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Comparative effectiveness of microdecompression and laminectomy for central lumbar spinal stenosis: Study protocol for an observational study

机译:中央型腰椎管狭窄症微压缩和椎板切除术的疗效比较:观察性研究的研究方案

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摘要

Introduction: This observational study is designed to test the equivalence between the clinical effectiveness of microdecompression and laminectomy in the surgical treatment of central lumbar spinal stenosis. Lumbar spinal stenosis is the most frequent indication for spinal surgery in the elderly, and as the oldest segment of the population continues to grow its prevalence is likely to increase. However, data on surgical outcomes are limited. Open or wide decompressive laminectomy, often combined with medial facetectomy and foraminotomy, was formerly the standard treatment. In recent years a growing tendency towards less invasive decompressive procedures has emerged. At present, many spine surgeons perform microdecompression for central lumbar spinal stenosis. Methods and analysis: Prospectively registered treatment and outcome data are obtained from the Norwegian Registry for Spine Surgery. The primary outcome measure is change in Oswestry disability index between baseline and 12-month follow-up. Secondary outcome measures are changes in health-related quality of life measured by the Euro-Qol-5D between baseline and 12-month follow-up, perioperative complications, and duration of surgical procedures and length of hospital stay. Ethics and dissemination: The study has been evaluated and approved by the regional committee for medical research in central Norway and all participants provided written informed consent. The findings of this study will be disseminated through peer-reviewed publications.
机译:简介:这项观察性研究旨在测试微减压和椎板切除术在中央腰椎管狭窄手术治疗中的临床有效性之间的等效性。腰椎管狭窄是老年人脊柱外科手术最常见的适应症,并且随着人口的最老部分的持续增长,其患病率可能会增加。但是,有关手术结果的数据有限。开放或广泛减压椎板切除术,通常与内侧小平面切除术和椎间孔切开术结合,以前是标准治疗方法。近年来,出现了越来越少的侵入性减压程序的趋势。目前,许多脊柱外科医生对中央腰椎管狭窄症进行微减压。方法和分析:前瞻性注册的治疗和结果数据来自挪威脊柱外科注册处。主要结局指标是基线和12个月随访之间Oswestry残疾指数的变化。次要结果指标是通过Euro-Qol-5D在基线和12个月的随访,围手术期并发症,手术时间和住院时间之间与健康相关的生活质量变化。伦理和传播:这项研究已经由挪威中部地区医学研究区域委员会评估和批准,所有参与者均提供了书面知情同意书。这项研究的结果将通过同行评审的出版物进行传播。

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