Virtual Reality in Orthopaedic Surgical Education: A Randomized Controlled Trial

Virtual Reality Clinical Trial

— VR-ORS  

Official title:

Effectiveness of Virtual Reality in Orthopaedic Surgical Education: A Multistage Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05830786
• Other study ID #: 44020
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 16, 2023
• Est. completion date: May 2024

Study information

• Verified date: April 2023
• Source: University of Toronto
• Contact: Robert Koucheki, MD
• Phone: 416-619-5546
• Email: Robert.koucheki[@]mail.utoronto.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 subspecialties (such as sports, arthroplasty, and spine surgery).

Overall, in this multi-stage comprehensive randomized controlled the aim is to assess:

1. If IVR simulation using head-mounted displays (HMD) is superior to the current standard of training for orthopaedic surgery residents and medical students.

2. Determine if it is feasible to incorporate immersive headset virtual reality simulation into residency training programs and medical school curriculums.

3. Assess the longitudinal application of IVR training on medical student and resident surgical education.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Being a University of Toronto medical student.

• Being a University of Toronto orthopaedic surgery resident.

Exclusion Criteria:

• Previous graduation from an orthopaedic surgery residency in Canada or abroad.

Related Conditions & MeSH terms

• Surgical Education
• Virtual Reality

Intervention

Device:
• Immersive virtual reality (IVR)
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.

Other:
• Traditional hands on orthopaedic workshop group
Hands-on orthopaedic workshop sessions (including arthroscopy simulators, cadaveric models, and Sawbones®) in differing orthopaedic subspecialties (including sports, arthroplasty, and spine surgery).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks after the training sessions, over 30 minutes testing period
Secondary	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.	2 weeks after the training sessions, over 30 minutes testing period
Secondary	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.	2 weeks after the training sessions, over 30 minutes testing period
Secondary	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.	2 weeks after the training sessions, over 30 minutes testing period
Secondary	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.	2 weeks after the training sessions, over 30 minutes testing period