隨著高齡化社會的來臨，骨質疏鬆症已成為全球老年人口常見疾病，此病症導致脊椎體壓迫性骨折風險增加，椎體成形術是有效的最小侵入式療法，由於是經皮手術，其穿刺精準度是該治療方法最大的風險，本研究的主要目的是要提供精準穿刺參考路徑，降低術中X光的拍攝次數，同時加速新執業醫師的養成訓練。為了達到上述臨床目標，先前研究提出PV Guide系統，使用兩張C-arm影像與持針機構規劃並導引穿刺路徑，建立穿刺準度量化方法，降低X光拍攝量，in Vitro實驗已完成，初步證實可行。
為了使PV Guide系統進入人體臨床試驗，本研究在可消毒的可攜式平台上重新整合實現先前研究尚未整合的硬軟體系統。為了更提升系統精度，採用全域失真校正方法降低影像外圍的像差，成功將影像外圍平均誤差降低至0.133±0.069 mm，與先前系統誤差0.405±0.489 mm相比，平均與標準差減少65%以上；為了得到影像定位部分的誤差，本研究以自製治具驗證量測穿刺方位，得到穿刺針尖點平均誤差1.002±0.174 mm，加上T-bar機構的誤差1.261±0.634 mm，獲得整體系統誤差為2.263±0.657 mm。根據台灣人脊椎尺寸統計資料，在椎體成形術上此誤差是臨床上可接受的範圍。

With the coming of aging society, osteoporosis became one of the general elderly diseases all over the world. This disease could increase the risk of compression fracture, which can be healed by percutaneous vertebroplasty, an effective minimally invasive spinal surgery for the disease. Because it is percutaneous way of treatment, precision of the puncture trajectories is the riskiest procedure during surgery. The purpose of this research is to provide accurate puncture trajectories and reduce the number of fluoroscopy demanding during surgery. Nevertheless, to reduce apprenticeship training curve for novice physicians. To solve clinical issues above, our previous study, a C-arm-based guiding system for percutaneous vertebroplasty, named PV guide system, was developed. The developed system reduces the demanding of radiographs, and allow to quantifying the deviation between puncture planning and practical trajectory. Previous study has feasibility examined by in Vitro.

In order to enter the stage of clinical trial, we have transferred the Windows into Android platform, and have refabricated and packed the sensors to be a sterilizable equipment. Global distortion correction method was applied to reduce the deviations occurs around the rim of imaging. Compare to the system errors 0.405±0.489 mm in our previous research, PV 1.0, errors in this study was decrease to 0.133±0.069 mm. The average and standard deviations dramatically decreased more than 65%. To investigate the accuracy of puncture trajectory, a self-made phantom was fabricated and applied. The average deviation of pin tips of the phantom was 1.002±0.174mm. The system errors become 2.263±0.657 mm that include the errors of pin trajectories, 1.002±0.174mm, and the errors of the needle holder mechanism. Base on the study of pedicle dimensions in Taiwanese, the system error is acceptable for patients with the treatment of percutaneous vertebroplasty.

[1] 鮑卓倫醫師, "骨質疏鬆症與脊椎壓迫性骨折 先進骨科手術介紹─經皮椎體成形術," <http://www.femh.org.tw/epaperadmin/viewarticle.aspx?ID=2654>, accessed on 23 May 2016.
[2] 魏銘政，管姿婷, "骨質疏鬆症的迷思," <http://www.jah.org.tw/form/index-1.asp?m=3&m1=8&m2=363&gp=361&id=348>, accessed on 24 May 2016.
[3] 林志隆，王建國，"骨質疏鬆性脊椎體壓迫性骨折之另類治療--人工骨水泥經皮椎體成形術，"高醫醫訊月刊第二十三卷第十二期，2004/5。
[4] Stryker, "Stryker - Medical Devices & Equipment Manufacturing Company," <http://www.stryker.com/en-us/index.htm>, accessed on 20 May 2016.
