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

Abstract

Study design

Experimental and observational study

Objectives

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.

Methods

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.

Results

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.

Conclusion

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.