Study of Collagenase Injection Therapy for Treatment of Zone II Flexor Tendon Adhesions in the Hand
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Restoration of PIP and DIP joint motion.
研究概览
简要总结
The purpose of this study is to dissolve flexor tendon adhesions associated with failed tendon repair surgery.
详细描述
In an open label study, collagenase injection therapy was investigated in 3 subjects for it's ability to lyse flexor tendon adhesions in zone II of the hand.
Results indicate that two of three subjects had improved range of finger motion at the PIP and DIP joints. This may obviate the need for patients to have tenolysis hand surgery to correct the finger flexion contracture of the PIP and DIP joints. Detailed controlled studies remain to be done.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •zone II flexor tendon adhesion of at least one finger
排除标准
- •any chronic, serious or uncontrolled medical condition
- •inability to conform to study visits (12-15 per year)
研究组 & 干预措施
Collagenase Injection
Injection of collagenase into adhesion restricting tendon gliding
干预措施: Collagenase (Drug)
Collagenase Injection
Injection of collagenase into adhesion restricting tendon gliding
干预措施: Collagenase injection (Drug)
结局指标
主要结局
Restoration of PIP and DIP joint motion.
时间窗: 6 months
次要结局
- Hand Grip strength (kg)(6 months)
研究者
Marie A. Badalamente
Professor
Stony Brook University