Smart Trepanation System: Preclinical Analysis of Safety, Efficiency, and User Satisfaction

Abstract

To reduce the risk of dural tears during craniotomies and the associated complications, we developed the Smart Trepanation System (STS) that provides an image- and sensor-based automatic control of the cutting depth of a manually guided soft tissue preserving saw. This article presents the results of an initial user-centered evaluation. Interactive usability tests with six neurosurgeons were conducted. Resection time and accuracy were recorded in a standardized laboratory setting and compared with a standard craniotome. User satisfaction and subjective workload were assessed using the National Aeronautics and Space Administration Task Load Index scale and a questionnaire regarding intuitiveness, fault tolerance, learnability, and user satisfaction. The mean resection time after getting used to the STS was 36.4 ± 9.2 second longer than with the conventional craniotome. All task load indexes except for the temporal demand were rated higher when using the STS, but all were rated smaller than 3 and thus classified as only a small extra task load. The questionnaire showed that the system is not only feasible but also accepted by surgeons and that the user interaction seems to be designed as intuitive, fault tolerant, and easy to learn. Although the conventional craniotome seems to perform a trepanation faster and with less workload, the advantage of performing a dura-preserving trepanation with significantly smaller cutting gaps outweighs those disadvantages. For validation of those promising in vitro results, further studies have to be conducted in a fresh human cadaver model or in a clinical setting.