氧化素全膝关节置换术与钴铬设计的12年疗效比较:来自澳大利亚骨科协会国家关节置换术登记处的17,577个假体的分析

C. Vertullo, P. Lewis, S. Graves, L. Kelly, M. Lorimer, P. Myers
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引用次数: 26

摘要

背景:氧化锆(Oxinium)被引入作为钴铬(CoCr)的替代承载表面,以减少聚乙烯磨损和减少全膝关节置换术的无菌机械故障。虽然非比较报告被认为是有希望的,但我们意识到没有短期或长期的临床研究表明Oxinium在聚乙烯上作为承载表面的优势。使用来自全国关节置换登记的数据,我们比较了使用Oxinium股骨假体和使用相同假体设计但使用CoCr股骨假体的全膝关节置换术(TKA)后的长期结果。方法:该队列包括17577例采用非交联聚乙烯骨水泥的Genesis-II十字保留全膝关节置换术,其中11608例采用CoCr股骨假体,5969例采用Oxinium股骨假体。对1999年9月1日至2013年12月31日期间在澳大利亚进行的骨水泥gen - ii Oxinium和CoCr保留椎体tka的翻修风险累积百分比和风险比(HR)进行了评估。此外,还探讨了年龄和髌骨表面修复的诊断及影响。结果:对于所有翻修原因,Oxinium组和CoCr组在任何年龄组翻修风险的HR均无差异(HR = 0.92[95%可信区间(CI), 0.78 ~ 1.08];P = 0.329),松动或溶解,或无菌原因,但≥75岁患者组的松动或溶解除外(P = 0.033)。在这些患者中,使用Oxinium股骨假体的TKA具有更高的翻修率。年轻患者优先接受Oxinium股骨假体。髌骨置换或非髌骨置换不影响翻修风险。在12年时,CoCr Genesis-II假体的累计修正率为4.8% (95% CI, 4.2%至5.4%),Oxinium Genesis-II假体的累计修正率为7.7% (95% CI, 6.2%至9.5%)。结论:在这项涉及相同假体设计的队列研究中,与相同的CoCr股骨假体相比,Oxinium股骨假体在所有年龄组(包括<55岁的患者)中并没有降低所有原因的翻修率,松动或松解,或者当感染作为翻修原因被移除时。Oxinium组分的累积修正百分比大于CoCr组分。证据等级:治疗性III级。有关证据水平的完整描述,请参见作者说明。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Twelve-Year Outcomes of an Oxinium Total Knee Replacement Compared with the Same Cobalt-Chromium Design: An Analysis of 17,577 Prostheses from the Australian Orthopaedic Association National Joint Replacement Registry
Background: Oxidized zirconium (Oxinium) was introduced as an alternative bearing surface to cobalt-chromium (CoCr) in an attempt to reduce polyethylene wear and decrease aseptic mechanical failure of total knee replacements. While noncomparative reports have been described as promising, we were aware of no short or long-term clinical studies showing the superiority of Oxinium on polyethylene as a bearing surface. Using data from a comprehensive national joint replacement registry, we compared the long-term outcomes after cruciate-retaining total knee arthroplasty (TKA) with an Oxinium femoral component and those with the same prosthetic design but with a CoCr femoral component. Methods: The cohorts consisted of 17,577 cemented Genesis-II cruciate-retaining total knee replacements using non-cross-linked polyethylene, which included 11,608 with CoCr femoral components and 5,969 with Oxinium femoral components. The cumulative percent revision and hazard ratio (HR) for revision risk were estimated for the cemented Genesis-II Oxinium and CoCr cruciate-retaining TKAs performed in Australia from September 1, 1999, to December 31, 2013. In addition, the revision diagnoses and the effects of age and patellar resurfacing were examined. Results: No difference in the HR for revision risk was found between the Oxinium and CoCr cohorts for any age category for all causes of revision (HR = 0.92 [95% confidence interval (CI), 0.78 to 1.08]; p = 0.329), loosening or lysis, or aseptic causes, except for loosening or lysis in the group of patients who were ≥75 years old (p = 0.033). In these patients, TKA with Oxinium femoral components had a higher rate of revision. Younger patients preferentially received Oxinium femoral components. The revision risk was not affected by patellar resurfacing or nonresurfacing. At 12 years, the cumulative percent revision was 4.8% (95% CI, 4.2% to 5.4%) for the CoCr Genesis-II prosthesis compared with 7.7% (95% CI, 6.2% to 9.5%) for the Oxinium Genesis-II prosthesis. Conclusions: In this cohort study involving the same prosthetic design, Oxinium femoral components did not reduce revision rates for all causes, loosening or lysis, or when infection as a cause of revision was removed compared with the same CoCr femoral component across all age groups including patients who were <55 years old. The cumulative percent revision was greater for the Oxinium components than for the CoCr components. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
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