<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/NCT04404010</url>
  </required_header>
  <id_info>
    <org_study_id>20200008-01H</org_study_id>
    <nct_id>NCT04404010</nct_id>
  </id_info>
  <brief_title>Virtual Reality vs Technical Video in Surgical Training</brief_title>
  <official_title>Effectiveness of Immersive Virtual Reality Training Compared to Instructional Technical Surgical Video: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PrecisionOS Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ottawa Hospital Research Institute</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 use of instructional technical surgical videos is common in orthopaedic education. Many&#xD;
      residents have used instructional technical surgical training videos prior to medical school,&#xD;
      as well as during their residency program, and at instructional courses. The use of&#xD;
      instructional technical surgical videos and multimedia is considered an adjunctive training&#xD;
      method for orthopaedic residents to learn operative procedures.&#xD;
&#xD;
      Immersive virtual reality (iVR) is increasingly used in surgical education. Recently, iVR has&#xD;
      shown transfer of skill training in orthopaedics. The continued study of the effectiveness of&#xD;
      iVR training in orthopaedic education could benefit new competency based orthopaedics&#xD;
      residency programs.&#xD;
&#xD;
      The purpose of this study is to compare the effectiveness of instructional technical surgical&#xD;
      video training to immersive iVR training for teaching technical skills of reverse total&#xD;
      shoulder arthroplasty. Our hypothesis was that iVR improved learning effectiveness compared&#xD;
      to standard technical surgical video. Secondary objectives include validating a virtual&#xD;
      reality ratings scale through correlation to real-world performance.&#xD;
&#xD;
      We proposed a randomized, blinded intervention-control trial directly comparing immersive iVR&#xD;
      versus technical surgical instructional video training in the teaching of reverse shoulder&#xD;
      arthroplasty in senior residents, learning at the 2020 annual Canadian Shoulder and Elbow&#xD;
      Society meeting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The use of instructional technical surgical videos is common in orthopaedic education. Many&#xD;
      residents have used instructional technical surgical training videos prior to medical school,&#xD;
      as well as during their residency program, and at instructional courses. The use of&#xD;
      instructional technical surgical videos and multimedia is considered an adjunctive training&#xD;
      method for orthopaedic residents to learn operative procedures.&#xD;
&#xD;
      Immersive virtual reality (iVR) is increasingly used in surgical education. Recently, iVR has&#xD;
      shown transfer of skill training in orthopaedics. The continued study of the effectiveness of&#xD;
      iVR training in orthopaedic education could benefit new competency based orthopaedics&#xD;
      residency programs.&#xD;
&#xD;
      The purpose of this study is to compare the effectiveness of instructional technical surgical&#xD;
      video training to immersive iVR training for teaching technical skills of reverse total&#xD;
      shoulder arthroplasty. Our hypothesis was that iVR improved learning effectiveness compared&#xD;
      to standard technical surgical video. Secondary objectives include validating a virtual&#xD;
      reality ratings scale through correlation to real-world performance, and to determine&#xD;
      efficiency of learning in both groups.&#xD;
&#xD;
      Currently, technical surgical instructional videos are pervasive in orthopaedic teaching&#xD;
      education. Immersive VR, another form of teaching, is increasingly being used in surgical&#xD;
      education. The production of an immersive VR suite with tactile and user metric feedback may&#xD;
      be an advance over current bench top simulator technology, allowing for greater immersion and&#xD;
      interaction, leading to better understanding of surgical planning and implementation. The&#xD;
      development of this technology could provide trainees with immersive levels of training not&#xD;
      previously seen, with improved learning of technical skills over media such as manufacturer&#xD;
      technical documents. The effectiveness of training and efficiency of training of the novel&#xD;
      immersive VR training systems need to be evaluated as they are increasingly incorporated into&#xD;
      competency based, contemporary residency education.&#xD;
&#xD;
      We proposed a randomized, blinded intervention-control trial directly comparing immersive iVR&#xD;
      versus technical surgical instructional video training in the teaching of reverse shoulder&#xD;
      arthroplasty in senior (fourth and fifth year) residents, learning at the 2020 annual&#xD;
      Canadian Shoulder and Elbow Society meeting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 30, 2020</start_date>
  <completion_date type="Actual">February 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2020</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>Objective Structured Assessment of Technical Skills (OSATS)</measure>
    <time_frame>During surgery up until immediately after surgery.</time_frame>
    <description>The Objective Structured Assessment of Technical Skills (OSATS) outcome measure is a validated assessment tool used for grading overall technical ability during surgery. This checklist contains 27 items, in which an assessor will mark off whether the task was completed successfully or not. For each item done correctly, it is worth 1 point. For each item done incorrectly, no point is awarded. All points are totalled for a maximum possible score of 27 points (minimum score of 0 and maximum score of 27). A higher score indicates a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global Ratings Scale (GRS)</measure>
