A Post Market, Open-Label Study of the Safety and Efficacy of Delayed Manipulation After Xiaflex Treatment in Subjects With Dupuytren's Contracture
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 37
- 试验地点
- 4
- 主要终点
- Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)
研究概览
简要总结
The purpose of this study is to determine if of manipulation of digits following collagenase injection for treatment of Dupuytren's contracture is effected by the amount of time between injection and manipulation.
详细描述
Patients with Metacarpophalangeal joint contractures caused by Dupuytren's disease will be evaluated as to the timing of the finger manipulation procedure that is performed following collagenase injection. Three groups will be evaluated: group 1 will have the manipulation procedure on the day following collagenase injection, group 2 will have the manipulation procedure on the second day following collagenase injection,and group 3 will have the manipulation procedure on the fourth day following collagenase injection,
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
- 是
入选标准
- •Adult subjects (> 18 years) of either gender with an metacarpophalangeal joint contracture and a palpable cord of > 20 degrees of a digit (excluding the thumb) due to Dupuytren's contracture
排除标准
- •Any subject who has had prior surgical, percutaneous needle aponeurotomy or Xiaflex treatment for Dupuytren's contracture.
- •Any subject using anti-coagulant therapy other than low dose aspirin (up to 150mg/day).
- •Any subject in the opinion of the MD investigators with chronic, severe or terminal medical illness which would make them unsuitable for study participation.
- •Any subject with known allergy to Xiaflex (Clostridial collagenase).
- •Any subject who cannot conform to the study visit schedule
结局指标
主要结局
Percentage of Patients With Clinical Improvement (> 50% Reduction in Contracture)
时间窗: 30 days after injection
次要结局
- Percentage of Patients Obtaining Clinical Success at 90 Days (<=5 Degree Residual Contracture)(90 days)
研究者
F. Thomas D. Kaplan, MD
MD
Indiana Hand to Shoulder Center