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Clinical evaluation of the preliminary safety and effectiveness of a minimally invasive interspinous process device APERIUS(®) in degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication.APERIUS(®)微创棘突间装置治疗伴有症状性神经源性间歇性跛行的退变性腰椎管狭窄症的初步安全性和有效性的临床评估。
Eur Spine J. 2012 Dec;21(12):2565-72. doi: 10.1007/s00586-012-2330-z. Epub 2012 May 8.
2
Aperius interspinous implant versus open surgical decompression in lumbar spinal stenosis.经皮棘突间撑开器植入术与开放式减压手术治疗腰椎管狭窄症的比较。
Spine J. 2011 Oct;11(10):933-9. doi: 10.1016/j.spinee.2011.08.419.
3
Quantitative radiologic criteria for the diagnosis of lumbar spinal stenosis: a systematic literature review.定量放射学标准在腰椎椎管狭窄症诊断中的应用:系统文献回顾。
BMC Musculoskelet Disord. 2011 Jul 28;12:175. doi: 10.1186/1471-2474-12-175.
4
Effectiveness of interspinous implant surgery in patients with intermittent neurogenic claudication: a systematic review and meta-analysis.棘突间植入手术治疗间歇性神经源性跛行患者的有效性:系统评价和荟萃分析。
Eur Spine J. 2011 Oct;20(10):1596-606. doi: 10.1007/s00586-011-1873-8. Epub 2011 Jun 11.
5
Interspinous spacers in the treatment of degenerative lumbar spinal disease: our experience with DIAM and Aperius devices.棘突间撑开器治疗退变性腰椎疾病:我们对 DIAM 和 Aperius 装置的经验。
Eur Spine J. 2011 May;20 Suppl 1(Suppl 1):S20-6. doi: 10.1007/s00586-011-1753-2. Epub 2011 Mar 16.
6
Clinical outcomes and quality of life 1 year after open microsurgical decompression or implantation of an interspinous stand-alone spacer.开放显微手术减压或植入棘突间独立间隔器1年后的临床结果和生活质量
Minim Invasive Neurosurg. 2010 Aug;53(4):179-83. doi: 10.1055/s-0030-1263108. Epub 2010 Dec 3.
7
The Felix-trial. Double-blind randomization of interspinous implant or bony decompression for treatment of spinal stenosis related intermittent neurogenic claudication.菲利克斯试验。棘突间植入物或骨减压治疗与椎管狭窄相关间歇性神经源性跛行的双盲随机分组。
BMC Musculoskelet Disord. 2010 May 27;11:100. doi: 10.1186/1471-2474-11-100.
8
Aperius PercLID stand alone interspinous system for the treatment of degenerative lumbar stenosis: experience on 152 cases.用于治疗退变性腰椎管狭窄症的Aperius PercLID独立棘突间系统:152例经验
J Spinal Disord Tech. 2010 May;23(3):203-7. doi: 10.1097/BSD.0b013e31819b08da.
9
Does an interspinous device (Coflex) improve the outcome of decompressive surgery in lumbar spinal stenosis? One-year follow up of a prospective case control study of 60 patients.棘突间装置(Coflex)是否能改善腰椎管狭窄症减压手术后的疗效?一项前瞻性病例对照研究的 60 例患者 1 年随访结果。
Eur Spine J. 2010 Feb;19(2):283-9. doi: 10.1007/s00586-009-1229-9. Epub 2009 Dec 5.
10
Interspinous implants (X Stop, Wallis, Diam) for the treatment of LSS: is there a correlation between radiological parameters and clinical outcome?用于治疗腰椎管狭窄症的棘突间植入物(X Stop、Wallis、Diam):放射学参数与临床结果之间存在相关性吗?
Eur Spine J. 2009 Oct;18(10):1494-503. doi: 10.1007/s00586-009-1081-y. Epub 2009 Jun 27.

经皮棘突间撑开器与开放性减压术的比较:2 年临床疗效和生活质量随访。

Percutaneous interspinous spacer versus open decompression: a 2-year follow-up of clinical outcome and quality of life.

机构信息

Department of Orthopedic and Trauma Surgery, University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany,

出版信息

Eur Spine J. 2013 Sep;22(9):2015-21. doi: 10.1007/s00586-013-2790-9. Epub 2013 Apr 27.

DOI:10.1007/s00586-013-2790-9
PMID:23625306
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3777069/
Abstract

PURPOSE

Percutaneous interspinous stand-alone spacers offer a simple and effective technique to treat lumbar spinal stenosis with neurogenic claudication. Nonetheless, open decompressive surgery remains the standard of care. This study compares the effectiveness of both techniques and the validity of percutaneous interspinous spacer use.

METHODS

Forty-five patients were included in this open prospective non-randomized study, and treated either with percutaneous interspinous stand-alone spacers (Aperius(®)) or bilateral open microsurgical decompression at L3/4 or L4/5. Patient data, operative data, COMI, SF-36, PCS and MCS, ODI, and walking distance were collected 6 weeks, 3, 6, 9, 12, and 24 months post-surgery.

RESULTS

Group 1 (n = 12) underwent spacer implantation, group 2 (n = 33) open decompression. Five patients from group 1 required implant removal and open decompression during follow-up (FU); one patient was lost to FU. From group 2, seven patients were lost to FU. Remaining patients were assessed as above. After 2 years, back pain, leg pain, ODI, and quality of life improved significantly for group 2. Remaining group 1 patients (n = 6) reported worse results. Walking distance improved for both groups.

CONCLUSION

Decompression proved superior to percutaneous stand-alone spacer implantation in our two observational cohorts. Therapeutic failure was too high for interspinous spacers.

摘要

目的

经皮棘突间单杠式撑开器为治疗伴有神经源性跛行的腰椎管狭窄症提供了一种简单有效的方法。然而,开放式减压手术仍然是标准的治疗方法。本研究比较了这两种技术的效果和经皮棘突间单杠式撑开器使用的有效性。

方法

本开放性前瞻性非随机研究纳入了 45 例患者,分别采用经皮棘突间单杠式撑开器(Aperius®)或 L3/4 或 L4/5 双侧开放式显微减压术进行治疗。收集患者数据、手术数据、COMI、SF-36、PCS 和 MCS、ODI 和步行距离,术后 6 周、3 个月、6 个月、9 个月、12 个月和 24 个月进行评估。

结果

第 1 组(n=12)行撑开器植入术,第 2 组(n=33)行开放式减压术。第 1 组中有 5 例患者在随访期间需要移除植入物并进行开放式减压(FU);1 例患者失访。第 2 组中有 7 例患者失访。剩余的患者进行了如上评估。2 年后,第 2 组的腰痛、腿痛、ODI 和生活质量显著改善。第 1 组剩余 6 例患者报告结果较差。两组的步行距离均有所改善。

结论

在我们的两个观察队列中,减压术比经皮棘突间单杠式撑开器植入术更有效。对于棘突间撑开器,治疗失败率太高。