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研究生：	柯伯彥 Ko, Po-Yen
論文名稱：	免縫結免導引器微創阿基里斯肌腱急性撕裂傷縫合-臨床個案系列研究及動物模型力學研究 Jigless Knotless Minimally Invasive Repair of Acute Midsubstance Achilles Tendon Rupture: Clinical Case Series and Animal Biomechanical Study
指導教授：	蘇芳慶 Su, Fong-Chin
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：	2022
畢業學年度：	110
語文別：	英文
論文頁數：	96
中文關鍵詞：	阿基里斯肌腱斷裂、微創、力學研究、週期性拉伸測試
外文關鍵詞：	Achilles tendon rupture, minimally invasive, biomechanical study, cyclic loading test
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阿基里斯肌腱斷裂容易發生在從事休閒運動的中年男性族群。目前阿基里斯肌腱手術縫合術式仍舊沒有共識。在過去已發表的文獻，我們可發現傳統開創手術、微創縫合，及經皮縫合這些手術方式各有其擁戴者。但近年來，為了減少傳統開創令人詬病的傷口併發症，已有數種微創手術方式發表於文獻，甚至商業化之微創縫合導引器械也應運而生。但即使在足踝外科醫師的努力下，微創縫合造成的腓神經損傷仍無法克服，其原因為當執行近端肌腱的經皮縫合時，無法辨認腓神經的位置，且腓神經於足跟以上大約七公分位置便會經過阿基里斯肌腱外側，穿針引線時便容易扎傷此處之腓神經，當腓神經受傷後，其臨床症狀為外踝及足部外側之持續麻木感。於是，我們發展了新的微創縫合方式-無導引器無縫結微創縫合，可以避免腓神經損傷。且此種縫合方式簡易且不須額外的縫合導引器械。另外手術後可讓病患提早復健及返回工作崗位及運動生活。
於是，我們設計了一連串的實驗，主要目的有三個: (一) 評估阿基里斯肌腱斷裂的病患再經過無導引器無縫結微創縫合後在臨床上功能的恢復。(二) 以動物阿基里斯基健檢體力學模型，評估無導引器無縫結微創縫合與開創手術及模擬其他商業化導引器械之微創縫合在力學實驗表現的差異。(三) 以動物阿基里斯肌腱檢體力學模型，評估無導引器無縫結微創縫合與臨床上最常使用的開創縫合手術在力學實驗表現的差異。
結果顯示，在追蹤滿一年的臨床表現，病患在接受無導引器無縫結微創手術後功能恢復良好，滿一年之美國骨科足踝學會之後足量表(American Orthopaedic Foot and Ankle Society Ankle–Hindfoot Scale)為滿分，平均術後45.5天可返回工作崗位，147.5天可回復受傷前運動水準，在力學上，我們以1Hz週期性拉伸測試來驗證力學強度，前250個週期為20-100牛頓，第二個250週期為20-190牛頓，最後250個週期為20-369牛頓，存活週期定義為張力迅速地滑落時所需之週期數，無導引器無縫結微創縫合和雙股柯氏縫合(two strand Krackow suture)及其他模擬商業化導引縫合結構的組別包括艾思瑞斯經皮導引阿基里斯肌腱縫合系統(Arthrex Percutaneous Achilles Repair System®)、艾思瑞斯迅速橋接系統( Arthrex Speedbridge®)、阿基隆縫合系統 (Achillon suture jig®) 的比較，拉伸存活週期數分別為552.3 ± 72.8, 204.3 ± 33.3, 395.9 ± 96.0, 641.6 ± 48.7及 397.1 ± 80.9。其中事後比較顯示無導引器無縫結微創縫合及艾思瑞斯迅速橋接系統間無統計學顯著差異，但卻顯著優於其他三個組別(P<0.01)。進一步的力學實驗亦為1Hz週期性拉伸測試，前1000個週期為20-100牛頓，第二個1000個週期為20-190牛頓，最後1000個週期為20-369牛頓，此次存活週期定義為縫合處間隙達到一公分所需週期數，無導引器無縫結微創縫合和其他開創縫合包括四股柯氏縫合(four strand Krackow suture)及三重捆束縫合法(triple bundle repair)的比較，拉伸存活週期束分別為 2073.6 ± 319.9, 1425.3 ± 26 8.9 及2639.3 ± 263.6。事後分析比較三組差異達到統計學顯著差異(P<0.017)。上述結果顯示無導引器無縫結微創縫合達到滿意的臨床預後，且其強度不亞於其他商業化導引器械之微創縫合。另外與其他開創縫合比較，力學強度勝於臨床上最常使用的開創縫合方式(即為四股柯氏縫合法，four strand Krackow suture)。故我們發展的微創縫合方式(無導引器無縫結微創縫合)可安全又有效率的應用在急性阿基里斯肌腱斷裂的病患上。

