Siddiqui Manal, Smith Francis W, Wardlaw Douglas
Department of Orthopaedics, Woodend Hospital, Aberdeen, Scotland, UK.
Spine (Phila Pa 1976). 2007 May 20;32(12):1345-8. doi: 10.1097/BRS.0b013e31805b7694.
Prospective observational study.
To prospectively assess the clinical outcome of patients with symptomatic lumbar spinal stenosis before and at periodic intervals after X Stop implantation and to compare the data with previous studies.
The X Stop Interspinous Process Distraction Device is a relatively new interspinous implant designed for patients with symptomatic spinal stenosis particularly neurogenic claudication. Previously, a randomized study has shown a 75% improvement in symptoms and physical function at 1-year post-X Stop implantation for lumbar spinal stenosis. The only other study is a preliminary report of only 10 patients with variable intervals of clinical outcome assessment.
Forty consecutive patients were enrolled and surgically treated with X Stop implantation. The X Stop device was implanted at the stenotic segment, which was either at 1 or 2 levels in each patient. They were clinically evaluated at the preoperative, 3-month, 6-month, and 1-year stage with clinical questionnaires (Zurich Claudication Questionnaire, Oswestry Disability Index, and SF-36).
Sixteen patients failed to complete all the questionnaires at all time intervals and hence were excluded, leaving 24 patients who had completed all questionnaire at all time interval. By 12 months, 54% of these 24 patients reported clinically significant improvement in their symptoms, 33% reported clinically significant improvement in physical function, and 71% expressed satisfaction with the procedure. 29% of the patients required caudal epidural after 12 months after surgery for recurrence of their symptoms of neurogenic claudication.
The results of this prospective observational study indicate that X Stop offers significant short-term improvement over a 1-year period. It is a safe, effective, and less invasive alternative for treatment of lumbar spinal stenosis. Our results, however, are less favorable than the previous multicenter, randomized study.
前瞻性观察性研究。
前瞻性评估有症状的腰椎管狭窄症患者在植入X Stop前后及定期随访时的临床结局，并将数据与既往研究进行比较。
X Stop棘突间撑开装置是一种相对较新的棘突间植入物，专为有症状的椎管狭窄症患者，尤其是神经源性间歇性跛行患者设计。此前，一项随机研究表明，腰椎管狭窄症患者在植入X Stop后1年，症状和身体功能改善率达75%。另一项研究只是仅10例患者的初步报告，临床结局评估间隔时间不一。
连续纳入40例患者，接受X Stop植入手术治疗。X Stop装置植入狭窄节段，每位患者的狭窄节段为1个或2个椎体节段。在术前、术后3个月、6个月和1年时，采用临床问卷（苏黎世间歇性跛行问卷、Oswestry功能障碍指数和SF - 36）对患者进行临床评估。
16例患者未能在所有时间点完成所有问卷，因此被排除，剩余24例患者在所有时间点均完成了所有问卷。到12个月时，这24例患者中54%报告症状有临床显著改善，33%报告身体功能有临床显著改善，71%对手术表示满意。29%的患者在术后12个月因神经源性间歇性跛行症状复发需要进行骶管硬膜外注射。
这项前瞻性观察性研究结果表明，X Stop在1年期间能带来显著的短期改善。它是治疗腰椎管狭窄症的一种安全、有效且侵入性较小的替代方法。然而，我们的结果不如之前的多中心随机研究那么理想。
