[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545275":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":28,"studyPopulation":20,"armGroups":29,"interventions":42,"overallOfficials":20,"centralContacts":51,"locations":20,"responsibleParty":60,"collaborators":20,"id":62,"slug":20,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":20,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":20,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":84,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":20},{"fullName":5,"class":6},"Université Paris-Sud","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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).",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":6,"observationalModel":20,"timePerspective":20,"maskingInfo":24},"RANDOMIZED","PARALLEL",{"masking":25,"maskingDescription":20,"whoMasked":26},"SINGLE",[27],"PARTICIPANT","Detailed Study Protocol\n\nPrimary Study - Validation of 3D Interactive Model for Teaching AO Spine Classification for Thoracic and Lumbar Spine Fractures\n\nIntroduction:\n\nThoracic 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.\n\nObjectives:\n\nThis 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.\n\nMethods:\n\nThis prospective randomized validation study will start in May 2024.\n\n* 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.\n* Participant Selection: Sixty orthopedic residents nationwide will be recruited. Sample size determination considered resource availability and study duration.\n* 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).\n* Statistical Analysis: Data analysis will utilize Stata version 16.0. Descriptive statistics and comparative analyses will be employed, considering a significance level of p \\\u003C 0.05.\n* 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.\n\nTwo additional studies will be conducted as follows, with the same protocol :\n\n1. 3D screen-based simulator of a complete Transforaminal Interbody Lumbar Fusion (TLIF) surgical procedure\n2. Comparison between Virtual Reality and Screen-based simulators for Transforaminal Interbody Lumbar Fusion (TLIF) surgical procedure.",[30,36],{"label":31,"type":32,"description":33,"interventionNames":34},"3D model group","EXPERIMENTAL","Residents having access to the 3D model",[35],"Other: Education through a 3D model",{"label":37,"type":38,"description":39,"interventionNames":40},"Traditional teaching group","ACTIVE_COMPARATOR","Residents having access to traditional educational support",[41],"Other: Education through a traditional pedagogical support",[43,47],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":20},"Education through a 3D model","Training through a 3D model of the spine fractures",[31],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":20},"Education through a traditional pedagogical support","Training through a traditional pedagogical support",[37],[52,57],{"name":53,"role":54,"phone":55,"phoneExt":20,"email":56},"Léonard CHATELAIN, MD","CONTACT","+33646288048","leonard.chatelain@gmail.com",{"name":58,"role":54,"phone":20,"phoneExt":20,"email":59},"Antonia BLANIE, MD","antonia.blanie@aphp.fr",{"type":61,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100545275",false,"NCT06379776","3D Model - Classification of Thoracic and Lumbar Spinal Fractures.","Classification of Thoracic and Lumbar Spinal Fractures. Development of an Interactive 3D Model for Pedagogy.","Inclusion Criteria:\n\n* Residents entering residency in Orthopaedic Surgery for the first study on AO Spine classification of thoracolumbar fractures\n* Any resident in Orthopaedic Surgery (from 1st year to 6th year) for the second and third study on TLIF surgical simulation\n* Written informed consent\n\nExclusion Criteria:\n\n* Any prior experience in spine surgery for the 1st year residents for the first study",true,"ALL","18 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"NA","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.\n\nThe main questions this study aims to answer are:\n\nDoes 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?\n\nParticipants will be randomly assigned to either:\n\nGroup 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.\n\nGroup B: Traditional teaching materials including slides, texts, and diagrams illustrating spine fractures according to the AO Spine classification.\n\nResearchers 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.\n\nParticipants 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.\n\nThe 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.",[79],"Lumbar Spine Disease",[81,82,83],"simulation","surgery","3D model","NOT_YET_RECRUITING","2024-04-17",{"date":87,"type":88},"2024-04-23","ACTUAL",{"date":90,"type":73},"2024-05-25",{"date":92,"type":73},"2026-09-30",{"name":5,"class":6}]