[5] 蔡諄樺，"脊椎手術輔助訓練系統設計與製作"，國立成功大學機械工程研究所碩士論文，2004。
[6] 顏毓宏，"智慧型脊椎手術導航流程與訓練系統之研發"，國立成功大學機械工程研究所碩士論文，2007。
[7] 侯誠育，"脊椎椎足鑽孔手術導引定位建之研發"，國立成功大學機械工程研究所碩士論文，2009。
[8] 莊禮魁，"應用於脊椎後固定術之光學式脊椎椎足鑽孔導航系統"，國立成功大學機械工程研究所碩士論文，2010。
[9] 鎖皓泉，"應用於椎體成形術之C-arm穿刺導引雛型系統"，國立成功大學機械工程研究所碩士論文，2014。
[10] 黃上瑋，"螺桿機構與慣性量測單元應用於C-arm經皮穿刺導引系統"，國立成功大學機械工程研究所碩士論文，2016。
[11] Tsai, R., "A Versatile Camera Calibration Technique for High-accuracy 3D Machine Vision Metrology Using Off-the-shelf TV Cameras and Lenses," IEEE Journal on Robotics and Automation, Vol.3, No.4, pp.323-344, 1987.
[12] Yeung, A. T. and Yeung, C. A., "Advances in Endoscopic Disc and Spine Surgery: Foraminal Approach," Surgical technology international, Vol.11, pp.255-263, 2003.
[13] Yeung, A. T., "The Evolution of Percutaneous Spinal Endoscopy and Discectomy: State of the Art," The Mount Sinai journal of medicine, Vol.67, No.4, pp.327-332, 2000.
[14] Yeung, A. T. and Tsou, P. M., "Posterolateral Endoscopic Excision for Lumbar Disc Herniation: Surgical Technique, Outcome, and Complications in 307 Consecutive Cases," Spine, Vol.27, No.7, pp.722-731, 2002.
[15] Discectomy™, "What is SED/YESS?," <http://www.sciatica.com/sed-surgery.html>, accessed on 26 May 2016.
[16] Amber, K. T., Landy, D. C., Amber, I., Knopf, D., and Guerra, J., "Comparing the Accuracy of Ultrasound Versus Fluoroscopy in Glenohumeral Injections: A Systematic Review and Meta-analysis," Journal of Clinical Ultrasound, Vol.42, No.7, pp.411-416, Sep, 2014.
[17] Jee, H., Lee, J. H., Park, K. D., Ahn, J., and Park, Y., "Ultrasound-Guided Versus Fluoroscopy-Guided Sacroiliac Joint Intra-Articular Injections in the Noninflammatory Sacroiliac Joint Dysfunction: A Prospective, Randomized, Single-Blinded Study," Arch Phys Med Rehabil, Vol.95, No.2, pp.330-337, Feb, 2014.
[18] Clark, J. C., Jasmer, G., Marciano, F. F., and M., T. L., "Minimally Invasive Transforaminal Lumbar Interbody Fusions and Fluoroscopy: A Low-dose Protocol to Minimize Ionizing Radiation," Neurosurgical Focus, Vol.35, No.2, p.E8, 2013.
[19] Tabaraee, E., Gibson, A. G., Karahalios, D. G., Potts, E. A., Mobasser, J.-P., and Burch, S., "Intraoperative Cone Beam–Computed Tomography with Navigation (O-ARM) Versus Conventional Fluoroscopy (C-ARM): A Cadaveric Study Comparing Accuracy, Efficiency, and Safety for Spinal Instrumentation," Spine, Vol.38, No.22, pp.1953-1958, 2013.
[20] Siewerdsen, J. H., Moseley, D. J., Burch, S., Bisland, S. K., Bogaards, A., Wilson, B. C., and Jaffray, D. A., "Volume CT with a Flat-panel Detector on a Mobile, Isocentric C-arm: Pre-clinical Investigation in Guidance of Minimally Invasive Surgery," Medical Physics, Vol.32, No.1, pp.241-254, 2005.
[21] Tjardes, T., Shafizadeh, S., Rixen, D., Paffrath, T., Bouillon, B., Steinhausen, E. S., and Baethis, H., "Image-guided Spine Surgery: State of the Art and Future Directions," European Spine Journal, Vol.19, No.1, pp.25-45, 2009.
[22] Pohlenz, P., Blessmann, M., Blake, F., Heinrich, S., Schmelzle, R., and Heiland, M., "Clinical Indications and Perspectives for Intraoperative Cone-beam Computed Tomography in Oral and Maxillofacial Surgery," Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology, Vol.103, No.3, pp.412-417, 2007.
[23] Rafferty, M. A., Siewerdsen, J. H., Chan, Y., Moseley, D. J., Daly, M. J., Jaffray, D. A., and Irish, J. C., "Investigation of C-Arm Cone-Beam CT-Guided Surgery of the Frontal Recess," The Laryngoscope, Vol.115, No.12, pp.2138-2143, 2005.
