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系統識別號 U0026-2607201117432600
論文名稱(中文) 長入軟組織後之人工韌帶力學特性
論文名稱(英文) Mechanical Property of LARS Artificial Ligament after Tissue Ingrowth
校院名稱 成功大學
系所名稱(中) 醫學工程研究所碩博士班
系所名稱(英) Institute of Biomedical Engineering
學年度 99
學期 2
出版年 100
研究生(中文) 王焯林
研究生(英文) Cho-Lin Wang
學號 p8891107
學位類別 博士
語文別 英文
論文頁數 92頁
口試委員 指導教授-張志涵
口試委員-蘇芳慶
口試委員-曾慶誠
口試委員-蔡昆宏
口試委員-張立東
口試委員-許瑞廷
中文關鍵字 LARS人工韌帶  前十字韌帶  長入軟組織  力學特性 
英文關鍵字 LARS artificial ligament  anterior cruciate ligament  tissue ingrowth  mechanical property 
學科別分類
中文摘要 使用LARS人工韌帶替代膝關節十字韌帶斷裂後重建術時之替代韌帶,始自於1980年代。雖説骨科醫師及生物材料力學專家,莫不期望被植入之人工韌帶可以於植入後,逐漸於人工韌帶內長入類似韌帶內結締組織構造之軟組織,以取代會隨著時間,因人工材質材料疲乏而逐漸失去原先張力的人工韌帶。目前雖有一些學著提出他們的研究報告證實,軟組織確實可以長入人工韌帶內。也有學者做過研究指出,纖維細胞可以和由聚酯纖維編織而成的人工韌帶具有良好的生物相容性,該細胞並可以於該材質間順利增生繁殖。Guidoin等人根據臨床上接受人工韌帶重建術後失敗而取出之人工韌帶做一系列分析,並下結論認為植入之人工韌帶會因長入軟組織而破壞其完整性,導致強度上的減弱,因而不認同人工韌帶長入軟組織後會帶來正面效果。 Poddevin等人則根據實驗室內之摩擦實驗結果,他們認為長入人工韌帶內的結締組織將可減少聚酯纖維間的摩擦,因而具有正面意義。迄今,長入軟組織後之人工韌帶其力學特性變化如何,仍未明瞭。這篇研究的目的是要根據動物實驗來瞭解長入軟組織後之人工韌帶其張力特性的變化及該人工韌帶生物相容性如何。在這個實驗裡,我們同時將26位接受LARS人工韌帶置換術後8至15年的病例加以分析。在動物實驗裡,我們分析的方法包括裸視解剖學、微電腦斷層分析、最大張力測試、掃瞄電子顯微鏡分析和組織病理切片檢視。臨床病例分析方法包括病患手術前及手術後,前十字韌帶往前牽引之位移量比較、Lyshom及Tegner指數比較及退化性關節炎變化比較。最後之推論,則根據動物實驗與臨床病例分析結果比較而來。本實驗,我們採用LARS人工韌帶。該人工韌帶設計結構不同於以往其他的人工韌帶。LARS人工韌帶設計中段位於關節內的部分,其聚酯纖維並未用橫向的纖維加以紮實編織,而是由多束的平行纖維所組成,且模擬左右前十字韌帶解剖學上扭轉走向先行預扭90度而成,如此設計有利於減少活動時纖維間之摩擦,並有利於軟組織長入其內。本實驗使用七條LARS人工韌帶,將其中五條分別固定於約十五公分長的骨板上,韌帶中段繼續維持原設計預扭90度,韌帶兩端有橫向編織紮實的部分則以矽質引流管套住,以避免軟組織長入其內。然後將其分別植入麝香豬腹部皮下組織內。另外剩下的兩條人工韌帶則作為對照組作為比較。其中一條韌帶,術後韌帶自傷口滑出,因而捨棄。六個月後,取出其餘的四條韌帶做力學張力特性、電腦斷層、掃瞄電子顯微鏡和組織病理相容性等研究。另外,我們將彰化秀傳紀念醫院最近十多年來曾經接受以LARS人工韌帶做前十字韌帶重建術後的臨床結果加以分析。動物研究結果顯示,纖維母細胞及膠原纖維長入人工韌帶中段未編織部分情況良好。然而,組織病理切片卻發現有12.2±2.2%的聚酯纖維旁出現異物巨大細胞。從實驗動物取出的四條人工韌帶,其力學張力-位移曲線顯示,具有類似人類韌帶的黏彈性特性。然而,該韌帶張力強度和未植入之對照組韌帶相比較卻減少了23.53±18.04%(p<0.001),且該韌帶延伸比增加了69.84±38.38%(p<0.002).經由高倍電子顯微鏡觀察聚酯纖維,並未發現纖維表面出現明顯的裂痕,因此,我們合理的推論,聚酯纖維周圍出現的異物巨大細胞會產生強氧化物,破壞聚酯纖維本身結構,因而減弱聚酯纖維的強度,並改變其力學特性。在臨床病例分析方面,將來自人體膝關節前十字韌帶重建術後數年,不幸失敗之患著,取出已部分斷裂的人工韌帶做力學分析,該人工韌帶張力-位移圖曲線變化,也很明顯表現出和從動物身上取出長有結締組織的人工韌帶一樣具有類似的張力-位移圖曲線變化。換句話說,該失敗之人工韌帶張力-位移曲線圖形與本實驗動物組中作為對照組的人工韌帶張力-位移曲線圖完全不同。但該韌帶最大張力強度的確降低很多。雖然在掃瞄電子顯微鏡檢視時,只有發現少量的結締組織長在聚酯纖維束間。再從臨床人工韌帶重建術後追蹤及分析8到15年,術後結果仍顯示出良好的現象。因此綜合動物實驗及臨床病例分析比對,本篇可做的結論是:LARS人工韌帶容許被植入生物體之結締組織長入其纖維束間。而且一旦長入結締組織後之人工韌帶其力學特性,張力-位移曲線圖和人類前十字韌帶的張力-位移曲線圖有類似的曲線變化,但長入結締組織後的人工韌帶,其最大張力強度會大幅下降約25﹪,但因人工韌帶本身強度遠大於人類十字韌帶的生理強度需求,因此接受人工韌帶重建手術仍是值得的。
英文摘要 LARS (Ligament Augmentation and Reconstruction System) artificial ligament was used as reconstructive material for ruptured anterior cruciate ligament since 1980’s. Orthopaedics and biomedical engineers expected that soft tissue, which was similar to the connective tissue of human ligament, grew into the implanted artificial ligaments after reconstructive procedures to replace the gradually fatigued material of artificial ligament as the time going. Several groups have confirmed that soft tissue grew into the implanted artificial ligament according their study. Some others also confirmed that the PET fibres and fibrous cells had good biocompatibility in their study. They also found the fibrous cells reproduced between the PET fibres. Guidoin et al concluded soft tissue ingrowth of artificial ligament decreased the strength because that integrity of artificial ligament was destructed according to the explanted artificial ligaments which took from the failure clinical cases. They did not agree to the positive effect after soft tissue ingrowth in implanted artificial ligament. According to the experimental results, Poddevin et al