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研究生：	黃建榮 Wong, Kin Weng
論文名稱：	3D列印鈦合金植入體於骨科手術之整合應用：從客製化重建之方法學驗證至新型標準化脛距跟骨骨髓內釘之開發 Integrated Application of 3D-Printed Titanium Alloy Implants in Orthopedic Surgery: From Methodological Validation in Patient-Specific Reconstruction to the Development of Novel Standardized Tibiotalocalcaneal Nail
指導教授：	楊岱樺 Yang, Tai-Hua
共同指導:	林峻立 Lin, Chun-Li
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：	2026
畢業學年度：	114
語文別：	英文
論文頁數：	90
中文關鍵詞：	3D列印、脛距跟關節融合術、有限元素分析、骨整合、客製化植入物
外文關鍵詞：	3D printing, Tibiotalocalcaneal arthrodesis, Finite element analysis, Osseointegration, Patient-specific implant
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3D列印技術（或稱積層製造）的快速發展徹底改變了骨科手術。它能夠製造傳統製造製程無法實現的複雜鈦合金幾何形狀，為複雜的解剖缺陷和功能性植入物優化提供了解決方案。本研究提出了一個全面的兩階段研究框架，首先對患者特異性重建進行方法學驗證，然後系統地開發和優化新型標準化脛距跟骨（TTC）髓內釘。
本研究首先進行一項涉及複雜患者客製化遠端股骨重建的策略性試驗研究，旨在建立可靠的數位化到物理的工作流程。透過整合電腦斷層掃描（CT）重建、電腦輔助設計（CAD）和非線性有限元素分析（FEA），本研究驗證了設計平台的預測精度。至關重要的是，FEA模擬在製造前識別出了晶格結構中的關鍵應力集中弱點，因此需要對幾何形狀進行最佳化，將銳角調整為圓角。此階段為大骨缺損提供了一個可行的肢體重建方案。更重要的是，它也確立了模擬驅動設計作為開發可承重植入物的可行方法。
基於此已驗證的方法，第二階段著重於解決踝關節融合手術中常用的傳統TTC髓內釘持續存在的機械缺陷，特別是生物力學不穩定性及壓縮不足。本研究開發了一種新型標準化髓內釘，其特點是具有三葉形橫截面和多導自壓縮螺紋系統。對比電腦計算分析和力學測試顯示，與圓形設計相比，三葉形幾何結構可將切向位移降低高達25%，而多導程螺紋機制可產生約40%的自壓縮力。這些幾何創新有效地解決了傳統植入物的機械缺陷，使治療方式從被動固定轉變為主動穩定。
最後階段旨在解決平衡機械強度和骨整合的終極挑戰。透過豬模型研究，本研究優化了植入物的多孔結構，以平衡孔隙率和強度之間的權衡。結果顯示純晶格結構雖然具有優異的生物潛力，但在生理負荷下容易發生疲勞失效。因此，本研究開發了一種「肋條增強型」晶格結構（TTC 4），在多孔支架內採用實心肋條作為承重支撐。與純晶格結構相比，這種優化設計將機械斷裂強度提高了161%，同時促進的新骨形成量比實心釘高出400%以上。本研究得出的結論為，採用兩階段研究框架驗證的功能梯度結構能夠在不影響機械安全性的前提下實現良好的骨整合。本研究結果促成了新型多功能TTC髓內釘的設計與開發，為下一代產品的研發奠定了基礎。

The rapid development of 3D printing technology (or additive manufacturing) has revolutionized orthopedic surgery. It enables the fabrication of complex titanium alloy geometries that are impossible with traditional manufacturing processes, providing solutions for complex anatomical defects and functional implant optimization. This research proposed a comprehensive two-stage research framework, starting with methodological validation of patient-specific reconstructions and progressing to the systematic development and biological optimization of novel standardized tibiotalocalcaneal (TTC) intramedullary nails.
This study began with a strategic pilot study involving complex patient-specific distal femoral reconstruction, aiming to establish a reliable digital-to-physical workflow. By integrating computed tomography (CT) reconstruction, computer-aided design (CAD), and nonlinear finite element analysis (FEA), the study validated the predictive accuracy of the design platform. Crucially, FEA simulations identified key stress concentration points in the lattice structure prior to manufacturing, necessitating geometry optimization from acute angles to rounded corners. This phase provided a feasible limb salvage solution for large bone defects. More importantly, it also established simulation-driven design as a viable methodology for developing reliable load-bearing implants.
Based on this validated methodology, the second phase focused on addressing the persistent mechanical failures of traditional TTC intramedullary nails commonly used in ankle fusion surgery, particularly mechanical instability and insufficient compression. This study developed a novel standardized intramedullary nail characterized by a trilobular cross-section and a multi-lead self-compressing thread system. Comparative computational analysis and mechanical testing showed that, compared to a circular design, the trilobular geometry reduced tangential displacement by up to 25%, while the multi-lead mechanism generated approximately 40% compression. These geometric innovations effectively addressed the fundamental mechanical defects of traditional implants, shifting the treatment modality from passive fixation to active stabilization.
The final phase aimed at addressing the ultimate challenge of balancing mechanical strength and osteointegration. Through a pig model study, the porous structure of the implant was optimized to balance the trade-off between porosity and structural integrity. Results showed that while pure lattice structures possessed excellent biological potential, they were prone to fatigue failure under physiological loads. Therefore, this study developed a "rib-reinforced" lattice structure (TTC 4), employing solid ribs as load bearing supports within a porous scaffold. Compared to pure lattice structures, this optimized design improved mechanical fracture strength by 161% while promoting more than 400% greater new bone formation than the solid nail. This research concluded that functionally graded structures validated using a two-stage research framework could achieve good osseointegration without compromising mechanical safety. The findings facilitated the design and development of a novel multifunctional TTC intramedullary nail, laying the foundation for the development of next-generation products.

