Mixed Reality vs. Traditional Arthroscopic Simulation

NCT07648056 | Active Not Recruiting

• 2 other identifiers: MR-ARTHRO-2025-012025/CE/P13
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Surgical Education; Clinical Competence

Keywords

Mixed Reality; Arthroscopy; Surgical Simulation; Psychomotor Skills; Medical Education; Knee Joint

Outcome Measures

Primary Outcomes (1)

• Psychomotor Skill Performance Assessed by the ASSET Scale

  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.

Secondary Outcomes (2)

• Perceived Workload Assessed by the SURG-TLX Scale

  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

  After the conclusion of the last session of phase 2, within a maximum period of 1 week.

Study Arms (2)

Traditional Simulator Group (TSG)

ACTIVE COMPARATOR

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.

Other: Traditional Simulator Training

Mixed Reality Simulator Group (MRSG)

EXPERIMENTAL

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.

Other: Mixed Reality Simulator Training

Interventions

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.

Traditional Simulator Group (TSG)

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.

Mixed Reality Simulator Group (MRSG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade da Coruña: lead
• Polytechnic Institute of Porto: collaborator
• Universidade do Porto: collaborator

Study Sites (1)

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

Porto, Portugal

Location

Related Publications (2)

• 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.

  PMID: 40627855 BACKGROUND

• 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.

  PMID: 39145896 BACKGROUND

Study Officials

• Javier P Loureiro, PhD

  Universidade da Coruña

  STUDY DIRECTOR

• Antonio J Marques, PhD

  Polytechnic Institute of Porto

  STUDY DIRECTOR

• Renato F Magalhaes, MSc

  Universidade da Coruña / Polytechnic Institute of Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding is applied to the evaluation phases. Surgical performance videos from Phase 1 (Baseline) and Phase 3 (Post-Intervention Evaluation) are recorded and anonymized to conceal the participants' identity and group allocation. The independent expert physicians (Outcomes Assessors) score these videos using the ASSET scale without knowing whether the participant underwent traditional training or Mixed Reality training.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor, Faculty of Health Sciences

Model Details: Participants are randomly assigned to one of two parallel training arms: a Control Group utilizing a traditional physical bench-model simulator, and an Experimental Group utilizing an immersive Mixed Reality (MR) simulator.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 15, 2026
• Study Start: October 20, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)