Conservative Versus Operative Treatment of Displaced Neck Fractures of the Fifth Metacarpal
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Disability of the Arm, Shoulder and Hand (DASH) questionnaire
研究概览
简要总结
This is a prospective, randomized, multi-center pilot study of isolated, displaced neck fractures of the fifth metacarpal. The patients are randomly assigned to osteosynthesis with antegrade intramedullary splinting or conservative treatment.
详细描述
The aim of this study is to provide criteria for treatment decisions in patients with isolated, displaced neck fractures of the fifth metacarpal. The primary outcome criterion is the functional status measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Secondary outcome criteria are pain, range of motion (ROM), grip strength, and radiological parameters.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •displaced neck fracture of the fifth metacarpal (at least 30° angulation)
- •isolated injury
- •age between 18 and 75 years
- •informed consent
排除标准
- •rotational displacement
- •open fracture
- •injury older than one week
- •treatment other than within this study
- •other relevant injuries of the upper extremities
- •other injury or disease of the hand
- •pregnancy
- •missing informed consent
- •incompliance
- •coagulopathy
- •allergy to metallic implants
- •Patients who have participated in any other device or drug clinical trial within the previous month
研究组 & 干预措施
A
antegrade intramedullary splinting
干预措施: antegrade intramedullary splinting (Procedure)
B
conservative treatment
干预措施: conservative treatment (Procedure)
结局指标
主要结局
Disability of the Arm, Shoulder and Hand (DASH) questionnaire
时间窗: 3 months
次要结局
- pain(3 months)