Department of Orthopaedics, Oregon Health and Science University, Portland, Oregon, United States.
Spectrum Research, Inc., Tacoma, Washington, United States.
Global Spine J. 2015 Jun;5(3):207-18. doi: 10.1055/s-0035-1552984.
Study Design Systematic review. Clinical Questions (1) Has the proportion and number of randomized controlled trials (RCTs) as an indicator of quality of evidence regarding lumbar fusion increased over the past 10 years? (2) Is there a difference in the proportion of RCTs among the four primary fusion diagnoses (degenerative disk disease, spondylolisthesis, deformity, and adjacent segment disease) over the past 10 years? (3) Is there a difference in the type and quality of clinical outcomes measures reported among RCTs over time? (4) Is there a difference in the type and quality of adverse events measures reported among RCTs over time? (5) Are there changes in fusion surgical approach and techniques over time by diagnosis over the past 10 years? Methods Electronic databases and reference lists of key articles were searched from January 1, 2004, through December 31, 2013, to identify lumbar fusion RCTs. Fusion studies designed specifically to evaluate recombinant human bone morphogenetic protein-2 or other bone substitutes, revision surgery studies, nonrandomized comparison studies, case reports, case series, and cost-effectiveness studies were excluded. Results Forty-two RCTs between January 1, 2004, and December 31, 2013, met the inclusion criteria and form the basis for this report. There were 35 RCTs identified evaluating patients diagnosed with degenerative disk disease, 4 RCTs evaluating patients diagnosed with degenerative spondylolisthesis, and 3 RCTs evaluating patients with a combination of degenerative disk disease and degenerative spondylolisthesis. No RCTs were identified evaluating patients with deformity or adjacent segment disease. Conclusions This structured review demonstrates that there has been an increase in the available clinical database of RCTs using patient-reported outcomes evaluating the benefit of lumbar spinal fusion for the diagnoses of degenerative disk disease and degenerative spondylolisthesis. Gaps remain in the standardization of reportage of adverse events in such trials, as well as uniformity of surgical approaches used. Finally, continued efforts to develop higher-quality data for other surgical indications for lumbar fusion, most notably in the presence of adult spinal deformity and revision of prior surgical fusions, appear warranted.
研究设计:系统回顾。临床问题:(1)作为评估腰椎融合术证据质量的指标,随机对照试验(RCT)的比例和数量在过去 10 年中是否有所增加?(2)在过去 10 年中,四种主要融合诊断(退行性椎间盘疾病、脊椎滑脱、畸形和邻近节段疾病)中 RCT 的比例是否存在差异?(3)随着时间的推移,RCT 中报告的临床结局测量的类型和质量是否存在差异?(4)随着时间的推移,RCT 中报告的不良事件测量的类型和质量是否存在差异?(5)在过去的 10 年中,按诊断分类,融合手术方法和技术是否随时间发生变化?方法:从 2004 年 1 月 1 日至 2013 年 12 月 31 日,检索电子数据库和关键文章的参考文献列表,以确定腰椎融合 RCT。排除专门用于评估重组人骨形态发生蛋白-2 或其他骨替代物、翻修手术研究、非随机比较研究、病例报告、病例系列和成本效益研究的融合研究。结果:2004 年 1 月 1 日至 2013 年 12 月 31 日期间,有 42 项 RCT 符合纳入标准,并构成本报告的基础。有 35 项 RCT 评估了退行性椎间盘疾病患者,4 项 RCT 评估了退行性脊椎滑脱患者,3 项 RCT 评估了退行性椎间盘疾病和退行性脊椎滑脱混合患者。没有 RCT 评估畸形或邻近节段疾病患者。结论:本结构审查表明,使用患者报告的结果评估腰椎融合术治疗退行性椎间盘疾病和退行性脊椎滑脱诊断的益处,可获得的 RCT 临床数据库有所增加。在这些试验中,不良事件报告的标准化以及所使用的手术方法的一致性仍然存在差距。最后,似乎需要继续努力为腰椎融合的其他手术适应证制定更高质量的数据,尤其是在成人脊柱畸形和先前手术融合的翻修方面。
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