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研究生： 張志偉
Chang, Chih-Wei
論文名稱： 利用保留髓腔方式進行全人工膝關節置換-新式微創手術與器材之研發
Medullae-preserved Total Knee Arthroplasty- The Development of New Minimally Invasive Surgical Techniques and Related Devices
指導教授： 張志涵
Chang, Chih-Han
學位類別： 博士
Doctor
系所名稱： 工學院 - 生物醫學工程學系
Department of BioMedical Engineering
論文出版年： 2019
畢業學年度： 107
語文別： 英文
論文頁數： 70
中文關鍵詞： 全人工膝關節置換 、微創 、髓腔保留 、失血 、手術準確度
外文關鍵詞： total knee arthroplasty, minimally invasive, preservation of medullae, blood loss, surgical accuracy
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    • 研究背景: 全人工膝關節置換手術(Total Knee Arthroplasty, TKA)數目隨老年人口增長急遽增加。但病患常對手術相關風險與併發症存有疑慮；以安全、有效且侵入性小的微創手術(Minimally Invasive Surgery, MIS)進行，遂成其主要訴求。過去研究針對微創手術方式，著重的是減少軟組織的破壞；但對於術中保留骨髓腔的完整性並未多做著墨；且現有多數膝關節置換手術仍採取侵入髓腔的髓腔內導引方式(Intramedullary, IM)來完成多數骨頭的裁切。

    研究目的: 本研究主要目的為探究以保留髓腔方式，也就是以髓外導引方式(Extramedullary, EM)來進行微創膝關節置換，相對於髓腔內導引方式手術所產生的臨床差異；在驗證此方法的臨床優勢後，將依常用手術原理、目標來設計便於術中使用的裁切工具，並藉由臨床成果來證實該工具的安全及有效性。

    研究方法:本研究一共包含了兩項臨床驗證；首先是以回溯式蒐集2013三月-2014六月由同一術者分別以傳統IM與不依賴IM導引的徒手持鋸方式經EM來執行單側首次TKA的125位病患，於住院期間各項臨床數據(特別是失血相關與早期術後功能回復等)來進行比較； 其次，應用所發展出的新式EM輔助切割器具來執行TKA手術，以前瞻式方式蒐集在2017年五月至十一月間以此新式器械輔助下所執行TKA病患，量測其在術後三個月x光影像追蹤的下肢排列角度與植入物位置，與同時期用傳統IM方式進行TKA的結果，來比較兩種不同方式的手術精確度；另外也對兩組病患的早期術後相關數據進行比較，以確認保留髓腔在減少TKA失血的優勢。

    結果: 在第一項研究中，採徒手持鋸EM方式進行TKA的65位病人住院期間失血相關指標，無論是平均血紅素的降低(Hb loss)、估算失血量(Calculated Blood Loss)與凝血相關的D-dimer術後上升程度(D-dimer elevation)，都明顯比傳統IM導引方式進行60例TKA來的少(分別為1.92 vs.2.35g/dL; 618 vs. 756ml及813 vs. 1343 ng/dL; p < 0.05) --顯示術中保留髓腔在減少手術失血的臨床優勢! 接著在第二項研究中，以新式EM輔助切割工具進行的37例TKA與傳統IM方式進行的29例TKA相較，兩組術後影像量測下肢排列與植入物位置的結果相仿(平均機械軸角度2.74 vs. 2.76; 平均縱切面股骨組件角度5.27 vs.3.83; 平均縱切面脛骨組件角度89.9 vs.89.6; p > 0.05)，且兩組未達手術目標(誤差3度內)的病患(outlier)比例相似(9/29 vs. 11/37)，種種代表兩種手術方式的準確度相似；以EM輔助切割工具進行手術，其術後平均失血量(Hb loss)與D-dimer上升程度仍較傳統IM方式來的少(分別為1.9 vs.2.3 g/dL; 681 vs. 1246 ng/dL; p < 0.05)。 此外，兩項研究中，以髓腔外或髓腔內導引方式進行的手術時間相仿，無明顯統計差異。

    結論: 以保留髓腔方式進行全膝人工關節置換，更進一步符合微創精神；不論是由徒手持鋸或依新式EM輔助切割工具進行，相較於傳統髓腔內導引方式都可以有效減少手術失血與凝血相關風險，對於臨床上特定病患有其顯著效益!

