jRCT1040220134已完成不适用
10 years follow-up study of chemonucleolysis with condoliase after phase III clinical trials (6603/1031) of condoliase for lumbar disc herniation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Intervertebral disc degeneration
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- No limit 至 No limit（—）
- 性别
- All
入选标准
- •Ptients who had received condoliase 1.25 U injection in a phase III clinical study in Japan.
排除标准
- •Ptients for whom consent do not been obtained in this study.
- •Ptients who are judged unsuitable for conducting this study by the principal investigator, and some others.
结局指标
主要结局
Intervertebral disc degeneration
Pfirrmann classification
Changes in cartilage endplates and adjacent vertebral bodies
Change in Modic Type
次要结局
- Neurological examination
- Dysfunction
研究者
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