concluded that soft tissue ingrowth of artificial ligament decrease the friction of fibres. Therefore, the effect was positive. Up to now the influence of the soft tissue ingrowth of implanted artificial ligament on the mechanical properties of the artificial ligament is uncertain. The purpose of this research was to study the mechanical property and biocompatibility after tissue ingrowth into LARS artificial ligament according to animal experiment. At the same time, in this study we analyzed the finally clinical results of 26 cases who received LARS artificial ligament reconstructive procedure for 8 – 15 years. In animal experiment, we analysed it by gross anatomy, micro-computed tomography study, ultimate extension test, scanning electric microscopy study and histopathological study. In clinical cases, we analysed it by comparison with anterior drawing displacement, Lyshom score, Tegner activity score and degenerative change of osteoarthtitis of pre-operative and post-operative and ultimate tension test of explanted LARS artificial ligament. The final inferences were according to the comparison between the animal experiment and clinical cases analysis. In this study, we adapted LARS artificial ligament. The design of this artificial ligament was different from the past other artificial ligament. The intra-articular fibres of the LARS artificial ligament are designed as unknotted free bundles of fibres set in a pre-twist 900 spiral configuration to mimic the native orientation of the ACL. This special design shall decrease the friction between fibers during movement of joint. On the other hand, the porous structure of the middle part of artificial ligament allows further fibroblastic ingrowth and accumulation of collagen fibers. There were total seven LARS artificial ligaments in this study. Five of them were fixed on the bone plate15 cm in length which kept pre-twist 900 on the middle part the artificial ligament. Two ends of knitted part of artificial ligament were enveloped by Panrose drain to prevent soft tissue ingrowth. These artificial ligaments were implanted subcutaneously in the abdomen of five mini pet pigs. The residual two artificial ligaments serve as control group. One of implanted artificial ligament slid out from the wound. We gave up this sample. After six months of implantation, four successful implants were explanted and tested including ultimate tension test, micro-computed tomography study, scanning electric microscopy study and biocompatibility study by microscopy. In addision, we analysed and compared the final results of clinical cases which received LARS artificial ligament reconstruction on Show Chwan Memorial Hospital in recent 10 years. The results of animal experiment showed that fibroblasts and collagen fibres had well grown into the unknotted middle part of the LARS. However, 12.2±2.2% of PET fibres was surrounded by foreign body giant cells in histopathological study. Force-displacement curve of four explanted LARS artificial ligaments of animal experiment exhibited similar viscoelastic character of human ligament. The tensile strength of the explanted LARS decreased by 23.53±18.04% (p < 0.001) and the elongation of the middle part of the explanted LARS increased by 69.84±38.38% (p < 0.002) in comparison with unimplanted control ligaments. There was no significant cracking or fragmentation on surface of the PET fibers by scanning electric microscopy study. We inferred that strength of PET was decreased and mechanical