椎弓根外入路单球囊扩张注入骨水泥修复治疗骨质疏松性椎体压缩骨折

Single balloon kyphoplasty using extrapedicular approach for osteoporotic vertebral compression fracture

背景:椎体后凸成型术治疗骨质疏松性椎体压缩骨折多采用经椎弓根入路双球囊法,虽然疗效满意,但耗时长,器材费用高,且医生和患者接受X射线照射剂量大。目的:评价单球囊后凸成形术治疗骨质疏松性椎体压缩骨折的效果。设计、时间及地点:自身前后对照观察,于2004-08/2006-08在上海交通大学医学院附属仁济医院骨科完成。材料:椎体成型器和骨水泥均为美国Kyphon公司产品。干预:骨质疏松性椎体压缩骨折患者21例全麻取俯卧位,在C型臂X射线机定位下行骨折椎体椎弓根外入路单球囊扩张注入骨水泥。主要观察指标:通过术前、术后24h、末次随访时目测类比疼痛评分进行临床疗效评估。通过侧位X射线片术前、术后24h、末次随访时后凸角比较,术后24h、末次随访时椎体前缘高度恢复率(%)比较及正位X射线片术后24h、末次随访时椎体两侧高度比较进行影像学评估。同时观察骨水泥注入后有无渗漏、外溢及材料宿主反应。结果:21例患者均进入结果分析,随访时间≥6个月。术后24h平均目测类比疼痛评分及平均后凸角较术前降低(P<0.01),末次随访时与术后24h相比差异无显著性意义(P>0.01)。术后24h、末次随访时平均椎体前缘高度恢复率差异无显著性意义(P>0.01)。术后24h及末次随访时椎体两侧平均高度差异无显著性意义(P>0.01)。骨水泥注入后未发生并发症及材料宿主反应。结论:经椎弓根外入路单球囊扩张注入骨水泥治疗骨质疏松性椎体压缩骨折能恢复椎体高度,减轻后凸畸形,有效缓解疼痛,且无骨水泥渗漏、外溢发生。

BACKGROUND： Kyphoplasty is an effective procedure for the treatment of osteoporotic vertebral compression fractures. Although two balloons kyphoplasty using transpedicular approach is now widely used and has achieved satisfactory clinical outcomes, this method is time-consuming, high medical cost, and increases the radiation exposure of the doctor and patient concerned. OBJECTIVE： To evaluate the therapeutic effect of single balloon kyphoplasty using extrapedicular approach in patients with osteoporotic vertebral compression fractures. DESIGN, TIME AND SETTING： A self-controlled observation was performed at Department of orthopaedics, Renji Hospital, Medical College of Shanghai Jiao Tong University from August 2004 to August 2006. MATERIALS： The kyphoplasty instrument and bone cement were products of Kyphon, USA. METHODS： Twenty-one patients with osteoporotic vertebral compression fractures were selected. The patients underwent single balloon kyphoplasty using extrapedicular approach at prone position under general anesthesia with the help of fluoroscopic machines. MAIN OUTCOME MEASURES： Clinical results were determined by the comparison of visual analog scale score of preoperative, 24-hour postoperative and final follow-up; Radiographic assessments were determined by the comparison of preoperative, 24-hour postoperative, and final follow-up Cobb angle on lateral X-ray view, the comparison of 24-hour postoperative, final follow-up anterior vertebral height restoration rate （%） on lateral X-ray view and the comparison of 24-hour postoperative, final follow-up bilateral vertebral height on antero-posterior X-ray view; bone cement leakage, spillover and response between material and host were also observed. RESULTS： Twenty-one patients were included in final analysis, and followed up for more than 6 months. The mean VAS pain score and mean Cobb angle were significantly decreased at the 24-hour postoperative follow-up compared with before surgery （P 〈 0.01）, and there were no significant difference between those at the 24-hour postoperative and the final follow-up （P 〉 0.01）. There were no significant differences in mean anterior vertebral height restoration rate （%） at the 24-hour postoperative and the final follow-up （P 〉 0.01）. There were no significant differences in mean bilateral vertebral height at the 24-hour postoperative and the final follow up （P 〉 0.01）. No complication or material-host responses occurred after bone cement injection. CONCLUSION： No bone cement leakage or spillover occurs in single balloon kyphoplasty using extrapedicular approach for the treatment of patients with osteoporotic vertebral compression fractures. In addition, this method can alleviate pain, restore vertebral body height and reduce kyphosis deformity effectively.