Pain Physician. 2013 Sep-Oct;16(5):E505-12.
Vertebral compression fractures are common among the elderly, which is conditioned by osteoporosis. They cause back pain and limit the patient's activities. The Kiva® VCF Treatment System is a new device to treat vertebral compression fractures. Compared to other methods, the utilization of the Kiva System reduces the risk for complications and delivers improvements in back pain reduction and functionality.
Evaluation of safety and effectiveness of the Kiva System in comparison to balloon kyphoplasty on the basis of matched pairs.
52 patients (47 - 89 years, 68 fractures) were treated with balloon kyphoplasty or with the new Kiva System. Back pain and impairment of motility were assessed preoperatively and 6 months postoperatively, with the Visual Analog Scale (VAS) and Oswestry Disability Index (ODI). The operation time and cement extravasation were recorded. Control radiographs were evaluated for new fractures and vertebral heights.
Mean VAS values in both groups improved from preoperatively 87.6 ± 12.8 and 83.1 ± 14.9 to 10.8 ± 20.8 and 24.6 ± 11.0 6 months after the treatment. The improvement after 6 months in the Kiva group was significantly better than in the balloon kyphoplasty group (P < 0.0001). Mean ODI scores in both groups also improved from 68.7% ± 15.8% in the Kiva group and 80.6% ± 8.6% in the balloon kyphoplasty group preoperatively to 24.8 ± 18.6% and 33.2 ± 6.3% 6 months after treatment. The mean operation time for the Kiva group was 12.7 ± 3.7 minutes per vertebra and cement leakage occurred in 6 patients. The mean operation time for the balloon kyphoplasty group was 34.1 ± 7.0 minutes per vertebra and cement leakage occurred in 8 patients. Anterior and mid vertebral height in the Kiva group increased from preoperatively 21.06 ± 7.44 mm and 18.36 ± 5.64 mm to postoperatively 22.41 ± 7.14 mm and 20.41 ± 6.00 mm. Anterior and mid vertebral height in the balloon kyphoplasty group increased from preoperatively 21.68 ± 2.06 mm and 21.97 ± 1.78 mm to postoperatively 25.09 ± 2.54 mm and 25.29 ± 2.10 mm. Vertebral height restoration could be therefore maintained with both procedures for 6 months. In the Kiva group 2 cases of nonadjacent fractures and one case of adjacent fractures were observed. In the balloon kyphoplasty group 9 cases of adjacent, as well as 5 cases of nonadjacent, fractures were observed. In the Kiva group significant fewer fractures occurred.
The study includes only 26 patients for each procedure, which were compared on the basis of matched pairs.
The Kiva System appears to be a safe and effective procedure for the treatment of vertebral compression fractures. Six months after treatment with the Kiva System, better VAS values than the values after the treatment with balloon kyphoplasty were recorded. Reduction in functional impairment was as successful as it was after balloon kyphoplasty. Vertebral height restoration was observed in both groups, which was sustained for 6 months. The risk of cement extravasation during the Kiva Treatment is nearly the same as in balloon kyphoplasty; however, it requires a shorter operation time and produces less new fractures.
椎体压缩性骨折在老年人中很常见，这是由骨质疏松症引起的。它们会导致背痛，并限制患者的活动。Kiva®VCF 治疗系统是一种治疗椎体压缩性骨折的新设备。与其他方法相比，Kiva 系统的使用降低了并发症的风险，并改善了背痛减轻和功能恢复。
基于配对比较，评估 Kiva 系统与球囊扩张椎体后凸成形术治疗椎体压缩性骨折的安全性和有效性。
52 例患者（47-89 岁，68 处骨折）分别接受球囊扩张椎体后凸成形术或新型 Kiva 系统治疗。术前和术后 6 个月采用视觉模拟评分（VAS）和 Oswestry 功能障碍指数（ODI）评估背痛和活动受限情况。记录手术时间和骨水泥渗漏情况。对照 X 线片评估新发骨折和椎体高度。
两组 VAS 值均从术前的 87.6±12.8 和 83.1±14.9 改善至术后 6 个月的 10.8±20.8 和 24.6±11.0。Kiva 组治疗后 6 个月的改善明显优于球囊扩张椎体后凸成形术组（P<0.0001）。两组 ODI 评分也从术前的 Kiva 组 68.7%±15.8%和球囊扩张椎体后凸成形术组 80.6%±8.6%改善至术后 6 个月的 24.8±18.6%和 33.2±6.3%。Kiva 组的平均手术时间为每椎体 12.7±3.7 分钟，6 例发生骨水泥渗漏。球囊扩张椎体后凸成形术组的平均手术时间为每椎体 34.1±7.0 分钟，8 例发生骨水泥渗漏。Kiva 组治疗前后的椎体前缘和中部高度分别从术前的 21.06±7.44mm 和 18.36±5.64mm 增加到术后的 22.41±7.14mm 和 20.41±6.00mm。球囊扩张椎体后凸成形术组治疗前后的椎体前缘和中部高度分别从术前的 21.68±2.06mm 和 21.97±1.78mm 增加到术后的 25.09±2.54mm 和 25.29±2.10mm。因此，两种方法均可在 6 个月内维持椎体高度的恢复。Kiva 组有 2 例非相邻骨折和 1 例相邻骨折，球囊扩张椎体后凸成形术组有 9 例相邻骨折和 5 例非相邻骨折。Kiva 组的骨折发生率明显较低。
本研究每组仅包括 26 例患者，基于配对比较进行比较。
Kiva 系统似乎是一种安全有效的治疗椎体压缩性骨折的方法。治疗后 6 个月，Kiva 系统治疗的 VAS 值优于球囊扩张椎体后凸成形术治疗的 VAS 值。功能障碍的减轻与球囊扩张椎体后凸成形术一样成功。两组均观察到椎体高度恢复，且持续 6 个月。Kiva 治疗过程中骨水泥渗漏的风险与球囊扩张椎体后凸成形术相似；然而，它需要更短的手术时间，并产生更少的新发骨折。
