【作者】 包拥政；

【导师】 吴强；

【作者基本信息】 汕头大学 ， 外科学， 2011， 硕士

【摘要】 目的:①观察一种新的高粘度骨水泥椎体成形后凸成形手术器械治疗骨质疏松椎体压缩性骨折的手术有效性、安全性。②评估该手术器械临床疗效及椎体后凸矫正效果。方法1、2010年8月至2011年2月收治的19例骨质疏松椎体压缩性骨折患者(男5例,女14例),年龄50-80岁,24个骨折椎体(T9:2个、T11:4个、T12:3个、L1:5个、L2:4个、L3:4个、L4:1个、L5:1个),局麻下后路经椎弓根穿刺用新研制的椎体后凸成形器械将高粘度低温骨水泥加压注入骨折椎体(18个椎体单侧穿刺,6个椎体双侧穿刺)。记录手术器械加压泵渗水、穿刺针弯曲、折断、穿刺顺畅、骨水泥注入量、骨水泥渗漏、出血量以及手术不良事件等指标;在X光片上测量手术前后椎体前缘、中部及后缘高度、后凸Cobb角(Kyphosis Cobb’s angle);利用视觉模拟评分法(Visual analogue scales, VAS)、Oswestry功能障碍指数(Oswestry disability index, ODI)评估手术前和术后第3天及术后1月疼痛、运动功能。2、所得数据分别用PASW Statistics 18.0进行统计学分析,分别计算手术前后椎体前缘、中部、后缘及平均高度、后凸Cobb角、VAS及ODI均数、标准差,并对所得数据进行正态分布检验,结果所得数据均不符合正态分布;将术前、术后2组所得的椎体前缘、中部、后缘及平均高度、后凸Cobb角、VAS及ODI测量值以及术后第3天VAS及ODI与术后1月VAS及ODI采用wilcoxon的符号配对秩和检验,P≤0.05为差异有显著性统计学意义;根据既往骨水泥注入量的研究分为高剂量组(>3.0ml)和低剂量组(≤3.0ml),对2组患者术后改善VAS、ODI、椎体前缘增加高度、椎体中部增加高度、椎体后缘增加高度及椎体平均增加高度、后凸Cobb角减小角度数采用非参数检验2个独立样本Mann-Whitney U检验,ρ≤0.05为差异有显著性统计学意义;根据术中单/双侧穿刺分为单侧穿刺组及双侧穿刺组,对2组术后较术前椎体前缘、中部、后缘及平均增加高度、后凸Cobb角减小角度采用非参数检验2个独立样本Mann-Whitney U检验,ρ≤0.05为差异有显著性统计学意义。统计手术时间、出血量、注入骨水泥量均数、标准差;计算安全、有效率百分比及骨水泥渗漏率及并发症、不良事件发生率。结果单个椎体手术时间72.83±12.67分钟,出血量3.91±4.21ml,骨水泥注入量3.27±0.99ml,4个椎体前方见骨水泥渗漏(16.67%),无相关临床症状,无其它并发症。30次穿刺均穿刺顺利,无受试者临床不良事件发生。术后1月随访1例患者死亡,余18例患者未发生椎体再骨折。术前椎体前缘高度:20.57±6.87mm,术后椎体前缘高度:24.70±9.03mm(P<0.01);术前椎体中部高度:23.70±6.09mm,术后椎体中部高度:25.68±6.37mm(P<0.01);术前椎体后缘高度:28.68±5.84mm,术后椎体后缘高度:28.69±5.86mm(P=0.08);术前椎体平均高度:24.32±6.11mm,术后椎体平均高度:26.36±6.33mm(P<0.01);术前后凸Cobb角:26.40±10.82°;术后后凸Cobb角:20.32±10.79°(P<0.01)。术前VAS:7.74±0.81分,术后3天VAS:3.37±0.89分(P<0.01),术后1月VAS:2.72±0.69分(与术后3天相比P<0.01);术前ODI:76.09±6.26%,术后3天ODI:32.78±9.20%(P<0.01),术后ODI评级:优4例,良13例,可1例,优良率94.74%,术后1月ODI:31.43±8.08%(与术后3天相比P=0.87),ODI评级:优2例,良16例,优良率100%。高剂量组(n=11)术后改善VAS:4.45±1.21分,低剂量组(n=8)术后改善VAS:4.25±0.71分(ρ=0.65);高剂量组(n=11)术后改善ODI:42.59±6.67%,低剂量组(n=8)术后改善ODI:44.29±5.07%(ρ=0.56);高剂量组椎体前缘增加高度(n=13):5.09±1.15mm,低剂量组椎体前缘增加高度(n=11):3.00±1.09mm(ρ<0.01);高剂量组椎体中部增加高度(n=13):2.84±1.58mm,低剂量组椎体中部增加高度(n=11):0.98±1.0mm(ρ<0.01);高剂量组椎体后缘增加高度(n=13):0.02±0.0mm,低剂量组椎体后缘增加高度(n=11):0.00±0.00mm(ρ=0.09);高剂量组椎体平均增加高度(n=13):2.65±0.89mm,低剂量组椎体平均增加高度(n=11):1.32±0.59mm(ρ<0.01);高剂量组后凸Coob角减小角度(n=12):7.37±2.35°,低剂量组后凸Coob角减小角度(n=11):0.082±0.060°(ρ=0.<0.01)。单侧穿刺椎体组前缘增加高度(n=18):4.08±1.69mm,双侧穿刺组椎体前缘增加高度(n=6):4.28±0.99mm(ρ=0.69);单侧穿刺组椎体中部增加高度(n=18):1.99±1.76mm;双侧穿刺组椎体中部增加高度(n=6):1.97±1.24mm(ρ=0.62);单侧穿刺组椎体后缘增加高度(n=18):0.01±0.03mm,双侧穿刺组椎体后缘增加高度(n=6):0.02±0.04mm(ρ=0.72);单侧穿刺组椎体平均增加高度(n=18):2.03±1.12mm;双侧穿刺组椎体平均增加高度(n=6):2.08±1.12mm(ρ=0.48);单侧穿刺组后凸Cobb角减小角度(n=17):6.08±2.29°;双侧穿刺组后凸Cobb角减小角度(n=6):6.08±2.10°(ρ=0.81)。结论1、本组研究中高粘度骨水泥椎体后凸成形器械手术过程顺利,无不良事件发生,安全、有效,操作简便。2、高粘度骨水泥后凸成形术可明显改善疼痛及运动功能;对椎体前缘、中部高度有较好的恢复,可矫正椎体后凸畸形;高剂量组可更好恢复椎体中部高度和椎体后凸Cobb角;单/双侧穿刺在恢复椎体高度、后凸Cobb角无明显差异。更多还原