Middle-aged men are susceptible to sustaining acute Achilles tendon rupture during engagement in recreational sports. The optimal surgical strategy for repairing midsubstance Achilles tendon rupture remains under debate. Techniques include percutaneous, mini-open, and open repair. Minimally invasive surgery techniques have been developed for preventing poor surgical wound healing and open-repair-associated infection. Specially designed commercial suture jigs assist surgeons in performing minimally invasive Achilles tendon repair. However, iatrogenic sural nerve injury has been attributed to percutaneous minimally invasive repair of Achilles tendon rupture. The sural nerve crossed Achilles tendon lateral border about 7 cm above calcaneal insertion site. Thus, when blinded percutaneous suture through the proximal stump of the Achilles tendon, the sural nerve was easily be penetrated by needle or ligated by the suture. In order to prevent sural nerve injury, we had designed the Jigless Knotless Internal Brace (JKIB) technique which could be performed in MIS fashioned.

The objectives of this investigation are listed as follows: 1) To assess the clinical outcomes of individuals undergoing JKIB repair for acute midsubstance Achilles tendon rupture. 2) To investigate the biomechanical characteristics in comparison of the JKIB and other minimally invasive Achilles tendon repair techniques simulating the use of a specially designed commercial suture jig by an animal biomechanical study under a progressive rehabilitation protocol. 3) To compare the JKIB repair method with open repair approaches by an animal biomechanical study under a progressive rehabilitation protocol.

In this case series, one-year postoperation, all patients scored 100 out of 100 points on the American Orthopaedic Foot and Ankle Society Ankle –Hindfoot Scale. The mean of time from surgery to return to work and to preoperative exercise level was 45.5 and 147.5 days, respectively. In biomechanical study, the 1 Hz cyclic loading test was conducted for evaluating the biomechanical strength. The three 250-cycle stages corresponded to cyclic loads of 20–100, 20–190, and 20–369 N, respectively. The survive cycle was defined as the cycles reached to a sudden drop in measured load. The jigless knotless internal brace was compared with two-strand Krackow suture and another suture structure simulating minimal invasive Achilles tendon repair under commercial jig including Arthrex Percutaneous Achilles Repair System®, Arthrex Speedbridge®, and Achillon suture jig®. The survival cycles were 552.3 ± 72.8, 204.3 ± 33.3, 395.9 ± 96.0, 641.6 ± 48.7 and 397.1 ± 80.9 separately. Post hoc analysis showed there was no significant difference between jigless knotless internal brace and Speedbridge. But, they differed from other three groups significantly (P<0.01). We conducted the further cyclic loading test, the three 1000-cycle stages corresponded to 1 Hz cyclic loads of 20–100, 20–190, and 20–369 N, respectively. This time, the survive cycle was defined as the number of cycles lead to 10-mm repair gap. The jigless knotless internal brace was compared with other open repairs including the clinical popular one, four-strand Krackow suture and the biomechanical most robust one, triple buddle repair. The survive cycles showed 2073.6 ± 319.9, 1425.3 ± 26 8.9 and 2639.3 ± 263.6 separately. The post hoc analysis showed the significant difference (p<0.017).
we report the effectiveness of our developed JKIB approach for the repair of acute midsubstance Achilles tendon rupture. Our procedure is a simple and reliable means of enabling early mobilization, as well as a return to weight-bearing exercise and recreational sports, among patients in recovery.
The biomechanical study showed that number of survived cycles in biomechanical testing corresponding to JKIB repair was not lower than those for other minimally invasive repair approaches. Furthermore, JKIB repair was more robust than the four-stranded Krackow sutures (4sK), which the most popular open repair strategy. In summary, the JKIB technique is feasible and reliable for the repair of Achilles tendon rupture.

