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研究生:林承學
研究生(外文):Cheng Xue Lin
論文名稱:實心椎弓骨釘應用於脊椎融合手術之研究:椎弓骨釘幾何形狀與骨質密度之影響
論文名稱(外文):Biomechanical Study of Solid Pedicle Screws on Spinal Fusion Surgery: Effects of Screw Geometry and Bone Quality
指導教授:戴金龍戴金龍引用關係
指導教授(外文):C. L. Tai
學位類別:碩士
校院名稱:長庚大學
系所名稱:醫療機電工程研究所
學門:工程學門
學類:機械工程學類
論文種類:學術論文
論文出版年:2016
畢業學年度:104
語文別:中文
論文頁數:111
中文關鍵詞:骨釘鬆脫椎弓骨釘骨釘拉出脊椎融合術
外文關鍵詞:Screw looseningPedicle screwSpinal fusion surgeryPullout test
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背景:椎弓骨釘的有效固定始終是骨科界的一大挑戰。過去雖有許多文獻藉由改變骨釘的型態(中空骨釘、擴張式骨釘、實心骨釘)及幾何形狀設計(螺距、螺深、螺徑)來提升骨釘的固定效果,但目前為止,卻少有報告探討實心椎弓骨釘的外/內徑形狀(Outer/Inner Diameter Shape)及螺紋幾何形狀(Thread Shape)等因素,對於術後骨釘固定效果的影響。為此,本研究乃針對前述不同幾何形狀之椎弓骨釘,探討以下兩議題:(1):骨質密度對於骨釘固定效果的影響。(2):預鑿孔大小、骨釘植入扭距與骨釘固定效果三者的關聯性。
方法:採用兩種不同密度(20 pcf、30 pcf)之人造骨材模擬不同骨質密度之人類椎骨。自行設計六款椎弓骨釘,分別為三種不同之螺峰/螺谷投影外型(錐度/錐度、錐度/平行、平行/平行),每種骨釘分別施以兩種不同螺牙形狀(V形牙、方形牙)。實驗方法則是將人造骨材先行施以不同孔徑之預鑿孔後(2.7mm、3.2mm、3.7mm),將前述六款骨釘分別植入人造骨材,骨釘植入時同步量測植入扭距。試件製備完成後,利用材料試驗機,進行骨釘拉出測試。
結果: (1) 相同骨質密度下,V形牙骨釘的拉出強度均顯著高於方形牙骨釘。其中又以螺峰/螺谷形狀為平行/錐度之V形牙骨釘具有最高的拉出強度(p < 0.05);(2)牙形設計(V形牙、方形牙)與骨釘植入扭距二者間無顯著相關性;(3)相同牙形條件下,預鑿孔孔徑愈小,植入扭距與抗拉出強度則愈大;(4) 擴大預鑿孔孔徑大幅降低骨釘拉出強度,其中又以預鑿孔孔徑為3.2 mm者,最為明顯。
結論:高骨質密度、低預鑿孔孔徑、骨釘外/內徑形狀為螺峰平行/螺谷錐度、骨釘螺紋形狀為V形牙的條件下,椎弓骨釘具有最高的穩定性。

Background: Robust fixation of pedicle screws remains challenge for Orthopedist. Previous studies have demonstrated that numerous factors such as screw types (perforation or expansion), screw designs (thread, thread pitch, shaft diameter) are related to screw anchoring strength. However, literatures addressing the influence of screw design including outer/inner diameter shape (cylindrical/ cylindrical, cylindrical/conical, conical/conical) and thread type (square or V-thread) on the screw fixation strength is lacking. Therefore, the aim of this study is to explore the mechanical performance of the aforementioned screws in two-fold: (1) Effect of bone quality on screw fixation strength; (2) Association among pilot-hole size, screw insertion torque and screw fixation strength.
Methods: Two types of synthetic bones (test blocks, 20 pcf and 30 pcf) were used to mimic human vertebral bones with different densities. Six kinds of pedicle screws were recruited. These include three different outer diameter shape/core diameter shape (conical/conical, cylindrical/conical and cylindrical/cylindrical) equipped with two different thread types (square or V-thread). Each screw was inserted into test blocks prepared with different diameters of pilot holes (2.7mm, 3.2mm and 3.7mm). During screw insertion, the insertion torque was measured simultaneously using a torque gauge. Following specimens preparation, screw pullout tests were then conducted using MTS testing machine.
Results: (1). Regardless of bone quality, V-shape groups have higher pullout strength as compared to square-shape groups. Additionally, V-type pedicle screws with cylindrical/conical shape exhibited the highest pullout strength among groups (p < 0.05). (2). No significant association was found between thread type (V- or Square) and insertion torque. (3). For screw with identical thread type (V- or Square), screws with a smaller pilot hole let to an increase in insertion torque and pullout strength. (4). Enlargement of pilot hole significantly reduced pullout strength, particularly for screw with a 3.3 mm pilot hole.
Conclusion: We concluded that V-type pedicle screws with cylindrical/conical shape presented the most robust fixation under circumstance of screws prepared with higher bone density and smaller pilot hole.

