<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/NCT04430270</url>
  </required_header>
  <id_info>
    <org_study_id>EGE18-5/41</org_study_id>
    <nct_id>NCT04430270</nct_id>
  </id_info>
  <brief_title>Perceptions of Orthopedic Prespecialists on Patient-Specific 3D Models.</brief_title>
  <official_title>Ethical Committee at Researches of Ege University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ege University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ege University</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>
      Background: Three-dimensional (3D) patient-specific anatomical model guidance is a reliable&#xD;
      tool in obtaining accurate bony cuts, precise implant placement, and satisfactory surgical&#xD;
      results. These can enhance surgeon's understanding of their patients' patho-anatomy also&#xD;
      helping in precise preoperative planning. So, the hypothesis of this study is that, in the&#xD;
      training of orthopaedic residency, 3D printed models reflecting the patient's individual&#xD;
      process provide a a foresight and a perception of the bone pathologies and osseous&#xD;
      relationships before orthopaedic intervention.&#xD;
&#xD;
      Methods: In this study, the investigators displayed our experience of creating realistic 3D&#xD;
      models in orthopaedic surgical case scenarios to evaluate the perceptions of fellows in&#xD;
      orthopaedic surgeon training. The investigators based our study on the comparision of the&#xD;
      perception of residents who were presented with four-step carousel consisting of different&#xD;
      scenarios as trauma (calcaneal fracture), deformity (hallux valgus), tumoral mass (sacral&#xD;
      chondrosarcoma), and reconstructive procedure (multidisciplinary cancer surgery). The X-ray&#xD;
      images, computed tomography (CT), and 1:1 solid models of the cases were included in each&#xD;
      step. The orthopaedic residents were asked to compare their perception level of the actual&#xD;
      scenarios in evaluating the effectiveness of each tool in terms of perceiving the orthopaedic&#xD;
      problem, understanding the bone pathology, classification of diagnosis and preoperative data&#xD;
      planning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      2.1. Study Group The study group consisted of 11 orthopaedic residents of University&#xD;
      Hospital. Ethics approval for this study was obtained from our university's Human Research&#xD;
      Ethics Committee (18-5/41). The work has been reported in line with the STROCSS criteria.&#xD;
&#xD;
      2.2. Selection of the sample cases The patients were chosen from the MRI examinations of the&#xD;
      ones who referred to same University Hospital Department of Orthopaedic and Traumatic Surgery&#xD;
      for diagnosis and treatment between the year of 2016 and 2018. Selection criteria for the 4&#xD;
      cases was the involved patients (age: 18-62 years) who required orthopaedic surgery, had no&#xD;
      previous orthopaedic nor traumatic operation, but on the other hand have bone pathology&#xD;
      leading to deformity, fracture, and suitable radiological imaging results for modeling. 4&#xD;
      cases that could serve as an example for orthopaedic surgical procedures were determined with&#xD;
      the consensus of experts in medical education, orthopaedic surgery and anatomy. The selected&#xD;
      cases were turned into real scenarios with history, medical examination findings, and imaging&#xD;
      methods. As data collection tool, descriptive grading scale was used to evaluate the&#xD;
      perceptions of each of these imaging methods in terms of their usefulness in seeing the&#xD;
      surgical problem, their efficiency in differential diagnosis and presurgical planning.&#xD;
&#xD;
      2.3.Image post-processing and segmentation Original CT images were converted into in Digital&#xD;
      Imaging and Communications in Medicine (DICOM) format. Files were transferred to a separate&#xD;
      workstation with Analyze 12.0 for post-processing and segmentation. Using free 3D Slicer&#xD;
      (version 4.10.1) software, a smoothing filter was also applied to the segmented volume data&#xD;
      to improve the surface quality of the model. The STL format for 3D printing was prepared.&#xD;
&#xD;
      2.4. Creating Life-size Patient-Specific 3D Model Mass Portal Pharaoh xd 20 printer was used&#xD;
      due to its documented accuracy for producing high-resolution 3D models of orthopaedic cases&#xD;
      from resin-based polymers.&#xD;
&#xD;
      2.5. Workshop Data collection shop A grading scale was developed for each case so that the&#xD;
      residents were able to make a comparison.&#xD;
&#xD;
        1. The grading scale developed for the trauma case (calcaneus fracture) consisted of 16&#xD;
           items including the appearance, classification and planning of the fracture surgery.&#xD;
&#xD;
        2. The scale for the case of deformity (hallux valgus) contained 7 items of classification,&#xD;
           questioning the degree of deformity and operation planning.&#xD;
&#xD;
        3. In the grading scale developed for the tumor case (chondrosarcoma), there were 13 items&#xD;
           questioning the location, size, spread and neighboring pelvic structures.&#xD;
&#xD;
        4. In the scale for the reconstructive case (thorax localized tumor), there were 13 items&#xD;
           questioning the location, size, spread and neighboring of intrathoracic structures, the&#xD;
           occurrence of a postoperative defect, and the reconstructive method in the presence of a&#xD;
           postoperative defect..&#xD;
&#xD;
      2.6. Survey A multi-item survey was prepared to assess fellow's perception of residency&#xD;
      training. The survey utilized by our group, addressed the issues in understanding patient&#xD;
      bone anatomy, seeing osseous pathology, independent decision-making, differential&#xD;
      pathological diagnosis, plan on key surgical steps, and preparation for unexpected events.&#xD;
      Residents who completed their examination in the stations evaluated each imaging method and&#xD;
      answered the questions on a scale of 10. Scoring in the scale (1 - 10) describes 0 = very low&#xD;
      and 10= the highest level.&#xD;
&#xD;
      2.7. Data collection Residents were asked to answer the grading scale by examining the X-ray,&#xD;
      CT and the 3D model from the first station. In addition, opinions about the models were&#xD;
