Data_Sheet_2_Evolution and Stagnation of Image Guidance for Surgery in the Lateral Skull: A Systematic Review 1989–2020.PDF

Objective: Despite three decades of pre-clinical and clinical research into image guidance solutions as a more accurate and less invasive alternative for instrument and anatomy localization, translation into routine clinical practice for surgery in the lateral skull has not yet happened. The aim of this review is to identify challenges that need to be solved in order to provide image guidance solutions that are safe and beneficial for use during lateral skull surgery and to synthesize factors that facilitate the development of such solutions.
Methods: Literature search was conducted via PubMed using terms relating to image guidance and the lateral skull. Data extraction included the following variables: image guidance error, imaging resolution, image guidance system, tracking technology, registration method, study endpoints, clinical target application, and publication year. A subsequent search of FDA 510(k) database for identified image guidance systems and extraction of the year of approval, intended use, and indications for use was performed. The study objectives and endpoints were subdivided in three time phases and summarized. Furthermore, it was analyzed which factors correlated with the image guidance error. Factor values for which an error ≤0.5 mm (μerror + 3σerror) was measured in more than one study were identified and inspected for time trends.
Results: A descriptive statistics-based summary of study objectives and findings separated in three time intervals is provided. The literature provides qualitative and quantitative evidence that image guidance systems must provide an accuracy ≤0.5 mm (μerror + 3σerror) for their safe and beneficial application during surgery in the lateral skull. Spatial tracking accuracy and precision and medical image resolution both correlate with the image guidance accuracy, and all of them improved over the years. Tracking technology with accuracy ≤0.05 mm, computed tomography imaging with slice thickness ≤0.2 mm, and registration based on bone-anchored titanium fiducials are components that provide a sufficient setting for the development of sufficiently accurate image guidance.
Conclusion: Image guidance systems must reliably provide an accuracy ≤0.5 mm (μerror + 3σerror) for their safe and beneficial use during surgery in the lateral skull. Advances in tracking and imaging technology contribute to the improvement of accuracy, eventually enabling the development and wide-scale adoption of image guidance solutions that can be used safely and beneficially during lateral skull surgery.

研究目标：尽管针对图像引导（image guidance）解决方案开展了三十年的临床前与临床研究，以期为器械与解剖结构定位提供更精准、微创的替代方案，但此类方案尚未能转化应用于侧颅外科的常规临床实践。本综述旨在明确：为开发可安全、有效地应用于侧颅外科手术的图像引导解决方案，需要解决哪些挑战；并综合梳理能够推动此类方案研发的关键因素。

研究方法：通过PubMed数据库开展文献检索，检索词涵盖图像引导（image guidance）与侧颅相关主题。数据提取包含以下变量：图像引导误差、成像分辨率、图像引导系统、跟踪技术、配准方法、研究终点、临床目标应用场景及发表年份。随后针对已识别的图像引导系统，检索FDA 510(k)数据库，提取其获批年份、预期用途及适用指征。将研究目标与研究终点划分为三个时间阶段并进行总结。此外，本研究分析了与图像引导误差相关的影响因素。针对在多项研究中均测得误差≤0.5 mm（均值误差+3倍标准差误差）的因素取值，进行了识别并分析其时间趋势。

研究结果：本研究提供了基于描述性统计的研究目标与研究发现的总结，相关内容按三个时间区间划分。现有文献提供了定性与定量证据，表明：若要安全、有效地将图像引导系统应用于侧颅外科手术，其必须达到≤0.5 mm（均值误差+3倍标准差误差）的准确度。空间跟踪准确度与精密度、医学成像分辨率均与图像引导准确度呈正相关，且三者均随时间推移不断提升。准确度≤0.05 mm的跟踪技术、层厚≤0.2 mm的计算机断层扫描成像、基于骨锚定钛基准标记物的配准方法，共同构成了开发足够精准的图像引导系统的充分基础条件。

研究结论：图像引导系统若要安全、有效地应用于侧颅外科手术，必须可靠地达到≤0.5 mm（均值误差+3倍标准差误差）的准确度。跟踪与成像技术的进步推动了准确度的提升，最终有望助力可安全、有效地应用于侧颅外科手术的图像引导方案的研发与大规模推广应用。