characters were influenced because foreign body cells around the fibers were persistently releasing potent oxidants to destruct the structure of polymer. In this clinical study, a partial rupture of artificial ligament, which took from the failure case after anterior cruciate ligament reconstruction, was analysed by ultimate tension test. The force-displacement curve of this artificial ligament exhibited similar to force-displacement curve of the explanted artificial ligament, which was grown into much of connective tissue, from the animal experiment. In other words, the force-displacement curve of this artificial ligament was significantly different from the force-displacement curve of the control artificial ligament. The ultimate strength of this artificial ligament, which took from failure clinical case, decreased significantly. Although, just a little of connective tissue grew into the bundle of PET fibres by scanning electric microscopy study. In clinical cases study, which was followed up for 8 to 15 years after artificial reconstruction, the final results revealed satisfactory. According to the results of animal experiment and clinical cases analysis, we inferred that connective tissue was able to growing into the bundles of fibres of LARS artificial ligament. Once the connective tissue grew into the bundles of artificial ligament, the artificial ligament exhibited the similar force-displacement curve as the human anterior cruciate ligament. The ultimate tension strength of this artificial ligament, which contained connective tissue, decreased significantly almost 25%. The ultimate tension strength was far more than the physiological demanding of human ligament. Therefore, it was worth to receive artificial ligament reconstruction.
論文目次 TABLE OF CONTENTS
ABSTRACT I
中文摘要 Ⅴ
致謝 Ⅷ
TABLE OF CONTENTS X
LIST OF TABLES XⅢ
LIST OF FIGURES XⅣ
LIST OF ABBREVIATIONS AND NOMENCLATURE XX
Chapter 1 General Introduction 1
1.1 Background 1
1.2 Gross Anatomy of the anterior cruciate ligament of the knee 3
1.3 Histology of the anterior cruciate ligament of the knee 5
1.4 Mechanical properties of the human anterior cruciate ligament 7
1.5 Literature reviews 10
1.6 General objectives 14
Chapter 2 Materials and Methods 16
2.1 Animal experiment 16
2.1.1 Materials 16
2.1.2 Methods 21
2.1.3 Postoperative care 25
2.1.4 Micro-computed tomography study 25
2.1.5 Mechanical testing 28
2.1.6 Scanning electron microscopy study 34
2.1.7 Histopathological study of the LARS artificial ligament with tissue ingrowths 35
2.1.8 Statistics 36
2.2 Clinical Cases Analysis 37
2.2.1 Patients and Methods 37
2.2.1.1 Patients 37
2.2.1.2 Operative procedure 38
2.2.1.3 Postoperative care and rehabilitation 39
2.2.1.4 Clinical assessment 40
2.2.1.5 Statistics 40
Chapter 3 Results 42
3.1 Animal Experiment 42
3.1.1 Gross observation 42
3.1.2 Micro-computed tomography study 43
3.1.3 Tensile test 46
3.1.4 Scanning electron microscopy study 51
3.1.5 Histopathological study of the LARS artificial ligament with tissue ingrowths 54
3.2 Clinical Cases Analysis 57
3.2.1 Knee Stability 61
3.2.2 Range of Motion 62
3.2.3 Knee function scores 62
Chapter 4 Discussion and Conclusion 64
4.1 Discussion of Animal experiment 64
4.2 Discussion of Clinical Cases Analysis 68
4.3 Conclusion 72
4.4 Future work 73
References 75
Appendix A: The Score of Lysholm and Gillquist for Evaluating Athletes after Knee Ligament surgery 89
Appendix B: Tegner Score of activity level 92
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