      recorded and they were given an average of 10 minutes for each station.&#xD;
&#xD;
      2.8. Data Analysis Descriptive statistics and Friedman test were used for comparison&#xD;
      analysis. Data were analyzed using IBM SPSS Statistics, version 24 (IBM Corp., Armonk, NY).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Actual">May 10, 2020</completion_date>
  <primary_completion_date type="Actual">June 10, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Creating life-size patient-specific orthopaedic surgery cases model</measure>
    <time_frame>The research took 12 months, 05.02.2020, Each participant spends 45 minutes for the survey.</time_frame>
    <description>A multi-item survey was prepared to assess fellow's perception of residency training. The survey utilized by our group, addressed the issues in understanding patient bone anatomy, seeing osseous pathology, independent decision-making, differential pathological diagnosis, plan on key surgical steps, and preparation for unexpected events. Residents who completed their examination in the stations evaluated each imaging method and answered the questions on a scale of 10. Scoring in the scale (1 - 10) describes 0 = very low and 10= the highest level.Descriptive statistics and Friedman test were used for comparison analysis. Data were analyzed using IBM SPSS Statistics, version 24 (IBM Corp., Armonk, NY).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">11</enrollment>
  <condition>Educational Problems</condition>
  <arm_group>
    <arm_group_label>Comparison of Perceptions of X-ray, CT and 3D Model</arm_group_label>
    <description>The study group consisted of 11 orthopaedic residents of University Hospital. Selection criteria for the 4 cases was the involved patients who required orthopaedic surgery. 4 cases for orthopaedic procedures were determined with the consensus of experts. As data collection tool was used to evaluate the perceptions of each of these imaging methods in terms of their usefulness in seeing the surgical problem, their efficiency in differential diagnosis and presurgical planning. CT images were converted into in the 3D model was prepared. The survey utilized by our group, addressed the issues in understanding bone anatomy, seeing pathology, and preparation for unexpected events. A multi-item survey was prepared to assess fellow's perception of residency training. Residents who completed their examination in the stations answered the questions on a scale of 10. Descriptive statistics and Friedman test were used for comparison analysis using IBM SPSS Statistics, version 24.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>Sequential Assignment</description>
    <arm_group_label>Comparison of Perceptions of X-ray, CT and 3D Model</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study group consisted of 11 orthopaedic residents of University Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:Calcaneal fracture, Sacral tumors, Hallux valgus deformity, Mediastinal&#xD;
        Tumors -&#xD;
&#xD;
        Exclusion Criteria:Tibial Fracture, Acetabular fracture, Femoral tumors, Pes planus&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>All assistants are men.</gender_description>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yelda PINAR, Prof. Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Medicine, Ege University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ege University, Faculty of Medicine</name>
      <address>
        <city>Izmir</city>
        <state>Bornova</state>
        <zip>TR-35100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ege University</investigator_affiliation>
    <investigator_full_name>Figen GOVSA</investigator_full_name>
    <investigator_title>Prof. Dr, Senior investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>In this study, we displayed our experience of creating realistic 3D models in orthopaedic surgical case scenarios to evaluate the perceptions of fellows in orthopaedic surgeon training. We based our study on the comparision of the perception of residents who were presented with four-step carousel consisting of different scenarios as trauma (calcaneal fracture), deformity (hallux valgus), tumoral mass (sacral chondrosarcoma), and reconstructive procedure (multidisciplinary cancer surgery). The X-ray images, computed tomography (CT), and 1:1 solid models of the cases were included in each step. The orthopaedic residents were asked to compare their perception level of the actual scenarios in evaluating the effectiveness of each tool in terms of perceiving the orthopaedic problem, understanding the bone pathology, classification of diagnosis and preoperative data planning.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Aim of this study, is also to show that the models can assist in the training of novice surgeons in complicated areas like trauma, deformity and cancer surgery. Yet another aim of the present study is to assess whether the 3D model could be more informative than standard X-ray and CT image visualizations in predicting the real outcome of the orthopaedic surgery cases.</ipd_time_frame>
    <ipd_access_criteria>With the help of 3D printing technology, in this study, it is possible to implement and evaluate a well-structured real patient scenario setup for orthopaedic and traumatic surgery training. The orthopaedic intervention based on scenarios for residency is more original since there is no prior study including both model building and the evaluation of the perception created by the model. It can be used to improve the understanding of pathoanatomical changes of bone disease and to guide surgical strategy.</ipd_access_criteria>
  </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/NCT04430270
org study id: EGE18-5/41
nct id: NCT04430270
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Background: Three-dimensional (3D) patient-specific anatomical model guidance is a reliable
      tool in obtaining accurate bony cuts, precise implant placement, and satisfactory surgical
      results. These can enhance surgeon's understanding of their patients' patho-anatomy also
      helping in precise preoperative planning. So, the hypothesis of this study is that, in the
      training of orthopaedic residency, 3D printed models reflecting the patient's individual
      process provide a a foresight and a perception of the bone pathologies and osseous
      relationships before orthopaedic intervention.

