经皮椎体支架内固定治疗骨质疏松性椎体压缩骨折的临床研究

A clinical study of percutaneous vertebral body stenting internal fixation for treatment of osteoporotic vertebral compression fractures

目的:观察经皮椎体支架内固定治疗骨质疏松性椎体压缩骨折(osteoporotic vertebral compression fracture,OVCF)的临床疗效和安全性。方法:回顾性分析80例OVCF患者的病例资料,其中采用经皮椎体支架内固定治疗40例(经皮椎体支架内固定组)、采用经皮椎体后凸成形术(percutaneous kyphoplasty,PKP)治疗40例(PKP组)。比较2组患者的骨水泥注入量、术中出血量、手术时间、胸腰椎疼痛视觉模拟量表(visual analogue scale,VAS)评分、Oswestry功能障碍指数(Oswestry disability index,ODI)、伤椎Beck指数、伤椎矢状位Cobb角和并发症发生率。结果:①一般结果。2组患者骨水泥注入量、术中出血量、手术时间比较,组间差异均无统计学意义[(2.29±1.39)mL,(1.85±1.25)mL,t=-1.541,P=0.061;(6.91±2.24)mL,(5.43±1.12)mL,t=-0.480,P=0.431;(33.61±7.31)min,(25.76±2.43)min,t=-6.59,P=0.542]。②胸腰椎疼痛VAS评分。时间因素和分组因素存在交互效应(F=44.059,P=0.000);2组患者的胸腰椎疼痛VAS评分总体比较,组间差异无统计学意义,即不存在分组效应(F=10.250,P=0.736);手术前后不同时间点胸腰椎疼痛VAS评分的差异有统计学意义,即存在时间效应(F=88.117,P=0.000);2组患者胸腰椎疼痛VAS评分随时间变化均呈下降趋势,但2组的下降趋势不完全一致[(7.95±0.59)分,(3.83±0.53)分,(2.21±0.59)分,(1.75±0.55)分,F=53.256,P=0.000;(7.88±0.57)分,(3.91±0.57)分,(2.33±0.88)分,(1.82±0.62)分,F=34.861,P=0.000];2组患者术前胸腰椎疼痛VAS评分比较,差异无统计学意义(t=0.342,P=0.731);术后2 d、3个月、6个月经皮椎体支架内固定组患者胸腰椎疼痛VAS评分均低于PKP组(t=2.556,P=0.002;t=3.251,P=0.000;t=4.101,P=0.003)。③ODI。时间因素和分组因素存在交互效应(F=45.476,P=0.000);2组患者的ODI总体比较,组间差异无统计学意义,即不存在分组效应(F=11.029,P=1.573);手术前后不同时间点ODI的差异有统计学意义,即存在时间效应(F=90.952,P=0.000);2组患者ODI随时间变化均呈下降趋势,且2组的下降趋势完全一致[(56.65±6.23)%,(20.53±3.85)%,(18.27±2.27)%,(17.13±2.615)%,F=52.586,P=0.000;(55.94±5.77)%,(20.51±3.89)%,(18.62±2.21)%,(17.31±2.11)%,F=38.366,P=0.000];2组患者术前及术后2 d、3个月、6个月ODI比较,组间差异均无统计学意义(t=-0.801,P=0.417;t=4.772,P=0.357;t=3.154,P=0.402;t=3.904,P=0.397)。④伤椎Beck指数。时间因素和分组因素存在交互效应(F=416.582,P=0.000);2组患者伤椎Beck指数总体比较,组间差异有统计学意义,即存在分组效应(F=34.567,P=0.000);手术前后不同时间点伤椎Beck指数差异有统计学意义,即存在时间效应(F=287.312,P=0.000);2组患者伤椎Beck指数随时间变化均呈先上升后基本保持不变的趋势,但2组趋势不完全一致(0.62±0.06,0.95±0.14,0.95±0.13,0.94±0.09,F=243.085,P=0.000;0.64±0.05,0.75±0.17,0.75±0.14,0.74±0.09,F=44.227,P=0.000);2组患者术前伤椎Beck指数比较,差异无统计学意义(t=-2.932,P=0.482);术后2 d、3个月、6个月经皮椎体支架内固定组患者伤椎Beck指数均高于PKP组(t=9.194,P=0.000;t=10.933,P=0.000;t=17.372,P=0.000)。⑤伤椎矢状位Cobb角。时间因素和分组因素存在交互效应(F=18.642,P=0.000);2组患者的伤椎矢状位Cobb角总体比较,组间差异无统计学意义,即不存在分组效应(F=8.822,P=0.639);手术前后不同时间点伤椎矢状位Cobb角的差异有统计学意义,即存在时间效应(F=63.503,P=0.000);2组患者伤椎矢状位Cobb角随时间变化均呈先下降后基本保持不变的趋势,但2组趋势不完全一致(18.85°±3.32°,11.89°±1.84°,12.21°±1.34°,11.62°±1.55°,F=25.137,P=0.000;18.66°±3.15°,14.54°±4.21°,15.23°±3.52°,14.21°±2.77°,F=38.366,P=0.000);2组患者术前伤椎矢状位Cobb角比较,差异无统计学意义(t=0.102,P=0.635);术后2 d、3个月、6个月经皮椎体支架内固定组患者伤椎矢状位Cobb角均小于PKP组(t=2.013,P=0.001;t=3.205,P=0.000;t=3.502,P=0.003)。⑥并发症发生率。经皮椎体支架内固定组发生骨水泥渗漏1例,PKP组发生骨水泥渗漏10例。2组患者均未发生相邻椎体骨折、神经根损伤等并发症。经皮椎体支架内固定组患者并发症发生率低于PKP组(χ^(2)=8.538,P=0.003)。结论:经皮椎体支架内固定治疗OVCF,与PKP相比,二者在骨水泥注入量、术中出血量、手术时间及恢复椎体功能方面相当,但前者更有利于缓解胸腰椎疼痛、恢复椎体正常形态,且安全性高。

