NCT00252551终止不适用
Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis - CLEOS Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 18
- 主要终点
- To evaluate the superiority of the osteosynthesis associated with a decompressive surgery in comparison with a simple decompressive surgery in the treatment of lumbar degenerative stenosis with spondylisthesis
研究概览
简要总结
Study to evaluate the superiority of the osteosynthesis associated with a decompressive surgery in comparison with a simple decompressive surgery in the treatment of lumbar degenerative stenosis with spondylolisthesis
详细描述
Randomized, comparative study on 152 patients with degenerative spondylolisthesis L4-L5 confirmed by radiography with radicular pain for whom the antalgic and anti-inflammatory treatment are not efficient for at least 3 months.
Patients randomized in 2 parallel groups (each group with 76 patients)
- one group with decompressive surgery + osteosynthesis
- one group with decompressive surgery Study duration : 18 months, including a selection visit, an inclusion with the surgical intervention, 3, 12, 18 months' follow up visits and a follow up call at 6 months.
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
- None
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
- •Patients with degenerative spondylolisthesis L4-L5 confirmed by radiography with radicular pain for whom the antalgic and anti-inflammatory treatment are not efficient for at least 3 months;
- •Patients who agree to take part in the study and to sign an Informed Consent Form
排除标准
- •Contre-indications to surgery or to vertebral isolated fixation L4-L5
- •Previous lumbar surgery
- •Work accidents
- •Psychiatric troubles that may interfere with the clinical evaluation
- •Pregnant women or women who could be pregnant during the study
- •Patient under special supervision or trusteeship
- •Refusal to sign the Informed Consent Form
- •No Public Health Insurance cover
结局指标
主要结局
To evaluate the superiority of the osteosynthesis associated with a decompressive surgery in comparison with a simple decompressive surgery in the treatment of lumbar degenerative stenosis with spondylisthesis
时间窗: M3, M12, M18
次要结局
- safety of the used surgical procedures(M3, M12, M18)
- improvement of patients' Quality of Life (SF36)(M18)
- radiologic stability of spondylolisthesis(M18)
研究者
研究点 (18)
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