一种常见膝关节置换术中胫骨脱粘和失败的高发生率:一项随访综述。
High rate of tibial debonding and failure in a popular knee replacement : a follow-up review.
作者信息
Keohane David, Sheridan Gerard A, Masterson Eric
机构信息
Department of Trauma and Orthopaedics, University Hospital Limerick, Limerick, Ireland.
Department of Trauma and Orthopaedics, Royal College of Surgeons Ireland, Dublin, Ireland.
出版信息
Bone Jt Open. 2022 Jun;3(6):495-501. doi: 10.1302/2633-1462.36.BJO-2022-0043.R1.
AIMS
Total knee arthroplasty (TKA) is a common and safe orthopaedic procedure. Zimmer Biomet's NexGen is the second most popular brand of implant used in the UK. The primary cause of revision after the first year is aseptic loosening. We present our experience of using this implant, with significant concerns around its performance with regards early aseptic loosening of the tibial component.
METHODS
A retrospective, single-surgeon review was carried out of all of the NexGen Legacy Posterior Stabilized (LPS) TKAs performed in this institute. The specific model used for the index procedures was the NexGen Complete Knee System (Legacy Knee-Posterior Stabilized LPS-Flex Articular Surface, LPS-Flex Femoral Component Option, and Stemmed Nonaugmentable Tibial Component Option).
RESULTS
Between 2013 and 2016, 352 NexGen TKAs were carried out on 331 patients. A total of 62 TKAs have been revised to date, giving an all-cause revision rate of 17.6% at a minimum of five years. Three of these revisions were due to infection. Overall, 59 of the revisions were performed for aseptic loosening (16.7%) of the tibial component. The tibial component was removed intraoperatively without instrumentation due to significant tibial debonding between the implant-cement interface.
CONCLUSION
While overall, we believe that early aseptic loosening is multi-factorial in nature, the significantly high aseptic revision rate, as seen by an experienced fellowship-trained arthroplasty surgeon, has led us to believe that there is a fundamental issue with this NexGen implant design. Continued implant surveillance and rigorous review across all regions using this particular implant is warranted based on the concerning findings described here. Cite this article: 2022;3(6):495-501.
目的
全膝关节置换术(TKA)是一种常见且安全的骨科手术。捷迈邦美公司的NexGen是英国第二大最常用的植入物品牌。术后第一年翻修的主要原因是无菌性松动。我们介绍了使用该植入物的经验,对其在胫骨部件早期无菌性松动方面的性能存在重大担忧。
方法
对本研究所进行的所有NexGen传统后稳定型(LPS)全膝关节置换术进行了单术者回顾性研究。索引手术使用的具体型号是NexGen全膝关节系统(传统膝关节 - 后稳定型LPS - 灵活关节表面、LPS - 灵活股骨部件选项和带柄不可增强胫骨部件选项)。
结果
2013年至2016年期间,对331例患者实施了352例NexGen全膝关节置换术。截至目前,共有62例全膝关节置换术进行了翻修,至少五年时的全因翻修率为17.6%。其中3例翻修是由于感染。总体而言,59例翻修是由于胫骨部件无菌性松动(16.7%)。由于植入物 - 骨水泥界面之间明显的胫骨脱粘,术中未使用器械就移除了胫骨部件。
结论
总体而言,我们认为早期无菌性松动本质上是多因素导致的,但正如一位经验丰富的接受过专科培训的关节置换外科医生所观察到的,无菌翻修率显著偏高,这使我们认为该NexGen植入物设计存在根本问题。基于此处所述的令人担忧的发现,有必要对使用这种特定植入物的所有地区进行持续的植入物监测和严格审查。引用本文:2022;3(6):495 - 501。