A Randomized Controlled Trial of the Treatment of Mallet Fractures: Conservative Versus Operative Using One Meniscus Arrow®
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 12
- 主要终点
- Extension deficit
研究概览
简要总结
Intra-articular fractures at the dorsal base of the distal phalanx of the hand are usually referred to as Mallet fractures. Treatment of Mallet fractures remains controversial. Although no differences in clinical results are reported between conservative treatment and operative treatment, operative treatment is suggested for fractures involving more than 30% of articular surface. There are many different operative techniques, all with specific disadvantages. The investigators hypothesis is that operative treatment of Mallet fractures with one Meniscus Arrow® has a better outcome than conservative treatment with a Mallet splint.
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
- 否
入选标准
- •avulsion fracture involving more than 30% of articular surface
排除标准
- •(sub)luxation of the distal phalanx
- •patients with a Mallet fracture developed 3 weeks or more prior to presentation
- •patients with a Mallet fracture with failure of conservative treatment
结局指标
主要结局
Extension deficit
时间窗: 1 year
To evaluate the extension deficit after conservative and operative treatment of a Mallet fracture using the Crawford criteria.
extension deficit
时间窗: 1 year
at every visit, the extension in the DIP joint, is measured
次要结局
- wound healing disturbances(1 year)
研究者
Dr. D.B. Wouters
Dr. D.B. Wouters
Conmed Linvatec Benelux