      Methods: In this study, the investigators displayed our experience of creating realistic 3D
      models in orthopaedic surgical case scenarios to evaluate the perceptions of fellows in
      orthopaedic surgeon training. The investigators based our study on the comparision of the
      perception of residents who were presented with four-step carousel consisting of different
      scenarios as trauma (calcaneal fracture), deformity (hallux valgus), tumoral mass (sacral
      chondrosarcoma), and reconstructive procedure (multidisciplinary cancer surgery). The X-ray
      images, computed tomography (CT), and 1:1 solid models of the cases were included in each
      step. The orthopaedic residents were asked to compare their perception level of the actual
      scenarios in evaluating the effectiveness of each tool in terms of perceiving the orthopaedic
      problem, understanding the bone pathology, classification of diagnosis and preoperative data
      planning.
2.1. Study Group The study group consisted of 11 orthopaedic residents of University
      Hospital. Ethics approval for this study was obtained from our university's Human Research
      Ethics Committee (18-5/41). The work has been reported in line with the STROCSS criteria.

      2.2. Selection of the sample cases The patients were chosen from the MRI examinations of the
      ones who referred to same University Hospital Department of Orthopaedic and Traumatic Surgery
      for diagnosis and treatment between the year of 2016 and 2018. Selection criteria for the 4
      cases was the involved patients (age: 18-62 years) who required orthopaedic surgery, had no
      previous orthopaedic nor traumatic operation, but on the other hand have bone pathology
      leading to deformity, fracture, and suitable radiological imaging results for modeling. 4
      cases that could serve as an example for orthopaedic surgical procedures were determined with
      the consensus of experts in medical education, orthopaedic surgery and anatomy. The selected
      cases were turned into real scenarios with history, medical examination findings, and imaging
      methods. As data collection tool, descriptive grading scale was used to evaluate the
      perceptions of each of these imaging methods in terms of their usefulness in seeing the
      surgical problem, their efficiency in differential diagnosis and presurgical planning.

      2.3.Image post-processing and segmentation Original CT images were converted into in Digital
      Imaging and Communications in Medicine (DICOM) format. Files were transferred to a separate
      workstation with Analyze 12.0 for post-processing and segmentation. Using free 3D Slicer
      (version 4.10.1) software, a smoothing filter was also applied to the segmented volume data
      to improve the surface quality of the model. The STL format for 3D printing was prepared.

      2.4. Creating Life-size Patient-Specific 3D Model Mass Portal Pharaoh xd 20 printer was used
      due to its documented accuracy for producing high-resolution 3D models of orthopaedic cases
      from resin-based polymers.

      2.5. Workshop Data collection shop A grading scale was developed for each case so that the
      residents were able to make a comparison.

        1. The grading scale developed for the trauma case (calcaneus fracture) consisted of 16
           items including the appearance, classification and planning of the fracture surgery.

        2. The scale for the case of deformity (hallux valgus) contained 7 items of classification,
           questioning the degree of deformity and operation planning.

        3. In the grading scale developed for the tumor case (chondrosarcoma), there were 13 items
           questioning the location, size, spread and neighboring pelvic structures.