    <time_frame>During surgery up until immediately after surgery.</time_frame>
    <description>The Global Ratings Scale (GRS) is a validated assessment tool used for grading operative performance. The GRS contains 7 categories: respect for tissue, time and motion, instrument handling, knowledge of instruments, flow of operation, use of assistants, and knowledge of specific procedure. Each category is graded using a 5-point Likert type scale, a higher number indicates a better outcome, with a maximum of 5 points per category. Each categorical score is totalled for a maximum overall score of 35 points (minimum score of 0 and maximum score of 35). A higher score indicates a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfer of Training (ToT)</measure>
    <time_frame>immediately after surgery.</time_frame>
    <description>Transfer of Training (ToT) outcome informs how much skill is gained in the iVR group compared to the control performance. This is measured using an equation. ToT equals the average time to complete surgical procedure (for those in instructional video group) minus the average time to complete the surgical procedure (for those in the iVR training group), divided by the average time to complete surgical procedure (for those in instructional video group). The outcome is presented as a cumulative ratio, and a numerical value is provided. A higher number indicates a better outcome. For the purpose of this project, there is not a spread of data for a single instance of training as we did not complete multiple repetitions, otherwise we would have incremental values for each.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfer Effectiveness Ratio (TER)</measure>
    <time_frame>Immediately before surgery up immediately after surgery.</time_frame>
    <description>Transfer Effectiveness Ratio (TER) outcomes informs on the skill comparison relative to the control, on real world training reduction times. TER equals the average time to complete surgical procedure (for those in instructional video group) minus the average time to complete the surgical procedure (for those in the iVR training group), divided by the average time to complete the iVR training. The outcome is presented as a cumulative ratio, and a numerical value is provided. A higher number, indicates a better outcome. For the purpose of this project, there is not a spread of data for a single instance of training as we did not complete multiple repetitions, otherwise we would have incremental values for each.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Surgical Training</condition>
  <arm_group>
    <arm_group_label>Immersive Virtual Reality</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to the immersive virtual reality (iVR) study arm, considered the &quot;intervention group&quot; will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgical Video</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants randomized to the standard video study arm, considered the &quot;control group&quot; will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Immersive Virtual Reality</intervention_name>
    <description>Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.</description>
    <arm_group_label>Immersive Virtual Reality</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Surgical Technical Instructional Video</intervention_name>
    <description>Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.</description>
    <arm_group_label>Surgical Video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Senior residents (4th and 5th year residents) attending 2020 CSES course&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>J Pollock, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ottawa Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Ottawa Skills and Simulation Centre</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>Lohre R, Bois AJ, Pollock JW, Lapner P, McIlquham K, Athwal GS, Goel DP. Effectiveness of Immersive Virtual Reality on Orthopedic Surgical Skills and Knowledge Acquisition Among Senior Surgical Residents: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2031217. doi: 10.1001/jamanetworkopen.2020.31217.</citation>
    <PMID>33369660</PMID>
  </results_reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <results_first_submitted>May 18, 2021</results_first_submitted>
  <results_first_submitted_qc>August 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">September 5, 2021</results_first_posted>
  <last_update_submitted>September 21, 2022</last_update_submitted>
  <last_update_submitted_qc>September 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immersive Virtual Reality</keyword>
  <keyword>Technical Training Video</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 6, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT04404010/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>1 participant was mistakenly consented (error in screening - participant was not a PGY4 or 5) and randomized to immersive virtual reality arm as part of study. After randomization, but prior to study testing we realized the participant was not eligible, therefore they were excluded prior to any further study procedures commenced.&#xD;
1 additional participant was mistakenly consented (error in screening - participant was not a PGY4 or 5), therefore excluded PRIOR to randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Immersive Virtual Reality</title>
          <description>Participants randomized to the immersive virtual reality (iVR) study arm, considered the &quot;intervention group&quot; will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology).&#xD;
Immersive Virtual Reality: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.</description>
        </group>
        <group group_id="P2">
          <title>Surgical Video</title>
          <description>Participants randomized to the standard video study arm, considered the &quot;control group&quot; will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video.&#xD;
