Surgical EducationVR-ORSNCT05830786
Virtual Reality in Orthopaedic Surgical Education: A Randomized Controlled Trial
A study testing Immersive virtual reality (IVR) and Traditional hands on orthopaedic workshop group in people with Surgical Education and Virtual Reality, run by University of Toronto.
Trial summary
Immersive virtual reality (IVR) surgical simulators are increasingly being used for learner education. The aim of this randomized controlled trial is to compare the efficacy of IVR to hands-on orthopaedic workshop sessions (such as arthroscopy simulators, cadaveric models, and Sawbones®) in various orthopaedic… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgical Education, Virtual Reality, Orthopaedic Training
- What is being tested?
- Immersive virtual reality (IVR) and Traditional hands on orthopaedic workshop group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 16 May 2023to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being a University of Toronto medical student.
- Being a University of Toronto orthopaedic surgery resident.
Who cannot join
- Previous graduation from an orthopaedic surgery residency in Canada or abroad.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Virtual Reality in Orthopaedic Surgical Education: A Multistage Randomized Controlled Trial
Immersive virtual reality (IVR) surgical simulators are increasingly being used for learner education. The aim of this randomized controlled trial is to compare the efficacy of IVR to hands-on orthopaedic workshop sessions (such as arthroscopy simulators, cadaveric models, and Sawbones®) in various orthopaedic subspecialties (such as sports, arthroplasty, and spine surgery).
Overall, in this multi-stage comprehensive randomized controlled the aim is to assess:
- If IVR simulation using head-mounted displays (HMD) is superior to the current standard of training for orthopaedic surgery residents and medical students.
- Determine if it is feasible to incorporate immersive headset virtual reality simulation into residency training programs and medical school curriculums.
- Assess the longitudinal application of IVR training on medical student and resident surgical education.
Read the detailed description
Study Stages:
Stage 1 - Medical students and orthopaedic residents participating in the Canadian Orthopaedic Surgery Medical Education Course 2023 (COSMEC) will be selected and computer randomized (1:1) into two groups of experimental (IVR) and control (arthroscopy simulator box), based on level of training. Allocation concealment will be ensured using central randomization. Trainees in both groups will receive a common didactic training for knee arthroscopy. Subsequently, trainees in the experimental group will undergo a IVR surgical training module and trainees in the control group will undergo a similar module using arthroscopy simulator box. Following the training modules, participants will complete knowledge tests, technical skill assessments on knee arthroscopy simulators, and experiential surveys.
Stage 2 - Medical students and orthopaedic residents participating in the 2023 University of Toronto Orthopaedic Surgery bootcamp will be selected and computer randomized (1:1) into two groups of experimental (IVR) and control (sawbones), based on level of training. Allocation concealment will be ensured using central randomization. Trainees in both groups will receive a common didactic training for femoral intramedullary nail (IMN) placement. Subsequently, trainees in the experimental group will undergo a IVR surgical training module and trainees in the control group will undergo a similar module using Sawbones ®. Following the training modules, participants will complete knowledge tests, technical skill assessments on cadaveric models, and experiential surveys.
Stage 3 - The protocol explained in stage 1 and 2 may be repeated for various orthopaedic sub-speciality (including arthroplasty and spine surgery) for the participants in the booth camp.
Stage 4 - All trainees may then be followed longitudinally over the course 6 months. Trainees' performance may be evaluated for procedures in which training was provided, based on preceptor evaluations (for example by completing standardised evaluation forms) on a voluntary basis.
- Conditions
- Surgical Education, Virtual Reality, Orthopaedic Training
- Being tested
- Immersive virtual reality (IVR), Traditional hands on orthopaedic workshop group
- Keywords
- Virtual Reality, Orthopaedic Training, Surgical Education, Head mounted display
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive virtual reality (IVR)Device
Also called head mounted display, virtual reality
Using Oculus Quest 2 (Reality Labs, Meta Platforms, United States) headsets the PrecisionOS platform version 3.0 (PrecisionOS Technology, Canada) virtual reality surgical modules will be utilized.
