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哪些因素与一种常用的双模块化 THA 设计中的颈部骨折有关?一项来自斯洛文尼亚的多中心、全国性研究。

What Factors Are Associated With Neck Fracture in One Commonly Used Bimodular THA Design? A Multicenter, Nationwide Study in Slovenia.

机构信息

S. Kovač, V. Levašič, Valdoltra Orthopaedic Hospital, Ankaran, Slovenia B. Mavčič, Department of Orthopaedic Surgery, University Medical Centre Ljubljana, Ljubljana, Slovenia M. Kotnik, Department of Orthopaedics, Celje General Hospital, Celje, Slovenia M. Sirše, S. K. Fokter, Department of Orthopaedics, University Medical Centre Maribor, Maribor, Slovenia.

出版信息

Clin Orthop Relat Res. 2019 Jun;477(6):1324-1332. doi: 10.1097/CORR.0000000000000646.


DOI:10.1097/CORR.0000000000000646
PMID:31136429
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6554145/
Abstract

BACKGROUND: Femoral stems with bimodular (head-neck as well as neck-body) junctions were designed to help surgeons address patients' hip anatomy individually. However, arthroplasty registers have reported higher revision rates in stems with bimodular junctions than in stems with modularity limited to the head-neck trunnion. However, to our knowledge, no epidemiologic study has identified patient-specific risk factors for modular femoral neck fractures, and some stems using these designs still are produced and marketed. QUESTIONS/PURPOSES: The purposes of this study were (1) to establish the survival rate free from aseptic loosening of one widely used bimodular THA design; (2) to define the proportion of patients who experienced a fracture of the stem's modular femoral neck; and (3) to determine factors associated with neck fracture. METHODS: In this retrospective, nationwide, multicenter study, we reviewed 2767 bimodular Profemur® Z stems from four hospitals in Slovenia with a mean followup of 8 years (range, 3 days to 15 years). Between 2002 and 2015, the four participating hospitals performed 26,132 primary THAs; this implant was used in 2767 of them (11%). The general indications for using this implant were primary osteoarthritis (OA) in 2198 (79%) hips and other indications in 569 (21%) hips. We followed patients from the date of the index operation to the date of death, date of revision, or the end of followup on March 1, 2018. We believe that all revisions would be captured in our sample, except for patients who may have emigrated outside the country, but the proportion of people immigrating to Slovenia is higher than the proportion of those emigrating from it; however, no formal accounting for loss to followup is possible in a study of this design. There were 1438 (52%) stems implanted in female and 1329 (48%) in male patients, respectively. A titanium alloy neck was used in 2489 hips (90%) and a cobalt-chromium neck in 278 (10%) hips. The mean body mass index (BMI) at the time of operation was 29 kg/m (SD ± 5 kg/m). We used Kaplan-Meier analysis to establish survival rates, and we performed a chart review to determine the proportion of patients who experienced femoral neck fractures. A binary logistic regression model that controlled for the potential confounding variables of age, sex, BMI, time since implantation, type of bearing, diagnosis, hospital, neck length, and neck material was used to analyze neck fractures. RESULTS: There were 55 (2%) aseptic stem revisions. Survival rate free from aseptic loosening at 12 years was 97% (95% confidence interval [CI] ± 1%). Fracture of the modular neck occurred in 23 patients (0.83%) with a mean BMI of 29 kg/m (SD ± 4 kg/m.) Twenty patients with neck fractures were males and 19 of 23 fractured necks were long. Time since implantation (odds ratio [OR], 0.55; 95% CI 0.46-0.66; p < 0.001), a long neck (OR, 6.77; 95% CI, 2.1-22.2; p = 0.002), a cobalt-chromium alloy neck (OR, 5.7; 95% CI, 1.6-21.1; p = 0.008), younger age (OR, 0.91; 95% CI, 0.86-0.96; p < 0.001), and male sex (OR, 3.98; 95% CI, 1.04-14.55; p = 0.043) were factors associated with neck fracture. CONCLUSIONS: The loosening and neck fracture rates of the Profemur® Z stem were lower than in some of previously published series. However, the use of modular femoral necks in primary THA increases the risk for neck fracture, particularly in young male patients with cobalt-chromium long femoral necks. The bimodular stem we analyzed fractured unacceptably often, especially in younger male patients. For most patients, the risks of using this device outweigh the benefits, and several dozen patients had revisions and complications they would not have had if a different stem had been used. LEVEL OF EVIDENCE: Level III, therapeutic study.

