Virtual Reality in Orthopaedic Surgical Education: A Randomized Controlled Trial

NCT05830786 | Unknown

• 1 other identifier: 44020
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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. 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. 2.Determine if it is feasible to incorporate immersive headset virtual reality simulation into residency training programs and medical school curriculums.
3. 3.Assess the longitudinal application of IVR training on medical student and resident surgical education.

Conditions

Surgical Education; Virtual Reality; Orthopaedic Training

Keywords

Virtual Reality; Orthopaedic Training; Surgical Education; Head mounted display

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Global Ratings Scale (GRS)

  2 weeks after the training sessions, over 30 minutes testing period

• Hand and body motion analysis using sensors

  2 weeks after the training sessions, over 30 minutes testing period

• Experimental and confidence questionnaire

  2 weeks after the training sessions, over 30 minutes testing period

• Time to complete the procedure

  2 weeks after the training sessions, over 30 minutes testing period

Study Arms (2)

Immersive virtual reality (IVR) group

EXPERIMENTAL

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

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).

Other: Traditional hands on orthopaedic workshop group

Interventions

Immersive virtual reality (IVR) 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.

Also known as: head mounted display, virtual reality

Immersive virtual reality (IVR) group

Traditional hands on orthopaedic workshop group OTHER

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

Traditional hands on orthopaedic workshop group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Being a University of Toronto medical student.
• Being a University of Toronto orthopaedic surgery resident.

You may not qualify if:

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

Sponsors & Collaborators

• University of Toronto: lead

MeSH Terms

Interventions

Smart Glasses

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Jesse Wolfstadt, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Peter Ferguson, MD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Johnathan R Lex, MB ChB

  University of Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Koucheki, MD

CONTACT

416-619-5546; Robert.koucheki@mail.utoronto.ca

Johnathan R Lex, MB ChB

CONTACT

416-619-5546; Johnathan.lex@mail.utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators and outcome assessors will be blinded to participant group allocation. Participants will also be blinded to group assignment up to the point of study initiation.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Lead Researcher

Study Record Dates

• First Submitted: March 5, 2023
• First Posted: April 26, 2023
• Study Start: May 16, 2023
• Primary Completion: September 1, 2023
• Study Completion: May 1, 2024
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share