Surgical Technical Instructional Video: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10">1 participant was mistakenly consented, enrolled and randomized as part of study. After randomization, but prior to study testing we realized the participant was not eligible (they were not a PGY4 or 5), therefore they were excluded prior to any further study procedures commenced. Therefore, only 9 participants completed all study procedures/were followed for purposes of study.</participants>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Mistakenly enrolled, withdrawn after randomization (did not meet eligibility criteria)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Immersive Virtual Reality</title>
          <description>Participants randomized to the immersive virtual reality (iVR) study arm, considered the &quot;intervention group&quot; will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology).&#xD;
Immersive Virtual Reality: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.</description>
        </group>
        <group group_id="B2">
          <title>Surgical Video</title>
          <description>Participants randomized to the standard video study arm, considered the &quot;control group&quot; will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video.&#xD;
Surgical Technical Instructional Video: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9"/>
                    <count group_id="B2" value="9"/>
                    <count group_id="B3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Structured Assessment of Technical Skills (OSATS)</title>
        <description>The Objective Structured Assessment of Technical Skills (OSATS) outcome measure is a validated assessment tool used for grading overall technical ability during surgery. This checklist contains 27 items, in which an assessor will mark off whether the task was completed successfully or not. For each item done correctly, it is worth 1 point. For each item done incorrectly, no point is awarded. All points are totalled for a maximum possible score of 27 points (minimum score of 0 and maximum score of 27). A higher score indicates a better outcome.</description>
        <time_frame>During surgery up until immediately after surgery.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Immersive Virtual Reality</title>
            <description>Participants randomized to the immersive virtual reality (iVR) study arm, considered the &quot;intervention group&quot; will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology).&#xD;
Immersive Virtual Reality: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.</description>
          </group>
          <group group_id="O2">
            <title>Surgical Video</title>
            <description>Participants randomized to the standard video study arm, considered the &quot;control group&quot; will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video.&#xD;
Surgical Technical Instructional Video: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Structured Assessment of Technical Skills (OSATS)</title>
          <description>The Objective Structured Assessment of Technical Skills (OSATS) outcome measure is a validated assessment tool used for grading overall technical ability during surgery. This checklist contains 27 items, in which an assessor will mark off whether the task was completed successfully or not. For each item done correctly, it is worth 1 point. For each item done incorrectly, no point is awarded. All points are totalled for a maximum possible score of 27 points (minimum score of 0 and maximum score of 27). A higher score indicates a better outcome.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" lower_limit="14.3" upper_limit="17.5"/>
                    <measurement group_id="O2" value="9.4" lower_limit="7.4" upper_limit="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Global Ratings Scale (GRS)</title>
        <description>The Global Ratings Scale (GRS) is a validated assessment tool used for grading operative performance. The GRS contains 7 categories: respect for tissue, time and motion, instrument handling, knowledge of instruments, flow of operation, use of assistants, and knowledge of specific procedure. Each category is graded using a 5-point Likert type scale, a higher number indicates a better outcome, with a maximum of 5 points per category. Each categorical score is totalled for a maximum overall score of 35 points (minimum score of 0 and maximum score of 35). A higher score indicates a better outcome.</description>
        <time_frame>During surgery up until immediately after surgery.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Immersive Virtual Reality</title>
            <description>Participants randomized to the immersive virtual reality (iVR) study arm, considered the &quot;intervention group&quot; will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology).&#xD;
Immersive Virtual Reality: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.</description>
          </group>
          <group group_id="O2">
            <title>Surgical Video</title>
            <description>Participants randomized to the standard video study arm, considered the &quot;control group&quot; will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video.&#xD;
Surgical Technical Instructional Video: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.</description>
          </group>
        </group_list>
        <measure>
          <title>Global Ratings Scale (GRS)</title>
          <description>The Global Ratings Scale (GRS) is a validated assessment tool used for grading operative performance. The GRS contains 7 categories: respect for tissue, time and motion, instrument handling, knowledge of instruments, flow of operation, use of assistants, and knowledge of specific procedure. Each category is graded using a 5-point Likert type scale, a higher number indicates a better outcome, with a maximum of 5 points per category. Each categorical score is totalled for a maximum overall score of 35 points (minimum score of 0 and maximum score of 35). A higher score indicates a better outcome.</description>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.8" spread="8.2"/>
