Früh H J, Kaddick C, Willmann G
Klinik für Orthopädie und Sportorthopädie, Biomechanik, Technische Universität München.
Biomed Tech (Berl). 1997 Dec;42(12):369-73. doi: 10.1515/bmte.1997.42.12.369.
Wear of the articulating surfaces of mating components of total hip endoprostheses is the most important technical factor limiting the functional lifetime of the prosthesis. Biolox ceramic femoral heads have been used successfully throughout the world for more than 20 years. In vitro tests and clinical results show that the artificial modular hip joint system employing a Caproman stem and a ball made of Biolox or Biolox -forte is resistant to mechanical failure. The threshold values for burst load and cyclic load prescribed by the FDA are achieved or bettered. Clinical results support those of the in vitro tests. The femoral head made of Biolox or Biolox -forte used in combination with cups and stems made of Caproman thus complies with the required standards.
全髋关节假体配对部件关节面的磨损是限制假体功能寿命的最重要技术因素。Biolox陶瓷股骨头在全球已成功使用20多年。体外测试和临床结果表明，采用Caproman柄和Biolox或Biolox-forte制成的球头的人工模块化髋关节系统抗机械故障。达到或超过了美国食品药品监督管理局规定的爆裂载荷和循环载荷阈值。临床结果支持体外测试结果。因此，与Caproman制成的髋臼杯和柄配合使用的Biolox或Biolox-forte制成的股骨头符合所需标准。
