Mixed Reality vs. Traditional Arthroscopic Simulation
10 juin 2026 mis à jour par: Javier Pereira, Universidade da Coruña
Comparative Effectiveness of Mixed Reality Versus Traditional Simulation in Arthroscopic Surgical Training: A Parallel-Group Randomized Trial
This randomized controlled trial evaluates and compares the educational effectiveness of two arthroscopic training platforms: a traditional physical bench-model simulator and an immersive Mixed Reality (MR) simulator.
Medical students and residents undergo a baseline assessment on a physical knee simulator and are then randomized into either the Traditional Simulator Group (TSG) or the Mixed Reality Simulator Group (MRSG).
Participants complete a three-session training protocol focusing on basic psychomotor skills.
Trainees are then evaluated on an anatomical knee task to measure true clinical skill transfer.
Performance is video-recorded and scored by independent, blinded physicians using the validated Arthroscopic Surgical Skill Evaluation Tool (ASSET).
Aperçu de l'étude
Statut
Actif, ne recrute pas
Les conditions
Intervention / Traitement
Description détaillée
This parallel-group randomized controlled trial aims to evaluate the educational efficacy of Mixed Reality in surgical education. Medical students and residents undergo a baseline assessment on a physical anatomical knee simulator to establish initial skill levels. Following this, participants are randomized into either the Traditional Simulator Group (TSG) or the Mixed Reality Simulator Group (MRSG).
The intervention consists of a three-session training protocol focusing on basic psychomotor skills (specifically horizontal and spatial triangulation) isolated from anatomical clutter. To evaluate true clinical skill transfer, trainees are then tested on an identical anatomical knee task. All performance sessions are video-recorded and subsequently scored by independent, blinded physicians using the validated Arthroscopic Surgical Skill Evaluation Tool (ASSET) to ensure objective outcome measurement.
Type d'étude
Interventionnel
Inscription (Estimé)
25
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Porto, Le Portugal
- Experimental Surgery Unit, ICBAS - School of Medicine and Biomedical Sciences, University of Porto
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Oui
La description
Inclusion Criteria:
- Participants aged 18 years or older.
- Medical students or junior orthopedic surgery trainees.
- Novices in arthroscopic procedures (no prior practical experience in arthroscopy).
- Voluntary agreement to participate and sign the informed consent form.
Exclusion Criteria:
- Any visual, cognitive, or physical impairment that prevents the proper execution of the simulated psychomotor tasks or the use of the MR glasses.
- Inability to attend all three scheduled training sessions.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Traditional Simulator Group (TSG)
Participants train using a traditional physical bench-model simulator.
The system features an enclosed chamber occluded from direct line-of-sight, forcing trainees to rely exclusively on an external video monitor for visual guidance.
The training consists of three individual sessions (maximum 10 minutes each) performing horizontal coordination and spatial triangulation tasks using physical tools.
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Execution of a three-session psychomotor training protocol utilizing a physical bench-model simulator with an external video monitor for visual guidance.
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Expérimental: Mixed Reality Simulator Group (MRSG)
Participants train using an immersive Mixed Reality (MR) simulator.
The system uses MR glasses to view holographic images inside the enclosure and provides instructional visual guidance via a virtual monitor, replacing the traditional external video monitor.
The training consists of three individual sessions (maximum 10 minutes each) performing horizontal coordination and spatial triangulation tasks using physical tools.
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Execution of a three-session psychomotor training protocol utilizing an immersive Mixed Reality simulator that provides holographic images and a virtual monitor for visual guidance.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Psychomotor Skill Performance Assessed by the ASSET Scale
Délai: Time Frame: Baseline (before intervention; assessment conducted after Phase 1, within up to 2 weeks) and immediately after completion of the intervention (assessment conducted after Phase 3, within up to 2 weeks.
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Psychomotor performance is evaluated using a modified Arthroscopic Surgical Skill Evaluation Tool (ASSET).
The total score ranges from 8 to 38, with higher scores indicating better surgical skill and performance.
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Time Frame: Baseline (before intervention; assessment conducted after Phase 1, within up to 2 weeks) and immediately after completion of the intervention (assessment conducted after Phase 3, within up to 2 weeks.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Perceived Workload Assessed by the SURG-TLX Scale
Délai: Time Frame: Baseline (before intervention; completed immediately after Phase 1 on the same day) and immediately after completion of the intervention (completed immediately after Phase 3 on the same day)
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Perceived cognitive and physical workload during the evaluation tasks is measured using an adapted Surgery Task Load Index (SURG-TLX).
The questionnaire evaluates six dimensions: mental demands, physical demands, temporal demands, task complexity, situational stress, and distractions using a 5-point Likert scale.
The total score ranges from 6 to 30, with higher scores indicating a higher perceived workload.
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Time Frame: Baseline (before intervention; completed immediately after Phase 1 on the same day) and immediately after completion of the intervention (completed immediately after Phase 3 on the same day)
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Perceived Workload Assessed by the NASA-TLX Scale
Délai: After the conclusion of the last session of phase 2, within a maximum period of 1 week.
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Perceived workload during the Phase 2 tasks is measured using an adapted NASA Task Load Index (NASA-TLX).
The questionnaire assesses six dimensions: mental demand, physical demand, temporal demand, performance, effort, and frustration.
Each item is rated on a 5-point Likert scale.
The total score ranges from 6 to 30, with higher scores indicating greater perceived workload.
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After the conclusion of the last session of phase 2, within a maximum period of 1 week.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Javier P Loureiro, PhD, Universidade da Coruña
- Directeur d'études: Antonio J Marques, PhD, Polytechnic Institute of Porto
- Chercheur principal: Renato F Magalhaes, MSc, Universidade da Coruña / Polytechnic Institute of Porto
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Magalhaes R, Oliveira A, Terroso D, Vilaca A, Veloso R, Marques A, Pereira J, Coelho L. Mixed Reality in the Operating Room: A Systematic Review. J Med Syst. 2024 Aug 15;48(1):76. doi: 10.1007/s10916-024-02095-7.
- Magalhaes R, Lima AC, Marques A, Pereira J, Santos LL. Usefulness of Mixed Reality in Surgical Treatment: Delphi Study. J Med Internet Res. 2025 Jul 8;27:e69964. doi: 10.2196/69964.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
20 octobre 2025
Achèvement primaire (Estimé)
1 juin 2026
Achèvement de l'étude (Estimé)
1 juin 2026
Dates d'inscription aux études
Première soumission
5 juin 2026
Première soumission répondant aux critères de contrôle qualité
10 juin 2026
Première publication (Réel)
15 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- MR-ARTHRO-2025-01
- 2025/CE/P13 (Autre identifiant: Comissao de Etica ICBAS)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Individual participant data will not be shared publicly to ensure the privacy and confidentiality of the participants, in accordance with the informed consent signed for this study and General Data Protection Regulation (GDPR) guidelines.
Aggregate data and statistical results will be made available through publication.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .