全内镜下腰椎椎体间融合术和可扩张通道下微创经椎间孔腰椎椎体间融合术的前瞻性对照研究

Full endoscopic lumbar interbody fusion versus minimally invasive transforaminal lumbar interbody fusion:a prospective controlled study

目的通过全内镜下腰椎椎体间融合术(full endoscopic lumbar interbody fusion,FE-LIF)与可扩张通道下微创经椎间孔腰椎椎体间融合术(minimally invasive transformational lumbar interbody fusion,MIS-TLIF)的前瞻性对照研究,评估FE-LIF的安全性、临床疗效及影像学结果。方法2018年8月至2020年8月,共100例单节段腰椎退变性疾病需要行腰椎融合手术治疗的患者被非随机分配到FE-LIF组(n=50)和MIS-TLIF组(n=50)。FE-LIF组采用全内镜下经椎间孔入路或椎板间隙入路腰椎椎体间融合术;MIS-TLIF组在可扩张通道下实施MIS-TLIF。术中记录射线暴露量、出血量及不同手术操作步骤耗费时间等指标。术后复查腰椎MRI及CT评估神经减压及椎体间融合情况。术后1周、3个月、6个月及1年时随访患者腰痛及腿痛的疼痛视觉模拟评分(visual analogue scale,VAS)及腰椎的Oswestry功能障碍指数(oswestry disability index,ODI)。术后1年时采用MacNab评估患者腰椎功能恢复情况,评估神经根功能恢复情况。结果所有手术顺利完成,未发生明显手术并发症。共有70例(FE-LIF组32例,MIS-TLIF组38例)获得全部随访资料。与MIS-TLIF组相比,FE-LIF组出血量少,但射线暴露量大、手术时间长(P<0.05)。两组患者术后腰椎MRI检查显示神经减压充分,患者术后腰痛及腿痛明显缓解,ODI评分明显改善(P<0.01);两组患者术前及术后各时间点腰痛VAS评分、腿痛VAS评分及ODI评分差异无统计学意义(P>0.05)。1年随访时,两组患者神经根感觉及运动功能明显恢复(P<0.05),MacNab两组间差异无统计学意义(FE-LIF组:19例优,12例良,1例可;MIS-TLIF组:22例优,15例良,1例可;P>0.05)。根据基于CT的Mannion椎体间融合标准,FE-LIF组在术后6个月及1年时的椎体间融合率明显优于MIS-TLIF组。结论FE-LIF是安全、有效的微创融合技术,临床疗效等同于MIS-TLIF,但手术时间延长、射线暴露量增多。

Objective To compare the safety and clinical efficacy between full endoscopic lumbar interbody fusion(FE-LIF)and minimally invasive transforaminal lumbar interbody fusion(MIS-TLIF)through a prospective controlled study.Methods From August 2018 to August 2020,100 patients with single-level lumbar degenerative disease were non-randomly assigned to FE-LIF(n=50)and MIS-TLIF(n=50)group.FE-LIF was performed on patients of the FE-LIF group through transforaminal or interlaminar approach;MIS-TLIF was performed with a tubular retractor system on patients of the MIS-TLIF group.Intraoperative radiographic exposure,blood loss and time spent on different surgical procedures were recorded.Lumbar Magnetic Resonance Imaging(MRI)and Computerized Tomography(CT)were used to evaluate nerve decompression and interbody fusion.Visual analog scale(VAS)and Oswestry Disability Index(ODI)of lumbar function were evaluated at 1 week,3 months,6 months,and 1 year after surgery.MacNab score and recovery of nerve root function(sensation,muscle strength,and tendon reflex)were evaluated 1 year after surgery.Results All operations were successfully completed without any obvious surgical complications.In total 70 cases,32 cases in the FE-LIF group and 38 cases in the MIS-TLIF group were followed up for at least 1 year.The FE-LIF group had less bleeding,but with higher radiation exposure and longer operation time than those of the MIS-TLIF group(P<0.05).The nerve decompression was sufficient,as shown by postoperative lumbar MRI.The lower back pain and leg pain were significantly relieved,and the ODI score was significantly increased after surgery(P<0.01)in both groups.There were no significant differences in lower back pain and leg pain VAS and ODI scores between the two groups at any follow-up point(P>0.05).The sensory and motor functions of nerve roots were significantly recovered in both groups at 1-year follow-up(P<0.05),and there were no significant differences in MacNab score between the two groups(FE-LIF group:excellent in 19 cases,good in 12 cases and fair in 1 case;MIS-TLIF group:22 cases excellent,15 cases good,1 case fair;P>0.05).According to the Mannion’s classification of fusion,the rate of interbody fusion in the FE-LIF group was significantly better than that of theMIS-TLIF group at 6 months and 1-year post-operation.Conclusions FE-LIF is a safe and effective minimally invasive lumbar interbody fusion,which has the same clinical efficacy as that of MIS-TLIF,but with longer operation time and increased radiation exposure.