[Kiva®椎体压缩骨折治疗系统——一种新型椎体压缩骨折强化系统疗效及患者安全性的临床研究]
[Kiva® VCF Treatment System - clinical study on the efficacy and patient safety of a new system for augmentation of vertebral compression fractures].
作者信息
Bornemann R, Otten L A, Koch E M W, Jansen T R, Kabir K, Wirtz D C, Pflugmacher R
机构信息
Klinik und Poliklinik für Orthopädie und Unfallchirurgie, Universitätsklinikum Bonn.
出版信息
Z Orthop Unfall. 2012 Dec;150(6):572-8. doi: 10.1055/s-0032-1327935. Epub 2013 Jan 7.
BACKGROUND
As a further alternative to previously used vertebral augmentation methods, the Kiva VCF Treatment System® was clinically investigated.
MATERIAL AND METHODS
The pilot study included 24 patients (mean age 74 years, 34 vertebrae).
RESULTS
During an operation period of 16.6 minutes on average 2.2 ± 1 mL of PMMA cement were injected. 87 % of patients were satisfied or very satisfied with this treatment. In 2 cases leakage of cement has been registered. The pain intensity was already reduced after 7 days to 69.5 mm (VAS scale 0-100). After 30 days, the difference from baseline was 76 mm. Significant improvements have also been shown in the Oswestry Score (functional ability), physical performance and mental well-being.
CONCLUSION
On the basis of these results, the new augmentation can be described as being effective in the treatment of painful vertebral fractures.
背景
作为此前使用的椎体强化方法的又一替代方案，对Kiva VCF治疗系统®进行了临床研究。
材料与方法
该初步研究纳入了24例患者（平均年龄74岁，34个椎体）。
结果
在平均16.6分钟的手术过程中，平均注入了2.2±1毫升的聚甲基丙烯酸甲酯（PMMA）骨水泥。87%的患者对该治疗感到满意或非常满意。有2例记录到骨水泥渗漏。疼痛强度在7天后已降至69.5毫米（视觉模拟评分法，VAS，范围0 - 100）。30天后，与基线的差异为76毫米。在奥斯维斯特里指数（功能能力）、身体表现和心理健康方面也显示出显著改善。
结论
基于这些结果，这种新的强化方法可被描述为在治疗疼痛性椎体骨折方面有效。
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