【摘要】：研究目的：人工關節(jié)無菌性松動是當前導致人工關節(jié)置換失敗的主要原因之一,而獲得骨-植入物界面的穩(wěn)定又是防止人工關節(jié)無菌性松動的關鍵所在。骨-植入物界面的穩(wěn)定取決于兩者的結合強度,即骨整合的效果,這與植入物的力學性能和表面特征密切相關。鈦具有較好的物理特性和良好的生物相容性,而鈮可以提高鈦合金的可加工性,且能增加鈦的強度,降低彈性模量。多孔表面設計有利于骨組織的長入,隨著骨組織長入到金屬植入物的多孔結構內部,獲得植入物和骨的結合,從而提供良好的生物學固定。本研究利用粉末冶金技術研制具有高孔隙率(60%)和理想力學強度的多孔鈦鈮合金,從生物力學、孔徑及孔隙率、體外生物相容性及體內骨整合效果等方面對該合金進行評估,以了解多孔鈦鈮合金的性能,為多孔鈦鈮合金的臨床應用提供基礎實驗依據。 方法：1.采用粉末冶金技術制作多孔鈦鈮合金并對其生物力學強度、孔徑及孔隙率等進行評估；2.體外生物相容性檢測,包括細胞毒性試驗(MTT),細胞粘附和增殖試驗(丫啶橙染色及掃描電鏡),炎癥因子檢測(IL-6)等；3.動物體內骨整合檢測,將設計好的合金試樣植入新西蘭大白兔股骨近端髓腔,分別于2,4,8周行X線攝片、掃描電鏡、能譜分析及力學拔出實驗。 結果：1.70%孔隙率多孔鈦鈮合金力學強度(抗壓強度為94.8MPa,彈性模量為2.23GPa)和松質骨接近；2.70%孔隙率多孔鈦鈮合金孔徑約為200-500μm,孔隙連通；3.MTT實驗顯示兔骨髓間充質干細胞對鈦鈮合金無毒性反應,材料毒性級別為0-1級；4.細胞粘附和增殖試驗顯示鈦鈮合金對兔骨髓間充質干細胞初期粘附和增殖無明顯影響,電鏡掃描見細胞在多孔鈦鈮合金材料表面生長良好,并向多孔材料孔隙內生長；5.炎癥因子(IL-6)檢測顯示多孔鈦鈮合金未引起明顯炎癥反應；6.新西蘭大白兔股骨近端髓腔多孔鈦鈮合金植入顯示材料植入動物體內未引起明顯炎癥反應,多孔鈦鈮合金植入體無松動；7.X線攝片顯示植入體與股骨皮質之間無低密度影；8.掃描電鏡及能譜分析顯示材料表面有較多鈣沉積,植入體內8周材料與骨緊密結合,類骨組織向材料孔隙內生長,骨整合效果良好,70%孔隙率多孔鈦鈮合金較40%孔隙率組骨整合效果好；9.力學拔出實驗顯示70%孔隙率組和40%孔隙率組拔出力量無顯著性差異(P0.05),但較致密組拔出力量大(P0.05)。 結論： 1.高孔隙率多孔鈦鈮合金具有較理想的抗壓強度和彈性模量； 2.鈦鈮合金具有良好的生物相容性； 3.高孔隙率多孔鈦鈮合金-骨界面骨整合效果良好。
[Abstract]:Objective: aseptic loosening of artificial joint is one of the main reasons for the failure of artificial joint replacement, and the stability of bone-implantation interface is the key to prevent aseptic loosening of artificial joint. The stability of the interface between bone and implantation depends on the binding strength of the two, that is, the effect of bone integration, which is closely related to the mechanical properties and surface characteristics of the implantation. Titanium has good physical properties and good biocompatibility, while niobium can improve the machinability of titanium alloy, increase the strength of titanium and reduce the elastic modulus. The design of porous surface is beneficial to the growth of bone tissue. As the bone tissue grows into the porous structure of metal implantation, the combination of implantation and bone can be obtained, thus providing good biological fixation. In this study, porous titanium-niobium alloys with high porosity (60%) and ideal mechanical strength were prepared by powder metallurgy technology. The biocompatibility in vitro and the effect of bone integration in vivo were evaluated in order to understand the properties of porous titanium-niobium alloy and to provide basic experimental basis for the clinical application of porous titanium-niobium alloy. Methods: 1. Porous titanium-niobium alloy was fabricated by powder metallurgy technology and its biomechanical strength, pore size and porosity were evaluated. Biocompatibility test in vitro, including cytotoxicity test (MTT), cell adhesion and proliferation test (acacia orange staining and scanning electron microscope), inflammatory factor detection (IL-6), etc. The designed alloy samples were implanted into the proximal pulp cavity of New Zealand white rabbits. X-ray film, scanning electron microscope (SEM), energy spectrum analysis and mechanical pullout test were performed at 2, 4 and 8 weeks, respectively. the results were as follows: (1) X-ray film, scanning electron microscope (SEM), energy spectrum analysis (EDS) and mechanical pullout test. Results: the mechanical strength (compressive strength 94.8 MPA, elastic modulus 2.23GPa) of 1.70% porosity porous titanium-niobium alloy was close to that of cancellous bone, and the pore size of 2.70% porosity porous titanium-niobium alloy was about 200-500 渭 m, and the pore size of porous titanium-niobium alloy was about 200-500 渭 m, and the porosity of porous titanium-niobium alloy was about 200-500 渭 m. 3.MTT test showed that rabbit bone marrow mesenchymal stem cells had no toxic reaction to titanium and niobium alloy, and the toxicity grade of the material was 0 鈮，

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