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Mixed Reality vs. Traditional Arthroscopic Simulation

2026年6月10日 更新者：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).

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

25

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 葡萄牙
      • Porto、葡萄牙
        • Experimental Surgery Unit, ICBAS - School of Medicine and Biomedical Sciences, University of Porto

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：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.
其他：Traditional Simulator Training
Execution of a three-session psychomotor training protocol utilizing a physical bench-model simulator with an external video monitor for visual guidance.
实验性的：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.
其他：Mixed Reality Simulator Training
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Psychomotor Skill Performance Assessed by the ASSET Scale
大体时间：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.
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.
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.

次要结果测量

结果测量
措施说明
大体时间
Perceived Workload Assessed by the SURG-TLX Scale
大体时间：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)
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.
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)
Perceived Workload Assessed by the NASA-TLX Scale
大体时间：After the conclusion of the last session of phase 2, within a maximum period of 1 week.
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.
After the conclusion of the last session of phase 2, within a maximum period of 1 week.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Universidade da Coruña

合作者

Universidade do Porto
Polytechnic Institute of Porto

调查人员

  • 研究主任：Javier P Loureiro, PhD、Universidade da Coruña
  • 研究主任：Antonio J Marques, PhD、Polytechnic Institute of Porto
  • 首席研究员：Renato F Magalhaes, MSc、Universidade da Coruña / Polytechnic Institute of Porto

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年10月20日

初级完成 (估计的)

2026年6月1日

研究完成 (估计的)

2026年6月1日

研究注册日期

首次提交

2026年6月5日

首先提交符合 QC 标准的

2026年6月10日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年6月15日

上次提交的符合 QC 标准的更新

2026年6月10日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • MR-ARTHRO-2025-01
  • 2025/CE/P13 (其他标识符：Comissao de Etica ICBAS)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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