;
          -  Patient affiliated to or beneficiary of social insurance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients institutionalized&#xD;
&#xD;
          -  Patients who have already received an ipsilateral total knee arthroplasty&#xD;
&#xD;
          -  Patients with chronic inflammatory arthritis&#xD;
&#xD;
          -  Cognitive or behavioral disorders making assessment impossible&#xD;
&#xD;
          -  Inability to speak and write French&#xD;
&#xD;
          -  TKA indicated for other reason than osteoarthritis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>François Rannou, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AP-HP, Descartes University, INSERM</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pascal Richette, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Lariboisière</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emmanuel Coudeyre, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>September 18, 2018</last_update_submitted>
  <last_update_submitted_qc>September 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Total knee arthroplasty</keyword>
  <keyword>Total knee replacement</keyword>
  <keyword>Knee osteoarthritis</keyword>
  <keyword>Education</keyword>
  <keyword>Exercise</keyword>
  <keyword>Handicap</keyword>
  <keyword>Function</keyword>
  <keyword>Cost-effectiveness</keyword>
  <keyword>Cost-utility</keyword>
  <keyword>Quality of life</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/NCT01671917
org study id: AOM 10042
nct id: NCT01671917
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether a standardized education and exercise
      program proposed before a total knee replacement for knee osteoarthritis is effective in
      functional recovery after surgery.
Knee osteoarthritis leads to deficiencies in muscle strength, knee range of motion and
      balance, and cardio respiratory deconditioning that contribute to alter abilities to perform
      activities of daily living. It is the principal indication for total knee arthroplasty (TKA).
      Patients' functional state and pain level are generally improved after TKA and the physical
      and functional status pre-TKA are predictive of recovery after surgery. Decreasing length of
      stay at surgery departments and promoting return at home after TKA are recommended. The
      recommendations of the Health Authority in France (HAS) and the new law of finance for French
      clinics contribute to shorter hospital stays and to restrain the conditions of admission to
      Physical Medicine and Rehabilitation department after TKA.Exercise and education programs
      conducted before TKA could help better prepare patients for surgery, improve functional
      outcome and accelerate functional recovery after surgery thus reducing the length of stay in
      orthopedic departments and facilitate return to home (directly or after a stay in PMR
      departments). The type of program necessary to achieve those goals remains to be defined.A
      systematic review of the literature associated with an analysis of practices about the
      relevance of rehabilitation programs before TKA, concluded that the implementation of such
      programs before TKA was likely to reduce the length of stay in surgery departments and
      improve the rate of direct return to home after surgery but that high quality trials were
      lacking. It also suggested that association of exercise programs with educational ones could
      be more effective than exercise or education alone, particularly for fragile patients with
      impaired functional capacity, co-morbidities and/or social problems.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The percentage of patients able to quit independently the orthopedic department
time frame: at day 4 post-surgery
description: Assessed by the ability to perform lying-sitting and sitting-standing transfers, walk 30 meters and go up and down one floor at day 4 (± 1 day) after the surgery. Each item will be scored on a 4-class scale (0, unable to perform and 3, able to perform independently). Ability to quite the orthopedic department will be defined as scoring 3 out of 3 for all 4 assessed items on the day of discharge from the orthopedic department.
measure: Changes from baseline in functional recovery
time frame: 6 months post-surgery
description: Assessed by the area under the curve of the function subscale of the WOMAC index within the first 6 months post-surgery
measure: Changes from baseline in mean knee pain in the previous 48 hrs
time frame: 6 months post-surgery
description: Assessed by a self-administered 11-point numeric rating scale (0, no pain and 100, maximal pain)
measure: Changes from baseline in mean knee pain in the previous 48 hrs
time frame: 12 months post-surgery
description: Assessed by a self-administered 11-point numeric rating scale (0, no pain and 100, maximal pain)
measure: Changes from baseline in mean function in the previous 48 hrs
time frame: 6 months post-surgery
description: Assessed by the self-administered WOMAC function subscale (0, best function and 100, worse function)
measure: Changes from baseline in mean function in the previous 48 hrs
time frame: 12 months post-surgery
description: Assessed by the self-administered WOMAC function subscale (0, best function and 100, worse function)
measure: Changes from baseline in mean quality of life
time frame: 6 months post-surgery
description: Assessed by the physical and mental components of the self-administered SF-12 questionnaire (0, worse quality of life and 100, best quality of life) and by the self-administered EQ-5D-3L questionnaire (11111, best quality of life and 33333, worse quality of life)
measure: Changes from baseline in mean quality of life
time frame: 12 months post-surgery
description: Assessed by the physical and mental components of the self-administered SF-12 questionnaire (0, worse quality of life and 100, best quality of life) and by the self-administered EQ-5D-3L questionnaire (11111, best quality of life and 33333, worse quality of life)
measure: Changes from baseline in the mean number of steps in the previous week
time frame: 6 months post-surgery
description: Assessed by the self-reported number of steps monitored by a podometer
measure: Changes from baseline in the mean number of steps in the previous week
time frame: 12 months post-surgery
description: Assessed by the self-reported number of steps monitored by a podometer
measure: Satisfaction with the treatment
time frame: 6 months post-surgery
description: Assessed by a self-administered 11-point numeric rating scale (0, not satisfied and 100, totally satisfied)
measure: Satisfaction with the treatment
time frame: 12 months months post-surgery
description: Assessed by a self-administered 11-point numeric rating scale (0, not satisfied and 100, totally satisfied)
measure: Cost-effectiveness
time frame: 6 months post-surgery
description: Assessed by the cost-utility ratio
measure: Cost-effectiveness
time frame: 12 months months post-surgery
description: Assessed by the cost-utility ratio
measure: Adverse events
time frame: 12 months post-surgery
description: Assessed by self reporting using an open-ended question
arm group label: Educational and exercise program
arm group type: Experimental
arm group label: Usual care
arm group type: Active Comparator
intervention type: Other
intervention name: Educational and exercise program
description: 4 (twice a week) group education sessions lasting 30 minutes plus an education booklet about knee replacement
4 (twice a week) sessions of an exercise programme lasting 1 hour
arm group label: Educational and exercise program
intervention type: Other
intervention name: Usual care
description: Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.
arm group label: Usual care
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
healthy volunteers: No
last name: François Rannou, MD, PhD
role: Principal Investigator
affiliation: AP-HP, Descartes University, INSERM
last name: Pascal Richette, MD, PhD
role: Principal Investigator
affiliation: CHU Lariboisière
last name: Emmanuel Coudeyre, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee