Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06714539

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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,

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None.

Treatment and study plan

Patient Specific Virtual Reality Stimulation

Device

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.

Primary outcomes

  1. 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

  1. Create a highly automated image analysis pipeline for the creation of patient specific 3D spine models with sufficient fidelity for surgical simulation.

    Time frame: 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.

  2. Perceived utility of high-fidelity simulation of surgical spine procedures that make use of patient specific models.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Michael Hardisty

CONTACT

[email protected]

416-480-5790

Ms. Nivedita Upadhyay

CONTACT

[email protected]

416-480-4285

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Sunnybrook Research Institute

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.