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One-year results of X Stop interspinous implant for the treatment of lumbar spinal stenosis.

机译:X Stop棘突间植入物治疗腰椎管狭窄症的一年结果。

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STUDY DESIGN: Prospective observational study. OBJECTIVE: 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. SUMMARY OF BACKGROUND DATA: 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. METHOD: 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). RESULTS: 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. CONCLUSION: 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.
机译:研究设计:前瞻性观察研究。目的:前瞻性评估有症状的腰椎管狭窄症患者在X Stop植入术之前和之后的定期临床疗效,并将这些数据与以前的研究进行比较。背景资料摘要:X Stop棘突间转移装置是一种相对较新的棘突间植入物,设计用于有症状的椎管狭窄症患者,尤其是神经源性lau行。以前,一项随机研究显示,X停止植入后1年用于腰椎管狭窄症的症状和身体功能改善了75%。唯一的另一项研究是仅对10名患者进行临床结果评估的可变间隔的初步报告。方法:连续入选40例患者,并进行X Stop植入手术治疗。 X Stop设备被植入狭窄段,每位患者的狭窄段水平为1或2。他们在术前,3个月,6个月和1年阶段通过临床问卷(苏黎世C行问卷,Oswestry残疾指数和SF-36)进行了临床评估。结果:16名患者未能在所有时间间隔内完成所有问卷,因此被排除在外,剩下24名患者在所有时间间隔内均完成了所有问卷。到12个月时,这24名患者中有54%报告其症状临床上显着改善,33%报告其身体功能上临床上显着改善,71%对手术表示满意。 29%的患者在术后12个月后需要再次行尾硬膜外麻醉,以恢复神经源性lau行症状。结论:这项前瞻性观察研究的结果表明,X Stop可以在1年内显着改善短期症状。它是治疗腰椎管狭窄症的一种安全,有效且侵入性小的方法。但是,我们的结果比以前的多中心随机研究不利。

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