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

Overview

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.

Interventions

• Device Patient Specific Virtual Reality Stimulation
  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 outcome measures

• 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]

Secondary outcome measures (2)

• 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.]
• 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.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• None.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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

Identifiers

NCT: NCT06714539 · 6489

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