Patient Specific Virtual Reality for Simulation of Spine Procedures: an Intelligent Image Segmentation, Registration and 3-dimensional Visualization in a Unified Virtual Reality Workflow for Image Guided Therapy, and Education - Physician Testing

The goal of this clinical trial is to learn if patient specific virtual reality (VR) simulations can be used for surgical orthopaedic education in resident and fellow physician populations.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgical Education
• Intervention / Treatment: Device: Patient Specific Virtual Reality Stimulation

Detailed Description

This project will combine advanced 3d visualization, interaction, medical image segmentation, and registration to create and integrate a virtual reality (VR) model into surgical orthopaedic education. The work has 3 aspects,

1) creating a patient specific 3D model with high accuracy of anatomic structures using patient specific medical imaging in an automated fashion, 2) interacting with 3D models of the patients, allowing the surgical procedures to be performed in virtual reality (including the resection of tissues, and placement of implants), 3) integrating the VR simulator into the surgical education of orthopaedic residents and fellows in training. This platform will reduce the time and cost associated with use of patient specific data, ultimately enabling pre-operative planning, post-procedural assessment and surgical simulation of spine procedures. The technology will improve surgical training, and the options for pre-treatment planning that will lead to better patient care, more efficient use of operating room time, and better trained surgeons.

• Study Type: Interventional
• Enrollment (Estimated): 13
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Michael Hardisty; Phone Number: 416-480-5790; Email: m.hardisty@utoronto.ca
• Study Contact Backup: Name: Ms. Nivedita Upadhyay; Phone Number: 416-480-4285; Email: OrthoRes@sunnybrook.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any resident of fellow physician enrolled in the participating site's spine surgery training program.

Exclusion Criteria:

• None.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Specific Virtual Reality Stimulation; Physician participants will engage with the patient specific virtual reality simulator through multi-player teaching and individual practice modes.	Device: Patient Specific Virtual Reality Stimulation; A novel virtual reality (VR) simulator for spine procedures that will take patient specific medical imaging (3D scans) and create a virtual patient that surgical procedures can be performed on.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effectiveness of patient specific VR surgical simulations for orthopaedic education, focusing on spinal decompression with or without instrumentation.	Participants will complete study questionnaires before and after the testing sessions that ask them to list relevant structures involved in spinal decompression surgery. Participants will rate their confidence and motivation using the VR tool on a scale of 1 (highly confidence) to 10 (low confidence).	Up to 4 months for residents; up to 1 year for fellows

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Create a highly automated image analysis pipeline for the creation of patient specific 3D spine models with sufficient fidelity for surgical simulation.	The performance of the pipeline will be measured by the total registration error, quantifying overlap of segmentation of structures, and the distance between landmarks.	Through study completion, an average of 5 years.
Perceived utility of high-fidelity simulation of surgical spine procedures that make use of patient specific models.	Orthopaedic residents and fellows will test the tool, following, they will fill out a questionnaire about the utility of the tool for learning and surgical planning. Participants will report their agreeableness to statements about the utility on a scale of 1 (strongly disagree) to 5 (strongly agree), and provide their own comments.	Through study completion, an average of 5 years.

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Sunnybrook Research Institute
• Investigators: Principal Investigator: Dr. Michael Hardisty, Sunnybrook Research Institute

Publications and helpful links

General Publications

• Chen T, Zhang Y, Ding C, Ting K, Yoon S, Sahak H, Hope A, McLachlin S, Crawford E, Hardisty M, Larouche J, Finkelstein J. Virtual reality as a learning tool in spinal anatomy and surgical techniques. N Am Spine Soc J. 2021 Apr 14;6:100063. doi: 10.1016/j.xnsj.2021.100063. eCollection 2021 Jun.

Study record dates

Study Major Dates

• Study Start (Estimated): December 2, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 25, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Reality; Spine Surgery; Treatment Planning; Surgical Education; Physician Testing
• Other Study ID Numbers: 6489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: As a non-FDA regulated trial the investigators are unsure how useful the data will be externally, but will post if there is interest.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No