        4. In the scale for the reconstructive case (thorax localized tumor), there were 13 items
           questioning the location, size, spread and neighboring of intrathoracic structures, the
           occurrence of a postoperative defect, and the reconstructive method in the presence of a
           postoperative defect..

      2.6. Survey A multi-item survey was prepared to assess fellow's perception of residency
      training. The survey utilized by our group, addressed the issues in understanding patient
      bone anatomy, seeing osseous pathology, independent decision-making, differential
      pathological diagnosis, plan on key surgical steps, and preparation for unexpected events.
      Residents who completed their examination in the stations evaluated each imaging method and
      answered the questions on a scale of 10. Scoring in the scale (1 - 10) describes 0 = very low
      and 10= the highest level.

      2.7. Data collection Residents were asked to answer the grading scale by examining the X-ray,
      CT and the 3D model from the first station. In addition, opinions about the models were
      recorded and they were given an average of 10 minutes for each station.

      2.8. Data Analysis Descriptive statistics and Friedman test were used for comparison
      analysis. Data were analyzed using IBM SPSS Statistics, version 24 (IBM Corp., Armonk, NY).
observational model: Case-Control
time perspective: Retrospective
measure: Creating life-size patient-specific orthopaedic surgery cases model
time frame: The research took 12 months, 05.02.2020, Each participant spends 45 minutes for the survey.
description: A multi-item survey was prepared to assess fellow's perception of residency training. The survey utilized by our group, addressed the issues in understanding patient bone anatomy, seeing osseous pathology, independent decision-making, differential pathological diagnosis, plan on key surgical steps, and preparation for unexpected events. Residents who completed their examination in the stations evaluated each imaging method and answered the questions on a scale of 10. Scoring in the scale (1 - 10) describes 0 = very low and 10= the highest level.Descriptive statistics and Friedman test were used for comparison analysis. Data were analyzed using IBM SPSS Statistics, version 24 (IBM Corp., Armonk, NY).
arm group label: Comparison of Perceptions of X-ray, CT and 3D Model
description: The study group consisted of 11 orthopaedic residents of University Hospital. Selection criteria for the 4 cases was the involved patients who required orthopaedic surgery. 4 cases for orthopaedic procedures were determined with the consensus of experts. As data collection tool was used to evaluate the perceptions of each of these imaging methods in terms of their usefulness in seeing the surgical problem, their efficiency in differential diagnosis and presurgical planning. CT images were converted into in the 3D model was prepared. The survey utilized by our group, addressed the issues in understanding bone anatomy, seeing pathology, and preparation for unexpected events. A multi-item survey was prepared to assess fellow's perception of residency training. Residents who completed their examination in the stations answered the questions on a scale of 10. Descriptive statistics and Friedman test were used for comparison analysis using IBM SPSS Statistics, version 24.
intervention type: Behavioral
intervention name: Survey
description: Sequential Assignment
arm group label: Comparison of Perceptions of X-ray, CT and 3D Model
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
gender based: Yes
gender description: All assistants are men.
minimum age: 24 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yelda PINAR, Prof. Dr.
role: Study Chair
affiliation: Faculty of Medicine, Ege University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ege University
investigator full name: Figen GOVSA
investigator title: Prof. Dr, Senior investigator
sharing ipd: Yes
ipd description: In this study, we displayed our experience of creating realistic 3D models in orthopaedic surgical case scenarios to evaluate the perceptions of fellows in orthopaedic surgeon training. We based our study on the comparision of the perception of residents who were presented with four-step carousel consisting of different scenarios as trauma (calcaneal fracture), deformity (hallux valgus), tumoral mass (sacral chondrosarcoma), and reconstructive procedure (multidisciplinary cancer surgery). The X-ray images, computed tomography (CT), and 1:1 solid models of the cases were included in each step. The orthopaedic residents were asked to compare their perception level of the actual scenarios in evaluating the effectiveness of each tool in terms of perceiving the orthopaedic problem, understanding the bone pathology, classification of diagnosis and preoperative data planning.
ipd info type: Study Protocol
ipd time frame: Aim of this study, is also to show that the models can assist in the training of novice surgeons in complicated areas like trauma, deformity and cancer surgery. Yet another aim of the present study is to assess whether the 3D model could be more informative than standard X-ray and CT image visualizations in predicting the real outcome of the orthopaedic surgery cases.
ipd access criteria: With the help of 3D printing technology, in this study, it is possible to implement and evaluate a well-structured real patient scenario setup for orthopaedic and traumatic surgery training. The orthopaedic intervention based on scenarios for residency is more original since there is no prior study including both model building and the evaluation of the perception created by the model. It can be used to improve the understanding of pathoanatomical changes of bone disease and to guide surgical strategy.