Treatment of Spinal Stenosis and Spolilolisthesis With Percutaneous Interspinous Spacers. A Phase III Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- oswestry disability Index
研究概览
简要总结
Symptomatic lumbar spinal stenosis is the most common indication for spinal surgery. However, more than one-third of the patients undergoing surgery for lumbar stenosis report dissatisfaction with the results. On the other hand, conservative treatment has shown positive results in some cases. This trial will compare the outcomes of surgical versus non-surgical treatment for lumbar stenosis.
详细描述
This is a three-centre randomised controlled trial in which 200 patients with symptomatic lumbar spinal stenosis will be randomised into one of two treatment arms. The patients in the surgical arm will undergo decompression of the neural structures by use of any open or minimally invasive (MIS) technique with or without fusion; the patients in the non-surgical arm will undergo imaging assisted percutaneous interspinous spacer insertion with fusion.
The primary outcome of the study will be the Oswestry Disability Index. Secondary outcomes will include motor amplitude and degree of denervation activity obtained by means of nerve conduction studies and electromyography.
Patient-reported outcome measures will be also used as secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-85 years.
- •Clinical symptoms of lumbar spinal stenosis (pseudoclaudication) indicating and motivating surgery. Numeric Rating Scale in lower limbs ≥
- •MRI with finding of lumbar spinal stenosis at 1-3 lumbar levels. Dural sac area ≤75 mm2 or degree of stenosis C or D according to Schizas's classification.34
- •The patient has given oral and written informed consent to participate.
排除标准
- •Degenerative deformity with Cobb angle >20°.
- •Symptomatic osteoarthritis in the lower limbs that affects and limits the patient's function.
- •Arterial insufficiency (claudication intermittent).
- •Former lumbar surgery other than disc hernia.
- •Conditions that affect the spine, such as ankylosing spondylitis, diffuse idiopathic skeletal hyperostosis, spondylodiscitis/infections, malignancy and neurological diseases.
- •Heart and lung diseases presenting a significant risk for surgery or making it impossible for the patient to take part in a percutaneous arm of treatment (American Society of Anesthesiologists (ASA) score >3).
- •Polyneuropathies.
- •Psychological factors rendering the patient incapable of inclusion in the trial (eg, drug addiction, dementia).
结局指标
主要结局
oswestry disability Index
时间窗: 52 weeks
system based on a % scale, with higher scores indicating greater disability; clinically important difference to improvement: 10%
次要结局
- Numeric Rating Scale (NRS)(26 and 52 weeks)
- neurophysiological measurements (NCSs/EMG)(52 weeks)
- Euro Quality of life Five-Dimensional descriptive system questionnaire (EQ-5D)(26 and 52 weeks)
- subjective walking ability tool(26 and 52 weeks)
研究者
Alessandro Napoli
Associate Professor of Radiology and Interventional Radiology, Department of Radiological, Pathological and Oncological Sciences
University of Roma La Sapienza