アルカリ熱処理生体活性化チタンおよびチタン合金の整形外科用インプラントの開発

本研究的目的如下：1.确认碱处理和热处理钛（AH-Ti）或钛合金（AR-TiA）与骨结合。比较AH-Ti与生物活性陶瓷和多孔钛的骨结合强度.通过碱处理和热处理（AH处理）使市售螺钉或植入物具有生物活性，并将其生物相容性和生物活性与未处理对照品进行比较。观察其骨结合强度随时间的变化，结果表明：1. AH-Ti和AH-TiA在模拟体液中均在其表面形成类骨磷灰石层。（参考文献1）AH-Ti或AH-TiA与兔胫骨化学结合。（参考文献2，3，4）3.将表面光滑的AH-Ti和未处理的Ti圆柱体半穿入犬股骨，证实AH-Ti的骨结合能力。（参考文献5）4.使用具有多孔表面的圆柱体进行与3相同的实验，并且证实了AH处理对骨结合强度的增强。（参考文献6）5. AH-Ti和AH-TiA在高湿条件下保存后，其形成磷灰石的能力下降。在AH处理后立即用蒸馏水洗涤材料被证明可以防止这种劣化。结果表明，AH-Ti的骨结合强度通过这种洗涤处理得到增强。AH-Ti（A）的骨结合能力在多种实验条件下得到了证实。这项技术有望提高骨-假体结合强度，计划今年开始使用AH处理的非骨水泥型髋关节股骨柄进行临床实验。

The purposes of this study were as follows.1. To confirm that alkali- and heat-treated titanium (AH-Ti) or titanium alloy (AR-TiA) bonds to bone.2. To compare the bone-bonding strength of AH-Ti with that of bioactive ceramics or porous titanium.3. To make screws or implants on the market be bioactive using alkali- and heat-treatment (AH treatment), and to compare their biocompatibility and bioactivity with those of untreated control. To examine chronological changes of their bone-bonding strength.As a result, the following facts were clarified.1. Both AH-Ti and AH-TiA formed bone-like apatite layer on their surface in the simulated body fluid. (Ref.1)2. AH-Ti or AH-TiA bonded to rabbit tibiae chemically. (Ref.2,3,4)3. AH-Ti and untreated Ti cylinders with smooth surface were inserted into canine femora hemi-transcortically, and bone bonding ability of AH-Ti was confirmed. (Ref.5)4. The same experiment as 3 was performed using cylinders with porous surface, and enhancement of bone-bonding strength by AH treatment was demonstrated. (Ref.6)5. When AH-Ti and AH-TiA were preserved in high humidity condition, their ability for apatite formation decreased. Washing the material by distilled water just after the AH treatment was proved to prevent this deterioration. It was demonstrated that bone-bonding strength of AH-Ti was enhanced by this washing treatment. (Paper in preparation)The bone-bonding ability of AH-Ti(A) was demonstrated in many experimental condiotions. This technique is expected to enhance bone-prosthesis bonding strength, and a clinical experiment using AH-treated cementless hip stems is planed to start this year.