Willmann G
CeramTec AG, Medical Products Division, Plochingen, Germany.
Clin Orthop Relat Res. 2000 Oct(379):22-8. doi: 10.1097/00003086-200010000-00004.
In the 1970s it was first realized that the properties of alumina ceramics could be exploited to provide better implants for orthopaedic applications. Applications depend on the fact that ceramics provided wear characteristics suitable for bearing surfaces in total hip replacement. Resultant orthopaedic use had more than 20 years' clinical success. To date more than 2.5 million alumina femoral heads have been implanted. Published reports of fracture rates of the alumina heads range between 0% for ceramics manufactured after 1990 and 13.4% for ceramics manufactured before 1990. These high fracture rates were caused by materials manufactured by companies that are not on the market today. These old aluminas had a low density, had a very coarse microstructure, and were not in compliance with specifications that are valid today. Materials scientists have substantially improved the mechanical strength of alumina. There are three generations of medical grade aluminas. The latest generation is an alumina that is hot isostatic pressed, laser marked, and proof tested. This material has been on the market since 1994. The fracture rates of the most commonly used ceramics have been analyzed by various groups, and are based on .5 million femoral heads to 1.5 million femoral heads. The fracture rate of ceramic Biolox femoral heads are 0.026 % for first generation alumina, 0.014% for second generation alumina, and 0.004% for femoral heads manufactured after 1994. Analyzing the clinical experience of more than 20 years, it can be concluded that all the improvements have produced reliable ceramic femoral heads.
20世纪70年代,人们首次意识到氧化铝陶瓷的特性可用于制造更适合骨科应用的植入物。这些应用基于这样一个事实:陶瓷具有适合全髋关节置换中承重表面的磨损特性。由此产生的骨科应用已取得了20多年的临床成功。迄今为止,已植入了超过250万个氧化铝股骨头。已发表的氧化铝股骨头骨折率报告显示,1990年后生产的陶瓷骨折率为0%,而1990年前生产的陶瓷骨折率为13.4%。这些高骨折率是由如今已不在市场上的公司生产的材料导致的。这些旧的氧化铝密度低,微观结构非常粗糙,不符合如今有效的规格。材料科学家已大幅提高了氧化铝的机械强度。有三代医用级氧化铝。最新一代是经过热等静压、激光标记和验证测试的氧化铝。这种材料自1994年起投放市场。不同团队分析了最常用陶瓷的骨折率,分析基于50万个至150万个股骨头。第一代氧化铝陶瓷Biolox股骨头的骨折率为0.026%,第二代氧化铝为0.014%,1994年后生产的股骨头为0.004%。分析20多年的临床经验可以得出结论,所有这些改进都生产出了可靠的陶瓷股骨头。