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纳米斯™短柄髋关节植入物24个月的临床和影像学结果:一项前瞻性单中心研究。

Clinical and radiographic outcomes with the Nanos™ short-stem hip implant at 24 months: A prospective, single-center study.

作者信息

Budde Stefan, Schwarze Michael, Floerkemeier Thilo, Plagge Jochen, Wirries Nils, Windhagen Henning, Thorey Fritz, Derksen Alexander

机构信息

Department of Orthopaedic Surgery at Diakovere Annastift, Hannover Medical School, Hannover, Germany.

Laboratory for Biomechanics and Biomaterials, Department of Orthopaedic Surgery at Diakovere Annastift, Hannover Medical School, Hannover, Germany.

出版信息

J Orthop. 2020 Jun 6;20:326-331. doi: 10.1016/j.jor.2020.06.007. eCollection 2020 Jul-Aug.

Abstract

AIM

Short-stem total hip arthroplasty is designed to preserve proximal bone stock in case of eventual revision, potentially benefiting younger and more active patients. This prospective, single-center study assessed the safety and performance of the partially neck-sparing Nanos™ short-stem uncemented prosthesis at 24 months using clinical outcome scores and radiographic results.

METHODS

Between April 2011 and February 2015, 52 subjects (mean age, 54.9 years) underwent total hip arthroplasty and were followed up at 3, 6, 12 and 24 months. The primary outcome was improvement in quality of life as measured by the Short-Form 36 Mental Component Score (SF-36 MCS). Secondary clinical outcomes included the Harris Hip Score, Hip Disability and Osteoarthritis Outcome Score, Postel Merle d'Aubigné-Score, Activity Level University of California, Los Angeles score, and Pain Visual Analogue Scale. Complications and radiographic images were also recorded at each follow-up.

RESULTS

Mean SF-36 MCS score significantly improved from baseline to final follow up at 24 months (61.3 vs. 79.5, respectively; p < 0.001). All secondary clinical outcomes also showed significant improvement (p < 0.001) during this time period. Neutral stem positioning was achieved in 45 subjects (86.5%). Two subjects (3.8%) underwent revisions: one for a periprosthetic fracture unrelated to the study device and another due to a prosthetic joint infection. Intraoperatively, one fissure fracture of the acetabulum occurred.

CONCLUSION

Total hip arthroplasty with the Nanos short-stem led to significant clinical improvements and a high subjective satisfaction rate at 24 months. Further follow-up will determine whether these effects are sustained in the long term.

摘要

目的

短柄全髋关节置换术旨在保留近端骨量,以备日后翻修之需,这可能使年轻且活动量较大的患者受益。本前瞻性单中心研究使用临床结局评分和影像学结果,评估了部分保留股骨颈的Nanos™短柄非骨水泥假体在24个月时的安全性和性能。

方法

2011年4月至2015年2月期间,52名受试者(平均年龄54.9岁)接受了全髋关节置换术,并在3、6、12和24个月时进行随访。主要结局是通过简明健康状况调查量表精神健康分量表(SF-36 MCS)衡量的生活质量改善情况。次要临床结局包括Harris髋关节评分、髋关节残疾与骨关节炎疗效评分、Postel Merle d'Aubigné评分、加州大学洛杉矶分校活动水平评分以及疼痛视觉模拟量表评分。每次随访时还记录并发症和影像学图像。

结果

从基线到24个月的最终随访,平均SF-36 MCS评分显著改善(分别为61.3和79.5;p < 0.001)。在此期间,所有次要临床结局也均显示出显著改善(p < 0.001)。45名受试者(86.5%)实现了假体柄中立位。两名受试者(3.8%)接受了翻修:一名因与研究装置无关的假体周围骨折,另一名因假体关节感染。术中发生1例髋臼裂纹骨折。

结论

使用Nanos短柄进行全髋关节置换术在24个月时带来了显著的临床改善和较高的主观满意度。进一步随访将确定这些效果是否能长期持续。

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