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非金属对金属假体的 ARMD 患者行全髋关节翻修术的风险如何?来自澳大利亚国家关节置换登记处的一项研究。

What Is the Risk of THA Revision for ARMD in Patients with Non-metal-on-metal Bearings? A Study from the Australian National Joint Replacement Registry.

机构信息

R N. de Steiger, Department of Surgery, Epworth Healthcare, University of Melbourne, Richmond, Australia and Australian Orthopaedic Association National Joint Replacement Registry.

A. Hatton, Y. Peng, South Australian Health and Medical Research Institute, South Adelaide, Australia.

出版信息

Clin Orthop Relat Res. 2020 Jun;478(6):1244-1253. doi: 10.1097/CORR.0000000000001277.

Abstract

BACKGROUND

There are increasing reports of corrosion between the femoral head and trunnion in primary conventional THA, resulting in metal particulate release often termed trunnionosis. There may be heightened awareness of this condition because of severe soft-tissue reactions initially thought to be solely attributable to prostheses with a metal-on-metal (MoM) bearing surface. It is unclear what percentage of revisions for THA with non-MoM bearing surfaces can be attributed to trunnionosis and to what extent adverse reaction to metal debris (ARMD) seen with MoM bearings may also be seen with other bearing surfaces in THA.

QUESTIONS/PURPOSES: We analyzed data from a large national registry to ask: (1) What is the revision risk for the indication of ARMD in patients with conventional THA and modern non-MoM bearing surfaces such as metal or ceramic-on-cross-linked polyethylene (XLPE) or ceramic-on-ceramic? (2) What prosthesis factors are associated with an increased risk of such revision? (3) What is the relative revision risk for ARMD in THAs with large-head MoM bearings, small-head MoM bearings, and non-MoM modern bearing surfaces?

METHODS

The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) longitudinally maintains data on all primary and revision joint arthroplasties, with nearly 100% capture. The study population included all THAs using modern bearing surfaces (defined as metal or ceramic heads-on-XLPE and ceramic-on-ceramic bearing couples) revised because of ARMD between September 1999 and December 2018. Prostheses with modular necks were excluded. The cumulative percent revision (CPR) because of ARMD was determined. The study group consisted of 350,027 THAs with a modern bearing surface, 15,184 THAs with a large-head MoM bearing (≥ 36 mm), and 5474 THAs with a small head MoM bearing (≤ 32 mm). The patients in the group who received the modern bearing surfaces were slightly older than the patients in the groups who received the large- and small-head bearing surfaces, with a mean age 68 years (SD 12) versus a mean age 63 years (SD 12), and a mean age 62 years (SD 11), respectively. There was a higher proportion of women in the modern bearing surface group; 55% (193,312 of 350,027), compared with 43% (6497 of 15,184) in the large-head MoM group and 50% (2716 of 5474) in the small-head MoM group. The outcome measure was the CPR, which was defined using Kaplan-Meier estimates of survivorship to describe the time to the first revision for ARMD at 17 years. Hazard ratios (HR) from Cox proportional hazards models, adjusting for age and sex, were performed to compare the revision rates among groups. The registry defines a revision as a reoperation of a previous hip arthroplasty in which one or more of the prosthetic components is replaced or removed, or one or more components is added.

RESULTS

The CPR for ARMD for patients with a modern bearing surface at 17 years was 0.1% (95% confidence interval 0.0 to 0.1). After controlling for age and sex, we found that cobalt chrome heads, two specific prostheses (Accolade® I and M/L Taper), and head sizes ≥ 36 mm were associated with an increased risk of revision for ARMD. Metal-on-XLPE had a higher risk of revision for ARMD than ceramic-on-ceramic or ceramic-on-XLPE (HR 3.4 [95% CI 1.9 to 6.0]; p < 0.001). The Accolade 1 and the M/L Taper stems had a higher risk of revision than all other stems (HR, 8.3 [95% CI 4.7 to 14.7]; p < 0.001 and HR 14.4 [95% CI 6.0 to 34.6]; p < 0.001, respectively). Femoral stems with head sizes ≥ 36 mm had a higher rate of revision for ARMD than stems with head sizes ≤ 32 mm (HR 3.2 [95% CI 1.9 to 5.3]; p < 0.001).Large-head MoM bearings had a greater increase in revision for ARMD compared with modern bearing surfaces. The CPR for patients with a large-head MoM bearing at 17 years for ARMD was 15.5% (95% CI 14.5 to 16.6) and it was 0.1% for modern bearing surfaces (HR 340 [95% CI 264.2 to 438.0]; p < 0.001). Modern bearing surfaces likewise had a lower HR for revision for ARMD than did THAs with small-head MoM bearings, which had a 0.9% (95% CI 0.7 to 1.4) CPR compared with modern bearings from 0 to 9 years (HR 10.5 [95% CI 6.2 to 17.7]; p < 0.001).

CONCLUSIONS

The revision risk for ARMD with modern bearing surfaces in THA is low. The Accolade 1 and the M/L Taper stem have a higher risk of revision for ARMD and cobalt-chrome heads, and head sizes ≥ 36 mm have a higher rate of revision than ≤ 32 mm head sizes. ARMD is a rare failure mode for THA with non-MoM bearings, but in patients presenting with unexplained pain with no other obvious cause, this diagnosis should be considered and investigated further.

