Performance and usability of an intraoperative registration paste frame for a spine surgical navigation system

Abstract

• The design of medical equipment needs to meet the requirements of safety and effectiveness. Performance and usability test by surgeons can help medical equipment close to the surgical process. • According to the performance test, it confirms that the combination of PEEK and ceramic balls can achieve the best registration accuracy. • After analyzing the usability test results of 5 surgeons, it is believed that the registration patch needs to be light, fit the patient's table, and easy to hold, etc. Therefore, the L-shaped design is suitable for navigation surgery. Experimental and observational study Despite the rapid development of various spine surgical navigation systems, they are not yet widespread. The possible explanation is that navigation accuracy is not guaranteed and user errors still occur. Therefore, we develop four different intraoperative registration paste frames and conducted simulated spine surgery in a hybrid room environment. Through performance and usability tests, we aim to evaluate the proper registration tool for spine surgical navigation system. Five spine surgeons used the spine surgical navigation system and a robotic 3D C-arm to execute performance and usability tests for four different intraoperative registration paste frames. In performance test, we measured the registration and navigation accuracies. As for usability test, three observers recorded the user errors during operation and surgeons filled out a questionnaire after the procedure. Statistical analysis was performed to evaluate the test result between different paste frame designs. L-type intraoperative registration paste frame made by PEEK achieved small registration error (0.060 ± 0.014 mm) and small navigation error (1.30 ± 0.69 mm). The usability test showed that the L-type design not only reduced the operational risk, but also increased satisfaction. Through the performance and usability tests, we identified the L-type intraoperative registration paste frame made by PEEK as a promising registration tool in spine surgical navigation system. Further study in the clinical setting with more case numbers is necessary to consolidate this finding.