【Abstract】 Object①To investigate the safety and efficiency of a new percutaneous kyphoplasty surgical instrument with high viscosity bone cement.②To observe the clinical outcome of the osteoporosis thoracolumbar compression fractures. Methods1. 19 patients with osteoporosis thoracolumbar compression fractures were included (4 male and 15 female, age range 53-80 years old, average age 69.63±8.39 years old). 24 osteoporosis thoracolumbar compression fractures(T9:2, T11:4, T12:3, L1:5, L2:4, L3:4, L4:1, L5:1) were received a new percutaneous kyphoplasty surgical instrument with high viscosity bone cement, of which 18 vertebras were received unipedicular percutaneous kyphoplasty, while other 6 vertebras were received bipedicular percutaneous kyphoplasty. The indexes such as pump water seepage, bone cement leakage, bone biopsy needle bending or breaking, bleeding volume and postoperative adverse events were observed and recorded. The anterior, midline, posterior and average vertebral height, kyphosis Cobb’s angle, visual analogue scales(VAS) and modified Simplified Chinese Version of Oswestry Disability Index(ODI) were determined before and after operation 3 days and 1 month later.2、The dates of The anterior, midline, posterior and average vertebral height, kyphosis Cobb’s angle, VAS and ODI determined before and after operation 3 days and 1month later were analyzed by the PASW Statistics 18.0.ResultsThe percutaneous kyphoplasty surgical instrument with high viscosity bone cement was safe and efficient. There was no adverse events occurred in 30 operative procedures, 82.83±12.67 min for a vertebra, bleeding volume 3.91±4.21 ml, injected bone cement volume 3.27±0.99 ml. 4 bone cement leakage in front of vertebra were observed without clinical symptoms, No other complications were observed. One patient dead after the following visited 1 month later, and no fresh fracture or refracture were observed.The anterior vertebral height before operation: 20.57±6.87mm, the anterior vertebral height after operation: 24.70±9.03mm(P<0.01); the midline vertebral height before operation: 23.70±6.09mm, the midline vertebral height after operation: 25.68±6.37mm(P < 0.01); the posterior vertebral height before operation: 28.68±5.84mm, the posterior vertebral height after operation: 28.69±5.86mm(P=0.08); the average vertebral height before operation: 24.32±6.11mm, the average vertebral height after operation: 26.36±6.33mm(P < 0.01); the kyphosis Cobb’s angle before operation: 26.40±10.82°, the kyphosis Cobb’s angle after operation: 20.32±10.79°(P<0.01). The VAS score before operation:7.74±0.81, the VAS score after operation 3 days: 3.37±0.89(P<0.01), the VAS score after operation 1 month: 2.72±0.69(P<0.01, compared with the VAS score after operation 3 days); the ODI before operation:76.09±6.26%, the ODI after operation 3 days: 32.78±9.20%(P < 0.01), the ODI after operation 1 month: 31.43±8.08%(P=0.87 ,compared with the ODI after operation 3 days). According to the ODI scale, there were 4 patients excellent, 14 patient good and one medium after operation 3 days, there were 2 patients excellent, 16 patient good after operation 1 month. High bone cement