<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/NCT03238521</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_9855_PEDI-PDS</org_study_id>
    <nct_id>NCT03238521</nct_id>
  </id_info>
  <brief_title>Could the Intraoperative Radiation Exposure (Fluoroscopy) of Percutaneous Pedicle Screw Fixation be Reduced Using an Electronic Conductivity Device?</brief_title>
  <acronym>PEDI-PDS</acronym>
  <official_title>Could the Intraoperative Radiation Exposure (Fluoroscopy) of Percutaneous Pedicle Screw Fixation be Reduced Using an Electronic Conductivity Device? A Prospective, Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      To compare classical pedicle finder versus pedicle finder with impedancemetry on the&#xD;
      perioperative radiation exposure of PPTLO. These two devices are already used in common&#xD;
      practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 11, 2017</start_date>
  <completion_date type="Anticipated">May 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose area product in cGy.cm2 (DAP)</measure>
    <time_frame>Surgery Day</time_frame>
    <description>Dose area product in cGy.cm2 (DAP)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiation duration in seconds (measured on the fluoroscope);</measure>
    <time_frame>Surgery Day</time_frame>
    <description>Radiation duration in seconds (measured on the fluoroscope);</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiation rate</measure>
    <time_frame>Surgery Day</time_frame>
    <description>Radiation rate on:1 ring carried by the surgeon (passive dosimeter),1 passive dosimeter worn at the surgeon's eye level, 1 passive dosimeter on the fluoroscope,1 active dosimeter placed on the bust of the surgeon under the lead apron</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Path of pedicle screws extracted from fluoroscopic images</measure>
    <time_frame>Day 2 after surgery</time_frame>
    <description>Trajectory of pedicle screws;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operating time in minutes.</measure>
    <time_frame>Surgery Day</time_frame>
    <description>Operating time in minutes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Fracture Fixation, Internal</condition>
  <arm_group>
    <arm_group_label>classical pedicle finder</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Spinal osteosynthesis with classical pedicle finder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pedicle finder with impedancemetry</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Spinal osteosynthesis with pedicle finder with impedancemetry</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spinal osteosynthesis with classical pedicle finder</intervention_name>
    <description>Posterior thoracic and lumbar osteosynthesis with classical pedicle finder</description>
    <arm_group_label>classical pedicle finder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Spinal osteosynthesis with pedicle finder with impedancemetry</intervention_name>
    <description>Posterior thoracic and lumbar osteosynthesis with pedicle finder with impedancemetry</description>
    <arm_group_label>pedicle finder with impedancemetry</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women between 18 and 80 years-old;&#xD;
&#xD;
          -  Patient with an indication of PPTLO for one or two segments&#xD;
&#xD;
          -  Patient in a position to understand protocol information;&#xD;
&#xD;
          -  Patient who received information about the protocol and who did not show opposition to&#xD;
             participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of posterior spinal fusion surgery on the spinal level concerned by the study;&#xD;
&#xD;
          -  Morbid obesity (body mass index greater than 35 kg / m²);&#xD;
&#xD;
          -  Major incapable (safeguard of justice, guardianship) and persons deprived of liberty.&#xD;
&#xD;
          -  Simultaneous participation in another research protocol involving the human person&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan LEBHAR, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rennes University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jonathan LEBHAR, MD</last_name>
    <phone>299285753</phone>
    <phone_ext>+0033</phone_ext>
    <email>Jonathan.LEBHAR@chu-rennes.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Orthopedic surgery division</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathan LEBHAR, MD</last_name>
      <email>jonathan.lebhar@chu-rennes.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 28, 2018</last_update_submitted>
  <last_update_submitted_qc>August 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03238521
org study id: 35RC16_9855_PEDI-PDS
nct id: NCT03238521
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare classical pedicle finder versus pedicle finder with impedancemetry on the
      perioperative radiation exposure of PPTLO. These two devices are already used in common
      practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Dose area product in cGy.cm2 (DAP)
time frame: Surgery Day
description: Dose area product in cGy.cm2 (DAP)
measure: Radiation duration in seconds (measured on the fluoroscope);
time frame: Surgery Day
description: Radiation duration in seconds (measured on the fluoroscope);
measure: Radiation rate
time frame: Surgery Day
description: Radiation rate on:1 ring carried by the surgeon (passive dosimeter),1 passive dosimeter worn at the surgeon's eye level, 1 passive dosimeter on the fluoroscope,1 active dosimeter placed on the bust of the surgeon under the lead apron
measure: Path of pedicle screws extracted from fluoroscopic images
time frame: Day 2 after surgery
description: Trajectory of pedicle screws;
measure: Operating time in minutes.
time frame: Surgery Day
description: Operating time in minutes.
arm group label: classical pedicle finder
arm group type: Active Comparator
description: Spinal osteosynthesis with classical pedicle finder
arm group label: pedicle finder with impedancemetry
arm group type: Experimental
description: Spinal osteosynthesis with pedicle finder with impedancemetry
intervention type: Procedure
intervention name: Spinal osteosynthesis with classical pedicle finder
description: Posterior thoracic and lumbar osteosynthesis with classical pedicle finder
arm group label: classical pedicle finder
intervention type: Procedure
intervention name: Spinal osteosynthesis with pedicle finder with impedancemetry
description: Posterior thoracic and lumbar osteosynthesis with pedicle finder with impedancemetry
arm group label: pedicle finder with impedancemetry
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jonathan LEBHAR, MD
role: Principal Investigator
affiliation: Rennes University Hospital
last name: Jonathan LEBHAR, MD
phone: 299285753
phone ext: +0033
email: Jonathan.LEBHAR@chu-rennes.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor