<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/NCT02216448</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-14-1236-DP-CTIL</org_study_id>
    <nct_id>NCT02216448</nct_id>
  </id_info>
  <brief_title>Arthroscopy Simulator Training vs OR Training Knee</brief_title>
  <acronym>ASTOR</acronym>
  <official_title>The Benefit of Arthroscopic Simulator Training Versus Operating Room Training in Diagnostic Knee Arthroscopy for Residents With Basic Arthroscopic Skills</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheba Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheba Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare between two groups of residents with basic&#xD;
      arthroscopic skills in diagnostic knee arthroscopy. The first group will train on a knee&#xD;
      arthroscopic simulator in a lab, and the second group will perform diagnostic knee&#xD;
      arthroscopy in the operating room. Both groups will be assessed by senior arthroscopy surgeon&#xD;
      in the operating room based on selected competencies following the Global Rating System.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Technical problems with simulator&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Global rating scale</measure>
    <time_frame>completion of training</time_frame>
    <description>About 3 months will be needed for both study arms to complete the training in the arthroscopy lab and in the OR. Then, both will be assessed by the global rating scale for arthroscopy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>simulator parameters</measure>
    <time_frame>Completion of training</time_frame>
    <description>Secondary outcome measures are technical parameters provided by the simulator for each trainee. At the end of the training sessions, about 3 months from the beginning of the study, this parameters can be collected.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Knee Arthroscopy Skills</condition>
  <arm_group>
    <arm_group_label>simulator training</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Training knee simulator in Lab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OR training</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Training in the OR - 2 knee arthroscopies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training knee simulator</intervention_name>
    <description>Training in a lab on a virtual reality knee arthroscopy simulator</description>
    <arm_group_label>simulator training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>OR Training</intervention_name>
    <description>Training on diagnostic knee arthroscopy in the OR</description>
    <arm_group_label>OR training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Orthopedic residents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sheba Tel Hashomer</name>
      <address>
        <city>Ramat Gan</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>April 19, 2018</last_update_submitted>
  <last_update_submitted_qc>April 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Dr. Dan Prat MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Arthroscopy skills</keyword>
  <keyword>Knee</keyword>
  <keyword>Virtual reality</keyword>
  <keyword>Simulator</keyword>
  <!-- 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/NCT02216448
org study id: SHEBA-14-1236-DP-CTIL
nct id: NCT02216448
lead sponsor: 
has dmc: No
The purpose of this study is to compare between two groups of residents with basic
      arthroscopic skills in diagnostic knee arthroscopy. The first group will train on a knee
      arthroscopic simulator in a lab, and the second group will perform diagnostic knee
      arthroscopy in the operating room. Both groups will be assessed by senior arthroscopy surgeon
      in the operating room based on selected competencies following the Global Rating System.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Global rating scale
time frame: completion of training
description: About 3 months will be needed for both study arms to complete the training in the arthroscopy lab and in the OR. Then, both will be assessed by the global rating scale for arthroscopy.
measure: simulator parameters
time frame: Completion of training
description: Secondary outcome measures are technical parameters provided by the simulator for each trainee. At the end of the training sessions, about 3 months from the beginning of the study, this parameters can be collected.
arm group label: simulator training
arm group type: Other
description: Training knee simulator in Lab
arm group label: OR training
arm group type: Other
description: Training in the OR - 2 knee arthroscopies.
intervention type: Other
intervention name: Training knee simulator
description: Training in a lab on a virtual reality knee arthroscopy simulator
arm group label: simulator training
intervention type: Other
intervention name: OR Training
description: Training on diagnostic knee arthroscopy in the OR
arm group label: OR training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Sheba Medical Center
investigator full name: Dr. Dan Prat MD
investigator title: MD