Traditional hands on orthopaedic workshop groupOther
Hands-on orthopaedic workshop sessions (including arthroscopy simulators, cadaveric models, and Sawbones®) in differing orthopaedic subspecialties (including sports, arthroplasty, and spine surgery).
| Study group | Role | What they receive |
|---|---|---|
| Immersive virtual reality (IVR) group | Experimental | The experimental group will experience various surgical training modules using immersive virtual reality. Receives: Device: Immersive virtual reality (IVR) |
| Traditional hands on orthopaedic workshop group | Active comparator | Hands-on orthopaedic workshop sessions (including arthroscopy simulators, cadaveric models, and Sawbones®) in differing orthopaedic subspecialties (including sports, arthroplasty, and spine surgery). Receives: Other: Traditional hands on orthopaedic workshop group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Structured Assessment of Technical Skills (OSATS)
The primary outcome of the study is to assess trainee procedural performance using simulators or cadaveric models between the experimental (IVR) and control groups, measured by Objective Structured Assessment of Technical Skill (OSATS) score.
Measured: 2 weeks after the training sessions, over 30 minutes testing period
Secondary outcomes (4)
Global Ratings Scale (GRS)
GRS will be used as a secondary outcome measure to evaluate the performance of the surgical trainees who will be participating in the study. The GRS scores will be recorded by expert evaluators who will observe the trainees performing the surgical procedure. The scores will be analyzed to assess the effect of the intervention on the overall performance of the trainees.
Measured: 2 weeks after the training sessions, over 30 minutes testing period
Hand and body motion analysis using sensors
Motion analysis is used to evaluate the effectiveness of the training intervention and can help identify areas for improvement in surgical technique. By incorporating this objective measure, we can gain a more comprehensive understanding of the impact of the training interventions on surgical performance.
Measured: 2 weeks after the training sessions, over 30 minutes testing period
Experimental and confidence questionnaire
Experimental and confidence questionnaire will be used to assess the participants' confidence level and perception of their own skills in performing the simulated laparoscopic task. This questionnaire will include questions regarding their comfort level with the equipment, confidence in their ability to complete the task accurately and efficiently, and their overall perception of their own skill level. The questionnaire will be administered after each simulation session and will be used to assess any changes in the participants' confidence and perception of their own abilities throughout the study. The results of this questionnaire will provide valuable insight into the participants' perceived skill level, and may be used to inform future training programs or interventions aimed at improving surgical skills.
Measured: 2 weeks after the training sessions, over 30 minutes testing period
Time to complete the procedure
This secondary outcome will measure the total time required to complete the procedure, from the start of the procedure to the end. The time will be recorded in minutes using a stopwatch, and any breaks or interruptions during the procedure will be noted.
Measured: 2 weeks after the training sessions, over 30 minutes testing period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start16 May 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Koucheki, University of Toronto
- Investigators
- Jesse Wolfstadt, MD, Principal investigator, University of TorontoPeter Ferguson, MD, Principal investigator, University of TorontoJohnathan R Lex, MB ChB, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830786
- Sponsor's protocol ID
- 44020
- Acronym
- VR-ORS
- Status last verified
- Apr 2023
- First submitted
- 5 Mar 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not going to be shared with other researchers. All participants' information will be de-identified. Participants are identified in research records only with a unique study identification number that is linked in a master code-breaking enrollment log. Aggregate data will be analyzed.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality in Orthopaedic Surgical Education: A Multistage Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05830786
- Acronym / sponsor ID
- VR-ORS / 44020
- Conditions
- Surgical Education, Virtual Reality, Orthopaedic Training
- Keywords
- Virtual Reality, Orthopaedic Training, Surgical Education, Head mounted display
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 16 May 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 26 Apr 2023 (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.
Immersive virtual reality (IVR) surgical simulators are increasingly being used for learner education. The aim of this randomized controlled trial is to compare the efficacy of IVR to hands-on orthopaedic workshop sessions (such as arthroscopy simulators, cadaveric models, and Sawbones®) in various orthopaedic subspecialties (such as sports, arthroplasty, and spine surgery).
Overall, in this multi-stage comprehensive randomized controlled the aim is to assess:
- If IVR simulation using head-mounted displays (HMD) is superior to the current standard of training for orthopaedic surgery residents and medical students.
- Determine if it is feasible to incorporate immersive headset virtual reality simulation into residency training programs and medical school curriculums.
- Assess the longitudinal application of IVR training on medical student and resident surgical education.
