棘突间动态稳定装置Coflex治疗腰椎管狭窄症的10年以上随访观察

Observation of the interspinous dynamic stabilizer Coflex for the treatment of lumbar spinal stenosis for more than 10 years of follow-up

目的评估棘突间动态稳定系统Coflex治疗腰椎管狭窄症10年以上的临床疗效及对关节突退变的影响。方法收集我院自2009年1月至2013年6月采用减压联合Coflex棘突间动态稳定手术治疗的22例腰椎管狭窄症患者,其中男10例,女12例;年龄40~76岁,平均(59.6±12.6)岁。所有患者均完善影像学和临床评估。影像学评估包括:手术节段及其邻近节段腰椎活动度(range of motion,ROM),椎间隙高度(intervertebral space height,ISH),椎间孔高度(intervertebral foraminal height,IFH)和关节突退变情况及邻近节段退变(adjacent segment degeneration,ASD)发生率;临床评估包括:患者术前及末次随访时疼痛视觉模拟评分(visual analogue scale,VAS),Owestry功能障碍指数(Owestry disability index,ODI)及日本骨科协会(Japanese Orthopaedic Association,JOA)评分,同时记录手术相关并发症。结果共收集22例腰椎管狭窄症患者,随访时间121~175个月,平均156个月。临床疗效方面,术前和末次随访时腰痛VAS、腿痛VAS、ODI、JOA评分分别为7.36±0.67、7.09±0.70、50.45±6.46、12.82±1.33和1.82±0.98、1.64±0.81、9.09±5.39、22.82±2.93,末次随访时所有评分均较术前改善,与术前相比差异有统计学意义(P<0.01)。影像学评估方面,无论手术节段还是相邻上下节段,ISH及IFH术后与术前相比差异有统计学意义(P<0.05);末次随访时,ISH及IFH与术前相比差异无统计学意义(P>0.05)。末次随访时,手术节段ROM与术前相比差异有统计学意义(P<0.05);但对相邻上下节段,ROM与术前相比差异无统计学意义(P>0.05)。关节突退变方面,末次随访时,相邻上节段与术前相比差异有统计学意义(P<0.05),手术节段及相邻下节段与术前相比差异无统计学意义(P>0.05)。结论Coflex治疗腰椎管狭窄症10年以上临床疗效肯定。同时,Coflex能够有效维持ISH及IFH,保留了椎间活动度,此外,还能有效减缓手术节段关节突关节退变。

Objective To evaluate the clinical efficacy of Coflex in the treatment of lumbar spinal stenosis for more than 10 years and its effect on articular degeneration.Methods From January 2009 to June 2013,22 patients with lumbar spinal stenosis were treated with decompression combined with Coflex interspinous process dynamic stabilization,and all patients were assessed by imaging and clinical evaluation.Imaging evaluation included lumbar range of motion (ROM),intervertebral space height (ISH),intervertebral foraminal height (IFH),facet degeneration and adjacent segment degeneration (ASD) incidence;Clinical evaluation included the visual analogue scale (VAS),Owestry disability index (ODI) and Japanese orthopaedic association score (JOA) preoperatively and at the final follow-up.Procedure-related complications were recorded.Results A total of 22 patients with lumbar spinal stenosis were collected.The average age was (59.6±12.6) years (range:40-76 years).The follow-up time was 121-175 months,with an average of 156 months.VAS low back pain,VAS leg pain,ODI and JOA were improved at the last follow-up (1.82±0.98,1.64±0.81,9.09±5.39,22.82±2.93) than that preoperatively (7.36±0.67,7.09±0.70,50.45±6.46,12.82±1.33) (P < 0.01).In terms of imaging evaluation,there were statistically significant differences in ISH and IFH preoperatively and postoperatively (P < 0.05);but there was no significant difference between ISH and IFH at the last follow-up (P > 0.05).At the last follow-up,there were statistically significant differences in ROM in the surgical segment compared with that before operation (P < 0.05),but there was no significant difference in ROM in the adjacent upper and lower segments compared with the data preoperatively (P > 0.05).In terms of articular degeneration,there were statistically significant differences between the adjacent upper segment and the preoperative segment at the last follow-up (P < 0.05),but there was no significant difference between the surgical segment and the adjacent inferior segment compared with the preoperative segment (P > 0.05).Conclusions Coflex is effective in the treatment of lumbar spinal stenosis for more than 10 years.At the same time,Coflex can effectively maintain ISH and IFH,preserve intervertebral range of motion,and effectively slow down the degeneration of facet joint in the surgical segment.