中文摘要  2
Abstract  5
致謝  7
Table of Contents  9
List of Figures  12
List of Tables  17
Chapter 1 Introduction  18
1 Achilles tendon rupture  18
1.1 Anatomy of Achilles tendon  18
1.2 Epidemiological background  20
1.2 Pathophysiology  21
1.3 Treatment options in acute Achilles tendon rupture  22
1.4 Operation options in Acute Achilles tendon rupture  22
1.5 Complications in open and minimal invasive surgery of acute Achilles tendon repair  29
2 Motivation and objectives	 31

Chapter 2 Materials and Methods	 33
1 Clinical Study of Jigless Knotless Internal Brace Repair of Acute Midsubstance Achilles Tendon Rupture  33
1.1 Patients  33
1.2 Surgical technique  33
1.3 Rehabilitation protocol  37
2 Biomechanical Comparison of the Jigless Knotless Internal Brace Technique with Other Minimally Invasive Repair Methods under a Progressive Rehabilitation Protocol  37
2.1 Sample collection and preparation  37
2.2 Surgical procedure  39
2.3 Biomechanical testing  40
2.4 Statistical analysis  44
3 Biomechanical Comparison of Jigless Knotless Internal Brace Repair and Other Open Repair Approaches Under a Progressive Rehabilitation Protocol – Repair gap analysis  47
3.1 Sample collection and preparation  47
3.2 Surgical procedure  49
3.3 Biomechanical testing  49
3.4 Statistical analysis  52

Chapter 3 Result  55
1 Clinical Result of Jigless Knotless Internal Brace Repair of Acute Midsubstance Achilles Tendon Rupture  55
1.1 Demographic data  55
1.2 Complications  55
1.3 Functional outcomes  55
2 Biomechanical Comparison Result of the Jigless Knotless Internal Brace Technique with Other Minimally Invasive Repair Methods under a Progressive Rehabilitation Protocol  58
2.1 Survived cycles  58
2.2 Cyclic displacement  59
2.3 Failure modes  64
3 Biomechanical Comparison Result of Jigless Knotless Internal Brace Repair and Other Open Repair Approaches Under a Progressive Rehabilitation Protocol – Repair gap analysis  65
3.1 Survived cycles  65
3.2 Number of cycles to repair gap creation  65
3.3 Failure modes  70

Chapter 4 Discussion and Limitations  71
1 Clinical Findings of Jigless Knotless Internal Brace Repair of Acute Midsubstance Achilles Tendon Rupture  71
1.1 Sural nerve injury in previous minimal invasive surgery of Achilles tendon repair  71
1.2 The way to preserve the local vascular circulation when repair the Achilles tendon  72
1.3 The suitable rehabilitation protocol to improve the clinical outcome  73
1.4 The highlights and limitations in the present research  78
2 Biomechanical Comparison of the Jigless Knotless Internal Brace Technique with Other Minimally Invasive Repair Methods under a Progressive Rehabilitation Protocol  79
2.1 The specimen elongation in biomechanical study  79
2.2 The suture structure in comparison groups  79
2.3 The trends of biomechanical strength in comparison groups compared with previous biomechanical research  80
2.4 The difference in failure mode compared with previous biomechanical research  81
2.5 The highlights and limitations in the present research  83
3 Biomechanical Comparison of Jigless Knotless Internal Brace Repair and Other Open Repair Approaches Under a Progressive Rehabilitation Protocol – Repair gap analysis  84
3.1 The repair gap in specimen in biomechanical study  84
3.2 The application in the post operation rehabilitation protocol from the result of present study  84
3.3 The outstanding of suture structure of jigless knotless internal brace compared with four- strand Krackow suture  85
3.4 The highlights and limitations in the present research  86

Chapter 5 Conclusion  88

References	89
                                    

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