NCT02474576已完成不适用
Percutaneous Aponeurotomy in the Treatment of Dupuytren's Disease
Groupe Hospitalier Diaconesses Croix Saint-Simon2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2015年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Frequency of local relapse at 24 months
研究概览
简要总结
The efficiency of percutaneous aponeurotomy in the treatment of Dupuytrens disease is well known. However, the duration of the clinical improvement after aponeurotomy is not well known.
This study aims primarily at measuring the incidence rate of local relapse of Dupuytrens-induced finger flessum, within two years following treatment by percutaneous aponeurotomy in Dupuytrens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient suffers from Dupuytren disease
- •Patient has at least one finger with at least 20° flessum on the metacarpophalangeal joint and/or on the proximal interphalangeal joint
- •Patient has chosen to benefit from local treatment
排除标准
- •Pregnancy
- •Breastfeeding
- •No social insurance
结局指标
主要结局
Frequency of local relapse at 24 months
时间窗: 24 months after treatment by aponeurotomy
the statistical unit is the finger treated by aponeurotomy (we expect an average of 2 fingers treated for one patient included). Local relapse is defined as the recurrence of a finger flessum superior by 20° to the articular range initially obtained after aponeurotomy
次要结局
- Frequency of local relapse at 60 months(60 months after treatment by aponeurotomy)
- Primary success rate of aponeurotomy(3 months after treatment)
- Frequency of local relapse at 48 months(48 months after treatment by aponeurotomy)
- Frequency of local relapse at 12 months(12 months after treatment by aponeurotomy)
- Frequency of local relapse at 36 months(36 months after treatment by aponeurotomy)
研究者
研究点 (2)
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