Virtual Reality in Orthopaedic Surgical Education: A Randomized Controlled Trial

NCT ID: NCT05830786

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2024-05-31

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.

Conditions

Surgical Education; Virtual Reality; Orthopaedic Training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Immersive virtual reality (IVR) group

The experimental group will experience various surgical training modules using immersive virtual reality.

Group Type: EXPERIMENTAL

Immersive virtual reality (IVR)

Intervention Type: DEVICE

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 group

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

Group Type: ACTIVE_COMPARATOR

Traditional hands on orthopaedic workshop group

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

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).

Intervention Type: OTHER

Other Intervention Names

head mounted display; virtual reality

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Robert Koucheki

Principal Investigator, Lead Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesse Wolfstadt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Peter Ferguson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Johnathan R Lex, MB ChB

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Central Contacts

Robert Koucheki, MD

Role: CONTACT

Robert.koucheki@mail.utoronto.ca

416-619-5546

Johnathan R Lex, MB ChB

Role: CONTACT

Johnathan.lex@mail.utoronto.ca

416-619-5546

Other Identifiers

44020

Identifier Type: -

Identifier Source: org_study_id