Objective:To observe the clinical outcomes and safety of percutaneous vertebral body stenting(VBS)internal fixation for treatment of osteoporotic vertebral compression fractures(OVCFs).Methods:The medical records of 80 OVCFs patients were analyzed retrospectively.Forty patients were treated with percutaneous VBS internal fixation(percutaneous VBS internal fixation group)and 40 ones with percutaneous kyphoplasty(PKP)(PKP group).The consumption of bone cement,intraoperative blood loss,operative time,thoracolumbar pain visual analogue scale(VAS)score,Oswestry disability index(ODI),injured vertebrae Beck index,injured vertebrae sagittal Cobb’s angle and complication incidence were compared between the 2 groups.Results:①There was no statistical difference in consumption of bone cement,intraoperative blood loss and operative time between the 2 groups(2.29±1.39 vs 1.85±1.25 mL,t=-1.541,P=0.061;6.91±2.24 vs 5.43±1.12 mL,t=-0.480,P=0.431;33.61±7.31 vs 25.76±2.43 minutes,t=-6.59,P=0.542).②There was interaction between time factor and group factor in thoracolumbar pain VAS score(F=44.059,P=0.000).There was no statistical difference in thoracolumbar pain VAS scores between the 2 groups in general,in other words,there was no group effect(F=10.250,P=0.736).There was statistical difference in thoracolumbar pain VAS scores between different timepoints before and after the surgery,in other words,there was time effect(F=88.117,P=0.000).The thoracolumbar pain VAS scores presented a downward trend over time in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(7.95±0.59,3.83±0.53,2.21±0.59,1.75±0.55 points,F=53.256,P=0.000;7.88±0.57,3.91±0.57,2.33±0.88,1.82±0.62 points,F=34.861,P=0.000).There was no statistical difference in thoracolumbar pain VAS scores between the 2 groups before the surgery(t=0.342,P=0.731),while the thoracolumbar pain VAS scores decreased in percutaneous VBS internal fixation group compared to PKP group at postsurgical day 2,month 3 and month 6(t=2.556,P=0.002;t=3.251,P=0.000;t=4.101,P=0.003).③There was interaction between time factor and group factor in ODI(F=45.476,P=0.000).There was no statistical difference in ODI between the 2 groups in general,in other words,there was no group effect(F=11.029,P=1.573).There was statistical difference in ODI between different timepoints before and after the surgery,in other words,there was time effect(F=90.952,P=0.000).The ODI presented a downward trend over time in the 2 groups,and the 2 groups were completely consistent with each other in the variation tendency(56.65±6.23,20.53±3.85,18.27±2.27,17.13±2.615%,F=52.586,P=0.000;55.94±5.77,20.51±3.89,18.62±2.21,17.31±2.11%,F=38.366,P=0.000).There was no statistical difference in ODI between the 2 groups before the surgery and at postsurgical day 2,month 3 and month 6(t=-0.801,P=0.417;t=4.772,P=0.357;t=3.154,P=0.402;t=3.904,P=0.397).