Multicenter Randomized Clinical Trial of Highly Cross-Linked Polyethylene Versus Conventional Polyethylene in 518 Primary TKAs at 10 Years.

IF 4.4 1区医学 Q1 ORTHOPEDICS

Journal of Bone and Joint Surgery, American Volume Pub Date : 2024-11-06 DOI:10.2106/JBJS.24.00445

Harold I Salmons, Dirk R Larson, Cedric J Ortiguera, Henry D Clarke, Mark J Spangehl, Mark W Pagnano, Michael J Stuart, Matthew P Abdel

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引用次数: 0

Abstract

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.

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高交联聚乙烯与传统聚乙烯在 518 例初次 TKAs 中的多中心随机临床试验（10 年）。

背景：第二代高交联聚乙烯（HXLPE）彻底改变了全髋关节置换术。然而，HXLPE 在初级全膝关节置换术（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 HXLPE 和传统超高分子量聚乙烯（UHMWPE）插入物在初级 TKA 中的植入存活率、并发症、放射学结果和临床疗效：我们招募了 518 名患者（518 个膝关节），他们在 1 个三级转诊网络内的 3 个中心接受了初级 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。所有患者都接受了初次TKA，并植入了骨水泥后方稳定胫骨嵌体和髌骨复位。随机化是通过分层动态分配进行的。患者的研究组分配是双盲的：对照组（254个膝关节）使用超高分子量聚乙烯内衬（N2Vac；史赛克）进行TKA；治疗组（264个膝关节）使用HXLPE内衬（X3；史赛克）。对Kaplan-Meier存活率、放射学结果和临床疗效进行了评估。该试验已在ClinicalTrials.gov上注册。平均随访时间为11年：结果：无翻修和无再次手术的10年总体存活率分别为96%和94%。两组患者的翻修或再手术风险没有差异（P>0.05）。共有19例翻修手术。翻修适应症包括假体周围关节感染（14个膝关节）、不稳定性（4个膝关节），以及因超高分子量聚乙烯内衬周围骨溶解导致髌骨骨折而进行的开放复位内固定术（ORIF）（1个膝关节）。在 HXLPE 组中，没有因聚乙烯磨损、骨溶解或支柱骨折而进行翻修。其他方面的放射学结果和临床结果相似：值得注意的是，HXLPE组未发现与磨损相关的故障，但超高分子量聚乙烯组有1例骨溶解：有关证据等级的完整描述，请参阅 "作者须知"。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Bone and Joint Surgery, American Volume 医学-外科

CiteScore

8.90

自引率

7.50%

发文量

660

审稿时长

1 months

期刊介绍： The Journal of Bone & Joint Surgery (JBJS) has been the most valued source of information for orthopaedic surgeons and researchers for over 125 years and is the gold standard in peer-reviewed scientific information in the field. A core journal and essential reading for general as well as specialist orthopaedic surgeons worldwide, The Journal publishes evidence-based research to enhance the quality of care for orthopaedic patients. Standards of excellence and high quality are maintained in everything we do, from the science of the content published to the customer service we provide. JBJS is an independent, non-profit journal.