ISRCTN88702314已完成未知
Cost effectiveness and quality of life after treatment of lumbar spinal stenosis with the X-STOP® Interspinous Process Distraction (IPD) device or laminectomy: a prospective randomised trial
niversity College London Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 47 人开始时间: 2008年6月4日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 47
研究概览
简要总结
2021 results in https://pubmed.ncbi.nlm.nih.gov/33530059/ (added 03/02/2021)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age: 18-80
- •2. Sex: males and non-pregnant females
- •3. Chronic leg pain with or without back pain of greater than 6 months duration, partially or completely relieved by adopting flexed posture and who are suitable candidates for posterior lumbar surgery
- •4. Those who have completed at least 6 months of conservative treatment without obtaining adequate symptomatic relief
- •5. Degenerative changes at one or two adjacent levels between L1-S1 confirmed by X-ray, computerised tomography (CT) or magnetic resonance imaging (MRI) scan
排除标准
- •1. Fixed motor deficit
- •2. Active infection or metastatic disease
- •3. Degenerative spondylolisthesis >= Meyerding Grade 2
- •4. Known allergy to implant materials
- •5. Severe osteoporosis or rheumatoid arthritis
- •6. Cauda equina syndrome
研究者
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