The PLUS study: Preventing LUmbar Disc Surgery - PLUS study

ZonMW0 个研究点开始时间: 2017年7月20日最近更新: 2017年10月2日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•Incapacitating lumbosacral radicular syndrome with leg pain (with or without back pain) that had lasted for a minimum of 6 weeks
•with or without mild neurological deficit (MRC higher than 3)
•MRI which confirms a lumbar HNP that compromises the spinal nerve and can explain the clinical symptoms of the patient
•The patients should according to usual care have an indication for lumbar HNP operation by a neurosurgeon.
•Signed informed consent for participation in the study
•18 years and
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 46

•A potentially eligible subject who meets any of the following criteria will be excluded from participation in this study:
•Patients exclude suffering from cauda equina syndrome
•Previous spine surgery at the same level during the previous 6 months
•Previous transforminal injections at the same level during the previous 6 months
•Bony stenosis
•Spondylolisthesis
•Pregnancy
•Complicated disc herniation requiring more operations
•Severe coexisting disease e.g. osteoporosis, dementia
•Patient with contra-indications for steroids injections
•Insufficient knowledge of the Dutch language
•Emergency surgery as determined by the neurosurgeon
•Severe paresis MRC less than or equal to 3
•Being allergic for OMNIPAQUE 240

发起方