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选择性腰椎椎间融合术后使用微创融合技术是否与更好的疗效相关?一项全国性前瞻性患者报告结局登记研究的分析。

Is the use of minimally invasive fusion technologies associated with improved outcomes after elective interbody lumbar fusion? Analysis of a nationwide prospective patient-reported outcomes registry.

作者信息

McGirt Matthew J, Parker Scott L, Mummaneni Praveen, Knightly John, Pfortmiller Deborah, Foley Kevin, Asher Anthony L

机构信息

Carolina Neurosurgery and Spine Associates, 225 Baldwin Ave, Charlotte, NC 28204, USA.

Department of Neurosurgery, Vanderbilt University Medical Center, 1161 21st Ave So, Nashville, TN 37232, USA.

出版信息

Spine J. 2017 Jul;17(7):922-932. doi: 10.1016/j.spinee.2017.02.003. Epub 2017 Feb 27.

Abstract

BACKGROUND CONTEXT

Over the last decade, clinical investigators and biomedical industry groups have used significant resources to develop advanced technologies that enable less invasive spine fusions. These minimally invasive surgery (MIS) technologies often require increased expenditures by hospitals and payers. Although several small single center studies have suggested MIS technologies decrease surgical morbidity and reduce hospital stay, evidence documenting benefit from a patient perspective remains limited. Furthermore, MIS outcomes have yet to be evaluated from the perspective of multiple practice types representing the broad spectrum of US spine surgery.

PURPOSE

This study aimed to examine a population of patients who underwent one- or two-level interbody lumbar fusion diagnosed with lumbar stenosis or Grade 1 spondylolisthesis in an observational, prospective national registry for the purposes of determining how MIS and traditional open technologies affect postsurgical and patient-reported outcomes (PROs).

STUDY DESIGN/SETTING: This study used observational analysis of prospectively collected data.

PATIENT SAMPLE

The sample consisted of cases from the National Neurosurgery Quality and Outcomes Database (NQOD).

OUTCOME MEASURES

Numeric rating scale for back and leg pain, Oswestry Disability Index, EuroQol-5D, return to work, and perioperative morbidity were the outcome measures.

METHODS

The NQOD is a prospective PROs registry enrolling patients undergoing elective spine surgery from 60 hospitals in 27 US states via representative sampling. We analyzed the NQOD aggregate dataset (2010-2014) to identify one- and two-level lumbar interbody fusion procedures performed for lumbar stenosis or Grade 1 spondylolisthesis with 12 months' follow-up where surgical instrumentation and implant types were clearly identified. Perioperative and 1-year outcomes were compared between cases performed with MIS enabling technologies versus traditional open technologies before and after propensity matching.

RESULTS

There were 467 (24%) patients who underwent elective interbody lumbar fusion using MIS enabling technologies whereas 1,480 (76%) underwent the procedure using traditional open technologies. The MIS patients were slightly healthier (American Society of Anesthesiologists grade), had private insurance more frequently, and underwent two-level fusion less frequently. Unmatched, the MIS cohort was associated with reduced blood loss, a 0.7-day reduction in mean length of hospital stay, and 5% reduced need for post-discharge inpatient rehabilitation, but equivalent 90-day safety measures. After propensity matching, the MIS cohort remained associated with reduced blood loss and a shorter length of stay for one-level fusion (p<.05) but had equivalent length of stay for two-level fusion. Outcomes in all other 90-day safety measures were similar. In both unadjusted and propensity-matched comparison, MIS versus open technologies were associated with equivalent return to work, patient-reported pain, physical disability, and quality of life at 3 and 12 months' follow-up.

CONCLUSIONS

In a representative sampling registry of elective interbody lumbar spine fusion procedures spanning 27 US states, nearly a quarter of procedures performed from 2010 to 2014 used minimally invasive enabling technologies. Regardless of approach, interbody lumbar fusion was associated with significant and sustained improvements in all measured health domains. When used in everyday care by a wide spectrum of spine surgeons in non-research settings, the use of MIS technologies was associated with reduced intraoperative blood loss but only a half-day reduction in mean length of hospital stay for one-level fusions. Minimally invasive surgery was not associated with any improved perioperative safety measures or 12-month outcomes. Although MIS enabling technologies may increase some in-hospital care efficiencies, MIS clinical outcomes are similar to open surgery for patients undergoing one- and two-level interbody lumbar fusions.

摘要

背景信息

在过去十年中,临床研究人员和生物医学行业团体投入了大量资源来开发先进技术,以实现侵入性较小的脊柱融合手术。这些微创手术(MIS)技术通常需要医院和支付方增加支出。尽管一些小型单中心研究表明MIS技术可降低手术发病率并缩短住院时间,但从患者角度证明其益处的证据仍然有限。此外,尚未从代表美国脊柱手术广泛范围的多种手术类型的角度评估MIS的结果。

目的

本研究旨在调查在一个观察性、前瞻性全国登记处接受一或两级椎间融合术治疗腰椎管狭窄症或I度腰椎滑脱症的患者群体,以确定MIS和传统开放技术如何影响术后和患者报告的结果(PROs)。

研究设计/设置:本研究对前瞻性收集的数据进行观察性分析。

患者样本

样本包括来自国家神经外科质量与结果数据库(NQOD)的病例。

结果测量指标

背痛和腿痛的数字评分量表、Oswestry功能障碍指数、欧洲五维健康量表、重返工作岗位情况以及围手术期发病率为结果测量指标。

方法

NQOD是一个前瞻性PROs登记处,通过代表性抽样纳入来自美国27个州60家医院接受择期脊柱手术的患者。我们分析了NQOD汇总数据集(2010 - 2014年),以识别因腰椎管狭窄症或I度腰椎滑脱症而进行的一或两级腰椎椎间融合手术,且有12个月随访,手术器械和植入物类型明确的病例。在倾向匹配前后,比较使用MIS启用技术与传统开放技术进行的病例的围手术期和1年结果。

结果

有467例(24%)患者使用MIS启用技术接受了择期腰椎椎间融合术,而1480例(76%)患者使用传统开放技术进行了该手术。MIS组患者(美国麻醉医师协会分级)健康状况稍好,更常拥有私人保险,且接受两级融合手术的频率较低。在未匹配时,MIS组患者术中失血减少,平均住院时间缩短0.7天,出院后住院康复需求减少5%,但90天安全指标相当。倾向匹配后,MIS组患者在一级融合手术中仍与术中失血减少和住院时间缩短相关(p<0.05),但在两级融合手术中住院时间相当。所有其他90天安全指标的结果相似。在未调整和倾向匹配比较中,MIS与开放技术在3个月和

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