Decompression Alone vs. Decompression and Instrumented Fusion for the Management of Lumbar Spinal Stenosis Associated With Stable Degenerative Spondylolisthesis: A Pragmatic Randomized Clinical Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 16
- 主要终点
- Proportion of patients who receive randomized allocation
研究概览
简要总结
The purpose of this study is to assess the feasibility of a full-scale multicenter randomized, controlled trial comparing the effectiveness of two surgical treatments for a condition associated with lumbar spinal stenosis called degenerative lumbar spondylolisthesis. Both treatments are currently used, but individual surgeons use different selection criteria for each treatment and use the procedures at different rates. The two procedures are decompression with fusion (the most common surgical procedure for spondylolisthesis) and midline-sparing decompression alone (which is also a standard treatment, but is not as widely used for treating spondylolisthesis). The investigators plan to collect the evidence on the following:
- The feasibility of the trial protocol, and
- Preliminary data on the effectiveness of each treatment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients deemed to be surgical candidates with focal (1-2 level) lumbar spinal stenosis (LSS) and associated stable degenerative spondylolisthesis with the following characteristics:
- •a clinical history of back, buttock and leg pain with walking or standing that is improved when lying, sitting or bending forward
- •a clinical history of leg symptoms that are greater than or equal to back symptoms with walking or standing, and
- •greater than 6 months of symptoms with failed conservative care
- •aged 50 or over
- •sufficient fluency in English or French to provide informed consent and complete questionnaires with or without the need of an interpreter
排除标准
- •Greater than 25% listhesis or spinal instability as demonstrated by motion (>5mm of translation) on flexion extension radiographs or non-loaded (MRI/CT or supine x-rays) to loaded imaging (standing radiograph)
- •Presence of kyphosis (>0 degrees at the affected level or globally), degenerative scoliosis (>10 degree using the Cobb method) with rotatory or lateral listhesis on preoperative x-rays
- •Clinical history of osteoporotic fracture or chronic oral steroid use
- •Previous posterior lumbar spinal surgery (excluding prior microdiscectomy)
- •Patients who have evidence of neurological disorders that affect physical function (e.g. peripheral neuropathy), neuromuscular disorders (e.g. multiple sclerosis, Parkinson's etc.) or systemic illness (e.g. inflammatory arthritis) that affects physical function
研究组 & 干预措施
Decompression alone
Midline-sparing spinal decompression alone
干预措施: Spinal decompression (Procedure)
Decompression with fusion
Spinal decompression surgery with instrumented spinal fusion
干预措施: Spinal decompression (Procedure)
Decompression with fusion
Spinal decompression surgery with instrumented spinal fusion
干预措施: Spinal fusion (Procedure)
结局指标
主要结局
Proportion of patients who receive randomized allocation
时间窗: 2 years
Proportion of patients who adhere to randomized allocation
时间窗: 2 years
Number of patients refusing to consent due to randomization
时间窗: 1 year
Number of eligible patients
时间窗: 1 year
Reasons for refusal to consent
时间窗: 1 year
Number, type and severity of adverse events
时间窗: End of hospital stay (average 6.5 days post-surgery)
Number of patients recruited
时间窗: 1 year
Number of patients refusing to consent due to blinding
时间窗: 1 year
Blinding status
时间窗: 1.5 months post-surgery
Patient's assessment of which treatment they received
Oswestry Disability Index (ODI)
时间窗: 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery
10-item patient-reported questionnaire measuring disability related to low back pain. Each item has six response options ranging from 0 to 5; the responses are summed and rescaled so 0 indicates no disability and 100 indicates extreme disability.
次要结局
- Short-Form 12 scores: Physical Function, Bodily Pain, Physical Component Summary(Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery)
- Patient Health Questionnaire-9 score(Baseline)
- Costs incurred by patients(monthly from 1.5 to 12 months post-surgery; 24 months post-surgery)
- Euro-QoL health utility index(Baseline; 6-18 weeks, 6 months (optional), 12 months, and 24 months post-surgery)
- Hospital cost(End of hospital stay (average 6.5 days post-surgery))
- Healthcare services used(Referral to 1 year post-surgery)