Face, content, and construct validity of a novel VR/AR surgical simulator of a minimally invasive spine operation.

Mixed-reality surgical simulators are seen more objective than conventional training. The simulators' utility in training must be established through validation studies. Establish face-, content-, and construct-validity of a novel mixed-reality surgical simulator developed by McGill University, CAE-Healthcare, and DePuy Synthes. This study, approved by a Research Ethics Board, examined a simulated L4-L5 oblique lateral lumbar interbody fusion (OLLIF) scenario. A 5-point Likert scale questionnaire was used. Chi-square test verified validity consensus. Construct validity investigated 276 surgical performance metrics across three groups, using ANOVA, Welch-ANOVA, or Kruskal-Wallis tests. A post-hoc Dunn's test with a Bonferroni correction was used for further analysis on significant metrics. Musculoskeletal Biomechanics Research Lab, McGill University, Montreal, Canada. DePuy Synthes, Johnson & Johnson Family of Companies, research lab. Thirty-four participants were recruited: spine surgeons, fellows, neurosurgical, and orthopedic residents. Only seven surgeons out of the 34 were recruited in a side-by-side cadaver trial, where participants completed an OLLIF surgery first on a cadaver and then immediately on the simulator. Participants were separated a priori into three groups: post-, senior-, and junior-residents. Post-residents rated validity, median > 3, for 13/20 face-validity and 9/25 content-validity statements. Seven face-validity and 12 content-validity statements were rated neutral. Chi-square test indicated agreeability between group responses. Construct validity found eight metrics with significant differences (p < 0.05) between the three groups. Validity was established. Most face-validity statements were positively rated, with few neutrally rated pertaining to the simulation's graphics. Although fewer content-validity statements were validated, most were rated neutral (only four were negatively rated). The findings underscored the importance of using realistic physics-based forces in surgical simulations. Construct validity demonstrated the simulator's capacity to differentiate surgical expertise.

Development and Validation of a Mixed Reality Configuration of a Simulator for a Minimally Invasive Spine Surgery Using the Workspace of a Haptic Device and Simulator Users.

Most surgical simulators leverage virtual or bench models to simulate reality. This study proposes and validates a method for workspace configuration of a surgical simulator which utilizes a haptic device for interaction with a virtual model and a bench model to provide additional tactile feedback based on planned surgical manoeuvers. Numerical analyses were completed to determine the workspace and position of a haptic device, relative to the bench model, used in the surgical simulator, and the determined configuration was validated using device limitations and user data from surgical and nonsurgical users. For the validation, surgeons performed an identical surgery on a cadaver prior to using the simulator, and their trajectories were then compared to the determined workspace for the haptic device. The configuration of the simulator was determined appropriate through workspace analysis and the collected user trajectories. Statistical analyses suggest differences in trajectories between the participating surgeons which were not affected by the imposed haptic workspace. This study, therefore, demonstrates a method to optimally position a haptic device with respect to a bench model while meeting the manoeuverability needs of a surgical procedure. The validation method identified workspace position and user trajectory towards ideal configuration of a mixed reality simulator.