臺灣博碩士論文加值系統

在這個新的世紀，人類的壽命隨著文明發展逐漸地延長，愈多國家面臨著人口老年化的窘境，雖然人類變得較長壽，但是老年疾病卻從未消失，退化性關節炎就是其中一種。它發生的機率與患者的年齡成正比，嚴重的患者須接受全人工關節置換手術( Total Knee Arthroplasty or Total Hip Arthroplasty；TKA or THA )。因此，人工關節的市場目前仍不斷地增大中。
目前TKA元件發展已逐漸成熟，但在設計上仍有許多需要改進的地方，尤其是元件的抗疲勞特性。目前在文獻上仍非常罕見對於TKA疲勞特性的探討，因此發生人工關節疲勞破壞的病例逐漸地被發現。
本研究利用有限元素法並輔以文獻上實驗的資料，相互驗證以證實數值分析方法的可靠性。文中並對於Metal Backed Tibial Components (MBT)以及All-Polyethylene Tibial Component (APT)兩種TKA不同設計的脛骨組件進行疲勞特性分析與探討，並且以設計的觀點討論與改善元件抗疲勞破壞能力，提供往後TKA元件設計者較適當的設計方向。
雖然目前TKA市場仍以較高價的MBT為主流，但研究結果證明低價位的APT比MBT有較優良的抗疲勞特性。藉由本研究結果，建議專業骨科醫師在臨床上能考量患者實際狀況，推薦弱勢患者使用成本較低的APT進行關節置換手術。

In recent years, the metal-backed tibial components (MBT) is still the mainstream product in total knee arthroplasty (TKA) market though it has higher price compared with all-polyethylene tibial component (APT). Talking about the reasons of malfunction of TKA, the original one is worn-out problem, and the new issue found recently is fatigue failure problem. Most of the malfunctions of TKA occur in MBT system. Even though some investigators had published the experimental and finite element fatigue analyses of the tibial metal base-plate. Till now, no literature report or discussion focuses on the fatigue performances of MBT and APT simultaneously. The major purpose of our research is to investigate and compare the fatigue performances of MBT and APT based on the same boundary conditions. We also propose two different designs and try to improve the fatigue failure-resistant capabilities of MBT and APT.

The fatigue of MBT and APT of the total knee arthroplasty TKA are analyzed by using the computer-aided engineering analysis methods (CAE). In our studies, the fatigue failure-resistant capability of APT is more reliable than MBT. Results show MBT will fail when the osteolysis degree reaches 0.3mm, but APT will not fail until the osteolysis degree exceeds 0.6mm. Furthermore, we also discuss the design characteristics that affect the fatigue failure-resistant capability of TKA tibial components. We conclude that high stiffness structure has positive effect to improve the fatigue ability of MBT, and high toughness material has positive effect to improve the fatigue ability of APT.
According to our researches, we recommend that professional orthopedist can priorly suggest TKA patients to choose APT while considering the clinical situations. Cheaper and durable TKA is desired by whole patients.

誌 謝 I
摘 要 III
ABSTRACT IV
目 錄 VI
圖 目 錄 X
表 目 錄 XV
第一章 前言 - 1 -
1-1 研究背景 - 1 -
1-2 膝關節簡介 - 2 -
1-3 膝關節的疾病 - 5 -
1-3.1 退化性關節炎（Osteoarthritis） - 6 -
1-4 TKA簡介 - 8 -
1-4.1 TKA的構造 - 9 -
1-4.2 TKA在材料上的要求 - 12 -
1-4.3 TKA失敗的主因 - 13 -
1-4.4 TKA脛骨元件破壞的主因 - 13 -
1-4.5 近年TKA因金屬疲勞而導致失敗的案例 - 15 -
1-5 材料的疲勞 - 17 -
1-5.1 疲勞損傷 - 17 -
1-5.2 疲勞破壞特徵 - 18 -
1-6 疲勞相關定義 - 20 -
1-6.1 S-N曲線 - 21 -
1-6.2 Linear Damage Rule - 22 -
1-6.3 載荷型態 - 23 -
1-6.4 主應力修正 - 24 -
1-6.5 主應力修正關係式 - 25 -
1-7 研究動機與目的 - 27 -
1-8 文獻回顧 - 29 -
1-8.1 測試規範 - 29 -
1-8.2 ASTM與ISO兩者規範差異 - 33 -
1-8.3 疲勞測試相關文獻 - 34 -
第二章 研究方法 - 40 -
2-0 研究流程圖 - 41 -
2-1 三維實體模型的建立 - 42 -
2-2 有限元素分析 - 48 -
2-2.1 有限元素分析工具 - 49 -
2-2 材料性質的設定 - 51 -
2-3 網格模型的建立與其收斂測試 - 53 -
2-4 邊界條件 - 54 -
2-4.1 骨溶解程度 - 56 -
2-4.2 拘束 - 60 -
2-5 載荷 - 61 -
2-5.1 載荷位置 - 61 -
2-5.2 載荷大小 - 62 -
2-5.3 應力比與載荷頻率 - 63 -
2-6 後置處理 - 63 -
2-6.1 von Mises Stress - 64 -
2-7 應力集中與破壞位置判定 - 65 -
2-8 預測疲勞行為 - 65 -
第三章 結果 - 66 -
3-1 收斂測試 - 67 -
3-2 收斂測試結果 - 70 -
3-3 有限元素分析結果與實驗成果驗證 - 75 -
3-3.1 Baseplate系統有限元素分析結果與驗證 - 75 -
3-3.2 PE Insert系統有限元素分析結果與驗證 - 79 -
3-4 有限元素分析結果 - 83 -
3-5 疲勞特性分析分析 - 96 -
第四章 討論 - 104 -
4-1 與臨床資料對照 - 105 -
4-2 APT的優勢 - 106 -
4-3 MBT元件間的微移動 - 108 -
4-3 肋長度與疲勞特性 - 110 -
4-4 超高分子量聚乙烯層厚度與疲勞特性 - 122 -
4-5 UHMWPE機械性質的改變對疲勞特性的影響 - 134 -
4-5.1 取得UHMWPE材料樣本 - 135 -
4-5.2 取得UHMWPE材料性質 - 136 -
4-5.3 以有限元素法模擬UHMWPE拉伸試驗 - 140 -
4-5.4 改變UHMWPE材質對APT疲勞特性的影響 - 142 -
第五章 結論 - 148 -
參考文獻 - 150 -

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