NCT01538017已完成不适用
Comparing Injectable Collagenase (CI) and Percutaneous Needle Fasciotomy (PNF) for Dupuytren's Contracture (DC) Affecting Proximal Interphalangeal Joints (PIP). A Randomised Controlled Trial
Jeppe Lange, MD1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinical improvement
研究概览
简要总结
Comparing injectable collagenase and percutaneous needle fasciotomy for Dupuytren's contracture affecting proximal interphalangeal joints. An open label, medico-independent randomized controlled trial.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DC affecting PIP joint with Passive Extension Deficit (PED) more than 20 degrees
- •Clearly defined strings
排除标准
- •Allergies to used medication
- •International Normalised Ratio more than 2.0
- •Pregnancy and breastfeeding
- •Previous treatment for DC in affected finger
- •Former inclusion in the study with another string
- •Activity in disease at time of study
- •PED more than 20 degrees for Metacarpophalangeal or Distal Interphalangeal joint in affected digit
研究组 & 干预措施
Collagenase injection
Active Comparator
Injection of collagenase obtained from Clostridium Histolyticum in contracture string
干预措施: Xiapex (Drug)
Percutaneous needle fasciotomy
Active Comparator
PNF ad modum Lermusiaux and Debeyre
干预措施: Percutaneous needle fasciotomy (Procedure)
结局指标
主要结局
Clinical improvement
时间窗: 2 years
Clinical improvement is defined as a contracture reduction 50% or more from baseline.
次要结局
未报告次要终点
研究者
Jeppe Lange, MD
M:D:
Regionshospitalet Silkeborg
研究点 (1)
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