3D Model - Classification of Thoracic and Lumbar Spinal Fractures.

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 16.0. Descriptive statistics and comparative analyses will be employed, considering a significance level of p < 0.05.
• 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 :

• 3D screen-based simulator of a complete Transforaminal Interbody Lumbar Fusion (TLIF) surgical procedure
• Comparison between Virtual Reality and Screen-based simulators for Transforaminal Interbody Lumbar Fusion (TLIF) surgical procedure.

Inclusion criteria

• Residents entering residency in Orthopaedic Surgery for the first study on AO Spine classification of thoracolumbar fractures
• Any resident in Orthopaedic Surgery (from 1st year to 6th year) for the second and third study on TLIF surgical simulation
• Written informed consent

Exclusion criteria

• Any prior experience in spine surgery for the 1st year residents for the first study