Educational ProblemsNCT04430270
Perceptions of Orthopedic Prespecialists on Patient-Specific 3D Models.
An observational study of Educational Problems, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Educational Problems
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 11 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2019to 10 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The study group consisted of 11 orthopaedic residents of University Hospital.
Inclusion Criteria:Calcaneal fracture, Sacral tumors, Hallux valgus deformity, Mediastinal Tumors -
Exclusion Criteria:Tibial Fracture, Acetabular fracture, Femoral tumors, Pes planus
-
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University, Faculty of Medicine
Izmir, Bornova, TR-35100
About this study
Official title: Ethical Committee at Researches of Ege University
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.
Read the detailed description
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.
- The grading scale developed for the trauma case (calcaneus fracture) consisted of 16 items including the appearance, classification and planning of the fracture surgery.
- The scale for the case of deformity (hallux valgus) contained 7 items of classification, questioning the degree of deformity and operation planning.
- In the grading scale developed for the tumor case (chondrosarcoma), there were 13 items questioning the location, size, spread and neighboring pelvic structures.
- 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).
- Conditions
- Educational Problems
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
Sequential Assignment
| Study group | Role | What they receive |
|---|---|---|
| Comparison of Perceptions of X-ray, CT and 3D Model | 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. Receives: Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Creating life-size patient-specific orthopaedic surgery cases model
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).
Measured: The research took 12 months, 05.02.2020, Each participant spends 45 minutes for the survey.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start10 Jan 2019
- Primary completion10 Jun 2019
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ProblemsStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Figen GOVSA, Ege University
- Investigators
- Yelda PINAR, Prof. Dr., Study chair, Faculty of Medicine, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430270
- Sponsor's protocol ID
- EGE18-5/41
- Status last verified
- Jun 2020
- First submitted
- 3 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethical Committee at Researches of Ege University
- ClinicalTrials.gov ID
- NCT04430270
- Acronym / sponsor ID
- EGE18-5/41
- Conditions
- Educational Problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 12 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- The grading scale developed for the trauma case (calcaneus fracture) consisted of 16 items including the appearance, classification and planning of the fracture surgery.
- The scale for the case of deformity (hallux valgus) contained 7 items of classification, questioning the degree of deformity and operation planning.
- In the grading scale developed for the tumor case (chondrosarcoma), there were 13 items questioning the location, size, spread and neighboring pelvic structures.
- 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).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison of Perceptions of X-ray, CT and 3D Model | – | Behavioral: SurveyThe 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. |
Who may qualify
- Ages
- 24 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study group consisted of 11 orthopaedic residents of University Hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveySequential Assignment | Behavioural | Comparison of Perceptions of X-ray, CT and 3D Model |
Primary outcome
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yelda PINAR, Prof. Dr. study chair
Faculty of Medicine, Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Educational Problems, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.