摘要

背景:带有双模块化(头颈和颈体)接头的股骨柄旨在帮助外科医生根据患者的髋部解剖结构单独进行手术。然而,关节置换登记处报告称,带有双模块化接头的股骨柄的翻修率高于仅具有头颈转节模块化的股骨柄。然而,据我们所知,尚无针对模块化股骨颈骨折的特定患者风险因素的流行病学研究,并且仍在生产和销售一些使用这些设计的股骨柄。

问题/目的:本研究的目的是:(1) 确定一种广泛使用的双模块化 THA 设计的无无菌松动生存率;(2) 确定发生柄模块化股骨颈骨折的患者比例;以及 (3) 确定与颈骨折相关的因素。

方法:在这项回顾性、全国性、多中心研究中,我们回顾了来自斯洛文尼亚四家医院的 2767 个 Profemur® Z 双模块化柄,平均随访 8 年(范围 3 天至 15 年)。在 2002 年至 2015 年期间,四家参与医院进行了 26132 例初次 THA;其中 2767 例(11%)使用了该植入物。使用该植入物的一般适应证为原发性骨关节炎(OA)2198 髋(79%)和其他适应证 569 髋(21%)。我们从索引手术日期随访患者,直至死亡、翻修或 2018 年 3 月 1 日随访结束。我们认为,我们的样本中可能会包括所有的翻修病例,除非患者可能已经移民到国外,但移民到斯洛文尼亚的人数高于移民离开的人数;然而,对于这种设计的研究,不可能对失访进行正式的核算。分别有 1438 个(52%)柄植入女性患者和 1329 个(48%)柄植入男性患者。使用钛合金颈的有 2489 髋(90%),使用钴铬合金颈的有 278 髋(10%)。手术时的平均体重指数(BMI)为 29 kg/m(标准差 ± 5 kg/m)。我们使用 Kaplan-Meier 分析来确定生存率,并进行图表审查以确定发生股骨颈骨折的患者比例。使用二元逻辑回归模型,控制年龄、性别、BMI、植入时间、轴承类型、诊断、医院、颈长和颈材料等潜在混杂变量,分析颈骨折。

结果:有 55 例(2%)无菌性柄翻修。12 年时无无菌松动生存率为 97%(95%置信区间[CI]±1%)。发生模块化颈骨折的患者有 23 例(0.83%),平均 BMI 为 29 kg/m(标准差±4 kg/m)。20 例颈骨折患者为男性,23 例骨折颈中 19 例较长。植入时间(优势比[OR],0.55;95%CI,0.46-0.66;p<0.001)、长颈(OR,6.77;95%CI,2.1-22.2;p=0.002)、钴铬合金颈(OR,5.7;95%CI,1.6-21.1;p=0.008)、年龄较小(OR,0.91;95%CI,0.86-0.96;p<0.001)和男性(OR,3.98;95%CI,1.04-14.55;p=0.043)是颈骨折的相关因素。

结论:Profemur® Z 柄的松动和颈骨折发生率低于先前一些发表的系列。然而,在初次 THA 中使用模块化股骨颈会增加颈骨折的风险,尤其是在钴铬合金长股骨颈的年轻男性患者中。我们分析的双模块化股骨柄骨折频率高得令人无法接受,尤其是在年轻的男性患者中。对于大多数患者来说,使用该器械的风险大于收益,有几十名患者因使用了该器械而进行了翻修和出现了并发症,而如果使用了其他股骨柄,则他们本可以避免这些情况。

证据等级:III 级,治疗性研究。

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[2]
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[4]
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Materials (Basel). 2021-6-3

[5]
Dual Modular Titanium Alloy Femoral Stem Failure Mechanisms and Suggested Clinical Approaches.

Materials (Basel). 2021-6-4

[6]
Bilateral neck fracture in bimodular femoral stem after primary total hip arthroplasty: a case report.

BMC Musculoskelet Disord. 2021-4-16

[7]
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[8]
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[9]
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[10]
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本文引用的文献

[1]
Early fracture of the modular neck of a MODULUS femoral stem.

Arthroplast Today. 2016-10-28

[2]
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[3]
Cementless modular neck stems: are they a safe option in primary total hip arthroplasty?

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Exchangeable Femoral Neck (Dual-Modular) THA Prostheses Have Poorer Survivorship Than Other Designs: A Nationwide Cohort of 324,108 Patients.

Clin Orthop Relat Res. 2017-8

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Clin Orthop Relat Res. 2016-1

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Titanium alloy femoral neck fracture--clinical and metallurgical analysis in 6 cases.

Acta Orthop. 2016

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