无机诱导因子支架材料用于腰椎椎间融合的研究

Clinical effect of inorganic active element bone scaffold materials used in lumbar interbody fusion

目的探讨无机诱导因子支架材料在腰椎后路经椎间孔入路椎间融合术(transforaminal lumbar interbody fusion,TLIF)中行椎间融合治疗腰椎退行性疾病的近期疗效。方法采用TLIF治疗腰椎管狭窄症患者52例,所有患者均为单节段融合。依据椎间融合所采用的材料不同分为无机诱导支架材料组(A组)和减压后自体骨组(B组)。采用疼痛视觉模拟评分(VAS)、日本骨科学会评分(JOA)、Oswestry功能障碍指数问卷表(ODI)对患者术前术后疼痛、神经功能、生活质量进行评估;术后随访行X片和/或CT检查观察腰椎生理曲度、内固定在位状态和植骨融合等情况。结果全部患者获得随访,随访12~21个月,平均(14.5±4.7)个月。两组患者手术均顺利完成,无严重手术并发症。手术时间:A组76min^118min,平均(90.6±36.5)min,B组72min^132min,平均(95±32.7)min;术中出血量:A组100~240ml,平均(158.7±78.4)ml,B组115~255ml,平均(170.7±61.5)ml;两组差异无统计学意义。两组患者术后神经功能及临床症状均较术前得到明显改善。A组VAS评分术前平均为(7.5±1.7)分,术后12个月时改善为(2.5±1.2)分;ODI评分术前平均为(43.3±3.6)分,术后12个月为(10.7±2.9)分;JOA评分术前为(9.43±2.55)分,术后12个月为(16.07±1.02)分。B组VAS评分术前平均为(8.1±1.1)分,术后12个月为(2.4±1.7)分;ODI评分术前平均为(44.3±4.6)分,术后12个月为(12.7±4.1)分;JOA评分术前为(8.79±3.01)分,术后12个月时改善为(15.01±3.15)分。其差异均有统计学意义,P均<0.05。A,B两组术前、术后1周、术后12个月随访在VAS评分,ODI评分和JOA评分比较无统计学意义。随访期间两组患者均未见融合器下沉及内固定松动等并发症。X片和/或CT二维重建提示术后12个月所有病例椎间植骨均获得骨性融合。结论腰椎后路经椎间孔入路椎间融合内固定术中应用无机诱导因子支架材料能够获得同自体骨融合相近的椎间融合效果和临床疗效,治疗腰椎退行性疾病的近期临床疗效满意。

Objective To evaluate the effect of inorganic active element bone scaffold materials used in Transforaminal Lumbar Interbody Fusion in the treatment of lumbar degenerative diseases. Method From Jul 2014 to Oct 2015, a total of 52 lumbar stenosis cases were treated with one level standard TLIF operation. Inorganic active element bone scaffold materials were used for interbody fusion in 32 lumbar stenosis cases （Group A） and autogenous bone from laminectomy were used in 20 cases. Eighteen male cases and 14 female cases were included in group A （L4-5 14cases, L5-S1 11cases, L3-4 7cases, with the average age of 57.3±7.4years（47-82years）） and 8 male cases and 12 female cases were included in group B （（L4-511 cases, LS-S 1 6cases, L3-4 3cases, with the average age of 54.3±5.5years（45-73years））. VAS, JOA and ODI scores were evaluated at pre-, post- operation and follow up visits. X ray or/and CT scan were used to evaluate interbody fusion and lumbar lordosis. Results All patients were followed up for at least 12 months （12-21 months, with the average of 14.5±4.7months）. There was no statistical difference between group A and B in operating time （group A：90.6±36.5min,76min-118min; group B： 95±32.7min,72min- 132min） and blood loss （group A： 158.7±78.4ml, 100-240ml; group B： 170.7±61.5mi, 115-255mI）. Nerve function and clinical symptoms were improved in all patients. VAS score in group A decreased from 7.5±1.7 pre- operation to 2.5：±1.2 at 12 months＇ post operation（P〈0.05）. ODI score in group A was improved from 43.3±3.6 preoperation to 10.7a：2.9 at 12 months＇ post operation（P〈0.05）. JOA score in group A was improved from 9.43±2.55 preoperation to 16.07±1.02 at 12 months＇ post operation（P〈0.05）. VAS score in group B decreased from 8.1± 1.1 preoperation to 2.4±4.1 at 12 months＇ post operation（P〈0.05）. ODI score in group A was improved from 44.3±4.6 preoperation to 12.7±4.1 at 12 months＇ post operation（P〈0.05）. JOA score in group A was improved from 8.79±3.01 preoperation to 15.01±3.15 at 12 months＇ post operation（P〈0.05）. No statistical difference was found between group A and B at pre-operation ,1 week after operation and postoperative 12 months follow-up in the VAS score, ODI score and JOA score. Neither cage sinking or internal fixation loosen was founded during 12 months follow up. All cases were found interbody fusion on X-ray film or/and CT scan with 2-D reconstruction. Conclusion Inorganic active element bone scaffold materials used in TLIF in treatment of lumbar degenerative disease lead to good clinical effect and high interbody fusion.