LEVEL OF EVIDENCE

Level III, therapeutic study.

摘要

背景

在初次常规全髋关节置换术(THA)中,越来越多的报告显示股骨头与轴颈之间发生腐蚀,导致金属颗粒释放,通常被称为轴颈病。由于最初认为仅归因于具有金属-金属(MoM)关节面的假体的严重软组织反应,人们可能对这种情况的认识有所提高。目前尚不清楚多大比例的非 MoM 关节面的 THA 翻修归因于轴颈病,以及 MoM 关节面的金属颗粒反应(ARMD)在多大程度上也可能出现在 THA 的其他关节面中。

问题/目的:我们分析了一个大型国家注册中心的数据,以探讨:(1)对于使用现代非 MoM 关节面(如金属或陶瓷对交联聚乙烯(XLPE)或陶瓷对陶瓷)的常规 THA 患者,ARMD 的翻修风险有多大?(2)哪些假体因素与这种翻修风险增加有关?(3)在使用大尺寸 MoM 关节面、小尺寸 MoM 关节面和非 MoM 现代关节面的 THA 中,ARMD 的相对翻修风险有多大?

方法

澳大利亚矫形协会国家关节置换登记处(AOANJRR)纵向保存了所有初次和翻修关节置换术的所有数据,接近 100%的捕获率。研究人群包括因 ARMD 而在 1999 年 9 月至 2018 年 12 月期间翻修的所有使用现代关节面(定义为金属或陶瓷头对 XLPE 和陶瓷对陶瓷关节对)的 THA。带模块化颈部的假体被排除在外。确定因 ARMD 而进行的累积百分比翻修(CPR)。研究组包括 350027 例使用现代关节面的 THA、15184 例使用大尺寸 MoM 关节面的 THA(≥36mm)和 5474 例使用小尺寸 MoM 关节面的 THA(≤32mm)。与接受大、小尺寸 MoM 关节面的患者相比,接受现代关节面的患者年龄稍大,平均年龄为 68 岁(标准差 12 岁),而接受大尺寸 MoM 关节面的患者平均年龄为 63 岁(标准差 12 岁),接受小尺寸 MoM 关节面的患者平均年龄为 62 岁(标准差 11 岁)。现代关节面组中女性比例较高;55%(350027 例中的 193312 例),而大尺寸 MoM 关节面组为 43%(15184 例中的 6497 例),小尺寸 MoM 关节面组为 50%(5474 例中的 2716 例)。主要结局指标是 CPR,通过 Kaplan-Meier 生存估计来描述 17 年时首次因 ARMD 而进行翻修的时间,以此定义。使用 Cox 比例风险模型进行调整年龄和性别后的危险比(HR),以比较各组的翻修率。该登记处将翻修定义为对以前的髋关节置换术进行的再手术,其中一个或多个假体部件被更换或移除,或者一个或多个部件被添加。

结果

在 17 年时,使用现代关节面的患者因 ARMD 的 CPR 为 0.1%(95%置信区间 0.0 至 0.1)。在控制年龄和性别后,我们发现钴铬头、两种特定假体(Accolade® I 和 M/L Taper)和≥36mm 头大小与 ARMD 翻修风险增加有关。金属对 XLPE 的 ARMD 翻修风险高于陶瓷对陶瓷或陶瓷对 XLPE(HR 3.4 [95%CI 1.9 至 6.0];p <0.001)。Accolade 1 和 M/L Taper 柄与所有其他柄相比,翻修风险更高(HR 8.3 [95%CI 4.7 至 14.7];p <0.001 和 HR 14.4 [95%CI 6.0 至 34.6];p <0.001)。头大小≥36mm 的股骨柄的 ARMD 翻修率高于头大小≤32mm 的股骨柄(HR 3.2 [95%CI 1.9 至 5.3];p <0.001)。与现代关节面相比,大尺寸 MoM 关节面的 ARMD 翻修风险更高。在 17 年时,大尺寸 MoM 关节面患者因 ARMD 的 CPR 为 15.5%(95%CI 14.5 至 16.6),而现代关节面患者为 0.1%(HR 340 [95%CI 264.2 至 438.0];p <0.001)。现代关节面与小尺寸 MoM 关节面的 THA 相比,其 ARMD 翻修风险也较低,小尺寸 MoM 关节面的 0.9%(95%CI 0.7 至 1.4)CPR 与 0 至 9 年的现代关节面相比(HR 10.5 [95%CI 6.2 至 17.7];p <0.001)。

结论

THA 中使用现代关节面的 ARMD 翻修风险较低。Accolade 1 和 M/L Taper 柄的 ARMD 翻修风险更高,钴铬头和≥36mm 头大小的翻修率高于≤32mm 头大小。非 MoM 关节面的 THA 发生 ARMD 是一种罕见的失效模式,但对于出现不明原因疼痛且无其他明显原因的患者,应考虑并进一步调查这种诊断。

证据水平

III 级,治疗性研究。

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