目錄
指導教授推薦書
口試委員審定書
致謝 - iii -
中文摘要 - iv -
Abstract - vi -
目 錄 - viii -
圖 目 錄 - xii -
表 目 錄 - xvi -
第一章 緒論 - 1 -
1.1 研究背景 - 1 -
1.2 研究動機 - 2 -
1.3 研究目的 - 3 -
第二章 文獻回顧 - 4 -
2.1椎間盤病變 - 4 -
2.2 椎體融合術 - 5 -
2.3 椎弓骨釘 - 8 -
2.3.1椎弓骨釘簡介 - 8 -
2.3.2 椎弓骨釘與骨質間介面強度 - 9 -
第三章 研究方法 - 17 -
3.1 研究流程概述 - 17 -
3.2 實驗目的 - 18 -
3.3 實驗材料 - 19 -
3.3.1 椎弓骨釘設計 - 19 -
3.3.2 人造骨材 - 22 -
3.4 實驗儀器 - 23 -
3.4.1 材料加工儀器 - 23 -
3.4.2 實驗機台及夾具 - 26 -
3.5 實驗方法 - 28 -
3.5.1 實驗流程圖 - 28 -
3.5.2 第一部份:骨質密度的影響 - 29 -
3.5.3第二部份:預鑿孔徑大小的影響 - 36 -
第四章 結果 - 38 -
4.1 第一部份:骨質密度的影響 - 38 -
4.1.1 拉出強度及植入扭力測試 - 38 -
4.1.2 各型式骨釘在不同骨質密度下之固定效果 - 46 -
4.2 第二部份:預鑿孔徑大小的影響 - 49 -
4.2.1拉出強度及扭力測試 - 49 -
4.2.2 各型式骨釘在不同預鑿孔徑下之固定效果 - 61 -
第五章 討論 - 64 -
5.1 椎弓骨釘改良方法 - 64 -
5.2 骨材嵌入螺牙之體積 - 66 -
5.2.1骨材嵌入螺牙之體積分析 - 67 -
5.3 骨釘固定效果 - 71 -
5.3.1 骨質密度的影響 - 71 -
5.3.2 預鑿孔徑大小的影響 - 72 -
5.3.3 牙形設計的影響 - 74 -
5.3.4 螺紋型態的影響 - 75 -
5.4 實驗限制 - 76 -
第六章 結論 - 77 -
參考文獻 - 78 -
附錄 A - 85 -
附錄 B - 91 -


