Surgical EducationNCT07648056
Mixed Reality vs. Traditional Arthroscopic Simulation
A study testing Traditional Simulator Training and Mixed Reality Simulator Training in people with Surgical Education and Clinical Competence, run by Universidade da Coruña at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Education, Clinical Competence
- What is being tested?
- Traditional Simulator Training and Mixed Reality Simulator Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Oct 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Experimental Surgery Unit, ICBAS - School of Medicine and Biomedical Sciences, University of Porto
Porto
About this study
Official title: 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).
Read the detailed description
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.
- Conditions
- Surgical Education, Clinical Competence
- Being tested
- Traditional Simulator Training, Mixed Reality Simulator Training
- Keywords
- Mixed Reality, Arthroscopy, Surgical Simulation, Psychomotor Skills, Medical Education, Knee Joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Simulator TrainingOther
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 TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Mixed Reality Simulator Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: After the conclusion of the last session of phase 2, within a maximum period of 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start20 Oct 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surgical EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Collaborators
- Polytechnic Institute of Porto, Universidade do Porto
- Responsible party
- Principal investigator, Javier Pereira, Universidade da Coruña
- Investigators
- Javier P Loureiro, PhD, Study director, Universidade da CoruñaAntonio J Marques, PhD, Study director, Polytechnic Institute of PortoRenato F Magalhaes, MSc, Principal investigator, Universidade da Coruña / Polytechnic Institute of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648056
- Sponsor's protocol ID
- MR-ARTHRO-2025-01
- Other IDs
- 2025/CE/P13
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 40627855Magalhaes 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.
PubMed 39145896
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Mixed Reality Versus Traditional Simulation in Arthroscopic Surgical Training: A Parallel-Group Randomized Trial
- ClinicalTrials.gov ID
- NCT07648056
- Acronym / sponsor ID
- MR-ARTHRO-2025-01
- Conditions
- Surgical Education, Clinical Competence
- Keywords
- Mixed Reality, Arthroscopy, Surgical Simulation, Psychomotor Skills, Medical Education, Knee Joint
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Collaborators
- Polytechnic Institute of Porto, Universidade do Porto
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Traditional Simulator Group (TSG) | Active comparator | Other: Traditional Simulator TrainingParticipants 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. |
| Mixed Reality Simulator Group (MRSG) | Experimental | Other: Mixed Reality Simulator TrainingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Simulator TrainingExecution of a three-session psychomotor training protocol utilizing a physical bench-model simulator with an external video monitor for visual guidance. | Other | Traditional Simulator Group (TSG) |
| Mixed Reality Simulator TrainingExecution of a three-session psychomotor training protocol utilizing an immersive Mixed Reality simulator that provides holographic images and a virtual monitor for visual guidance. | Other | Mixed Reality Simulator Group (MRSG) |
Primary outcome
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.
2 secondary outcomes
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 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 40627855Magalhaes 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.
- Background: PubMed 39145896Magalhaes 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier P Loureiro, PhD study director
Universidade da Coruña
Antonio J Marques, PhD study director
Polytechnic Institute of Porto
Renato F Magalhaes, MSc principal investigator
Universidade da Coruña / Polytechnic Institute of Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Simulator Training and Mixed Reality Simulator Training in people with Surgical Education and Clinical Competence, run by Universidade da Coruña at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07648056, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.