Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgical Education
Keywords: Surgical Education
Virtual Reality
Spine Surgery
Treatment Planning
Physician Testing
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Sunnybrook Research Institute
First posted: 2024-12-03
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None.

Primary outcomes:
measure: Evaluate the effectiveness of patient specific VR surgical simulations for orthopaedic education, focusing on spinal decompression with or without instrumentation.
timeFrame: Up to 4 months for residents; up to 1 year for fellows
Secondary outcomes:
measure: Create a highly automated image analysis pipeline for the creation of patient specific 3D spine models with sufficient fidelity for surgical simulation.
timeFrame: Through study completion, an average of 5 years.
measure: Perceived utility of high-fidelity simulation of surgical spine procedures that make use of patient specific models.
timeFrame: Through study completion, an average of 5 years.
Other outcomes:
Locations:
Study officials:
affiliation: Sunnybrook Research Institute
name: Dr. Michael Hardisty
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.