Simon Peh1, Anindita Chatterjea2, Julian Pfarr3, Jost Philipp Schäfer3, Matthias Weuster4, Tim Klüter4, Andreas Seekamp4, Sebastian Lippross4. 1. Department of Orthopedics and Trauma Surgery, University Hospital Schleswig-Holstein, Arnold-Heller-Strasse 3, 24105 Kiel, Germany. Electronic address: Simon.Peh@uksh.de. 2. Image Guided Therapy Systems, Philips Healthcare, Veenpluis 4-6, 5684 PC, Best, the Netherlands. 3. Department of Radiology and Neuroradiology, University Hospital Schleswig-Holstein, Arnold-Heller-Strasse 3, 24105 Kiel, Germany. 4. Department of Orthopedics and Trauma Surgery, University Hospital Schleswig-Holstein, Arnold-Heller-Strasse 3, 24105 Kiel, Germany.
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 with 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 two dimensional/three dimensional 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 postoperative conventional computed tomography. RESULTS: The overall accuracy of ARSN was 94% compared with an accuracy of 88% for fluoroscopy. The difference was not statistically significant. In the thoracic region, accuracy with ARSN was 92% compared with 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 intraoperative 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.
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 with 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 two dimensional/three dimensional 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 postoperative conventional computed tomography. RESULTS: The overall accuracy of ARSN was 94% compared with an accuracy of 88% for fluoroscopy. The difference was not statistically significant. In the thoracic region, accuracy with ARSN was 92% compared with 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 intraoperative 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.
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