BACKGROUND Second-generation highly cross-linked polyethylene (HXLPE) has revolutionized total hip arthroplasty. However, the long-term risks and benefits of HXLPE in primary total knee arthroplasty (TKA) remain unknown. This randomized clinical trial evaluated implant survivorship, complications, radiographic results, and clinical outcomes of HXLPE and conventional ultra-high molecular weight polyethylene (UHMWPE) inserts in primary TKAs. METHODS We enrolled 518 patients (518 knees) who underwent primary TKA in 3 centers within 1 tertiary referral network. The mean age was 67 years, the mean body mass index was 32 kg/m2, and 58% of the patients were women. All of the patients underwent primary TKA with a cemented posterior-stabilized tibial insert and patellar resurfacing. Randomization proceeded via stratified dynamic allocation. The patients were blinded to their study group allocation: those in the control group (254 knees) underwent TKA with an UHMWPE insert (N2Vac; Stryker); those in the treatment group (264 knees) received an HXLPE insert (X3; Stryker). Kaplan-Meier survivorship, radiographic results, and clinical outcomes were assessed. This trial was registered with ClinicalTrials.gov. The mean follow-up was 11 years. RESULTS The 10-year overall survivorship free from any revision and from any reoperation was 96% and 94%, respectively. There were no differences in the risk of revision or reoperation between the groups (p > 0.05). There were a total of 19 revisions. Revision indications included periprosthetic joint infection (14 knees), instability (4 knees), and open reduction and internal fixation (ORIF) for a patellar fracture due to osteolysis around a UHMWPE insert (1 knee). There were no revisions due to polyethylene wear, osteolysis, or fracture of the post in the HXLPE group. The radiographic results and clinical outcomes were otherwise similar. CONCLUSIONS Notably, no wear-related failures were identified in the HXLPE group, but there was 1 case of osteolysis in the UHMWPE group. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

中文翻译：

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10 年时在 518 例主要 TKA 中高度交联聚乙烯与常规聚乙烯的多中心随机临床试验。


背景 第二代高度交联聚乙烯 （HXLPE） 彻底改变了全髋关节置换术。然而，HXLPE 在初次全膝关节置换术 （TKA） 中的长期风险和益处仍然未知。这项随机临床试验评估了原发性 TKA 中 HXLPE 和常规超高分子量聚乙烯 （UHMWPE） 插入物的植入物存活率、并发症、放射学结果和临床结果。方法 我们招募了 518 例患者 （518 例膝关节），他们在 1 个三级转诊网络内的 3 个中心接受了初次 TKA。平均年龄为 67 岁，平均体重指数为 32 kg/m2,58% 的患者为女性。所有患者均接受了骨水泥后稳定胫骨插入物和髌骨表面置换的初次 TKA。随机化通过分层动态分配进行。患者对他们的研究组分配不知情：对照组患者（254 个膝关节）接受了带有 UHMWPE 插入物 （N2Vac;史崔克）;治疗组 （264 个膝关节） 接受 HXLPE 插入物 （X3;Stryker）。评估 Kaplan-Meier 生存率、影像学结果和临床结局。该试验已在 ClinicalTrials.gov 注册。平均随访时间为 11 年。结果 无任何翻修和无任何再次手术的 10 年总生存率分别为 96% 和 94%。两组之间翻修或再次手术的风险没有差异 （p > 0.05）。总共有 19 次修订。翻修适应症包括假体周围关节感染 （14 个膝关节）、不稳定 （4 个膝关节） 和切开复位和内固定 （ORIF） 因 UHMWPE 插入物周围骨质溶解 （1 个膝关节） 引起的髌骨骨折。 在 HXLPE 组中，由于聚乙烯磨损、骨溶解或柱断裂而没有翻修。影像学结果和临床结局在其他方面相似。结论 值得注意的是，HXLPE 组未发现与磨损相关的失败，但 UHMWPE 组有 1 例骨溶解。证据级别 治疗 I 级。有关证据级别的完整描述，请参阅作者说明。