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

NCT06379776 | Not Yet Recruiting

• 1 other identifier: LabForSIMS-LC1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lumbar Spine Disease

Keywords

simulation; surgery; 3D model

Outcome Measures

Primary Outcomes (1)

• Specific Questionnaire

  The primary outcome measure will be the final score on the post-test questionnaire assessing the student's knowledge. Each of the three studies will have specific questionnaire.

  Immediately after the intervention

Secondary Outcomes (2)

• Objective Structured Assessment of Technical Skills (OSATS)

  Immediately after the intervention

• Subjective questionnaire

  Immediately after the intervention

Study Arms (2)

3D model group

EXPERIMENTAL

Residents having access to the 3D model

Other: Education through a 3D model

Traditional teaching group

ACTIVE COMPARATOR

Residents having access to traditional educational support

Other: Education through a traditional pedagogical support

Interventions

Education through a 3D model OTHER

Training through a 3D model of the spine fractures

3D model group

Education through a traditional pedagogical support OTHER

Training through a traditional pedagogical support

Traditional teaching group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Université Paris-Sud: lead

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Léonard CHATELAIN, MD

CONTACT

+33646288048; leonard.chatelain@gmail.com

Antonia BLANIE, MD

CONTACT

antonia.blanie@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: April 23, 2024
• Study Start: May 25, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP