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Active, Not Recruiting

NCT Number: NCT07648056

Mixed Reality vs. Traditional Arthroscopic Simulation

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Surgical Education Clinical Competence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Experimental Surgery Unit, ICBAS - School of Medicine and Biomedical Sciences, University of Porto

Porto, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional Simulator Training

Other

Execution of a three-session psychomotor training protocol utilizing a physical bench-model simulator with an external video monitor for visual guidance.

Mixed Reality Simulator Training

Other

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.

Primary outcomes

  1. Psychomotor Skill Performance Assessed by the ASSET Scale

    Time frame: 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.

Secondary outcomes

  1. Perceived Workload Assessed by the SURG-TLX Scale

    Time frame: 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.

  2. Perceived Workload Assessed by the NASA-TLX Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidade da Coruña

Other

Collaborators

  • Polytechnic Institute of Porto
  • Universidade do Porto

Registry information

Official study title

Comparative Effectiveness of Mixed Reality Versus Traditional Simulation in Arthroscopic Surgical Training: A Parallel-Group Randomized Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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