后路有限减压联合Coflex动态稳定术治疗腰椎管狭窄症的临床研究

A clinical study of the posterior limited decompression combined with Coflex dynamic stabilization for the treatment of lumbar stenosis

目的应用后路Coflex动态稳定术治疗退行性腰椎管狭窄,评价其安全性和临床有效性。方法 2007年9月至2008年8月,28例连续的退行性腰椎管狭窄症患者行后路有限减压、椎板间Coflex动态稳定术。其中男性13例,女性15例;年龄38～72岁,平均54.8岁。本组患者术前均有下腰痛以及下肢神经症状或间歇性跛行症状,并经过X线平片以及动力片、CT和MRI检查确认病变节段和诊断。本组患者接受单节段手术27例,双节段手术1例。手术方式均为全身麻醉下有限开窗减压、Coflex椎板间动态稳定术。手术前后对患者的VAS视觉疼痛评分和改良Oswestry残障指数评分进行评价,通过动力平片评价手术节段腰椎活动情况。随访时调查患者对手术治疗的满意度。结果所有患者安全完成手术,手术时间60-120min,平均78min,出血量180～310ml.平均210ml。无神经损伤、大出血等并发症发生。术后5d佩戴软腰围下地活动,术后7d出院。术后1、3、6、12、24和36个月门诊随访,进行临床和影像学(腰椎正侧位、动力位X线片)评价。本组发生并发症3例(93%)。本组所有病例均获得24个月以上随访,随访时间24-36个月,平均25.2个月。平均VAS视觉疼痛评分由术前的8.1到术后的2.8,最后随访为2.6;Oswestry评分由术前的54.3到术后的21.8,最后随访为23.2。上述评价指标手术前后均有显著统计学差别。随访中手术节段屈伸活动良好,活动度2°～6°,平均3.6°。未发现假体移位脱出现象。随访时本组患者对本次手术治疗满意度为89.3%(25/28)。结论退行性腰椎管狭窄症应用Coflex动态稳定术,可以通过微小创伤手术,直接彻底解除神经压迫,改善患者神经症状,同时良好保留了手术节段腰椎的运动功能,随访结果表明中期疗效显著,长期疗效有待进一步观察。

Objective To evaluate the clinical efficacy and safety of posterior coflex dynamic stabilization for the treatment of degenerative lumbar stenosis. A perspective clinical and radiographic study was conducted. Methods Between September 2007 and August 2008, 28 consecutive patients with degenerative lumbar stenosis were treated with selective decompression from posterior approach and coflex interspinous dynamic stabilization. There were 13 males and 15 females with an average age of 54.8 years （range; 38-72 years）. All patients presented with low back pain, neural symptoms of lower limbs and neurological claudication preoperatively and pathological segments and diagnosis were confirmed by imaging studies of plain and dynamic X-ray, CT and MRI scan. 27 patients underwent single level procedure and 1 patient underwent double level procedures. Selective windowing for decompression and coflex interspinous dynamic stabilization were applied under general anesthesia. The evaluations of VAS score and modified ODI score were made preoperatively and postoperatively. The range of motion （ROM） of surgery level and adjacent level, and disc space height at the surgery level were evaluated by dynamic radiographic results. Patients＇ degree of satisfaction to the treatment was evaluated during the follow-up. Results All patients underwent surgery safely. The average operating time was 78rains （range; 60-120rains）. The average blood loss was 210ml （range; 180-310ml）. No major complication such as neurological injury, hemorrhoea and so on occurred. All patients qcere mobilized with protective belt 5 days postoperatively and discharged 7 days postoperatively. Follow-up examinations were conducted at 1, 3, 6, 12 and 24 months postoperatively and clinical and radiographic evaluations were carried out （anteroposterior view and lateral view of lumbar, hyperextension and hyperflexion view of X-ray）. Complications occurred in 3 cases, taking up 9.3%. All patients in this group were followed up for at least 24 months with an average of 25.2 months （range; 24-36 months）. The average VAS score was 8.1 preoperatively, 2.8 postoperatively and 2.6 in the latest follow up. The average ODI score was 54.3 preoperatively, 21.8 postoperatively and 23.2 in the latest follow up. All data above were statistically and significantly improved. During the follow-up, ROM of all the operated levels was well maintained with an average of 3.6~ （range; 20-6~） and there was no significant increase of ROM in the adjacent level. No implant migration was observed. 89.3% of the patients were satisfied with the treatment results in .the latest follow- up （25/28）. Conclusions Applying coflex interspinous dynamic stabilization, the treatment of degenerative lumbar stenosis can achieve satisfactory clinical outcomes. This technique has the advantages of small incision, direct and complete decompression, improvement of neurological symptoms, and well retaining of the motion in the operated segments. The follow-up results show that the medium-term effect is obvious. The long-term effect remains to be seen.