Accuracy of augmented reality surgical navigation for minimally invasive pedicle screw insertion in the thoracic and lumbar spine with a new tracking device

ABSTRACT Background Context Minimally invasive approaches are increasingly used in spine surgery. The purpose of navigation systems is to guide the surgeon and to reduce intraoperative x-ray exposure. Purpose This study aimed to determine the feasibility and clinical accuracy of a navigation technology based on augmented reality surgical navigation (ARSN) for minimally invasive thoracic and lumbar pedicle screw instrumentation compared to standard fluoroscopy-guided minimally invasive technique. Study Design/Setting Cadaveric laboratory study Methods ARSN was installed in a hybrid operating room, consisting of a flat panel detector c-arm with 2D/3D imaging capabilities and four integrated cameras in its frame. The surface-referenced navigation device does not require a bony reference but uses video cameras and optical markers applied to the patient's skin for tracking. In four cadavers, a total of 136 pedicle screws were inserted in thoracic and lumbar vertebrae. The accuracy was assessed by three independent raters in post-operative conventional ໿computed tomography (CT). Results The overall accuracy of ARSN was 94% compared to an accuracy of 88% for fluoroscopy. The difference was not statistically significant. In the thoracic region, accuracy with ARSN was 92% compared to 83% with fluoroscopy. With fluoroscopy, unsafe screws were observed in three normal cadavers and one with scoliosis. Using ARSN, unsafe screws were only observed in the scoliotic spine. No significant difference in the median of time for K-wire placement was recorded. As no intraoperative fluoroscopy was necessary in ARSN, the performing surgeon was not exposed to radiation. Conclusions In this limited cadaveric study minimally invasive screw placement using ARSN was demonstrated to be feasible and as accurate as fluoroscopy. It did not require any additional navigation time or use of any intra-operative x-ray imaging, thereby potentially permitting surgery in a protective lead garment-free environment. A well-powered clinical study is needed to demonstrate a significant difference in the accuracy between the two methods. Clinical Significance ARSN offers real time imaging of planned insertion paths, instrument tracking and overlay of three dimensional bony anatomy and surface topography. The referencing procedure, by optical recognition of several skin markers is easy and does not require a solid bony reference as necessary for conventional navigation which saves time. Additionally, ARSN may foster the reduction of intraoperative x-ray exposure to spinal surgeons.