Detailed description
Study Stages:
Stage 1 - Medical students and orthopaedic residents participating in the Canadian Orthopaedic Surgery Medical Education Course 2023 (COSMEC) will be selected and computer randomized (1:1) into two groups of experimental (IVR) and control (arthroscopy simulator box), based on level of training. Allocation concealment will be ensured using central randomization. Trainees in both groups will receive a common didactic training for knee arthroscopy. Subsequently, trainees in the experimental group will undergo a IVR surgical training module and trainees in the control group will undergo a similar module using arthroscopy simulator box. Following the training modules, participants will complete knowledge tests, technical skill assessments on knee arthroscopy simulators, and experiential surveys.
Stage 2 - Medical students and orthopaedic residents participating in the 2023 University of Toronto Orthopaedic Surgery bootcamp will be selected and computer randomized (1:1) into two groups of experimental (IVR) and control (sawbones), based on level of training. Allocation concealment will be ensured using central randomization. Trainees in both groups will receive a common didactic training for femoral intramedullary nail (IMN) placement. Subsequently, trainees in the experimental group will undergo a IVR surgical training module and trainees in the control group will undergo a similar module using Sawbones ®. Following the training modules, participants will complete knowledge tests, technical skill assessments on cadaveric models, and experiential surveys.
Stage 3 - The protocol explained in stage 1 and 2 may be repeated for various orthopaedic sub-speciality (including arthroplasty and spine surgery) for the participants in the booth camp.
Stage 4 - All trainees may then be followed longitudinally over the course 6 months. Trainees' performance may be evaluated for procedures in which training was provided, based on preceptor evaluations (for example by completing standardised evaluation forms) on a voluntary basis.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immersive virtual reality (IVR) group | Experimental | Device: Immersive virtual reality (IVR)The experimental group will experience various surgical training modules using immersive virtual reality. |
| Traditional hands on orthopaedic workshop group | Active comparator | Other: Traditional hands on orthopaedic workshop groupHands-on orthopaedic workshop sessions (including arthroscopy simulators, cadaveric models, and Sawbones®) in differing orthopaedic subspecialties (including sports, arthroplasty, and spine surgery). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Being a University of Toronto medical student.
- Being a University of Toronto orthopaedic surgery resident.
Key exclusion criteria (1 listed)
- Previous graduation from an orthopaedic surgery residency in Canada or abroad.
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 |
|---|---|---|
| Immersive virtual reality (IVR)Also: head mounted display, virtual realityUsing Oculus Quest 2 (Reality Labs, Meta Platforms, United States) headsets the PrecisionOS platform version 3.0 (PrecisionOS Technology, Canada) virtual reality surgical modules will be utilized. | Device | Immersive virtual reality (IVR) group |
| Traditional hands on orthopaedic workshop groupHands-on orthopaedic workshop sessions (including arthroscopy simulators, cadaveric models, and Sawbones®) in differing orthopaedic subspecialties (including sports, arthroplasty, and spine surgery). | Other | Traditional hands on orthopaedic workshop group |
Primary outcome
Objective Structured Assessment of Technical Skills (OSATS)
Time frame: 2 weeks after the training sessions, over 30 minutes testing period
The primary outcome of the study is to assess trainee procedural performance using simulators or cadaveric models between the experimental (IVR) and control groups, measured by Objective Structured Assessment of Technical Skill (OSATS) score.
4 secondary outcomes
Global Ratings Scale (GRS)
Time frame: 2 weeks after the training sessions, over 30 minutes testing period
Hand and body motion analysis using sensors
Time frame: 2 weeks after the training sessions, over 30 minutes testing period
Experimental and confidence questionnaire
Time frame: 2 weeks after the training sessions, over 30 minutes testing period
Time to complete the procedure
Time frame: 2 weeks after the training sessions, over 30 minutes testing period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No. IPD is not going to be shared with other researchers. All participants' information will be de-identified. Participants are identified in research records only with a unique study identification number that is linked in a master code-breaking enrollment log. Aggregate data will be analyzed.
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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.
Jesse Wolfstadt, MD principal investigator
University of Toronto
Peter Ferguson, MD principal investigator
University of Toronto
Johnathan R Lex, MB ChB principal investigator
University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Immersive virtual reality (IVR) and Traditional hands on orthopaedic workshop group in people with Surgical Education and Virtual Reality, run by University of Toronto.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Koucheki, MD (416-619-5546, Robert.koucheki@mail.utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Structured Assessment of Technical Skills (OSATS) (time frame: 2 weeks after the training sessions, over 30 minutes testing period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2023.