目的:法国最近的一份报告表明,在全髋关节置换术(THA)中使用钴铬股骨头与扩张型心肌病和心力衰竭的风险增加之间存在关联。钴铬是骨科植入物中常用的材料。如果报告的关联是因果关系,考虑到每年使用钴铬合金的数百万关节置换和其他骨科手术,后果将是巨大的。我们检查了含钴铬的THA是否与全因死亡风险增加有关,心脏结果,癌症,以及大型国家数据库中的神经退行性疾病。
方法:来自国家联合登记处的数据与NHS英国医院374,359例原发性THA的住院事件相关,随访长达14.5年。我们排除了任何双侧THA的患者,膝关节置换,除骨关节炎以外的适应症,55岁以下,以及在THA之前诊断一个或多个感兴趣的结果。植入物分为含钴-铬或不含钴-铬。植入物结构与全因死亡率和心力衰竭的风险之间的关联,癌症,并检查了神经退行性疾病。
结果:有158,677人(42.4%)的植入物含有钴铬。有47,963人死亡,27,332心脏结果,35,720种癌症,和22,025神经退行性疾病。没有证据表明使用钴铬合金植入物的患者具有更高的结局。
结论:含钴铬的THA没有增加全因死亡的风险,或者有临床意义的心脏结果,癌症或神经退行性疾病进入植入后的第二个十年。我们的发现将有助于使临床医生和全球越来越多的接受原发性THA的患者放心,使用含钴铬植入物与明显的不良全身效应无关。
OBJECTIVE: A recent report from France suggested an association between the use of cobalt-chrome femoral heads in total hip arthroplasties (THAs) and an increased risk of dilated cardiomyopathy and heart failure. Cobalt-chrome is a commonly used material in orthopaedic implants. If the reported association is causal, the consequences would be significant given the millions of joint replacements and other orthopaedic procedures in which cobalt-chrome is used annually. We examined whether cobalt-chrome-containing THAs were associated with an increased risk of all-cause mortality, heart outcomes, cancer, and neurodegenerative disorders in a large national database.
METHODS: Data from the National Joint Registry was linked to NHS English hospital inpatient episodes for 374,359 primary THAs with up to 14.5 years follow-up. We excluded any patients with bilateral THAs, knee replacements, indications other than osteoarthritis, aged under 55 years, and diagnosis of one or more outcome of interest before THA. Implants were grouped as either containing cobalt-chrome or not containing cobalt-chrome. The association between implant construct and the risk of all-cause mortality and incident heart failure, cancer, and neurodegenerative disorders was examined.
RESULTS: There were 158,677 individuals (42.4%) with an implant containing cobalt-chrome. There were 47,963 deaths, 27,332 heart outcomes, 35,720 cancers, and 22,025 neurodegenerative disorders. There was no evidence of an association that patients with cobalt-chrome implants had higher rates of any of the outcomes.
CONCLUSIONS: Cobalt-chrome-containing THAs did not have an increased risk of all-cause mortality, or clinically meaningful heart outcomes, cancer or neurodegenerative disorders into the second decade post-implantation. Our findings will help reassure clinicians and the increasing number of patients receiving primary THA worldwide that the use of cobalt-chrome containing implants is not associated with significant adverse systemic effects.