Mixed Reality vs. Traditional Arthroscopic Simulation
10 juni 2026 bijgewerkt door: 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).
Studie Overzicht
Toestand
Actief, niet wervend
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Geschat)
25
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Porto, Portugal
- Experimental Surgery Unit, ICBAS - School of Medicine and Biomedical Sciences, University of Porto
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Psychomotor Skill Performance Assessed by the ASSET Scale
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Perceived Workload Assessed by the SURG-TLX Scale
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Javier P Loureiro, PhD, Universidade da Coruña
- Studie directeur: Antonio J Marques, PhD, Polytechnic Institute of Porto
- Hoofdonderzoeker: Renato F Magalhaes, MSc, Universidade da Coruña / Polytechnic Institute of Porto
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
20 oktober 2025
Primaire voltooiing (Geschat)
1 juni 2026
Studie voltooiing (Geschat)
1 juni 2026
Studieregistratiedata
Eerst ingediend
5 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
10 juni 2026
Eerst geplaatst (Werkelijk)
15 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
15 juni 2026
Laatste update ingediend die voldeed aan QC-criteria
10 juni 2026
Laatst geverifieerd
1 juni 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- MR-ARTHRO-2025-01
- 2025/CE/P13 (Andere identificatie: Comissao de Etica ICBAS)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
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.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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