Department of Neurosurgery, Haaglanden Medisch Centrum, Den Haag, The Netherlands.
Department of Neurosurgery, University Medical Center Groningen, Groningen, The Netherlands.
BMJ Open. 2017 Nov 12;7(11):e017882. doi: 10.1136/bmjopen-2017-017882.
Patients with symptomatic spondylolisthesis are frequently treated with nerve root decompression, in addition to pedicle screw fixation and interbody fusion. Minimally invasive approaches are gaining attention in recent years, although there is no clear evidence supporting the proclamation of minimally invasive spine surgery (MISS) being better than open surgery. We present the design of the MISOS (Minimal Invasive Surgery versus Open Surgery) trial on the effectiveness of MISS versus open surgery in patients with degenerative or spondylolytic spondylolisthesis.
All patients (age 18-75 years) with neurogenic claudication or radicular leg pain based on low-grade degenerative or spondylolytic spondylolisthesis with persistent complaints for at least 3 months are eligible. Patients will be randomised into mini-open decompression with bilateral interbody fusion with percutaneous pedicle screw fixation (MISS), or conventional surgery with decompression and instrumented fusion with pedicle screws and bilateral interbody fusion (open). The primary outcome measure is Visual Analogue Scale of self-reported low back pain. Secondary outcome measures include improvement of leg pain, Oswestry Disability Index, patients' perceived recovery, quality of life, resumption of work, complications, blood loss, length of hospital stay, incidence of reoperations and documentation of fusion. This study is designed as a multicentre, randomised controlled trial in which two surgical techniques are compared in a parallel group design. Based on a 20 mm difference of low back pain score at 6 weeks (power of 90%, assuming 8% loss to follow-up), a total of 184 patients will be needed. All analyses will be performed according to the intention-to-treat principle.
The study has been approved by the Medical Ethical Review Board Southwest Holland in August 2014 (registration number NL 49044.098.14) and subsequently approved by the board of all participating hospitals. Dissemination will include peer-reviewed publications and presentations at national and international conferences.
NTR 4532, pre-results.
有症状的脊椎滑脱症患者常接受神经根减压治疗，此外还接受椎弓根螺钉固定和椎间融合术。近年来，微创方法受到关注，尽管没有明确的证据支持微创脊柱手术（MISS）优于开放手术。我们提出了 MISOS（微创与开放手术）试验的设计，该试验旨在研究退行性或峡部裂性脊椎滑脱症患者中 MISS 与开放手术的疗效。
所有符合以下条件的患者（年龄 18-75 岁）均有资格入选：有神经源性跛行或根性腿痛，基于低度退行性或峡部裂性脊椎滑脱症，持续抱怨至少 3 个月；患者将被随机分配到双侧经皮椎弓根螺钉固定的微创减压椎间融合术（MISS）或常规手术减压、椎弓根螺钉和双侧椎间融合器固定的器械融合术（开放）。主要观察指标是自我报告的腰痛视觉模拟评分。次要观察指标包括腿痛改善、Oswestry 残疾指数、患者感知的恢复、生活质量、恢复工作、并发症、出血量、住院时间、再手术发生率以及融合的记录。本研究设计为多中心随机对照试验，采用平行组设计比较两种手术技术。基于 6 周时腰痛评分 20mm 的差异（90%的效力，假设 8%的随访丢失），需要 184 例患者。所有分析均将根据意向治疗原则进行。
该研究已于 2014 年 8 月获得西南荷兰医疗伦理审查委员会的批准（注册号 NL 49044.098.14），随后获得所有参与医院委员会的批准。传播将包括同行评议的出版物和在国内外会议上的演讲。
NTR 4532，预结果。