                    <measurement group_id="O2" value="22.4" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Transfer of Training (ToT)</title>
        <description>Transfer of Training (ToT) outcome informs how much skill is gained in the iVR group compared to the control performance. This is measured using an equation. ToT equals the average time to complete surgical procedure (for those in instructional video group) minus the average time to complete the surgical procedure (for those in the iVR training group), divided by the average time to complete surgical procedure (for those in instructional video group). The outcome is presented as a cumulative ratio, and a numerical value is provided. A higher number indicates a better outcome. For the purpose of this project, there is not a spread of data for a single instance of training as we did not complete multiple repetitions, otherwise we would have incremental values for each.</description>
        <time_frame>immediately after surgery.</time_frame>
        <population>The ToT is calculated as a cumulative ratio. There isn't a spread of data for a single instance of training, however, if we had done more repetitions then we would have incremental values for each. Therefore, the single numerical value of ToT is 0.594 or 59.4%. Answer is based off of the following calculation: (Time (surgical video) - Time (immersive virtual reality) divided by the Time (surgical video)) multiplied by 100%.</population>
        <group_list>
          <group group_id="O1">
            <title>Transfer of Training Ratio</title>
            <description>A comparison of skill achievement compared to control performance. This informs how much skill is gained by training.</description>
          </group>
        </group_list>
        <measure>
          <title>Transfer of Training (ToT)</title>
          <description>Transfer of Training (ToT) outcome informs how much skill is gained in the iVR group compared to the control performance. This is measured using an equation. ToT equals the average time to complete surgical procedure (for those in instructional video group) minus the average time to complete the surgical procedure (for those in the iVR training group), divided by the average time to complete surgical procedure (for those in instructional video group). The outcome is presented as a cumulative ratio, and a numerical value is provided. A higher number indicates a better outcome. For the purpose of this project, there is not a spread of data for a single instance of training as we did not complete multiple repetitions, otherwise we would have incremental values for each.</description>
          <population>The ToT is calculated as a cumulative ratio. There isn't a spread of data for a single instance of training, however, if we had done more repetitions then we would have incremental values for each. Therefore, the single numerical value of ToT is 0.594 or 59.4%. Answer is based off of the following calculation: (Time (surgical video) - Time (immersive virtual reality) divided by the Time (surgical video)) multiplied by 100%.</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59.4" lower_limit="0" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Transfer Effectiveness Ratio (TER)</title>
        <description>Transfer Effectiveness Ratio (TER) outcomes informs on the skill comparison relative to the control, on real world training reduction times. TER equals the average time to complete surgical procedure (for those in instructional video group) minus the average time to complete the surgical procedure (for those in the iVR training group), divided by the average time to complete the iVR training. The outcome is presented as a cumulative ratio, and a numerical value is provided. A higher number, indicates a better outcome. For the purpose of this project, there is not a spread of data for a single instance of training as we did not complete multiple repetitions, otherwise we would have incremental values for each.</description>
        <time_frame>Immediately before surgery up immediately after surgery.</time_frame>
        <population>The TER is calculated as a cumulative ratio. There isn't a spread of data for a single instance of training, however, if we had done more repetitions then we would have incremental values for each. Therefore, the single numerical value of TER is 0.79. Answer is based off of the following calculation: (Time (surgical video) - Time (immersive virtual reality) divided by Time (simulated immersive virtual reality)).</population>
        <group_list>
          <group group_id="O1">
            <title>Transfer Effectiveness Ratio</title>
            <description>Skill comparison relative to control, incorporating improvements in task time. This informs real world training reduction times.</description>
          </group>
        </group_list>
        <measure>
          <title>Transfer Effectiveness Ratio (TER)</title>
          <description>Transfer Effectiveness Ratio (TER) outcomes informs on the skill comparison relative to the control, on real world training reduction times. TER equals the average time to complete surgical procedure (for those in instructional video group) minus the average time to complete the surgical procedure (for those in the iVR training group), divided by the average time to complete the iVR training. The outcome is presented as a cumulative ratio, and a numerical value is provided. A higher number, indicates a better outcome. For the purpose of this project, there is not a spread of data for a single instance of training as we did not complete multiple repetitions, otherwise we would have incremental values for each.</description>
