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12至14年后,骨水泥型与非骨水泥型髋臼组件的疗效无差异:一项比较Duraloc与Charnley杯的随机对照试验结果

No differences in outcomes between cemented and uncemented acetabular components after 12-14 years: results from a randomized controlled trial comparing Duraloc with Charnley cups.

作者信息

Bjørgul Kristian, Novicoff Wendy M, Andersen S T, Brevig K, Thu F, Wiig M, Ahlund O

机构信息

Department of Orthopaedic Surgery, University of Virginia Health System, Charlottesville, 22908-0159, USA.

出版信息

J Orthop Traumatol. 2010 Mar;11(1):37-45. doi: 10.1007/s10195-010-0082-2. Epub 2010 Mar 3.

Abstract

BACKGROUND

Even though there are multiple studies documenting the outcome of the Charnley low-friction arthroplasty as well as abundant studies on uncemented arthroplasties, there is a dearth of comparative studies of the uncemented acetabular component and a cemented component. In this study we aimed to document the long-term clinical and radiographic outcome as well as component survival in a randomized controlled trial.

MATERIALS AND METHODS

Two hundred fifteen patients (240 hips) were randomly allocated to receive a cemented Charnley cup or uncemented Duraloc 1200 cup. All patients received cemented Charnley stems and were evaluated clinically and radiographically after 6 months, and 2, 5, and 10 years.

RESULTS

Harris Hip Scores improved from 48.3 [95% confidence interval (CI) 45.0-51.6] to 90.2 [95% CI 87.9-92.6] in the Charnley group and from 49.3 [95% CI 86.9-91.3] in the Duraloc group at 6 months. After 10 years, the Charnley group's Harris Hip Score was 89.8 [95% confidence interval (CI) 87.0-92.6], and the Duraloc group's score was 87.3 (95% CI 84.1-90.6). In the radiographic analysis after 10 years, there was no statistical difference in the prevalence of radiographic signs of loosening. Nine cups were revised in the Charnley group, and five cups were removed in the Duraloc group. The difference was not statistically significant. There was no statistical difference between the cups when aseptic loosening was the end-point, nor in survival analyses.

CONCLUSIONS

There is no statistically significant difference in clinical or radiological outcome between the Charnley cup and the Duraloc after 10 years, and no difference in implant survival after 12-14 years. The uncemented Duraloc cup is as good as the cemented Charnley cup after 10 years.

摘要

背景

尽管有多项研究记录了Charnley低摩擦人工关节置换术的结果,以及大量关于非骨水泥型人工关节置换术的研究,但关于非骨水泥髋臼组件与骨水泥组件的比较研究却很匮乏。在本研究中,我们旨在通过一项随机对照试验记录长期临床和影像学结果以及组件生存率。

材料与方法

215例患者(240髋)被随机分配接受骨水泥型Charnley髋臼杯或非骨水泥型Duraloc 1200髋臼杯。所有患者均接受骨水泥型Charnley股骨柄,并在6个月、2年、5年和10年后进行临床和影像学评估。

结果

Charnley组的Harris髋关节评分从48.3[95%置信区间(CI)45.0 - 51.6]提高到6个月时的90.2[95%CI 87.9 - 92.6],Duraloc组为49.3[95%CI 86.9 - 91.3]。10年后,Charnley组的Harris髋关节评分为89.8[95%置信区间(CI)87.0 - 92.6],Duraloc组评分为87.3(95%CI 84.1 - 90.6)。在10年后的影像学分析中,松动的影像学征象发生率无统计学差异。Charnley组有9个髋臼杯被翻修,Duraloc组有5个髋臼杯被取出。差异无统计学意义。以无菌性松动为终点时,两组髋臼杯之间无统计学差异,生存分析中也无差异。

结论

10年后,Charnley髋臼杯和Duraloc髋臼杯在临床或影像学结果上无统计学显著差异,12 - 14年后植入物生存率也无差异。10年后,非骨水泥型Duraloc髋臼杯与骨水泥型Charnley髋臼杯效果相当。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/238c/2837808/b856782b34a9/10195_2010_82_Fig1_HTML.jpg

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