Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06379776
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-01-16
Brief Title:
3D Model - Classification of Thoracic and Lumbar Spinal Fractures
Sponsor:
Université Paris-Sud
Organization:
Université Paris-Sud
Study Overview
Official Title:
Classification of Thoracic and Lumbar Spinal Fractures Development of an Interactive 3D Model for Pedagogy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
The goal of this clinical trial is to evaluate and compare the effectiveness of a 3D interactive model versus traditional teaching methods in enhancing the teaching of thoracic and lumbar spine fractures classification AO Spine among orthopedic residents
The main questions this study aims to answer are
Does the use of a 3D interactive model improve residents knowledge regarding the AO Spine classification of spine fractures compared to traditional teaching methods To what extent does the utilization of a 3D interactive model enhance understanding of spinal anatomy injury mechanisms pathophysiology and fracture diagnosis among surgical residents
Participants will be randomly assigned to either
Group A Access to the 3D interactive model depicting thoracic and lumbar spine fractures based on the AO Spine classification They can explore fractures access textual information and anatomical annotations
Group B Traditional teaching materials including slides texts and diagrams illustrating spine fractures according to the AO Spine classification
Researchers will compare the post-training knowledge and confidence levels in managing spine fractures between the two groups to assess the efficacy of the 3D model
Participants will be required to fill out pre- and post-training questionnaires assessing their knowledge experience with 3D educational tools confidence levels in managing spine fractures and satisfaction with the teaching method
The study aims to ascertain if the use of the 3D model significantly enhances residents comprehension of spine fractures compared to conventional teaching methods within the orthopedic curriculum
The main questions this study aims to answer are
Does the use of a 3D interactive model improve residents knowledge regarding the AO Spine classification of spine fractures compared to traditional teaching methods To what extent does the utilization of a 3D interactive model enhance understanding of spinal anatomy injury mechanisms pathophysiology and fracture diagnosis among surgical residents
Participants will be randomly assigned to either
Group A Access to the 3D interactive model depicting thoracic and lumbar spine fractures based on the AO Spine classification They can explore fractures access textual information and anatomical annotations
Group B Traditional teaching materials including slides texts and diagrams illustrating spine fractures according to the AO Spine classification
Researchers will compare the post-training knowledge and confidence levels in managing spine fractures between the two groups to assess the efficacy of the 3D model
Participants will be required to fill out pre- and post-training questionnaires assessing their knowledge experience with 3D educational tools confidence levels in managing spine fractures and satisfaction with the teaching method
The study aims to ascertain if the use of the 3D model significantly enhances residents comprehension of spine fractures compared to conventional teaching methods within the orthopedic curriculum
Detailed Description:
Detailed Study Protocol
Primary Study - Validation of 3D Interactive Model for Teaching AO Spine Classification for Thoracic and Lumbar Spine Fractures
Introduction
Thoracic and lumbar spinal fractures are common in orthopedic and trauma surgery Despite various classifications available such as the AO Spine classification understanding these fractures especially for novice residents can be challenging In response a 3D interactive model has been developed to support the classification teaching A preliminary validation study with expert surgeons has been conducted
Objectives
This study aims to validate the effectiveness of a 3D model in teaching thoracic and lumbar spine fractures compared to traditional teaching methods The primary objective is to assess whether the use of the 3D model improves residents knowledge regarding AO Spine classification anatomy injury mechanisms pathophysiology and diagnosis of spine fractures
Methods
This prospective randomized validation study will start in May 2024
3D Model Design and Validation The pedagogical 3D model was created using Blender software Validation in terms of anatomical realism and adherence to AO Spine classification was performed through a pilot study involving 24 expert spine surgeons
Participant Selection Sixty orthopedic residents nationwide will be recruited Sample size determination considered resource availability and study duration
Study Protocol Data collection will involve questionnaires assessing pre-training knowledge experience with 3D tools confidence levels in managing spine fractures and post-training assessments Residents will be randomized into two groups 3D model group Group A and traditional teaching group Group B
Statistical Analysis Data analysis will utilize Stata version 160 Descriptive statistics and comparative analyses will be employed considering a significance level of p 005
Ethics Informed consent will be obtained Data will be anonymized stored securely Data handling will comply with privacy regulations At the end of the study all interns will access both teaching supports
Two additional studies will be conducted as follows with the same protocol
1 3D screen-based simulator of a complete Transforaminal Interbody Lumbar Fusion TLIF surgical procedure
2 Comparison between Virtual Reality and Screen-based simulators for Transforaminal Interbody Lumbar Fusion TLIF surgical procedure
Primary Study - Validation of 3D Interactive Model for Teaching AO Spine Classification for Thoracic and Lumbar Spine Fractures
Introduction
Thoracic and lumbar spinal fractures are common in orthopedic and trauma surgery Despite various classifications available such as the AO Spine classification understanding these fractures especially for novice residents can be challenging In response a 3D interactive model has been developed to support the classification teaching A preliminary validation study with expert surgeons has been conducted
Objectives
This study aims to validate the effectiveness of a 3D model in teaching thoracic and lumbar spine fractures compared to traditional teaching methods The primary objective is to assess whether the use of the 3D model improves residents knowledge regarding AO Spine classification anatomy injury mechanisms pathophysiology and diagnosis of spine fractures
Methods
This prospective randomized validation study will start in May 2024
3D Model Design and Validation The pedagogical 3D model was created using Blender software Validation in terms of anatomical realism and adherence to AO Spine classification was performed through a pilot study involving 24 expert spine surgeons
Participant Selection Sixty orthopedic residents nationwide will be recruited Sample size determination considered resource availability and study duration
Study Protocol Data collection will involve questionnaires assessing pre-training knowledge experience with 3D tools confidence levels in managing spine fractures and post-training assessments Residents will be randomized into two groups 3D model group Group A and traditional teaching group Group B
Statistical Analysis Data analysis will utilize Stata version 160 Descriptive statistics and comparative analyses will be employed considering a significance level of p 005
Ethics Informed consent will be obtained Data will be anonymized stored securely Data handling will comply with privacy regulations At the end of the study all interns will access both teaching supports
Two additional studies will be conducted as follows with the same protocol
1 3D screen-based simulator of a complete Transforaminal Interbody Lumbar Fusion TLIF surgical procedure
2 Comparison between Virtual Reality and Screen-based simulators for Transforaminal Interbody Lumbar Fusion TLIF surgical procedure
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