Clinical trial NCT05830786: Virtual Reality in Orthopaedic Surgical Education: A Randomized Controlled Trial
Official title: Effectiveness of Virtual Reality in Orthopaedic Surgical Education: A Multistage Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Education
Virtual Reality
Orthopaedic Training
Keywords: Virtual Reality
Orthopaedic Training
Surgical Education
Head mounted display
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective Structured Assessment of Technical Skills (OSATS)
timeFrame: 2 weeks after the training sessions, over 30 minutes testing period
Secondary outcomes:
measure: Global Ratings Scale (GRS)
timeFrame: 2 weeks after the training sessions, over 30 minutes testing period
measure: Hand and body motion analysis using sensors
timeFrame: 2 weeks after the training sessions, over 30 minutes testing period
measure: Experimental and confidence questionnaire
timeFrame: 2 weeks after the training sessions, over 30 minutes testing period
measure: Time to complete the procedure
timeFrame: 2 weeks after the training sessions, over 30 minutes testing period
Other outcomes:
Locations:
Study officials:
affiliation: University of Toronto
name: Jesse Wolfstadt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Peter Ferguson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Johnathan R Lex, MB ChB
role: PRINCIPAL_INVESTIGATOR
References: