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Clinical Trials/NCT06714539
NCT06714539
Not yet recruiting
Not Applicable

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

Sunnybrook Health Sciences Centre0 sites13 target enrollmentDecember 2, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgical Education
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
13
Primary Endpoint
Evaluate the effectiveness of patient specific VR surgical simulations for orthopaedic education, focusing on spinal decompression with or without instrumentation.
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2, 2024
End Date
December 31, 2030
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Michael Hardisty

Scientist

Sunnybrook Health Sciences Centre

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Evaluate the effectiveness of patient specific VR surgical simulations for orthopaedic education, focusing on spinal decompression with or without instrumentation.

Time Frame: 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 Outcomes

  • 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.)
  • 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.)

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