Goldstein Christina L, Macwan Kevin, Sundararajan Kala, Rampersaud Y Raja
Divisions of 1 Neurosurgery and.
Orthopedics, Toronto Western Hospital, University of Toronto, Ontario, Canada.
J Neurosurg Spine. 2016 Mar;24(3):416-27. doi: 10.3171/2015.2.SPINE14973. Epub 2015 Nov 13.
The objective of this study was to determine the clinical comparative effectiveness and adverse event rates of posterior minimally invasive surgery (MIS) compared with open transforaminal or posterior lumbar interbody fusion (TLIF/PLIF).
A systematic review of the Medline, EMBASE, PubMed, Web of Science, and Cochrane databases was performed. A hand search of reference lists was conducted. Studies were reviewed by 2 independent assessors to identify randomized controlled trials (RCTs) or comparative cohort studies including at least 10 patients undergoing MIS or open TLIF/PLIF for degenerative lumbar spinal disorders and reporting at least 1 of the following: clinical outcome measure, perioperative clinical or process measure, radiographic outcome, or adverse events. Study quality was assessed using the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) protocol. When appropriate, a meta-analysis of outcomes data was conducted.
The systematic review and reference list search identified 3301 articles, with 26 meeting study inclusion criteria. All studies, including 1 RCT, were of low or very low quality. No significant difference regarding age, sex, surgical levels, or diagnosis was identified between the 2 cohorts (856 patients in the MIS cohort, 806 patients in the open cohort). The meta-analysis revealed changes in the perioperative outcomes of mean estimated blood loss, time to ambulation, and length of stay favoring an MIS approach by 260 ml (p < 0.00001), 3.5 days (p = 0.0006), and 2.9 days (p < 0.00001), respectively. Operative time was not significantly different between the surgical techniques (p = 0.78). There was no significant difference in surgical adverse events (p = 0.97), but MIS cases were significantly less likely to experience medical adverse events (risk ratio [MIS vs open] = 0.39, 95% confidence interval 0.23-0.69, p = 0.001). No difference in nonunion (p = 0.97) or reoperation rates (p = 0.97) was observed. Mean Oswestry Disability Index scores were slightly better in the patients undergoing MIS (n = 346) versus open TLIF/PLIF (n = 346) at a median follow-up time of 24 months (mean difference [MIS - open] = 3.32, p = 0.001).
The result of this quantitative systematic review of clinical comparative effectiveness research examining MIS versus open TLIF/PLIF for degenerative lumbar pathology suggests equipoise in patient-reported clinical outcomes. Furthermore, a meta-analysis of adverse event data suggests equivalent rates of surgical complications with lower rates of medical complications in patients undergoing minimally invasive TLIF/PLIF compared with open surgery. The quality of the current comparative evidence is low to very low, with significant inherent bias.
本研究的目的是确定与开放式经椎间孔或后路腰椎椎间融合术(TLIF/PLIF)相比,后路微创手术(MIS)的临床比较有效性和不良事件发生率。
对Medline、EMBASE、PubMed、Web of Science和Cochrane数据库进行系统评价。对手检参考文献列表进行检索。由2名独立评估人员对研究进行审查,以识别随机对照试验(RCT)或比较队列研究,这些研究包括至少10例接受MIS或开放式TLIF/PLIF治疗退行性腰椎疾病的患者,并报告以下至少1项内容:临床结局指标、围手术期临床或过程指标、影像学结局或不良事件。使用推荐分级、评估、制定和评价(GRADE)方案评估研究质量。在适当情况下,对结局数据进行荟萃分析。
系统评价和参考文献列表检索共识别出3301篇文章,其中26篇符合研究纳入标准。所有研究,包括1项RCT,质量均为低或极低。两个队列(MIS队列856例患者,开放队列806例患者)在年龄、性别、手术节段或诊断方面未发现显著差异。荟萃分析显示,围手术期平均估计失血量、下床活动时间和住院时间的变化有利于MIS手术,分别减少260 ml(p < 0.00001)、3.5天(p = 0.0006)和2.9天(p < 0.00001)。手术技术之间的手术时间无显著差异(p = 0.78)。手术不良事件无显著差异(p = 0.97),但MIS病例发生医疗不良事件的可能性显著较低(风险比[MIS vs开放]=0.39,95%置信区间0.23 - 0.69,p = 0.001)。未观察到骨不连(p = 0.97)或再次手术率(p = 0.97)的差异。在中位随访时间24个月时,接受MIS(n = 346)的患者的平均Oswestry功能障碍指数评分略优于接受开放式TLIF/PLIF(n = 346)的患者(平均差异[MIS - 开放]=3.32,p = 0.001)。
这项对MIS与开放式TLIF/PLIF治疗退行性腰椎病变的临床比较有效性研究的定量系统评价结果表明,患者报告的临床结局相当。此外,不良事件数据的荟萃分析表明,与开放手术相比,微创TLIF/PLIF患者的手术并发症发生率相当,但医疗并发症发生率较低。当前比较证据的质量低至极低,存在显著的固有偏倚。