Department of Orthopedics, Clinical Sciences Lund, Lund University, Skåne University Hospital, Malmö, Sweden.
Spine (Phila Pa 1976). 2013 Aug 1;38(17):1436-42. doi: 10.1097/BRS.0b013e31828ba413.
Prospective randomized controlled study.
To compare the outcome of indirect decompression by means of the X-Stop (Medtronics Inc., Minneapolis, MN) implant with conventional decompression in patients with neurogenic intermittent claudication due to lumbar spinal stenosis.
Decompression is currently the "gold standard" for lumbar spinal stenosis but is afflicted with complications and a certain number of dissatisfied patients. Interspinous implants have been on the market for more than 10 years, but no prospective study comparing its outcome with decompression has been performed.
After power calculation, 100 patients were included: 50 in the X-Stop group and 50 in the decompression group. Patients with symptomatic 1- or 2-level lumbar spinal stenosis and neurogenic claudication relieved on flexion were included. X-Stop operations were performed under local anesthesia.The mean patient age was 69 (49-89) years, and the male/female distribution was 56/44. Minimal dural sac area was in all cases except two 80 mm or less.The noninferiority hypothesis included 6, 12, and 24 months of follow-up, and included. intention-to-treat as well as as-treated analyses.The primary outcome meansure was the Zürich Claudication Questionnaire, and the secondary outcome measures was the visual analogue scale pain, Short-Form 36 (SF-36), complications, and reoperations.
The primary and secondary outcome measures of patients in both groups improved significantly. The results were similar at 6, 12, and 24 months and at no time point could any statistical difference between the 2 types of surgery be identified. Three patients (6%) in the decompression group underwent further surgery, compared with 13 patients (26%) in the X-Stop group (P = 0.04). Results were identical in intention-to-treat and as-treated analyses.
For spinal stenosis with neurogenic claudication, decompressive surgery as well as X-Stop are appropriate procedures. Similar results were achieved in both groups, however, with a higher number of reoperations in the X-Stop group. Patients having X-Stop removal and decompression experienced results similar to those randomized to primary decompression.
前瞻性随机对照研究。
比较 X-Stop（美敦力公司，明尼苏达州明尼阿波利斯）植入物间接减压与传统减压治疗腰椎管狭窄症所致神经性间歇性跛行的疗效。
减压术目前是腰椎管狭窄症的“金标准”，但存在并发症，且部分患者不满意。棘突间植入物已上市 10 多年，但尚未进行比较其疗效与减压术的前瞻性研究。
根据功率计算，纳入 100 例患者：X-Stop 组 50 例，减压组 50 例。纳入有症状的 1 或 2 个节段腰椎管狭窄症和神经源性跛行患者，屈曲时缓解。X-Stop 手术在局部麻醉下进行。患者平均年龄为 69（49-89）岁，男女分布为 56/44。除 2 例外，所有病例的最小硬脑膜囊面积均小于 80mm。非劣效性假设包括 6、12 和 24 个月的随访，并包括意向治疗和实际治疗分析。主要结局测量指标为苏黎世跛行问卷，次要结局测量指标为视觉模拟疼痛评分、SF-36（健康调查简表）、并发症和再次手术。
两组患者的主要和次要结局指标均显著改善。6、12 和 24 个月时的结果相似，且在任何时间点，两种手术类型之间均未发现统计学差异。减压组 3 例（6%）患者接受了进一步手术，而 X-Stop 组 13 例（26%）患者（P=0.04）。意向治疗和实际治疗分析结果相同。
对于伴有神经性跛行的腰椎管狭窄症，减压手术和 X-Stop 都是合适的治疗方法。两组的结果相似，但 X-Stop 组的再手术数量较多。X-Stop 取出和减压的患者的结果与随机分组至原发性减压的患者相似。
