Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04430270
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2020-06-03
Brief Title:
Perceptions of Orthopedic Prespecialists on Patient-Specific 3D Models
Sponsor:
Ege University
Organization:
Ege University
Study Overview
Official Title:
Ethical Committee at Researches of Ege University
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 surgeons 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 patients 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 11 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
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 11 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:
21 Study Group The study group consisted of 11 orthopaedic residents of University Hospital Ethics approval for this study was obtained from our universitys Human Research Ethics Committee 18-541 The work has been reported in line with the STROCSS criteria
22 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
23Image 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 120 for post-processing and segmentation Using free 3D Slicer version 4101 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
24 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
25 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
26 Survey A multi-item survey was prepared to assess fellows 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
27 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
28 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
22 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
23Image 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 120 for post-processing and segmentation Using free 3D Slicer version 4101 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
24 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
25 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
26 Survey A multi-item survey was prepared to assess fellows 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
27 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
28 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None