Paxton Elizabeth W, Inacio Maria C S, Kurtz Steven, Love Rebecca, Cafri Guy, Namba Robert S
Surgical Outcomes and Analysis, Kaiser Permanente, 8954 Rio San Diego Drive, Suite 406, San Diego, CA, 92108, USA,
Clin Orthop Relat Res. 2015 Mar;473(3):999-1008. doi: 10.1007/s11999-014-4046-3.
Highly crosslinked polyethylene (HXLPE) was introduced to reduce wear and associated osteolysis in total knee arthroplasty (TKA). However, there is limited clinical evidence that HXLPE is more effective than conventional polyethylene (CPE) in TKA.
QUESTIONS/PURPOSES: (1) Do primary TKAs with HXLPE tibial inserts have a lower risk of revision (all-cause, aseptic, and septic) than TKAs with CPE tibial inserts? (2) In NexGen TKA (Zimmer Inc, Warsaw, IN, USA) bearings, do HXLPE tibial inserts have a lower risk of revision (all-cause, aseptic, and septic) than CPE tibial inserts? (3) In Press-Fit Condylar TKA (PFC or PFC Sigma; DePuy Inc, Warsaw, IN, USA), do HXLPE tibial inserts have a lower risk of revision (all-cause, aseptic, and septic) than procedures performed with CPE tibial inserts?
The Kaiser Permanente Total Joint Replacement Registry was used to identify primary TKAs (N = 77,084) performed during the study period (April 2001 to December 2011) with cobalt-chromium alloy on CPE (CoCr-CPE) and CoCr-HXLPE bearings. The registry has 95% voluntary participation and less than 9% were loss to followup during the 10-year study period. A total of 60,841 (79%) had CoCr-CPE bearings, 11,048 (14%) had CoCr-HXLPE bearings, and 5195 (7%) were unknown. Specific knee implant designs (NexGen, Zimmer and PFC-Sigma, DePuy Inc) were also evaluated. These implants represented 41% (31,793) and 49% (37,457), respectively, of the 77,084 TKAs of known implant types registered during that period; implant selection was at the discretion of the attending surgeon. Descriptive statistics and marginal Cox regression models with propensity score adjustments were applied to compare risk of revision for CoCr-CPE versus CoCr-HXLPE TKA bearings.
At 5 years followup, cumulative incidence of revision for CoCr-CPE and CoCr-XLPE were 2.7% and 3.1%, respectively. Adjusted risks of all-cause (hazard ratio [HR], 1.05; 95% confidence interval [CI], 0.86-1.29; p = 0.620), aseptic (HR, 1.01; 95% CI, 0.77-1.32; p = 0.954), and septic revision (HR, 1.11; 95% CI, 0.81-1.51; p = 0.519) did not differ in patients with CoCr-XLPE bearings compared with CoCr-CPE. Within TKAs with NexGen components, the adjusted risks of all-cause (HR, 1.14; 95% CI, 0.86-1.51; p = 0.354), aseptic (HR, 1.14; 95% CI, 0.79-1.65; p = 0.493), and septic revision (HR, 1.14; 95% CI, 0.76-1.73; p = 518) were similar in patients with CoCr-XLPE compared with those with CoCr-CPE bearings. Finally, within the TKAs with PFC components, the adjusted risks of all-cause (HR, 0.80; 95% CI, 0.49-1.30; p = 0.369), aseptic (HR, 0.62; 95% CI, 0.62-1.14; p = 0.123), and septic revision (HR, 0.97; 95% CI, 0.51-1.85; p = 0.929) were also similar in patients with CoCr-XLPE compared with those with CoCr-CPE bearings.
In this large study, we did not find differences in risk of revision for CoCr-HXLPE compared with CoCr-CPE bearings at 5 years followup. In selecting HXLPE in TKA, clinicians should consider the increased cost and lack of available evidence of performance for greater than 10 years followup. Future studies are necessary to evaluate longitudinal outcomes of CoCr-HXLPE versus conventional TKA bearings.
Level III, therapeutic study.
高交联聚乙烯(HXLPE)被引入以减少全膝关节置换术(TKA)中的磨损及相关骨溶解。然而,在TKA中,HXLPE比传统聚乙烯(CPE)更有效的临床证据有限。
问题/目的:(1)与使用CPE胫骨假体的TKA相比,使用HXLPE胫骨假体的初次TKA翻修(全因、无菌性和感染性)风险是否更低?(2)在美国印第安纳州华沙市的捷迈公司(Zimmer Inc)的NexGen TKA假体中,与CPE胫骨假体相比,HXLPE胫骨假体的翻修(全因、无菌性和感染性)风险是否更低?(3)在美国印第安纳州华沙市的迪普伊公司(DePuy Inc)的压配髁型TKA(PFC或PFC Sigma)中,与使用CPE胫骨假体的手术相比,HXLPE胫骨假体的翻修(全因、无菌性和感染性)风险是否更低?
利用凯撒医疗集团全关节置换登记系统,确定在研究期间(2001年4月至2011年12月)使用钴铬合金搭配CPE(CoCr-CPE)和CoCr-HXLPE轴承的初次TKA(N = 77,084)。该登记系统的自愿参与率为95%,在10年研究期间随访失访率低于9%。共有60,841例(79%)使用CoCr-CPE轴承,11,048例(14%)使用CoCr-HXLPE轴承,5195例(7%)情况不明。还对特定的膝关节植入物设计(NexGen,捷迈公司;PFC-Sigma,迪普伊公司)进行了评估。在该期间登记的已知植入物类型的77,084例TKA中,这些植入物分别占41%(31,793例)和49%(37,457例);植入物的选择由主刀医生自行决定。采用描述性统计和带有倾向得分调整的边际Cox回归模型,比较CoCr-CPE与CoCr-HXLPE TKA轴承的翻修风险。
在5年随访时,CoCr-CPE和CoCr-XLPE的累积翻修发生率分别为2.7%和3.1%。CoCr-XLPE轴承患者与CoCr-CPE轴承患者相比,全因翻修(风险比[HR],1.05;95%置信区间[CI],0.86 - 1.29;p = 0.620)、无菌性翻修(HR,1.01;95% CI,0.77 - 1.32;p = 0.954)和感染性翻修(HR,1.11;95% CI,0.81 - 1.51;p = 0.519)的调整风险无差异。在使用NexGen组件的TKA中,CoCr-XLPE轴承患者与CoCr-CPE轴承患者相比,全因翻修(HR,1.14;95% CI,0.86 - 1.51;p = 0.354)、无菌性翻修(HR,1.14;95% CI,0.79 - 1.65;p = 0.493)和感染性翻修(HR,1.14;95% CI,0.76 - 1.73;p = 0.518)的调整风险相似。最后,在使用PFC组件的TKA中,CoCr-XLPE轴承患者与CoCr-CPE轴承患者相比,全因翻修(HR,0.80;95% CI,0.49 - 1.30;p = 0.369)、无菌性翻修(HR,0.62;95% CI,0.35 - 1.14;p = 0.123)和感染性翻修(HR,0.97;95% CI,0.51 - 1.85;p = 0.929)的调整风险也相似。
在这项大型研究中,我们发现在5年随访时,CoCr-HXLPE轴承与CoCr-CPE轴承的翻修风险没有差异。在TKA中选择HXLPE时,临床医生应考虑成本增加以及缺乏超过10年随访的性能可用证据。未来有必要开展研究以评估CoCr-HXLPE与传统TKA轴承的长期疗效。
III级,治疗性研究。