Clinical trial NCT04430270: Perceptions of Orthopedic Prespecialists on Patient-Specific 3D Models.
Official title: Ethical Committee at Researches of Ege University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Educational Problems
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 11
Sex: MALE
Minimum age (years): 24
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study group consisted of 11 orthopaedic residents of University Hospital.

Brief 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. 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.

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).

Eligibility criteria: Inclusion Criteria:Calcaneal fracture, Sacral tumors, Hallux valgus deformity, Mediastinal Tumors -

Exclusion Criteria:Tibial Fracture, Acetabular fracture, Femoral tumors, Pes planus

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Primary outcomes:
measure: Creating life-size patient-specific orthopaedic surgery cases model
timeFrame: The research took 12 months, 05.02.2020, Each participant spends 45 minutes for the survey.
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University, Faculty of Medicine
state: Bornova
Study officials:
affiliation: Faculty of Medicine, Ege University
name: Yelda PINAR, Prof. Dr.
role: STUDY_CHAIR
References: