5. 結論與未來發展
5.2 未來發展
5.2.2 椎間融合器的發展
從生物力學的分析上，已知 TLIF 融合手術是可行的。但目前市面上，
配合 TLIF 手術專用之融合器的設計，仍有改善的空間。例如材料的選擇、
幾何形狀的規劃、填充補骨的空間等等。若能以現有的分析為基礎，進一 步找出較完整的融合器設計條件，針對現有的產品做最佳化或是開發新產 品，相信可以給予醫師和融合器使用者，在臨床上有更好的選擇。
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附錄A：預負荷對本研究模型的影響
本研究在進行分析時，為模擬腰椎在人體內實際的狀況，在脊椎上施 加了模擬人體自重的的預負荷。因為本研究的腰椎模型在幾何上，有和人 體相同的脊椎前凸(lordosis)，本研究的預負荷施加方式會影響椎節的可動角 度，尤其是在前後彎曲的方向上。表 A- 1 是 INT 模型中，各個動作配合不 同預負荷在 L3-L4 的角度變化。包括：(1)無預負荷(INT-N)；(2)預負荷較靠 近脊椎中央(INT-M，圖 A- 1 黃色箭頭處)；(3) 預負荷較靠近後側(INT-P，
圖 A- 1 綠色箭頭處)。結果顯示施加預負荷會造成椎節可動角度的減少，尤 其是在前後彎曲上。在 INT-M 的情形下，前彎動作僅減少約 0.5°，而在後 彎動作上則剩下不到 1°的變化；而 INT-P 的趨勢則相反，在前彎動作上剩 下不到 1°的變化。
為使預負荷施加後，對於椎節角度的影響最小，在 INT-M 到 INT-P 之 間，取四點作為預負荷施加的中心點，進行僅施加預負荷的分析。表 A- 2 是受預負荷後，預定的植入端(L3-L4)及鄰近端(L2-L3、L4-L5)椎節產生的 角度變化。由表中可知，預負荷施加在 INT_P 的位置時，對植入端椎節的 影響最小，對鄰近端椎節的影響則尚可接受；因為植入端椎節是本研究的 重點，因此以此位置為預負荷施加的中心。
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根據以上分析，模型在植入椎間融合器後，雖然表現出相較於 INT 有 ROM 減少，穩定度增加的情形，但在臨床上小於 1°的動作其實已經滿足融 合所需的穩定度了。在 TLIF-Ad、TLIF-Md、TLIF-Od 的前彎動作比較時，
因為其角度變化都在 1°以內，所以認為前彎動作上的差異，是可以接受的。
表 A- 1 INT 配合不同預負荷位置的角度變化
INT-N (°) INT-M (°) INT-P (°)
Flexion 3.678 3.186 0.785
Extension 3.31 0.943 3.238
Left Lateral Bending 3.816 2.062 2.42 Right Lateral Bending 3.816 2.062 2.42
Left Axial Rotation 2.183 1.928 1.656 Right Axial Rotation 2.183 1.928 1.656
圖 A- 1 INT_M(黃色箭頭)和 INT_P(綠色箭頭)的預負荷施加位置
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表 A- 2 僅施加預負荷的椎節角度變化
L2-L3 (°) L3-L4 (°) L4-L5 (°) INT_M2 0.622 0.396 4.028 INT_M6 0.071 0.840 1.544 INT_M8 1.547 0.657 0.884 INT_P 1.631 0.336 0.768
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附錄B：各模型 ROM 整理.
圖 B- 1 未施加預負荷並配合雙側椎足螺釘系統的 ROM
L2-L3 (Without Preload)
0
Flexion Extension Left Lateral Bending
Right Lateral Bending
Left Axial Rotation
L3-L4 (Without Preload)
0
Flexion Extension Left Lateral Bending
Right Lateral Bending
Left Axial Rotation
L4-L5 (Without Preload)
0
Flexion Extension Left Lateral Bending
Right Lateral Bending
Left Axial Rotation
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圖 B- 2 施加預負荷並配合雙側椎足螺釘系統的 ROM
L4-L5 (With Preload / Double Rods)
0
Flexion Extension Left Lateral TLIF anterior TLIF middle TLIF oblique L2-L3 (With Preload / Double Rods)
0
Flexion Extension Left Lateral TLIF anterior TLIF middle TLIF oblique
L3-L4 (With Preload / Double Rods)
0
Flexion Extension Left Lateral TLIF anterior TLIF middle TLIF oblique
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圖 B- 3 施加預負荷並配合單側椎足螺釘系統的 ROM
L2-L3 (With Preload / Single Rod)
0
Flexion Extension Left Lateral Bending
Right Lateral Bending
Left Axial Rotation TLIF anterior TLIF middle TLIF oblique
L3-L4 (With Preload / Single Rod)
0
Flexion Extension Left Lateral Bending
Right Lateral Bending
Left Axial Rotation TLIF anterior TLIF middle TLIF oblique
L4-L5 (With Preload / Single Rod)
0
Flexion Extension Left Lateral Bending
Right Lateral Bending
Left Axial Rotation TLIF anterior TLIF middle TLIF oblique
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Flexion Extension Left Lateral Bending
Right Lateral Bending
Left Axial Rotation
Rught Axial Rotation
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附錄D：兩節脊椎模型之比較
在得到經驗證後的五節脊椎模型後，因為是第一次使用在植入 TLIF 形 式融合器的分析上，本研究根據 Kettler[23]等人的體外試驗研究，取模型中 的兩個椎節，進行測試和比較。此部分的模型使用 L2 和 L3 兩節脊椎，分 別以傳統 PLIF 方式植入兩顆矩形融合器和以 TLIF 方式植入半月形融合 器。所有的組織移除部份和負荷方式皆參照 Kettler 等人的研究，且該研究 並未使用內固定器。
Kettler 等人的 ROM 分析結果如圖 D- 1 所示，是根據文獻內容的數據 整理而成；而兩節脊椎的分析結果如圖 D- 2 所示。考慮體外測試的個體差 異，在 PLIF 的結果上，結果是相近的。而在 TLIF 的趨勢上，向右彎曲及 向右扭轉的 ROM 皆比體外測試的結果高；向左彎曲及向左扭轉的 ROM 則 比體外測試的結果低。以此現象而言，認為本研究的模型較能確實表現出 小面關節移除與否的差異；且 Kettler 等人的個體差異較大，本研究的 ROM 結果，仍在其差異範圍之內。