Posterior Dynamic Stabilization Versus Fusion in the Treatment of Lumbar Degenerative Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Difference in Oswestry disability index (ODI) between treatment groups at 2 years post intervention
研究概览
简要总结
The purpose of this study is to compare posterior dynamic stabilization with fusion in the treatment of lumbar degenerative disease.
详细描述
Two strategies for treatment of degenerative lumbar instability are in frequent clinical use: fusion versus dynamic stabilization. Up to now it is not clear whether fusion (Gold-standard) or the non-fusion technique is superior. Nevertheless some data are available that dynamic stabilization as a less invasive technique can achieve similar or better results concerning patient satisfaction and re-OP rate compared with fusion as the standard therapy.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Mono- or bisegmental symptomatic lumbar degenerative disease with or without stenosis
- •Indication for fusion with (i) spondylolisthesis of at least 5mm or segmental vertebral motion of at least 3mm or 10º on flexion/extension radiographs, (ii) predominant low back pain in combination with Modic changes
- •Failure of adequate conservative measures for more than 3 months
- •Correctly signed informed consent form
排除标准
- •Olisthesis more than grade I, spondylolisthesis vera, spondylolysis without olisthesis or spinal deformity (i.e. scoliosis of more than 20°, sagittal imbalance)
- •Significant comorbidity impeding with surgical success (e.g. osteoporosis, rheumatoid arthritis, mental illness)
- •Previous fusion or stabilization surgery
研究组 & 干预措施
B
B - Dynamic (new)
干预措施: new (Procedure)
A
A - Fusion
干预措施: standard (Procedure)
结局指标
主要结局
Difference in Oswestry disability index (ODI) between treatment groups at 2 years post intervention
时间窗: 2 years after intervention
次要结局
未报告次要终点