中文摘要		ii
Abstract		iii
Acknowledgements	v
Table of Contents	vi
List of Tables	ix
List of Figures	x
Chapter 1: Introduction	1
1 Background and Clinical Challenges in Orthopedics	1
2 The Transformative Potential of 3D Printing in Orthopedics	2
3 Research Framework and Objectives: The Two-Stage Research Strategy	3
Chapter 2: Literature Review	6
1 Tibiotalocalcaneal (TTC) Arthrodesis	6
2 Key Biomechanical Principles in Orthopedic Implant Design	8
2.1 Stress Shielding Effect	8
2.2 Strain and Bone Healing	9
3 Advances in Medical 3D Printing	9
3.1 Current Applications in Orthopedics	9
3.2 Advantages of 3D Printing over Traditional Manufacturing	10
3.3 Limitations and Challenges of 3D Printing in Orthopedic Applications	11
3.4 Material Selection for 3D Printed Implants	12
4 The Role of Digital Medicine	13
4.1 The "Digital-to-Physical" Workflow in Preoperative Planning	13
4.2 Finite Element Analysis (FEA) in Device Optimization	13
5 Summary and Identification of Research Gaps	14
Chapter 3: Pilot Study: Validation of the Digital-to-Physical Workflow via Patient-Specific Distal Femoral Reconstruction	16
1 Introduction	16
1.1 The Imperative of Methodological Validation	16
1.2 Strategic Pilot Study	16
2 Materials and Methods (Case Study)	17
2.1 Patient-Specific Data Acquisition and Implant Design	17
2.2 Non-linear Finite Element Analysis (FEA) Setup	19
3 Results	21
3.1 Finite Element Analysis of von Mises Stress Distribution	21
3.2 Overall Construct Displacement Analysis	23
3.3 Strain Distribution at Implant-Bone Interface	24
3.4 Post-Manufacturing Quality Assessment	26
4 Discussion	27
4.1 The Significance of Stress Concentration Analysis	27
4.2 A Balanced Biomechanical Environment	28
4.3 The Necessity of Enhanced Fixation Strategies	28
4.4 Regulatory Challenges and Clinical Translation of 3D-Printed Customized Implants	28
4.5 Limitations of the Pilot Study	29
5 Summary of Pilot Study	29
Chapter 4: Development of a Novel TTC Nail: Addressing Mechanical Instability via Trilobular Design and Self-Compression	30
1 Introduction	30
2 Materials and Methods	30
2.1 Implant Design and Fabrication	30
2.2 Compression Test of the TTC Tri-nail	32
2.3 Finite Element Analysis	34
2.4 Four-point Bending Fatigue Testing	35
3 Results	37
3.1 Compression Effect Analysis	37
3.2 Finite Element Analysis Results	38
3.3 Mechanical Strength Test Results	41
4 Discussion	43
4.1 The Trilobular Cross-section design	43
4.2 Resolving the Compression Deficit with Multi-lead Mechanism	44
4.3 Mechanical Reliability of 3D Printed Titanium Implant	44
5 Summary	45
Chapter 5: Optimization of Biological Integration: Balancing Porosity and Strength in TTC Nail Design	46
1 Introduction	46
2 Materials and Methods	46
2.1 The Design and Manufacture of 3D-Printed TTC Nails	46
2.2 Manufacturing Process and Quality Control	48
2.3 Mechanical Testing	50
2.4 In Vivo Animal Study	51
2.5 Imaging and Analysis	52
3 Results	54
3.1 Manufacturing Precision and Quality Control	54
3.2 Mechanical Performance Analysis	55
3.3 Surgical Outcomes and Complications	56
3.4 Compression Mechanism Effectiveness	57
3.5 Bone Integration and Osteointegration Analysis	58
4 Discussion	60
4.1 Lessons from Porosity and Mechanical Failure	60
4.2 Solution: Strategic Rib Reinforcement (TTC 4)	60
4.3 Dual-Lead Compression Mechanism	61
4.4 Clinical Implications and Limitations	61
5 Summary	62
Chapter 6: Comprehensive Discussion	63
1 Evolution of the 3D Printing Platform: From Customization to Standardization	63
2 From Simulation to Reality	64
3 Balancing Mechanical Performance and Biological Function	65
4 A New Paradigm in Ankle Arthrodesis: The Clinical Significance of Enhanced Mechanical Stability and Active Compression	66
Chapter 7: Conclusion and Future Work	69
1 Conclusion and Major Contributions	69
2 Future Work and Clinical Translation	70
References		72
                                    

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