Department of Neurosurgery, Washington University School of Medicine, St. Louis, Missouri.
Department of Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Oper Neurosurg (Hagerstown). 2021 Feb 16;20(3):300-309. doi: 10.1093/ons/opaa398.
Augmented reality mediated spine surgery is a novel technology for spine navigation. Benchmark cadaveric data have demonstrated high accuracy and precision leading to recent regulatory approval. Absence of respiratory motion in cadaveric studies may positively bias precision and accuracy results and analogous investigations are prudent in live clinical scenarios.
To report a technical note, accuracy, precision analysis of the first in-human deployment of this technology.
A 78-yr-old female underwent an L4-S1 decompression, pedicle screw, and rod fixation for degenerative spine disease. Six pedicle screws were inserted via AR-HMD (xvision; Augmedics, Chicago, Illinois) navigation. Intraoperative computed tomography was used for navigation registration as well as implant accuracy and precision assessment. Clinical accuracy was graded per the Gertzbein-Robbins (GS) scale by an independent neuroradiologist. Technical precision was analyzed by comparing 3-dimensional (3D) (x, y, z) virtual implant vs real implant position coordinates and reported as linear (mm) and angular (°) deviation. Present data were compared to benchmark cadaveric data.
Clinical accuracy (per the GS grading scale) was 100%. Technical precision analysis yielded a mean linear deviation of 2.07 mm (95% CI: 1.62-2.52 mm) and angular deviation of 2.41° (95% CI: 1.57-3.25°). In comparison to prior cadaveric data (99.1%, 2.03 ± 0.99 mm, 1.41 ± 0.61°; GS accuracy 3D linear and angular deviation, respectively), the present results were not significantly different (P > .05).
The first in human deployment of the single Food and Drug Administration approved AR-HMD stereotactic spine navigation platform demonstrated clinical accuracy and technical precision of inserted hardware comparable to previously acquired cadaveric studies.
增强现实介导的脊柱手术是一种新型的脊柱导航技术。在基准尸体研究中，已证明其具有高精度和高精准度，这导致了该技术最近获得监管部门的批准。在尸体研究中，呼吸运动的缺失可能会对精度和准确性结果产生积极影响，因此在真实的临床环境中进行类似的研究是谨慎的。
报告首例人体应用该技术的技术说明和准确性、精准度分析。
一名 78 岁女性因退行性脊柱疾病接受 L4-S1 减压、椎弓根螺钉和棒固定术。通过 AR-HMD（xvision；Augmedics，芝加哥，伊利诺伊州）导航插入 6 枚椎弓根螺钉。术中计算机断层扫描用于导航注册以及植入物的准确性和精准度评估。一位独立的神经放射学家按照 Gertzbein-Robbins（GS）分级标准对临床准确性进行分级。通过比较 3 维（3D）（x、y、z）虚拟植入物与真实植入物位置坐标，分析技术精度，并以线性（mm）和角度（°）偏差报告。目前的数据与基准尸体数据进行了比较。
临床准确性（按 GS 分级标准）为 100%。技术精度分析得出平均线性偏差为 2.07mm（95%置信区间：1.62-2.52mm），角度偏差为 2.41°（95%置信区间：1.57-3.25°）。与之前的尸体数据（99.1%，2.03±0.99mm，1.41±0.61°；GS 准确性 3D 线性和角度偏差）相比，目前的结果无显著差异（P>.05）。
首个获得美国食品和药物管理局批准的单臂 AR-HMD 立体定向脊柱导航平台的人体应用显示，植入物的临床准确性和技术精度与之前获得的尸体研究相当。