          <population>The TER is calculated as a cumulative ratio. There isn't a spread of data for a single instance of training, however, if we had done more repetitions then we would have incremental values for each. Therefore, the single numerical value of TER is 0.79. Answer is based off of the following calculation: (Time (surgical video) - Time (immersive virtual reality) divided by Time (simulated immersive virtual reality)).</population>
          <units>Ratio Value</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.79" lower_limit="0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 day (duration of each participant's involvement in study)</time_frame>
      <desc>There are no serious risks associated with this study. The purpose of this study was to compare training methods to determine which one is most effective among orthopaedic surgical residents. There was a possibility for those in the virtual reality group to experience dizziness or nausea, however is considered mild and rare. Trained personnel were available to assist throughout the duration of training as well.</desc>
      <group_list>
        <group group_id="E1">
          <title>Immersive Virtual Reality</title>
          <description>Participants randomized to the immersive virtual reality (iVR) study arm, considered the &quot;intervention group&quot; will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology).&#xD;
Immersive Virtual Reality: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.</description>
        </group>
        <group group_id="E2">
          <title>Surgical Video</title>
          <description>Participants randomized to the standard video study arm, considered the &quot;control group&quot; will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video.&#xD;
Surgical Technical Instructional Video: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Danny P Goel</name_or_title>
      <organization>Precision OS Technology</organization>
      <phone>604-345-0401</phone>
      <email>danny@precisionostech.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04404010
org study id: 20200008-01H
nct id: NCT04404010
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The use of instructional technical surgical videos is common in orthopaedic education. Many
      residents have used instructional technical surgical training videos prior to medical school,
      as well as during their residency program, and at instructional courses. The use of
      instructional technical surgical videos and multimedia is considered an adjunctive training
      method for orthopaedic residents to learn operative procedures.

      Immersive virtual reality (iVR) is increasingly used in surgical education. Recently, iVR has
      shown transfer of skill training in orthopaedics. The continued study of the effectiveness of
      iVR training in orthopaedic education could benefit new competency based orthopaedics
      residency programs.

      The purpose of this study is to compare the effectiveness of instructional technical surgical
      video training to immersive iVR training for teaching technical skills of reverse total
      shoulder arthroplasty. Our hypothesis was that iVR improved learning effectiveness compared
      to standard technical surgical video. Secondary objectives include validating a virtual
      reality ratings scale through correlation to real-world performance.

      We proposed a randomized, blinded intervention-control trial directly comparing immersive iVR
      versus technical surgical instructional video training in the teaching of reverse shoulder
      arthroplasty in senior residents, learning at the 2020 annual Canadian Shoulder and Elbow
      Society meeting.
The use of instructional technical surgical videos is common in orthopaedic education. Many
      residents have used instructional technical surgical training videos prior to medical school,
      as well as during their residency program, and at instructional courses. The use of
      instructional technical surgical videos and multimedia is considered an adjunctive training
      method for orthopaedic residents to learn operative procedures.

      Immersive virtual reality (iVR) is increasingly used in surgical education. Recently, iVR has
      shown transfer of skill training in orthopaedics. The continued study of the effectiveness of
      iVR training in orthopaedic education could benefit new competency based orthopaedics
      residency programs.

      The purpose of this study is to compare the effectiveness of instructional technical surgical
      video training to immersive iVR training for teaching technical skills of reverse total
      shoulder arthroplasty. Our hypothesis was that iVR improved learning effectiveness compared
      to standard technical surgical video. Secondary objectives include validating a virtual
      reality ratings scale through correlation to real-world performance, and to determine
      efficiency of learning in both groups.

      Currently, technical surgical instructional videos are pervasive in orthopaedic teaching
      education. Immersive VR, another form of teaching, is increasingly being used in surgical
      education. The production of an immersive VR suite with tactile and user metric feedback may
      be an advance over current bench top simulator technology, allowing for greater immersion and
      interaction, leading to better understanding of surgical planning and implementation. The
      development of this technology could provide trainees with immersive levels of training not
      previously seen, with improved learning of technical skills over media such as manufacturer
      technical documents. The effectiveness of training and efficiency of training of the novel
      immersive VR training systems need to be evaluated as they are increasingly incorporated into
      competency based, contemporary residency education.