圖目錄
圖2-1、椎間盤突出示意圖 - 4 -
圖2-2、植入角度示意圖 - 10 -
圖2-3、直柱螺紋及錐柱螺紋骨釘 - 12 -
圖2-4、直柱螺紋與錐柱螺紋骨釘之勁度與拉出強度比較 - 12 -
圖2-5、骨釘與嵌入體積 - 13 -
圖2-6、硬質骨骨釘與鬆質骨骨釘 - 13 -
圖3-1、研究流程 - 17 -
圖3-2、方形牙椎弓骨釘 - 20 -
圖3-3、V形牙椎弓骨釘 - 20 -
圖3-4、六種椎弓骨釘螺紋示意圖 - 21 -
圖3-5、六種椎弓骨釘實體 - 21 -
圖3-6、人造骨材 - 22 -
圖3-7、REXON線鋸機 - 23 -
圖3-8、REXON台式鑽床 - 23 -
圖3-9、虎鉗 - 24 -
圖3-10、游標卡尺 - 24 -
圖3-11、椎弓骨釘鎖入工具設計圖 - 25 -
圖3-12、椎弓骨釘鎖入工具實體 - 25 -
圖3-13、ㄇ形夾具及定位桿 - 26 -
圖3-14、MTS材料試驗機台 - 27 -
圖3-15、實驗流程 - 28 -
圖3-16、適當大小之人造骨材 - 30 -
圖3-17、預鑿孔徑後之人造骨材 - 30 -
圖3-18、人造骨材固定 - 31 -
圖3-19、椎弓骨釘鎖入 - 31 -
圖3-20、椎弓骨釘X-光攝影 - 32 -
圖3-21、椎弓骨釘X-光攝影及植入後骨釘對照 - 32 -
圖3-22、扭力板手 - 33 -
圖3-23、扭力板手量測扭力(一) - 33 -
圖3-24、試件裝上機台(一) - 35 -
圖3-25、試件裝上機台(二) - 35 -
圖3-26、扭力板手測量扭力(二) - 36 -
圖4-1、力與位移曲線(20 pcf) - 39 -
圖4-2、最大抗拉強度(20 pcf) - 39 -
圖4-3、骨釘植入扭力(20 pcf) - 41 -
圖4-4、力與位移曲線(30 pcf) - 43 -
圖4-5、最大抗拉強度(30 pcf) - 43 -
圖4-6、骨釘植入扭力(30 pcf) - 45 -
圖4-7、第一部份力與位移曲線 - 47 -
圖4-8、第一部份最大拉出強度 - 47 -
圖4-9、第一部份植入扭力 - 48 -
圖4-10、力與位移曲線(2.7mm) - 50 -
圖4-11、最大拉出強度(2.7mm) - 50 -
圖4-12、植入最大扭力(2.7mm) - 52 -
圖4-13、力與位移曲線(3.2 mm) - 54 -
圖4-14、最大拉出強度(3.2 mm) - 54 -
圖4-15、植入最大扭力(3.2mm) - 56 -
圖4-16、力與位移曲線(3.7 mm) - 58 -
圖4-17、最大拉出強度(3.7 mm) - 58 -
圖4-18、植入最大扭力(3.7mm) - 60 -
圖4-19、第二部分拉出強度比較 - 62 -
圖4-20、各骨釘預鑿孔徑與植入扭力關係 - 62 -
圖4-21、扭力與拉出強度分布 - 63 -
圖5-1、骨釘搭配骨水泥使用 - 65 -
圖5-2、擴張式骨釘 - 65 -
圖5-3、骨釘拔出前及拔出後對照 - 66 -
圖5-4、骨釘拔出產生骨材導屑 - 66 -
圖5-5、骨材嵌入體積分析(1) - 68 -
圖5-6、骨材嵌入體積分析(2) - 68 -
圖5-7、骨材嵌入體積比較 - 69 -
圖5-8、骨材嵌入體積與最大拉出強度之關係 - 70 -
圖5-9、骨釘最大拉出強度 - 71 -
圖5-10、各骨釘預鑿孔徑與植入扭力 - 73 -
圖5-11、各骨釘於不同預鑿孔徑大小之拉出強度 - 73 -
圖5-12、方形牙與V形牙骨釘比較 - 74 -


表目錄
表4-1、第一部份各骨釘於20 pcf測試塊之拉出強度 - 40 -
表4-2、各骨釘拉出強度之p值(20 pcf) - 40 -
表4-3、第一部份各骨釘於30 pcf測試塊之拉出強度 - 44 -
表4-4、各骨釘拉出強度之p值(30 pcf) - 44 -
表4-5、第二部份各骨釘於預鑿孔徑2.7mm之拉出強度 - 51 -
表4-6、各骨釘拉出強度之p值(2.7mm) - 51 -
表4-7、第二部份各骨釘於預鑿孔徑3.2mm之拉出強度 - 55 -
表4-8、各骨釘拉出強度之p值(3.2mm) - 55 -
表4-9、第二部份各骨釘於預鑿孔徑3.7mm之拉出強度 - 59 -
表4-10、各骨釘拉出強度之p值(3.7mm) - 59 -
表5-1、骨材嵌入體積表 - 69 -



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