volume group(>3.0ml) and low bone cement volume group(≤3.0ml) were compared. The improved VAS score in high bone cement volume group(n=11): 4.45±1.21, the improved VAS score in low bone cement volume group(n=8): 4.25±0.71(ρ=0.76); the improved ODI in high bone cement volume group(n=11): 42.59±6.67%, the improved VAS score in low bone cement volume group(n=8): 44.29±5.07%(ρ=0.56); the improved anterior vertebral height in high bone cement volume group(n=13): 5.09±1.15mm, the improved anterior vertebral height in low bone cement volume group(n=11): 3.00±1.09mm(ρ<0.01); the improved midline vertebral height in high bone cement volume group(n=13): 2.84±1.58mm, the improved midline vertebral height in low bone cement volume group(n=11): 0.98±1.01mm(ρ<0.01); the improved posterior vertebral height in high bone cement volume group(n=13): 0.02±0.04mm, the improved posterior vertebral height in low bone cement volume group(n=11): 0.00±0.00mm(ρ=0.09); the improved average vertebral height in high bone cement volume group(n=13): 2.65±0.89mm, the improved average vertebral height in low bone cement volume group(n=11): 1.32±0.59mm(ρ<0.01); the improved kyphosis Cobb’s angle in high bone cement volume group(n=12): 7.37±2.35°, the improved kyphosis Cobb’s angle in low bone cement volume group(n=11): 4.68±0.65°(ρ<0.01). Unipedicular group and bipedicular group were seted up according to unipedicular or bipedicular in operative procedures. The improved anterior vertebral height in unipedicular group (n=18): 4.08±1.69mm, the improved anterior vertebral height in bipedicular group(n=6): 4.28±0.99mm(ρ=0.69); the improved midline vertebral height in unipedicular group(n=18): 1.99±1.76mm, the improved midline vertebral height in bipedicular group(n=6): 1.97±1.24(ρ=0.62); the improved posterior vertebral height in unipedicular group(n=18):0.01±0.03mm, the improved posterior vertebral height in bipedicular group(n=6): 0.02±0.04mm(ρ=0.72); the improved average vertebral height in unipedicular group(n=18): 2.03±1.12mm, the improved average vertebral height in bipedicular group (n=6): 2.08±1.12mm(ρ=0.48); the improved kyphosis Cobb’s angle in unipedicular group(n=17): 6.08±2.29°, the improved kyphosis Cobb’s angle in low injected bone cement volume group(n=11): 6.08±2.10°(ρ=0.81).Conclusions1.There was no adverse events in the operations.The percutaneous kyphoplasty surgical instrument with high viscosity bone cement was safe and effective and easily operated.2. A apparent recovery was observed in the anterior, midline vertebral height, kyphosis angel, VAS and ODI via percutaneous kyphoplasty with high viscosity bone cement, but didn’t to the posterior and average vertebral height. High injected volume group had a better recovery in midline vertebral height and kyphosis Cobb’s angle. There was no different in recovery of vertebral height and kyphosis Cobb’s angle between unipedicular group and bipedicular group.更多还原