<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/NCT04453163</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A00600-39</org_study_id>
    <nct_id>NCT04453163</nct_id>
  </id_info>
  <brief_title>Interest of the Patient Management by Improved Recovery After Surgery in Percutaneous Vertebroplasty</brief_title>
  <official_title>Interest of Improved Recovery After Surgery (IRAS) Management [RAAC in French] in Percutaneous Vertebroplasty</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>
      This research aims to demonstrate the benefits of the RAAC program for patients undergoing&#xD;
      cementoplasty, in particular on their level of anxiety and pain control throughout the&#xD;
      perioperative phase.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to compare the preoperative anxiety of patients hospitalized for a&#xD;
      percutaneous vertebroplasty, depending on whether or not they are managed in an RAAC program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 17, 2020</start_date>
  <completion_date type="Actual">December 19, 2022</completion_date>
  <primary_completion_date type="Actual">December 19, 2022</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Superiority of Improved Recovery After Surgery versus standard management over preoperative anxiety</measure>
    <time_frame>10 days</time_frame>
    <description>The main analysis consists of testing the superiority of Improved Recovery After Surgery versus standard management over preoperative anxiety, evaluated on a numerical scale of 0 to 10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain evaluation</measure>
    <time_frame>10 days</time_frame>
    <description>Evaluation of the pain on a numerical scale of 0 - no pain to 10 - maximum pain imaginable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>10 days</time_frame>
    <description>Evaluation of the patient satisfaction with care, assessed on a 5-level scale (not at all satisfied / somewhat dissatisfied / moderately satisfied / somewhat satisfied / very satisfied)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional impotence</measure>
    <time_frame>10 days</time_frame>
    <description>Evaluation of the functional impotence of low back pain by the Quebec score, which includes 20 questions on the ability to undertake daily activities, rated from 0 (no difficulty) to 5 (unable). The score therefore varies from 0 to 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of analgesics</measure>
    <time_frame>10 days</time_frame>
    <description>Evaluation of the consumption of analgesics expressed in mg of morphine equivalent.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Vertebral Compression</condition>
  <arm_group>
    <arm_group_label>RAAC program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If the patient is under the &quot;RAAC&quot; group, he/she will then be received in consultation by a RAAC specialist nurse, between the anesthesia / radiology consultation and the intervention. This RAAC nurse will explain the procedure and show him/her an information video on vertebroplasty. Information about managing anxiety and pain will also be provided. In addition, the day after the patient leaves the clinic, the RAAC nurse will call him/her to inquire.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard management program</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>If the patient is under the &quot;control&quot; group, he/she will be taken care of according to the standard protocol after a surgery in percutaneous vertebroplasty. The patient will not have a consultation with the specialized nurse.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Vertebroplasty</intervention_name>
    <description>Patient will undergo a surgery in percutaneous vertebroplasty</description>
    <arm_group_label>RAAC program</arm_group_label>
    <arm_group_label>Standard management program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 80 years or ≥ 18 years with oncological history;&#xD;
&#xD;
          -  Patient with vertebral compression fracture with indication for percutaneous&#xD;
             vertebroplasty;&#xD;
&#xD;
          -  Patient seen in preoperative anesthesia / radiology consultation more than 4 days&#xD;
             before the date of the vertebroplasty;&#xD;
&#xD;
          -  Having expressed their consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with a contraindication to percutaneous vertebroplasty, such as coagulation&#xD;
             disorders, or an allergy or hypersensitivity to any of the products administered&#xD;
             during the procedure;&#xD;
&#xD;
          -  Patient not affiliated to a social security scheme;&#xD;
&#xD;
          -  Patient participating in another clinical trial during the follow-up period;&#xD;
&#xD;
          -  Inability to understand information related to the study (linguistic, psychiatric,&#xD;
             cognitive reason, etc.).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinique Belharra</name>
      <address>
        <city>Bayonne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>January 26, 2023</last_update_submitted>
  <last_update_submitted_qc>January 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04453163
org study id: 2020-A00600-39
nct id: NCT04453163
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research aims to demonstrate the benefits of the RAAC program for patients undergoing
      cementoplasty, in particular on their level of anxiety and pain control throughout the
      perioperative phase.
The aim of the study is to compare the preoperative anxiety of patients hospitalized for a
      percutaneous vertebroplasty, depending on whether or not they are managed in an RAAC program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Superiority of Improved Recovery After Surgery versus standard management over preoperative anxiety
time frame: 10 days
description: The main analysis consists of testing the superiority of Improved Recovery After Surgery versus standard management over preoperative anxiety, evaluated on a numerical scale of 0 to 10
measure: Pain evaluation
time frame: 10 days
description: Evaluation of the pain on a numerical scale of 0 - no pain to 10 - maximum pain imaginable
measure: Patient satisfaction
time frame: 10 days
description: Evaluation of the patient satisfaction with care, assessed on a 5-level scale (not at all satisfied / somewhat dissatisfied / moderately satisfied / somewhat satisfied / very satisfied)
measure: Functional impotence
time frame: 10 days
description: Evaluation of the functional impotence of low back pain by the Quebec score, which includes 20 questions on the ability to undertake daily activities, rated from 0 (no difficulty) to 5 (unable). The score therefore varies from 0 to 100.
measure: Consumption of analgesics
time frame: 10 days
description: Evaluation of the consumption of analgesics expressed in mg of morphine equivalent.
arm group label: RAAC program
arm group type: Experimental
description: If the patient is under the "RAAC" group, he/she will then be received in consultation by a RAAC specialist nurse, between the anesthesia / radiology consultation and the intervention. This RAAC nurse will explain the procedure and show him/her an information video on vertebroplasty. Information about managing anxiety and pain will also be provided. In addition, the day after the patient leaves the clinic, the RAAC nurse will call him/her to inquire.
arm group label: Standard management program
arm group type: Other
description: If the patient is under the "control" group, he/she will be taken care of according to the standard protocol after a surgery in percutaneous vertebroplasty. The patient will not have a consultation with the specialized nurse.
intervention type: Procedure
intervention name: Vertebroplasty
description: Patient will undergo a surgery in percutaneous vertebroplasty
arm group label: RAAC program
arm group label: Standard management program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No