Minimally Invasive Spinal Decompression (MIS-D) Versus Minimally Invasive Spinal Decompression and Fusion (MIS-TLIF) for the Treatment of Lumbar Spinal Stenosis (LSS): A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- change in Oswestry Disability Index (ODI) score from baseline
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of two minimal invasive spine surgery, minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF), for patients diagnosed with lumbar spinal stenosis in terms of clinical outcomes, complications, reoperations, and other perioperative data.
详细描述
Lumbar spinal stenosis (LSS) is one of the most common degenerative spine diseases in older people and is associated with mechanical low back pain, radiculopathy and/or neurological claudication. The results of The Spine Patient Outcomes Research Trial (SPORT) reported that, surgical treatment in these patients led to significantly greater improvement in pain and function than nonsurgical treatment. Nowadays, decompression with instrumented or non-instrumented fusion is commonly practiced which is regarded as the "gold standard" surgery for LSS.
Over the last two decades, several retrospective studies comparing the surgical outcomes of decompression alone and decompression plus fusion for LSS have been published. Most of the studies concluded that decompression plus fusion had better clinical outcomes compared with decompression alone. However, in 2016, two randomized control trials (RCT) about LSS were published in the New England Journal of Medicine (NEJM) and raised some serious questions. The results of both studies showed that fusion did not have much additional value for patients with stable LSS, and moreover, it might be regard as an overcautious and unnecessary treatment, which were contradictory to most of the previous studies.
Over the past few years, minimally invasive spine surgery (MISS) has been improving rapidly due to the development of related instruments, more experienced surgeons, and patients' demands. Compared with open spine surgery, MISS has already proved to be associated with less surgical trauma and rapid recovery with similar clinical outcomes. Minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF) have been performed widely for the treatment of LSS. However, there is no previous study comparing MIS-D to MIS-TLIF in terms of clinical outcomes, complications, reoperations, and other perioperative data. Therefore, a randomized controlled trial comparing these 2 common MISS techniques is warranted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intermittent claudication with pain or numbness or weakness of lower limb(s) with or without low back pain
- •An imaging study (MRI or CT) showing single level lumbar spinal stenosis
排除标准
- •Insufficient conservative treatment (6 weeks)
- •Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention
- •Previous spinal surgery
- •Other comorbid conditions that contraindicating surgery
- •Possible pregnancy that contraindicating radiological examination
- •Age less than 18 years old
- •Combination with 2°spondylolisthesis or segmental instability (slip distance >4mm or angle change >10° in dynamic plain film)
- •Combination with other spinal disorder requiring advanced surgery (such as lumbar stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)
- •Equal to or more than two responsible level
结局指标
主要结局
change in Oswestry Disability Index (ODI) score from baseline
时间窗: preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively
The Oswestry Disability Index (ODI) is widely used to assess chronic low back pain. It contains ten sections including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and traveling. The ODI is ranging from 0 to 100, with higher scores indicating more disability related to pain.
次要结局
- MacNab criteria(2 month, 6 months, 1 year，2 years and 5 years postoperatively)
- change in visual analog scales (VAS) from baseline(preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively)
- change in European Quality of Life-5 Dimensions (EQ-5D) from baseline(preoperatively and 2 month, 6 months, 1 year，2 years and 5 years postoperatively)
研究者
Limin Rong
Prof., M.D.
Third Affiliated Hospital, Sun Yat-Sen University