Lumbar Spine DiseaseNCT06379776
3D Model - Classification of Thoracic and Lumbar Spinal Fractures.
A study testing Education through a 3D model and Education through a traditional pedagogical support in people with Lumbar Spine Disease, run by Université Paris-Sud.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spine Disease
- What is being tested?
- Education through a 3D model and Education through a traditional pedagogical support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 May 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Any prior experience in spine surgery for the 1st year residents for the first study
Trial locations and contacts
No sites are listed yet.
Antonia BLANIE, MD contact
About this study
Official title: Classification of Thoracic and Lumbar Spinal Fractures. Development of an Interactive 3D Model for Pedagogy.
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:
Read more
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.
Read the 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 :
- 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.
- Conditions
- Lumbar Spine Disease
- Being tested
- Education through a 3D model, Education through a traditional pedagogical support
- Keywords
- simulation, surgery, 3D model
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education through a 3D modelOther
Training through a 3D model of the spine fractures
Education through a traditional pedagogical supportOther
Training through a traditional pedagogical support
| Study group | Role | What they receive |
|---|---|---|
| 3D model group | Experimental | Residents having access to the 3D model Receives: Other: Education through a 3D model |
| Traditional teaching group | Active comparator | Residents having access to traditional educational support Receives: Other: Education through a traditional pedagogical support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after the intervention
Secondary outcomes (2)
Objective Structured Assessment of Technical Skills (OSATS)
Assessment questionnaire of the students technical skills during the validation phase on sawbones. OSATS scale ranges from 7 to 35 points: the higher the score, the better the technical surgical skills.
Measured: Immediately after the intervention
Subjective questionnaire
Final score on a subjective questionnaire evaluating ease of use, immersion and satisfaction with the simulator. Each item ranges from 1 to 10, 10 being the best score (easiest use of the simulator, best immersion, best satisfaction).
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start25 May 2024 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Paris-Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379776
- Sponsor's protocol ID
- LabForSIMS-LC1
- Status last verified
- Apr 2024
- First submitted
- 16 Jan 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD can be made available on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification of Thoracic and Lumbar Spinal Fractures. Development of an Interactive 3D Model for Pedagogy.
- ClinicalTrials.gov ID
- NCT06379776
- Acronym / sponsor ID
- LabForSIMS-LC1
- Conditions
- Lumbar Spine Disease
- Keywords
- simulation, surgery, 3D model
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Université Paris-SudUniversity, hospital or other
- Study start
- 25 May 2024 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D model group | Experimental | Other: Education through a 3D modelResidents having access to the 3D model |
| Traditional teaching group | Active comparator | Other: Education through a traditional pedagogical supportResidents having access to traditional educational support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Any prior experience in spine surgery for the 1st year residents for the first study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education through a 3D modelTraining through a 3D model of the spine fractures | Other | 3D model group |
| Education through a traditional pedagogical supportTraining through a traditional pedagogical support | Other | Traditional teaching group |
Primary outcome
Specific Questionnaire
Time frame: Immediately after the intervention
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.
2 secondary outcomes
Objective Structured Assessment of Technical Skills (OSATS)
Time frame: Immediately after the intervention
Subjective questionnaire
Time frame: Immediately after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: Yes. IPD can be made available on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia BLANIE, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing Education through a 3D model and Education through a traditional pedagogical support in people with Lumbar Spine Disease, run by Université Paris-Sud.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Léonard CHATELAIN, MD (+33646288048, leonard.chatelain@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific Questionnaire (time frame: Immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.