<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/NCT04460989</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A00075-34</org_study_id>
    <secondary_id>2020-A00075-34</secondary_id>
    <nct_id>NCT04460989</nct_id>
  </id_info>
  <brief_title>Assessment of Patient Satisfaction After Arthroplasty: A Comparative Study by Implant Type</brief_title>
  <acronym>ESPACE</acronym>
  <official_title>Evaluation of the Impact of Customization of Total Knee Prostheses on Patient Satisfaction and Functional Outcome of Arthroplasty.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GCS Ramsay Santé pour l'Enseignement et la Recherche</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GCS Ramsay Santé pour l'Enseignement et la Recherche</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>
      The main objective of this study is to evaluate the benefit of personalized prostheses&#xD;
      compared to conventional prostheses on patient satisfaction 24 months after total knee&#xD;
      arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective randomized monocentric prospective comparative study carried out as a single&#xD;
      blind study on two parallel groups (standard implant or customized implant).&#xD;
&#xD;
      Secondary Objectives: Compare between groups :&#xD;
&#xD;
        -  the functional outcome of the arthroplasty&#xD;
&#xD;
        -  pain progression&#xD;
&#xD;
        -  the evolution of the quality of life&#xD;
&#xD;
        -  the conditions of the surgery (duration of surgery, length of hospitalization, blood&#xD;
           loss)&#xD;
&#xD;
        -  the frequency of adverse events related to arthroplasty&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 2021</start_date>
  <completion_date type="Anticipated">September 2026</completion_date>
  <primary_completion_date type="Anticipated">September 2026</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>IKS self-questionnaire Score at M24</measure>
    <time_frame>24 MONTHS</time_frame>
    <description>The score obtained on the IKS self-questionnaire at 24 months will be compared between the two treatment groups by an analysis of covariance, with the basal IKS score as a covariate and the type of prosthesis as a factor.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SF12 score at M24</measure>
    <time_frame>24 months</time_frame>
    <description>The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>KOOS Score at M24</measure>
    <time_frame>24 months</time_frame>
    <description>The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forgotten Joint Score at M24</measure>
    <time_frame>24 months</time_frame>
    <description>The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">480</enrollment>
  <condition>Gonarthrosis</condition>
  <arm_group>
    <arm_group_label>standard implant</arm_group_label>
    <description>arthroplasty with a standard implant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>personalized implant</arm_group_label>
    <description>arthroplasty with a customized implant</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>arthroplasty</intervention_name>
    <description>total knee replacement</description>
    <arm_group_label>personalized implant</arm_group_label>
    <arm_group_label>standard implant</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with uni or bilateral primary gonarthrosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult man or woman who has signed consent to participate in the study&#xD;
&#xD;
          -  Patient with uni- or bilateral primary gonarthrosis&#xD;
&#xD;
          -  For which an indication for total knee arthroplasty has been established&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of knee arthroplasty or osteotomy&#xD;
&#xD;
          -  History of knee fracture&#xD;
&#xD;
          -  Inflammatory rheumatic disease or any other progressive concomitant disease that may&#xD;
             affect the patient's functional prognosis.&#xD;
&#xD;
          -  Joint or extra-articular deformities of the lower limb of traumatic origin&#xD;
&#xD;
          -  Neurological diseases, stroke sequelae&#xD;
&#xD;
          -  Mental disability or any other reason that may hinder the understanding or strict&#xD;
             application of the protocol&#xD;
&#xD;
          -  Patient not affiliated to the French social security scheme&#xD;
&#xD;
          -  Patient under legal protection, guardianship or trusteeship&#xD;
&#xD;
          -  Patient already included in another therapeutic study protocol or having participated&#xD;
             in another trial within the previous three months&#xD;
&#xD;
          -  Arthroplasty actually performed&#xD;
&#xD;
          -  Absence of per operative complications in bone (femoral or tibial bone), ligament&#xD;
             (rupture or disinsertion of the patellar or quadricipital tendon) or nerve (lesion of&#xD;
             the external popliteal sciatica).&#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_official>
    <last_name>MICHEL BONNIN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CENTRE ORTHOPÉDIQUE SANTY</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michel BONNIN, MD</last_name>
    <phone>04 37 53 00 26</phone>
    <phone_ext>33</phone_ext>
    <email>bonnin.michel@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tarik AIT SI SELMI, MD</last_name>
    <phone>04 37 53 07 04</phone>
    <phone_ext>33</phone_ext>
    <email>tarik.aitsiselmi@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Orthopédique Santy</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Michel BONNIN, MD</last_name>
      <email>bonnin.michel@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>TARIK AIT SI SELMI, MD</last_name>
      <email>tarik.aitsiselmi@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>August 16, 2021</last_update_submitted>
  <last_update_submitted_qc>August 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2021</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>Osteoarthritis, Knee</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/NCT04460989
org study id: 2020-A00075-34
secondary id: 2020-A00075-34
nct id: NCT04460989
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is to evaluate the benefit of personalized prostheses
      compared to conventional prostheses on patient satisfaction 24 months after total knee
      arthroplasty.
Prospective randomized monocentric prospective comparative study carried out as a single
      blind study on two parallel groups (standard implant or customized implant).

      Secondary Objectives: Compare between groups :

        -  the functional outcome of the arthroplasty

        -  pain progression

        -  the evolution of the quality of life

        -  the conditions of the surgery (duration of surgery, length of hospitalization, blood
           loss)

        -  the frequency of adverse events related to arthroplasty
observational model: Cohort
time perspective: Prospective
measure: IKS self-questionnaire Score at M24
time frame: 24 MONTHS
description: The score obtained on the IKS self-questionnaire at 24 months will be compared between the two treatment groups by an analysis of covariance, with the basal IKS score as a covariate and the type of prosthesis as a factor.
measure: SF12 score at M24
time frame: 24 months
description: The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point.
measure: KOOS Score at M24
time frame: 24 months
description: The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point.
measure: Forgotten Joint Score at M24
time frame: 24 months
description: The comparison between groups will be made on the evolution of scores, in relation to the baseline value, by an analysis of covariance with treatment and time as fixed factors, the subject as a random factor and the baseline value as a covariate. The interaction Time x Treatment will be added to the model. The effects of time and treatment will be tested at each evaluation point.
arm group label: standard implant
description: arthroplasty with a standard implant
arm group label: personalized implant
description: arthroplasty with a customized implant
intervention type: Procedure
intervention name: arthroplasty
description: total knee replacement
arm group label: personalized implant
arm group label: standard implant
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: MICHEL BONNIN, MD
role: Principal Investigator
affiliation: CENTRE ORTHOPÉDIQUE SANTY
last name: Michel BONNIN, MD
phone: 04 37 53 00 26
phone ext: 33
email: bonnin.michel@gmail.com
last name: Tarik AIT SI SELMI, MD
phone: 04 37 53 07 04
phone ext: 33
email: tarik.aitsiselmi@gmail.com
facility: 
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Osteoarthritis, Knee
sharing ipd: No