(Cost) Effectiveness of Surgery versus Prolonged Conservative Treatment in Patients with Intermittent Neurogenic Claudication caused by Lumbar Stenosis - The Verbiest Trial

eids Universitair Medisch Centrum0 个研究点目标入组 280 人开始时间: 待定最近更新: 2024年8月12日

适应症

试验速览

暂无简介。

•-at least 50 years old
•-at least 3 months intermittent neurogenic claudication, as noted by leg/buttock/groin pain with or without back pain or fatigue in the legs provoked by walking. Leg/buttock/groin pain or fatigue needs to be strongly relieved when flexed such as when sitting in a chair
•-has a narrowed lumbar spinal canal, nerve root canal or intervertebral foramen at
•one or more levels confirmed by MRI
•-has a regular indication for surgical intervention of INC
•-informed consent

•-has a 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 > 40 kg/m2
•-has previously had a laminectomy at the same level, has degenerative or lytic spondylolisthesis grade >1 (on a scale 1 to 4) at the affected level or 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 (e.g. severe ischemic heart disease, musculoskeletal or neurological conditions impairing walking ability, cognitive impairment (MMSE <25 points)
•-unable to read or write Dutch

发起方