Jäger Marcus, van Wasen Andrea, Warwas Sebastian, Landgraeber Stefan, Haversath Marcel, Group Vitas
Orthopaedic Department, University of Duisburg-Essen, University Hospital Essen ; Tuttlingen, Germany.
B. Braun Melsungen AG, Aesculap Division , Tuttlingen, Germany.
Orthop Rev (Pavia). 2014 Apr 22;6(2):5285. doi: 10.4081/or.2014.5285.
Since polyethylene is one of the most frequently used biomaterials as a liner in total hip arthroplasty, strong efforts have been made to improve design and material properties over the last 50 years. Antioxidants seems to be a promising alternative to further increase durability and reduce polyethylene wear in long term. As of yet, only in vitro results are available. While they are promising, there is yet no clinical evidence that the new material shows these advantages in vivo. To answer the question if vitamin-E enhanced ultra-high molecular weight polyethylene (UHMWPE) is able to improve long-term survivorship of cementless total hip arthroplasty we initiated a randomized long-term multicenter trial. Designed as a superiority study, the oxidation index assessed in retrieval analyses of explanted liners was chosen as primary parameter. Radiographic results (wear rate, osteolysis, radiolucency) and functional outcome (Harris Hip Scores, University of California-Los Angeles, Hip Disability and Osteoarthritis Outcome Score, Visual Analogue Scale) will serve as secondary parameters. Patients with the indication for a cementless total hip arthroplasty will be asked to participate in the study and will be randomized to either receive a standard hip replacement with a highly cross-linked UHMWPE-X liner or a highly cross-linked vitamin-E supplemented UHMWPE-XE liner. The follow-up will be 15 years, with evaluation after 5, 10 and 15 years. The controlled randomized study has been designed to determine if Vitamin-E supplemented highly cross-linked polyethylene liners are superior to standard XLPE liners in cementless total hip arthroplasty. While several studies have been started to evaluate the influence of vitamin-E, most of them evaluate wear rates and functional results. The approach used for this multicenter study, to analyze the oxidation status of retrieved implants, should make it possible to directly evaluate the ageing process and development of the implant material itself over a time period of 15 years.
由于聚乙烯是全髋关节置换术中作为衬垫最常用的生物材料之一，在过去50年里人们为改善其设计和材料性能付出了巨大努力。抗氧化剂似乎是一种有前景的选择，可长期进一步提高耐用性并减少聚乙烯磨损。截至目前，仅有体外实验结果。虽然这些结果很有前景，但尚无临床证据表明这种新材料在体内具有这些优势。为了回答维生素E增强型超高分子量聚乙烯（UHMWPE）是否能够提高非骨水泥型全髋关节置换术的长期生存率这一问题，我们启动了一项随机长期多中心试验。该研究设计为优效性研究，选择在取出的衬垫的翻修分析中评估的氧化指数作为主要参数。影像学结果（磨损率、骨溶解、透光线）和功能结果（Harris髋关节评分、加利福尼亚大学洛杉矶分校评分、髋关节残疾与骨关节炎结果评分、视觉模拟评分）将作为次要参数。有非骨水泥型全髋关节置换术指征的患者将被邀请参与该研究，并随机分为两组，分别接受使用高度交联的UHMWPE-X衬垫的标准髋关节置换或使用高度交联的补充维生素E的UHMWPE-XE衬垫。随访时间为15年，分别在5年、10年和15年后进行评估。这项对照随机研究旨在确定在非骨水泥型全髋关节置换术中，补充维生素E的高度交联聚乙烯衬垫是否优于标准的XLPE衬垫。虽然已经开展了多项研究来评估维生素E的影响，但大多数研究评估的是磨损率和功能结果。本多中心研究采用的分析取出植入物氧化状态的方法，应能够在15年的时间内直接评估植入材料本身的老化过程和发展情况。
