Department of Orthopaedic Surgery, Research School Caphri, Maastricht University Medical Centre, Maastricht, The Netherlands.
Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre, Maastricht, The Netherlands.
PLoS One. 2021 Mar 12;16(3):e0248483. doi: 10.1371/journal.pone.0248483. eCollection 2021.
Previous studies have already shown early proximal ingrowth, fast osseous integration, and a stable fit of the uncemented Symax hip stem, with excellent clinical and radiographic performance. Aims were to evaluate cumulative revision rates and reasons for revision of the Symax hip stem using Dutch Arthroplasty Register (LROI) data and to assess possible associations between patient characteristics and revision rate of the Symax hip stem.
All total hip arthroplasties with the uncemented Symax hip stem registered in the LROI between 2007 and 2017 were included (n = 5,013). Kaplan-Meier survival analysis was performed to assess the cumulative 1, 5 and 7-year revision percentages. Cox proportional hazard regression analysis was performed to assess the association between patient and procedural characteristics, and revision arthroplasty of the stem.
Cumulative 1, 5, and 7-year revision rates (with 95% confidence interval (CI)) for revision of any component were 1.5% (CI 1.2%-1.8%), 3.2% (CI 2.7%-3.7%), and 3.8% (CI 3.1%-4.4%) respectively. Cumulative 1, 5, and 7-year stem revision rates of the Symax hip stem were 0.9% (CI 0.6%-1.1%), 1.5% (CI 1.1%-1.9%), and 1.7% (CI 1.3%-2.1%) respectively. Periprosthetic fractures (n = 35) and loosening of the stem (n = 30) were the most common reasons for revision of the stem. Revision of the stem was associated with acute fracture as primary diagnosis (Hazard Ratio (HR) 2.4 (CI 1.3-4.3)), or history of a previous surgery to the affected hip (HR 2.7 (CI 1.4-5.2)).
This population-based registry study shows revision rates for the Symax hip stem comparable to those for best performing uncemented total hip arthroplasties in the Netherlands. Primary diagnosis of an acute fracture, and history of previous surgery on the affected hip, were significantly associated risk factors for revision of the Symax hip stem, and we discourage the use of the Symax hip stem in these patients.
先前的研究已经表明，Symax 非骨水泥髋关节假体具有早期近端骨长入、快速骨整合和稳定的匹配性，临床和影像学效果均十分出色。本研究旨在使用荷兰关节置换注册（LROI）数据评估 Symax 髋关节假体的累积翻修率和翻修原因，并评估患者特征与 Symax 髋关节假体翻修率之间的可能关联。
本研究纳入了 2007 年至 2017 年间在 LROI 中登记的所有使用非骨水泥 Symax 髋关节假体的全髋关节置换术（n=5013）。采用 Kaplan-Meier 生存分析评估 1、5 和 7 年累积翻修率。采用 Cox 比例风险回归分析评估患者和手术特征与假体翻修之间的关联。
任何组件翻修的累积 1、5 和 7 年翻修率（95%置信区间（CI））分别为 1.5%（CI 1.2%-1.8%）、3.2%（CI 2.7%-3.7%）和 3.8%（CI 3.1%-4.4%）。Symax 髋关节假体的累积 1、5 和 7 年翻修率分别为 0.9%（CI 0.6%-1.1%）、1.5%（CI 1.1%-1.9%）和 1.7%（CI 1.3%-2.1%）。假体周围骨折（n=35）和假体松动（n=30）是翻修的最常见原因。假体翻修与主要诊断为急性骨折（风险比（HR）2.4（CI 1.3-4.3））或髋关节既往手术史（HR 2.7（CI 1.4-5.2））相关。
这项基于人群的注册研究表明，Symax 髋关节假体的翻修率与荷兰表现最佳的非骨水泥全髋关节置换术相当。急性骨折的主要诊断和髋关节既往手术史是 Symax 髋关节假体翻修的显著相关危险因素，我们不建议在这些患者中使用 Symax 髋关节假体。
