棘突间动态内固定装置治疗腰痛的临床应用评价

Clinical evaluation of interspinous dynamic internal fixation for low back pain

目的 评价采用Coflex棘突间动态内固定植入术治疗腰痛的临床疗效及相关影像学改变.方法 2007年2月至2009年6月,对45例患者行Coflex棘突间内固定植入术,男26例,女19例;年龄45～70岁,平均51.4岁.治疗节段：L4.5 32例,L5S111例,L4.5、L5S1双节段2例.手术采用椎板开窗或部分切除,椎管减压后棘突间植入Coflex装置.按照Oswestry功能障碍指数（Oswestry disabi1ity index,ODI）和日本矫形外科学会（Japanese Orthopaedic Association,JOA）评分评价术前及术后随访时的临床疗效,计算恢复率.同时行影像学观察,包括椎间隙高度和椎间孔形态,手术节段椎体活动度和腰椎生理曲度,手术及相邻节段的MRI信号改变.结果 术后随访时间1O-34个月,平均24个月.ODI由术前62.82±10.42降至末次随访时11.80±3.35;JOA评分由9.00±2.63提高至24.65±1.86;最终疗效评价为显效的患者共40例,显效率为89%.L4.5、L5S1节段术后Cobb角分别为15.1°±3.9°和16.3°±3.8°,均较术前减小,生理曲度改善.L4.5节段椎体活动度（range of motion,ROM）由术前6.5°±1.5°增加至术后8.4°±2.6°,而L5S1节段ROM手术前后没有明显改变.无论是L4.5或是L5S1节段,末次随访时其椎间隙背侧高度、棘突顶距、椎间孔高度和椎间孔面积均较术前显著增加.结论 Coflex棘突间动态内固定中期随访临床疗效显著,并且保留了腰椎生理曲度和节段运动,增加并维持椎间隙高度和椎间孔面积,在手术节段椎间盘修复及防止相邻节段椎间盘退变等方面作用显著.

Objective To evaluate the mid-term clinical effects and the imaging changes of Coflex interspinous dynamic internal fixation for low back pain. Methods From February 2007 to June 2009,Coflex interspinous dynamic internal fixation was performed in a consecutive 45 patients. They included 26 males and 19 females, with an average of 51.4 years ranging in age from 45 to 70 years. Thirty-two cases were in L4.5 level, 11 in L5S1 level and 2 in both two levels. The patients were treated with limited laminectomy and implanted with Coflex device. Clinical outcomes were assessed by Oswestry disability index （ODI）scores and Japanese Orthopaedic Association （JOA） questionnaires before and after operation. The imaging examination was obtained to assess height of the intervertebral space, area of the intervertebral foramen,segment movement of the operation level, low lumbar curvature and signal of the lumbar disc on MRI. Results The follow-up time ranged from 10 to 34 months, with an average of 24 months. The ODI scores decreased significantly from 62.82±10.42 preoperatively to 11.80±3.35 postoperatively. The JOA scores were improved remarkably from 9.00±2.63 preoperatively to 24.65±1.86 postoperatively. The proportion with optimal effect was 89% （40 cases）. The Cobb angle after operation of L4.5 and L5S1 level was 15.1°±3.9° and 16.3°±3.8° respectively, which was significantly decreased after operation. The range of motion of the L4.5 level increased from 6.5°±1.5° to 8.4°±2.6° while the L5S1 level did not change notedly. The heights of the dorsal intervertebral disc, distance of the spinous processes, intervertebral foramen height and area were significantly higher than those before operation. Conclusion The Coflex interspinous dynamic internal fixation is available to reserve segment movement, to increase intervertebral space height and foramen area. Meanwhile,it is effective to self-repair and prevent degeneration for the disc in adjacent levels.