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

NCT06714539 | Not Yet Recruiting

• 1 other identifier: 6489
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgical Education

Keywords

Surgical Education; Virtual Reality; Spine Surgery; Treatment Planning; Physician Testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (1)

Patient Specific Virtual Reality Stimulation

EXPERIMENTAL

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

Interventions

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.

Patient Specific Virtual Reality Stimulation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Sunnybrook Research Institute: collaborator

Related Publications (1)

• 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.

  PMID: 35141628 BACKGROUND

Study Officials

• Dr. Michael Hardisty

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Michael Hardisty

CONTACT

416-480-5790; m.hardisty@utoronto.ca

Ms. Nivedita Upadhyay

CONTACT

416-480-4285; OrthoRes@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: December 3, 2024
• Study Start: December 2, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 3, 2024

Record last verified: 2024-11