[24] Terry, M. P., "Image-guidance for Surgical Procedures," Physics in Medicine and Biology, Vol.51, No.14, pp.505-540, 2006.
[25] Kim, C. W., Lee, Y.-P., Taylor, W., Oygar, A., and Kim, W. K., "Use of Navigation-assisted Fluoroscopy to Decrease Radiation Exposure During Minimally Invasive Spine Surgery," The Spine Journal, Vol.8, No.4, pp.584-590, 2008.
[26] Hofstetter, R., Slomczykowski, M., Sati, M., and Nolte, L. P., "Fluoroscopy as an Imaging Means for Computer-assisted Surgical Navigation," Computer Aided Surgery, Vol.4, No.2, pp.65-76, 1999.
[27] Tormenti, M. J., Kostov, D. B., Gardner, P. A., Kanter, A. S., Spiro, R. M., and Okonkwo, D. O., "Intraoperative Computed Tomography Image-Guided Navigation For Posterior Thoracolumbar Spinal Instrumentation In Spinal Deformity Surgery," Neurosurgical Focus, Vol.28, No.3, p.E11, 2010.
[28] Jaffray, D. A., Siewerdsen, J. H., Wong, J. W., and Martinez, A. A., "Flat-panel Cone-beam Computed Tomography for Image-guided Radiation Therapy," International Journal of Radiation Oncology*Biology*Physics, Vol.53, No.5, pp.1337-1349, 2002.
[29] Kim, T. T., Johnson, J. P., Pashman, R., and Drazin, D., "Minimally Invasive Spinal Surgery with Intraoperative Image-Guided Navigation," BioMed Research International, Vol.2016, pp.1-7, 2016.
[30] Rahmathulla, G., Nottmeier, E. W., Pirris, S. M., Deen, H. G., and Pichelmann, M. A., "Intraoperative Image-guided Spinal Navigation: Technical Pitfalls and Their Avoidance," Neurosurgical Focus, Vol.36, No.3, p.E3, 2014.
[31] Oertel, M. F., Hobart, J., Stein, M., Schreiber, V., and Scharbrodt, W., "Clinical and Methodological Precision of Spinal Navigation Assisted by 3D Intraoperative O-arm Radiographic Imaging," Journal of Neurosurgery: Spine, Vol.14, No.4, pp.532-536, 2011.
[32] Scheufler, K.-M., Franke, J., Eckardt, A., and Dohmen, H., "Accuracy of Image-Guided Pedicle Screw Placement Using Intraoperative Computed Tomography-Based Navigation With Automated Referencing," Neurosurgery, Vol.69, No.4, pp.782-795, 2011.
[33] Wood, M. and Mannion, R., "A Comparison of CT-based Navigation Techniques for Minimally Invasive Lumbar Pedicle Screw Placement," Journal of Spinal Disorders, Vol.24, No.1, pp.E1-E5, 2011.
[34] Wang, J. and Blackburn, T. J., "The AAPM/RSNA Physics Tutorial for Residents," RadioGraphics, Vol.20, No.5, pp.1471-1477, 2000.
[35] GE, "Image Intensifier Image Chain," <http://www.phoenix-xray.com/en/company/technology/principles_of_operation/principle_050.html>, accessed on 21 May 2016.
[36] Rai, L., Gibbs, J., and Wibowo, H., "A C-arm Calibration Method with Application to Fluoroscopic Image-guided Procedures," in Proceedings of Medical Imaging on Image-Guided Procedures, Robotic Interventions, and Modeling, pp.1-11, 2012.
[37] Brack, C., Götte, H., Gossé, F., Moctezuma, J., Roth, M., and Schweikard, A., "Towards Accurate X-Ray-Camera Calibration in Computer-Assisted Robotic Surgery," in Proceedings of International Symposium on Computer and Communication Systems for Image Guided Diagnosis and Therapy, Paris, pp.721-728, 1996.
[38] Kedgley, A. E., Fox, A.-M. V., and Jenkyn, T. R., "Image Intensifier Distortion Correction for Fluoroscopic RSA: The Need for Independent Accuracy Assessment," Journal of Applied Clinical Medical Physics, Vol.13, No.1, pp.197-204, 2012.
