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

NCT ID: NCT06379776

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-25
• Study Completion Date: 2026-09-30

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.

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 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 :

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.

Conditions

Lumbar Spine Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

3D model group

Residents having access to the 3D model

Group Type: EXPERIMENTAL

Education through a 3D model

Intervention Type: OTHER

Training through a 3D model of the spine fractures

Traditional teaching group

Residents having access to traditional educational support

Group Type: ACTIVE_COMPARATOR

Education through a traditional pedagogical support

Intervention Type: OTHER

Training through a traditional pedagogical support

Interventions

Education through a 3D model

Training through a 3D model of the spine fractures

Intervention Type: OTHER

Education through a traditional pedagogical support

Training through a traditional pedagogical support

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Paris-Sud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Léonard CHATELAIN, MD

Role: CONTACT

leonard.chatelain@gmail.com

+33646288048

Antonia BLANIE, MD

Role: CONTACT

antonia.blanie@aphp.fr

Other Identifiers

LabForSIMS-LC1

Identifier Type: -

Identifier Source: org_study_id