轴承表面材料与初次全髋关节置换术后翻修风险的关系:对国家关节登记处的 1,026,481 例髋关节置换术进行队列分析。

IF 15.8 1区 医学 Q1 Medicine PLoS Medicine Pub Date : 2024-11-07 eCollection Date: 2024-11-01 DOI:10.1371/journal.pmed.1004478
Michael R Whitehouse, Rita Patel, Jonathan M R French, Andrew D Beswick, Patricia Navvuga, Elsa M R Marques, Ashley W Blom, Erik Lenguerrand
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引用次数: 0

摘要

背景:初次髋关节置换术后再次手术(又称翻修)的风险部分取决于所使用的假体植入材料。目前的性能证据基于广泛的分类,将具有潜在不同翻修风险的不同材料归为一类。我们对国家关节登记处报告的初次全髋关节置换术(THR)的翻修率进行了调查,并按所用轴承表面的具体类型进行了分类:我们分析了英格兰和威尔士所有骨科单位的全髋关节置换手术。所有在 2003 年至 2019 年期间在公共和私营部门接受过初次髋关节置换术的患者都被纳入其中。我们使用灵活的参数生存分析来估算调整后的危险比 (HR),调查了全因和适应症特异性翻修风险。我们确定了带头和单体杯的初次全髋关节置换术或带头和外壳/衬垫组合的模块化髋臼组件全髋关节置换术。共分析了 1,026,481 例初次 THR(单体:n = 378,979 例,模块:n = 647,502 例),其中 20,869 例(2%)随后进行了翻修(单体:n = 7,381 例,模块:n = 13,488 例)。就单体植入物而言,与钴铬合金头和高交联聚乙烯(HCLPE)髋臼杯植入物相比,钴铬合金头和高交联聚乙烯(HCLPE)髋臼杯植入物患者单体髋臼植入物的全因翻修风险更高(术后 10 年的危险率为 1.28 95% 置信区间):钴铬合金(术后 10 年的危险率:1.28 95% 置信区间 [1.10,1.48])或不锈钢头(1.18 [1.02,1.36])和非 HCLPE 髋臼杯的患者翻修的全因风险更高。使用三角陶瓷头和 HCLPE 杯状种植体的患者在术后任何时期的翻修风险都较低(1.18 [1.02, 1.36])。对于模块化植入物,与使用钴铬合金头和 HCLPE 内衬的初次 THR 患者相比,模块化髋臼植入物的全因翻修风险变化不大。在整个术后期间,使用三角陶瓷(0.79 [0.73, 0.85])或氧化锆(0.65 [0.55, 0.77])头和 HCLPE 内衬的 THR 的翻修风险较低。在研究单体和模块化髋臼植入物的特定适应症翻修风险时,也发现了类似的结果。虽然这项大型非选择性分析首次对登记册中收集的众多特征进行了调整,但仍不能排除残余混杂因素:假体翻修受初次手术所用假体材料的影响,使用三角陶瓷或氧化锆头和HCLPE衬垫/髋臼杯的假体风险最低。还需要进一步研究种植体承载材料与再次住院风险、除翻修外的再次手术风险、死亡率以及这些材料的成本效益之间的关系。
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The association of bearing surface materials with the risk of revision following primary total hip replacement: A cohort analysis of 1,026,481 hip replacements from the National Joint Registry.

Background: The risk of re-operation, otherwise known as revision, following primary hip replacement depends in part on the prosthesis implant materials used. Current performance evidences are based on a broad categorisation grouping together different materials with potentially varying revision risks. We investigated the revision rate of primary total hip replacement (THR) reported in the National Joint Registry by specific types of bearing surfaces used.

Methods and findings: We analysed THR procedures across all orthopaedic units in England and Wales. All patients who received a primary THR between 2003 and 2019 in the public and private sectors were included. We investigated the all-cause and indication-specific risks of revision using flexible parametric survival analyses to estimate adjusted hazard ratios (HRs). We identified primary THRs with heads and monobloc cups or modular acetabular component THRs with head and shell/liner combinations. A total of 1,026,481 primary THRs were analysed (Monobloc: n = 378,979 and Modular: n = 647,502) with 20,869 (2%) of these primary THRs subsequently undergoing a revision episode (Monobloc: n = 7,381 and Modular: n = 13,488). For monobloc implants, compared to implants with a cobalt chrome head and highly crosslinked polyethylene (HCLPE) cup, the all-cause risk of revision for monobloc acetabular implant was higher for patients with cobalt chrome (hazard rate at 10 years after surgery: 1.28 95% confidence intervals [1.10, 1.48]) or stainless steel head (1.18 [1.02, 1.36]) and non-HCLPE cup. The risk of revision was lower for patients with a delta ceramic head and HCLPE cup implant, at any postoperative period (1.18 [1.02, 1.36]). For modular implants, compared to patients with a cobalt chrome head and HCLPE liner primary THR, the all-cause risk of revision for modular acetabular implant varied non-constantly. THRs with a delta ceramic (0.79 [0.73, 0.85]) or oxidised zirconium (0.65 [0.55, 0.77]) head and HCLPE liner had a lower risk of revision throughout the entire postoperative period. Similar results were found when investigating the indication-specific risks of revision for both the monobloc and modular acetabular implants. While this large, nonselective analysis is the first to adjust for numerous characteristics collected in the registry, residual confounding cannot be rule out.

Conclusions: Prosthesis revision is influenced by the prosthesis materials used in the primary procedure with the lowest risk for implants with delta ceramic or oxidised zirconium head and an HCLPE liner/cup. Further work is required to determine the association of implant bearing materials with the risk of rehospitalisation, re-operation other than revision, mortality, and the cost-effectiveness of these materials.

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来源期刊
PLoS Medicine
PLoS Medicine MEDICINE, GENERAL & INTERNAL-
CiteScore
17.60
自引率
0.60%
发文量
227
审稿时长
4-8 weeks
期刊介绍: PLOS Medicine is a prominent platform for discussing and researching global health challenges. The journal covers a wide range of topics, including biomedical, environmental, social, and political factors affecting health. It prioritizes articles that contribute to clinical practice, health policy, or a better understanding of pathophysiology, ultimately aiming to improve health outcomes across different settings. The journal is unwavering in its commitment to uphold the highest ethical standards in medical publishing. This includes actively managing and disclosing any conflicts of interest related to reporting, reviewing, and publishing. PLOS Medicine promotes transparency in the entire review and publication process. The journal also encourages data sharing and encourages the reuse of published work. Additionally, authors retain copyright for their work, and the publication is made accessible through Open Access with no restrictions on availability and dissemination. PLOS Medicine takes measures to avoid conflicts of interest associated with advertising drugs and medical devices or engaging in the exclusive sale of reprints.
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