Matharu G S, Nandra R S, Berryman F, Judge A, Pynsent P B, Dunlop D J
University of Oxford, Oxford, OX3 7LD, UK.
The Royal Orthopaedic Hospital, Birmingham, B31 2AP, UK.
Bone Joint J. 2017 May;99-B(5):592-600. doi: 10.1302/0301-620X.99B5.BJJ-2016-1232.R1.
To determine ten-year failure rates following 36 mm metal-on-metal (MoM) Pinnacle total hip arthroplasty (THA), and identify predictors of failure.
We retrospectively assessed a single-centre cohort of 569 primary 36 mm MoM Pinnacle THAs (all Corail stems) followed up since 2012 according to Medicines and Healthcare Products Regulation Agency recommendations. All-cause failure rates (all-cause revision, and non-revised cross-sectional imaging failures) were calculated, with predictors for failure identified using multivariable Cox regression.
Failure occurred in 97 hips (17.0%). The ten-year cumulative failure rate was 27.1% (95% confidence interval (CI) 21.6 to 33.7). Primary implantation from 2006 onwards (hazard ratio (HR) 4.30; 95% CI 1.82 to 10.1; p = 0.001) and bilateral MoM hip arthroplasty (HR 1.59; 95% CI 1.03 to 2.46; p = 0.037) predicted failure. The effect of implantation year on failure varied over time. From four years onwards following surgery, hips implanted since 2006 had significantly higher failure rates (eight years 28.3%; 95% CI 23.1 to 34.5) compared with hips implanted before 2006 (eight years 6.3%; 95% CI 2.4 to 15.8) (HR 15.2; 95% CI 2.11 to 110.4; p = 0.007).
We observed that 36 mm MoM Pinnacle THAs have an unacceptably high ten-year failure rate, especially if implanted from 2006 onwards or in bilateral MoM hip patients. Our findings regarding implantation year and failure support recent concerns about the device manufacturing process. We recommend all patients undergoing implantation since 2006 and those with bilateral MoM hips undergo regular investigation, regardless of symptoms. Cite this article: 2017;99-B:592-600.
确定36毫米金属对金属（MoM）Pinnacle全髋关节置换术（THA）术后十年的失败率，并找出失败的预测因素。
我们根据药品和医疗产品监管局的建议，对自2012年起随访的569例初次36毫米MoM Pinnacle THA（均为Corail股骨柄）的单中心队列进行了回顾性评估。计算全因失败率（全因翻修和未翻修的横断面影像失败），并使用多变量Cox回归确定失败的预测因素。
97例髋关节出现失败（17.0%）。十年累积失败率为27.1%（95%置信区间（CI）21.6至33.7）。2006年起初次植入（风险比（HR）4.30；95%CI 1.82至10.1；p = 0.001）和双侧MoM髋关节置换术（HR 1.59；95%CI 1.03至2.46；p = 0.037）可预测失败。植入年份对失败的影响随时间变化。术后四年起，2006年起植入的髋关节失败率显著高于2006年前植入的髋关节（八年时分别为28.3%；95%CI 23.1至34.5和6.3%；95%CI 2.4至15.8）（HR 15.2；95%CI 2.11至110.4；p = 0.007）。
我们观察到，36毫米MoM Pinnacle THA的十年失败率高得令人无法接受，特别是2006年起植入的或双侧MoM髋关节患者。我们关于植入年份与失败的研究结果支持了近期对该器械制造工艺的担忧。我们建议2006年起接受植入的所有患者以及双侧MoM髋关节患者定期接受检查，无论有无症状。引用本文：2017；99 - B：第本文：2017；99 - B：592 - 600页。