④There was interaction between time factor and group factor in injured vertebrae Beck index(F=416.582,P=0.000).There was statistical difference in injured vertebrae Beck index between the 2 groups in general,in other words,there was group effect(F=34.567,P=0.000).There was statistical difference in injured vertebrae Beck index between different timepoints before and after the surgery,in other words,there was time effect(F=287.312,P=0.000).The injured vertebrae Beck index presented a trend of going upward firstly and remaining basically unchanged subsequently over time in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(0.62±0.06,0.95±0.14,0.95±0.13,0.94±0.09,F=243.085,P=0.000;0.64±0.05,0.75±0.17,0.75±0.14,0.74±0.09,F=44.227,P=0.000).There was no statistical difference in injured vertebrae Beck index between the 2 groups before the surgery(t=-2.932,P=0.482),while the injured vertebrae Beck indexes increased in percutaneous VBS internal fixation group compared to PKP group at postsurgical day 2,month 3 and month 6(t=9.194,P=0.000;t=10.933,P=0.000;t=17.372,P=0.000).⑤There was interaction between time factor and group factor in injured vertebrae sagittal Cobb’s angle(F=18.642,P=0.000).There was no statistical difference in injured vertebrae sagittal Cobb’s angle between the 2 groups in general,in other words,there was no group effect(F=8.822,P=0.639).There was statistical difference in injured vertebrae sagittal Cobb’s angle between different timepoints before and after the surgery,in other words,there was time effect(F=63.503,P=0.000).The injured vertebrae sagittal Cobb’s angle presented a trend of going downward firstly and remaining basically unchanged subsequently over time in the 2 groups,while the 2 groups were inconsistent with each other in the variation tendency(18.85±3.32,11.89±1.84,12.21±1.34,11.62±1.55 degrees,F=25.137,P=0.000;18.66±3.15,14.54±4.21,15.23±3.52,14.21±2.77 degrees,F=38.366,P=0.000).There was no statistical difference in injured vertebrae sagittal Cobb’s angle between the 2 groups before the surgery(t=0.102,P=0.635),while the injured vertebrae sagittal Cobb’s angle decreased in percutaneous VBS internal fixation group compared to PKP group at postsurgical day 2,month 3 and month 6(t=2.013,P=0.001;t=3.205,P=0.000;t=3.502,P=0.003).⑥The bone cement leakage was found in 1 patient in percutaneous VBS internal fixation group and 10 patients in PKP group.No complications such as adjacent vertebral fracture and nerve root injury were found in the 2 groups.The complication incidence rate was lower in percutaneous VBS internal fixation group compared to PKP group(χ^(2)=8.538,P=0.003).Conclusion:The percutaneous VBS internal fixation is similar to PKP in consumption of bone cement,intraoperative blood loss,operative time and vertebral function recovery in treatment of OVCFs,while the former can be more conducive to thoracolumbar pain relief and vertebral body morphology recovery with high safety compared to the latter.