Accuracy Evaluation of a CAS System: Laboratory Protocol and Results with 6D Localizers, and Clinical Experiences in Otorhinolaryngology

Abstract

Objectives: The objective of the study reported in this article was to evaluate (1) localizer inaccuracies, one of the major sources of errors in Computer-Assisted Surgery (CAS) systems, and (2) the final errors obtained using surface-based registration in ear, nose, and throat (ENT) surgery. These objectives were met through (1) a technical evaluation of the accuracy and usability of several optical localizers under laboratory test conditions, and (2) a clinical measure of the global errors obtained when using a CAS system including one of the standard localizer systems (Flashpoint 5000®) in Functional Endoscopic Sinus Surgery (FESS).Patients and Methods: The technical evaluation of localizers consisted of series of geometric tests on four commercial systems. Clinical evaluation included the development of a laboratory CAS system using a markerless, skin surface registration method. This was based on a standard optical digitizing system (Flashpoint 5000®), which eliminates the need for the second CT scan, which is normally performed specifically to process the position of the fiducial markers. Global accuracy was then evaluated on 20 patients by subjective and visual comparison when placing a calibrated pointer on anatomical landmarks.Results: The results of the technical study indicate that the four commercial systems tested have levels of inaccuracy deemed acceptable for most CAS applications, including ENT surgery. The clinical study obtained a registration and calibration accuracy of less than 1.5 mm in 89.2% (SD=0.20 mm) of the cases studied. Our markerless skin surface points registration method is reliable, and allows patient head movements during the procedure. The accuracy tests performed show that this type of system can be used for ENT surgery with satisfaction.Conclusion: CAS systems enable the surgeon to have a more thorough understanding of the complicated anatomy of paranasal sinuses, and may be especially helpful in revision surgery when normal anatomic landmarks are lacking. Further studies are necessary in FESS to improve the CAS systems that are currently available, and to determine whether these systems can minimize the overall risk of complications.