A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 386
- 试验地点
- 13
- 主要终点
- Zurich Claudication Questionnaire (ZCQ)
研究概览
简要总结
A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis
详细描述
In this investigation, it will be investigated whether the effectiveness of surgical intervention with Coflex® is equivalent to surgical decompression after 12 months in people with intermittent claudication. The main advantage of coflex® might be a faster recovery after surgery, but after long term follow-up it is unknown if this treatment effect remains. Therefore in addition, it will be investigated whether surgical intervention with coflex® is more effective than surgical decompression on short-term follow-up (8 weeks to 6 months) and whether surgical intervention with coflex® is more cost-effective after 12 months than surgical decompression.
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
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent
- •is 40 to 85 years old at time of surgery
- •has INC, as noted by leg/buttock/groin pain with or without back pain. Leg/buttock/groin pain needs to be strongly relieved when flexed such as when sitting in a chair
- •has received at least three months of conservative care therapy which may have included, but is not limited to, physical therapy, bracing, systemic and/or injected medications
- •has a regular indication for surgical intervention of INC
- •has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at one or two levels confirmed by MRI
- •is physically and mentally willing and able to comply with, or has a caregiver who is willing and able to comply with, the post-operative evaluations.
排除标准
- •has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder dysfunction (bladder retention or incontinence)
- •has Paget's disease, severe osteoporosis or metastasis to the vertebrae
- •has significant scoliosis (Cobb angle > 25 degrees)
- •has a Body Mass Index (BMI) > 40 kg/m2
- •has had any surgery of the lumbar spine
- •has degenerative spondylolisthesis > grade 1 (on a scale 1 to 4) at the affected level
- •has significant instability of the lumbar spine
- •has severe comorbid conditions that will increase the risk to the patient or interfere with the evaluability of this study
- •has a fused segment at the indicated level.
- •has a herniated disk on the level of interest
结局指标
主要结局
Zurich Claudication Questionnaire (ZCQ)
时间窗: 5 years
ZCQ is a scale that measures physical function, symptom severity, and patient satisfaction for patients with spinal stenosis.
次要结局
- MRDQ(5 years)
- EuroQOL (EQ-5D)(5 years)
- SF-36(5 years)
- McGill Pain Questionnaire(5 years)
- VAS Leg Pain(5 years)
- Re-operations, revisions, and major complications(5 years)
- Radiographic Assessment(12 months)