碳质股骨头生物相容性的动物实验*★

背景：已有大量的临床和体外实验研究表明，低温热解各向同性碳具有优良的生物学性能，但作为人工关节假体涂层，置入髋关节内的研究还鲜见报道，其在人工半髋关节假体置换中的生物学性能还没有得到验证。 目的：通过动物假体置入实验，观察经低温热解各向同性碳(含硅)喷涂后碳质股骨头假体的组织相容性及表面摩擦磨损特性。 设计、时间及地点：动物体内进行碳质人工半髋关节替换，随机对照动物实验，于2008-10/2009-04在解放军第二军医大学动物实验中心完成。 材料：碳质人工半髋关节由吉林市中心医院提供。股骨头以碳石墨材料为基体，沉积含硅的低温热解各向同性碳为涂层。 方法：对16只成年新西兰大白兔进行右侧半髋关节置换术，置入碳质股骨头假体。按照观察时间点随机分为术后6周组4只，术后11周组6只，术后21周组6只，其中21周组从18周开始在动物实验中心草坪上进行诱导性运动，2 h/d。 主要观察指标：通过大体、X射线片、组织切片观察假体置入后的组织相容性及界面摩擦磨损现象。 结果：碳质股骨头假体在动物体内无毒副作用，无明显炎症反应和异物反应，在碳质假体周围发现有新生软骨组织，运动实验后碳质股骨头表面没有明显磨损和碳颗粒游离现象。 结论：涂膜碳质材料作为人工股骨头具有优良的生物相容性和耐磨特能，是一种极具应用前景的人工假体材料。 关键词：碳质股骨头；人工髋关节；生物相容性；新生软骨；磨损

Biocompatibility of carbon femoral head: An animal experiment

BACKGROUND: Previous experiments demonstrated that low-temperature isotropic pyrolytic carbon has excellent biological features. However, the research regarding low-temperature isotropic pyrolytic carbon prosthesis in hip joints, especially the biological features following hemiarthroplasty are poorly understood. OBJECTIVE: Utilizing implantation experiment, the aim of this study was to investigate the biocompatibility, as well as the interface wear properties of carbon femoral head prosthesis, coated with low-temperature isotropic pyrolytic carbon (silicon). DESIGN, TIME AND SETTING: In vivo hemiarthroplasty, randomized controlled animal experiment. The experiment was performed at the Experimental Animal Center, the Second Military Medical University of Chinese PLA, from October 2008 to April 2009. MATERIALS: Carbon femoral head prostheses were supplied by Jilin Central Hospital. The carbon femoral head prosthesis was coated with low-temperature isotropic pyrolytic carbon. METHODS: Carbon femoral head prostheses were implanted in 16 adult New Zealand white rabbits. The rabbits were sacrificed at weeks 6 (n=4), 11 (n=6), 21 (n=6), respectively. Rabbits in the 21-week group were induced to move from 18 weeks with 2 hours per day. MAIN OUTCOME MEASURES: The biocompatibility and the interface wear phenomena of the prostheses were investigated by general observation, X-ray observation and tissue slice observation. RESULTS: The carbon femoral head prostheses implanted in animals produced non-toxic side effects, without significant inflammatory response or foreign body reaction. Furthermore, new cartilage tissue around carbon prosthesis was found, while there was no obvious wear debris after sports experiments. CONCLUSION: The film coating carbon materials have excellent biocompatibility and good wear resistance as femoral head prosthesis. Thus, it is a kind of promising biomaterials in prosthesis manufacturing.