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

Not Applicable

Not yet recruiting

• Conditions: Surgical Education

• Registration Number: NCT06714539
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

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.

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 Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-11-28
• Last Update Submitted: 2024-11-28
• Study Start: 2024-12-02
• Study First Posted: 2024-12-03
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

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

Exclusion Criteria

• None.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of patient specific VR surgical simulations for orthopaedic education, focusing on spinal decompression with or without instrumentation.	Up to 4 months for residents; up to 1 year for fellows	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).

Secondary Outcome Measures

Name	Time	Method
Create a highly automated image analysis pipeline for the creation of patient specific 3D spine models with sufficient fidelity for surgical simulation.	Through study completion, an average of 5 years.	The performance of the pipeline will be measured by the total registration error, quantifying overlap of segmentation of structures, and the distance between landmarks.
Perceived utility of high-fidelity simulation of surgical spine procedures that make use of patient specific models.	Through study completion, an average of 5 years.	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.