Degenerative Lumbar Spondylolisthesis: Is Only Decompression Good Enough? A Prospective Randomized Clinical Multi- Institutional Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 267
- 试验地点
- 2
- 主要终点
- The Oswestry Disability Index
研究概览
简要总结
Lumbar Degenerative Spondylolisthesis (LDS) is a slippage of one vertebra over another caused by degeneration of facet joints, ligaments and intervertebral discs. Most patients suffer from symptoms related to spinal stenosis, such as radiating pain to the lower extremities, and typically increased pain in the lower limbs when walking upright and decreased when bending forward.
There is a moderate grade of evidence for whether patients will achieve better outcome after surgery when decompression is followed by fusion. In theory, fusion following decompression should give more stability to the operated level, thus less pain and less progression of the olisthesis. On the other hand, fusion procedures, in general, are associated with more severe complications and postoperative mortality than decompression alone.
In summary, there is still insufficient evidence for performing fusion in addition to decompression for patients with LDS. The investigators are planning a trial where the main aim is to detect whether the intervention-related difference in outcome between decompression alone (DA) and decompression followed by fusion with instrumentation (DF) is large enough to justify the use of the fusion procedure. The proposed trial is a randomized, controlled, multicentre, non- inferiority trial with two parallel groups, with 15 participating Norwegian hospitals. The main analysis will be performed 2 years after surgery with long-term follow-up planned at 5 and 10 years postoperatively.
详细描述
Purpose:
The aim of the study is to compare the efficacy of two principally different surgical methods for treating LDS and to investigate whether predictors will be associated with an intervention-related difference in outcome between the two groups.
Methods:
The Oswestry Disability Index (ODI) will be used as primary outcome measure in analyses at 2 year, 5 year and 10 year follow-up. Depending on whether the participants obtain a 30% or more ODI- improvement from before operation to follow-up, they will be dichotomized in a success group (responders) and in a non-success group (non- responders). The primary question is whether the proportion of patients with successful outcome in the DA group is not markedly less than in the DF group, at 2 years, 5 years and 10 years, respectively. Investigators have predefined the margin of "markedly less" to be δ = 0.15 (15%) which is consistent with the between- group difference Blumenthal et al used in the power analysis in a similar Food and Drug Administration- regulated non- inferiority RCT. With this margin it will be necessary to treat 6.7 patients with fusion in addition to decompression in order to obtain one patient with successful outcome.
The null hypothesis is that the proportion of patients with a successful outcome in the DF group (nDF) is higher than the proportion in the DA group (nDA) by an amount of at least 0.15 (δ):
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
- 是
入选标准
- •over 18 years of age
- •do understand Norwegian language, spoken and in writing
- •have a degenerative lumbar spondylolisthesis, with a slip >=3 mm, verified on standing plain x-rays in lateral view
- •have a spinal stenosis in the level of spondylolisthesis, shown on MRI
- •have clinical symptoms of spinal stenosis as neurogenic claudication or radiating pain into the lower limbs, not responding to at least 3 months of qualified conservative treatment
- •are able to give informed consent and to respond to the questionnaires.
排除标准
- •are not willing to give written consent
- •are participating in another clinical trial that may interfere with this trial
- •are ASA- classified > 3
- •are older than 80 years
- •are not able to comply fully with the protocol, including treatment, follow-up or study procedures (psychosocially, mentally and physical)
- •have cauda equina syndrome (bowel or bladder dysfunction) or fixed complete motor deficit
- •have a slip >=3 mm in more than one level
- •have an isthmic defect in pars interarticularis
- •have a fracture or former fusion of the thoracolumbal region
- •have had previous surgery in the level of spondylolisthesis
- •have a lumbosacral scoliosis more than 20 degrees verified on AP-view
- •have distinct symptoms in one or both legs due to other diseases, e.g. polyneuropathy, vascular claudication or osteoarthritis
- •have radicular pain due to a MRI verified foraminal stenosis in the slipped level, with deformation of the nerve root because of a bony narrowing in the vertical direction
结局指标
主要结局
The Oswestry Disability Index
时间窗: Prior to operation and 3 months, 1 year, 2 years, 5 years and 10 years postoperatively.
The Oswestry Disability Index (ODI) version 2.0 will be used as primary outcome measure. ODI is widely used by physicians treating patients with back-related symptoms and has been translated and validated for applications with Norwegian patients. It is a self-reported instrument comprising 10 sections where the patient is supposed to mark the most appropriate item. ODI scores range from 0 to 100, where 100 is the greatest impairment. The percentage change in ODI from baseline to follow- up will be computed. An individual cutoff value of 30% ODI- improvement will be used to dichotomize the patients in a success group and in a non- success group. This threshold value is estimated based on data from patients registered in the Norwegian registry for Spine Surgery The change in ODI from before operation to follow up will also be computed and reported as means.
次要结局
- Global Perceived Effect (GPE) scale:(3 months, 1 year, 2 years, 5 years and 10 years postoperatively.)
- Volume of blood loss and use of blood transfusion(At disharge from hospital at primary operation.)
- Numeric Rating Scale (NRS) for back- and leg pain(Prior to operation and 3 months, 1 year, 2 years, 5 years and 10 years postoperatively.)
- Duration of surgery(At disharge from hospital at primary operation.)
- Zürich Claudication Questionnaire (ZCQ):(Prior to operation and 3 months, 1 year, 2 years, 5 years and 10 years postoperatively.)
- Percentages of participants needing a reoperation.(3 months, 1 year, 2 years, 5 years and 10 years postoperatively.)
- Euroquol 5 dimensions questionnaire (EQ-5D)(Prior to operation, 3 months, 1 year, 2 years, 5 years and 10 years postoperatively.)
- Percentages of participants with adverse effects (complications)(During the hospital stay (average 2-3 days) and up to 10 years postoperatively.)
- Length of hospital stay(At disharge from hospital at primary operation.)