      We proposed a randomized, blinded intervention-control trial directly comparing immersive iVR
      versus technical surgical instructional video training in the teaching of reverse shoulder
      arthroplasty in senior (fourth and fifth year) residents, learning at the 2020 annual
      Canadian Shoulder and Elbow Society meeting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Objective Structured Assessment of Technical Skills (OSATS)
time frame: During surgery up until immediately after surgery.
description: The Objective Structured Assessment of Technical Skills (OSATS) outcome measure is a validated assessment tool used for grading overall technical ability during surgery. This checklist contains 27 items, in which an assessor will mark off whether the task was completed successfully or not. For each item done correctly, it is worth 1 point. For each item done incorrectly, no point is awarded. All points are totalled for a maximum possible score of 27 points (minimum score of 0 and maximum score of 27). A higher score indicates a better outcome.
measure: Global Ratings Scale (GRS)
time frame: During surgery up until immediately after surgery.
description: The Global Ratings Scale (GRS) is a validated assessment tool used for grading operative performance. The GRS contains 7 categories: respect for tissue, time and motion, instrument handling, knowledge of instruments, flow of operation, use of assistants, and knowledge of specific procedure. Each category is graded using a 5-point Likert type scale, a higher number indicates a better outcome, with a maximum of 5 points per category. Each categorical score is totalled for a maximum overall score of 35 points (minimum score of 0 and maximum score of 35). A higher score indicates a better outcome.
measure: Transfer of Training (ToT)
time frame: immediately after surgery.
description: Transfer of Training (ToT) outcome informs how much skill is gained in the iVR group compared to the control performance. This is measured using an equation. ToT equals the average time to complete surgical procedure (for those in instructional video group) minus the average time to complete the surgical procedure (for those in the iVR training group), divided by the average time to complete surgical procedure (for those in instructional video group). The outcome is presented as a cumulative ratio, and a numerical value is provided. A higher number indicates a better outcome. For the purpose of this project, there is not a spread of data for a single instance of training as we did not complete multiple repetitions, otherwise we would have incremental values for each.
measure: Transfer Effectiveness Ratio (TER)
time frame: Immediately before surgery up immediately after surgery.
description: Transfer Effectiveness Ratio (TER) outcomes informs on the skill comparison relative to the control, on real world training reduction times. TER equals the average time to complete surgical procedure (for those in instructional video group) minus the average time to complete the surgical procedure (for those in the iVR training group), divided by the average time to complete the iVR training. The outcome is presented as a cumulative ratio, and a numerical value is provided. A higher number, indicates a better outcome. For the purpose of this project, there is not a spread of data for a single instance of training as we did not complete multiple repetitions, otherwise we would have incremental values for each.
arm group label: Immersive Virtual Reality
arm group type: Active Comparator
description: Participants randomized to the immersive virtual reality (iVR) study arm, considered the "intervention group" will receive training on completion of a reverse shoulder arthroplasty using an iVR simulator (PrecisionOS Technology).
arm group label: Surgical Video
arm group type: Other
description: Participants randomized to the standard video study arm, considered the "control group" will receive training on completion of reverse shoulder arthroplasty using a technical surgical instructional video.
intervention type: Other
intervention name: Immersive Virtual Reality
description: Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.
arm group label: Immersive Virtual Reality
intervention type: Other
intervention name: Surgical Technical Instructional Video
description: Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.
arm group label: Surgical Video
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: J Pollock, MD
role: Principal Investigator
affiliation: The Ottawa Hospital
facility: 
country: Canada
citation: Lohre R, Bois AJ, Pollock JW, Lapner P, McIlquham K, Athwal GS, Goel DP. Effectiveness of Immersive Virtual Reality on Orthopedic Surgical Skills and Knowledge Acquisition Among Senior Surgical Residents: A Randomized Clinical Trial. JAMA Netw Open. 2020 Dec 1;3(12):e2031217. doi: 10.1001/jamanetworkopen.2020.31217.
PMID: 33369660
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 