    Most total knee arthroplasties (TKA) are executed using intramedullary (IM) instruments with certain risks and complications, though which is a cost-effective surgical intervention for the end stage of arthritic knees. To investigate the value of medullae preservation in the minimally invasive TKA, two different surgical approaches, intramedullary and extramedullary (EM) referencing, were compared. First a retrospective clinical review enrolling 125 subjects was conducted to compare the early clinical results of each group (IM vs. EM), and which verified the favorable bleeding profiles obtained in the EM group, including fewer hemoglobin reduction after surgery (1.92 vs. 2.35 g/ dL; p = 0.022) and less elevation of the product of clots (813.5 vs. 1342.6 ng/ dL; p = 0.015). After the development of an according EM cutting device, a prospective clinical study enrolling 66 subjects was performed to verify its clinical effectiveness using postoperative radiographic measurements. Similar corrected limb alignment (2.740 vs. 2.760 in mechanical alignments), components positions and even the proportion of radiographic outliers (29.7% vs. 31.0%) to the current IM-TKAs confirmed the surgical accuracy of the new EM devices while preserving the hemostatic benefits (p <0.05). Based on the fewer blood loss as well as the less clot production obtained in the EM-TKA in both studies, the surgical insult can be further minimized in current MIS-TKA through the preservation of bony medullae. The patients with bleeding tendency or intolerable to blood loss will be benefited with these EM techs and devices while undergoing primary TKAs.

    摘要 II 誌謝 VIII CONTENTS IX LIST OF FIGURES XII LIST OF TABLES XIII Chapter 1 INTRODUCTION 1 1.1 Research Background 1 1.2 Development of Knee Prostheses and Indications 2 1.3 Indications for Knee Arthroplasty and Alternative Treatments 7 1.4 Periop Complications and Long-term Outcomes after Knee Arthroplasty……………………..8 1.4.1 Perioperative Complications 8 1.4.2 Long-term Outcomes after TKA 10 1.5 Surgical Principles and Current Instruments 10 1.5.1 Surgical Principles 10 1.5.2 Conventional Guides and Related Issues 12 1.5.3 Updated Instruments for Primary TKAs 13 1.6 Statement of Problems and Rationales 16 1.7 Motivation and Objectives 19 1.7.1 Study 1: Can Extramedullary Preparation Reduce Surgical Invasiveness after TKA… 20 1.7.2 Study 2: Development of New EM Guides in TKA and Clinical Application 21 Chapter 2 MEDULLAE PRESERVATION TO REDUCE SURGICAL TRAUMA OF TOTAL KNEE ARTHROPLASTY 22 2.1 Literature Review and Expected Outcomes 22 2.2 Patients Selection 22 2.3 Surgical Methods and Implants 23 2.4 Assessment Methods 25 2.4.1 Bleeding Related Parameters 25 2.4.2 Other Perioperative Outcomes 26 2.5 Statistical Analysis 26 2.6 Results 26 Chapter 3 DEVELOPMENT OF NEW SURGICAL GUIDES 30 3.1 Design Features 30 3.2 Prototype and Finished Product 32 3.3 Suggested Surgical Procedures 36 Chapter 4 APPLICATION OF NEW JIGS IN PRIMARY TKA 40 4.1 Background and Objectives 40 4.2 Patients Selection 41 4.3 Surgical Methods: IM versus EM Referencing 41 4.4 Assessments 44 4.5 Statistical Analysis 46 4.6 Results 46 Chapter 5 DISCUSSION 50 5.1 Blood Loss - the Optimal Representative for Surgical Assault?.......................................50 5.2 Prolonged Surgical Duration- the Destiny of EM-TKA?...................................................52 5.3 Clinical Benefits beside Hemostatic Advantage of Medullae Preservation 53 5.4 Application of New EM Devices and associated Economic Impacts................................55 5.5 Limitations and Strengths...............................................................................................57 5.6 Future Directions and Works........................................................................................57 Chapter 6 CONCLUSION 59 REFERENCES 60 APPENDIX………………………………………………………………………… …….70

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