ISRCTN33762516已完成不适用
Flexible or solid stabilisation for lumbar spondylosis? A randomised controlled trial - Stage 1 - Feasibility Study
Zimmer Ltd (UK)0 个研究点目标入组 30 人开始时间: 2004年11月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects: Patients with severe chronic low back pain of at least 1 year's duration attributed to either post-discectomy pain or primary disc degeneration below L3 in whom conservative treatment has been ineffective and who elect to have spine stabilisation surgery.
- •Inclusion Criteria:
- •1. Age 25-65
- •2. Willing to participate
- •3. Back pain without radiculopathy and attributable to lumbar spondylosis
- •4. Conservative therapy tried and failed
- •5. Elect lumbar stabilisation (1 or 2 level, L3 downward)
- •6. Suitable for DYNESYS or standard posterolateral fusion (PLF) with pedicle screws and graft using a standardised procedure
- •7. Oswestry >30
排除标准
- •1. Mental illness (except mild depression)
- •2. No prior conservative therapy
- •3. Pathology such as fracture, infection, neoplasm
- •4. Poor understanding of English
- •5. Spinal stenosis
- •6. Spondyolisthesis
- •7. >2 level procedure required
- •8. Radicular pain
- •9. Litigation or compensation pending
研究者
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