Comparison of Different Surgical Treatments for Lumbar Spinal Stenosis. A Randomized Controlled Trial Comparing the Clinical and Radiological Results Using "Spinous Process Osteotomy", "Bilateral Laminotomy" and "Unilateral Laminotomy With Crossover"
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 465
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
Lumbar Spinal Stenosis (LSS) is a clinical entity were narrowing of the spinal canal gives a compression of the the neural and vascular structures in the spinal canal. This often gives neurogenic claudication and sometimes severe Low Back Pain (LBP). Surgery for LSS is today the most often performed procedure in the adult lumbar spine. Beneficial effect of surgical treatment is well documented by several clinical trials, and a Cochrane review article from 2005 concludes that surgical treatment is superior to non-surgical treatment. The surgical solution is to decompress the stenotic part of the lumbar spine. There is no consensus in the literature of which surgical method that gives best long term clinical results. The investigators are therefore planning a Randomized Controlled Trial, where they will compare clinical and radiological results of three different surgical methods for LSS. The main outcome of this study is to answer which surgical method that gives the best long term clinical results. And, secondary outcome is to find out how much increase of the Dural Sac Cross Sectional Area is needed to give a long time relief of the patients' symptoms.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have clinical symptoms of spinal stenosis as neurogenic claudication or radiating pain into the bilaterally to the lower limbs, not responding to at least 3 months of conservative treatment.
- •Radiological findings corresponding to the clinical symptoms of LSS. Central -stenosis, or lateral recess-stenosis.
- •be able to give informed consent and to answer the questionnaires.
- •over 18 years of age-have -not responding to at least 3 months of non-surgical treatment.
- •be able to understand Norwegian language, spoken and in writing
排除标准
- •have a degenerative lumbar spondylolisthesis, with a slip ≥ 3 mm verified on standing plain x-rays in lateral view.
- •are not willing to give written consent.
- •have former surgery in the level of stenosis.
- •fracture, or former fusion of the thoracolumbal region.
- •cauda equina syndrome (bowel or bladder dysfunction) or fixed complete motor deficit.
- •are ASA- classified 4 or
- •are older than 80 years
- •have a lumbosacral scoliosis more than 20 degrees verified on AP-view
- •have distinct symptoms in one or both of their legs due to other diseases, e.g. polyneuropaty, vascular claudication or osteoarthtris.
- •LSS in 4 or more levels.
- •not able to comply fully with the protocol, including treatment, follow-up or study procedures (psychosocially, mentally and physical).
- •the patient is participating in another clinical trial that may interfere with this trial
结局指标
主要结局
Oswestry Disability Index
时间窗: 2, 5 and 10 years after surgery
The investigators will monitor the ODI-index before and after surgery, and calculate the change of ODI after surgery compared to baseline. The primary outcome is a measurement of the change of ODI (version 2.0) from baseline in the three different surgical groups. This will be done by calculating the mean ODI improvement in each group. The investigators will also compare the proportion of "success patients" between the SPO group, the BL group and the UL group, 24 months after the operation. The investigators will dichotomize the patients, in a "succesful outcome group" and in a "non- succesful outcome group". The threshold value for being categorized as a "succesful outcome" will be computed in a planned study based on data from The Norwegian Registry for Spine Surgery (NORSpine). The investigators also plan to asses short time results after 2 years, intermediate results after 5 years, and long time results after 10 years.
次要结局
- Zurich claudification Scale, Numeric Rating Scale for leg pain, Numeric Rating Scale for back pain, EQ-5D, and self evaluated effect of surgery.(2, 5 and 10 years after surgery)