[39] Fahrig, R., Moreau, M., and Holdsworth, D. W., "Three-dimensional Computed Tomographic Reconstruction Using a C-arm Mounted XRII: Correction of Image Intensifier Distortion," Med Phys, Vol.24, No.7, pp.1097-106, Jul, 1997.
[40] Wang, X. and Ning, R., "Accurate and Efficient Image Intensifier Distortion Correction Algorithm for Volume Tomographic Angiography," Optical Engineering, Vol.37, No.3, pp.977-983, 1998.
[41] GE Healthcare, "OEC Fluorostar 7900 Digital Mobile C-arm," <http://www3.gehealthcare.com.sg/en-gb/products/categories/surgical_imaging/pain_management/oec_fluorostar_7900>, accessed on 12 May 2016.
[42] Siemens Healthineers, "Siremobil Compact L," <http://www.healthcare.siemens.com/surgical-c-arms-and-navigation/mobile-c-arms/siremobil-compact-l>, accessed on 23 May 2016.
[43] NXP Semiconductors, I2C-bus Specification and User Manual, 2014.
[44] OpenCV, "OpenCV," <http://opencv.org/>, accessed on 22 May 2016.
[45] Imebra, "Imebra DICOM SDK," <https://imebra.com/>, accessed on 23 May 2016.
[46] Siemens Healthineers, "ARCADIS Orbic 3D," <http://usa.healthcare.siemens.com/surgical-c-arms-and-navigation/mobile-c-arms/arcadis-orbic-3d>, accessed on 19 May 2016.
[47] 闫士举, C形臂x光锥测定装置, CN103376078 A.
[48] 林艳萍, 王成焘, 苏颖颖, 钱理为, and 闫士举, 可拆换式c形臂校准靶, CN100539946 C, June 22, 2006.
[49] 林艳萍, 王成焘, 苏颖颖, 钱理为, and 闫士举, C形臂校准靶校准模板结构, CN101194842 A, June 22, 2006.
[50] Zhang, Z., "A Flexible New Technique for Camera Calibration," IEEE Transactions on Pattern Analysis and Machine Intelligence, Vol.22, No.11, pp.1330-1334, 2000.
[51] GE OEC Medical Systems, Fluorostar 7900 Digital Mobile C-arm Operator's Manual, 2008.
[52] Zhang, H., Da, F. P., and Xing, D. K., "An Improved Algorithm for Subpixel Location of Circle Center," in Proceedings of Chinese Conference on Pattern Recognition, pp.1-6, 2008.
[53] Sauvola, J., Seppanen, T., Haapakoski, S., and Pietikainen, M., "Adaptive Document Binarization," in Proceedings of the Fourth International Conference on Document Analysis and Recognition, pp.147-152 vol.1, 1997.
[54] Canny, J., "A Computational Approach to Edge Detection," IEEE Transactions on Pattern Analysis and Machine Intelligence, Vol.8, No.6, pp.679-698, 1986.
[55] Fitzgibbon, A., Pilu, M., and Fisher, R. B., "Direct Least Square Fitting of Ellipses," IEEE Transactions on Pattern Analysis and Machine Intelligence, Vol.21, No.5, pp.476-480, 1999.
[56] OpenCV Dev Team, "Template Matching," <http://docs.opencv.org/2.4/doc/tutorials/imgproc/histograms/template_matching/template_matching.html>, accessed on 27 May 2016.
[57] The MathWorks, "What Is Camera Calibration?," <http://www.mathworks.com/help/vision/ug/camera-calibration.html>, accessed on 28 May 2016.
[58] Lucian, C., "Applying Kalman Filtering on a Quadruped Robot," 2012, <http://biorob.epfl.ch/files/content/sites/biorob/files/users/195094/imports/report.pdf>, accessed on 28 May 2016.
[59] Shimadzu, "WHA-200 OPESCOPE ACTIVO," <http://www.shimadzu.com/med/products/c-arm/m-k25cur00000058j5.html>, accessed on 23 May 2016.
[60] Lien, S.-B., Liou, N.-H., and Wu, S.-S., "Analysis of Anatomic Morphometry of the Pedicles and the Safe Zone for Through-pedicle Procedures in the Thoracic and Lumbar Spine," European Spine Journal, Vol.16, No.8, pp.1215-1222, 2007.
[61] Ritza, A., "Lumbar Spine Anatomy," <https://dralexritza.com/sciatic-low-back-pain/>, accessed on 30 May 2016.