Conservative Therapy of Fifth Metacarpal Neck Fractures - a Prospective Randomized Study Comparing Functional Treatment With Reposition and Finger Splinting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Brief Michigan-Hand-Outcome-Questionnaire
研究概览
简要总结
The purpose of this prospective randomized controlled clinical trial is to evaluate if functional treatment leads to a better functional outcome than a forearm cast and a finger splint in patients with fifth metacarpal neck fracture.
详细描述
This study represents a prospective randomized clinical trial comparing two different conservative treatment options in patients with fifth metacarpal neck fracture.
Patients meeting the inclusion criteria will be enrolled in the present study provided they give their consent. Informed written consent will be obtained. Randomization will be performed according to the CONSORT Guidelines of Prospective Randomized Trials using the software "Randomizer" by the Medical University of Graz. Patients allocated to the control group will receive a forearm cast with a finger splint in terms of an immobilizing treatment, while patients in the study group will receive buddy taping for fingers IV and V and an elastic bandage in terms of a functional treatment. Both groups will receive the allocated bandage or splint for 4 weeks. The clinical outcome will be assessed 12 weeks after trauma.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fifth Metacarpal Neck Fractures
- •Patient age between 18 and 70 years
排除标准
- •Palmar angulation >50° in first lateral x-ray
- •Pathologic fracture
- •Intraarticular fracture
- •Patients unable to consent
- •Polytraumatized patients
- •Pregnancy
- •Compound fractures
- •Multiple hand injuries
- •Patients initially presenting more than 7 days after injury
结局指标
主要结局
Brief Michigan-Hand-Outcome-Questionnaire
时间窗: at 12 weeks
patient-based standardised questionnaire (12 items, range 0-100, 100=ideal function, 0=poorest function)
次要结局
- Loss/Gain of Reduction(at 12 weeks)
- Treatment Failure(at 1, 2, 4 and 12 weeks)
研究者
Paul L Hoppe
Principal Investigator
Medical University of Vienna