Conservative Therapy of Proximal Phalanx Fractures - a Prospective Randomized Study Comparing the Lucerne Cast With Finger Splinting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 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 the lucerne cast leads to a better functional outcome than a forearm cast with a finger splint in patients with a proximal phalanx fracture.
详细描述
This study represents a prospective randomized controlled clinical trial comparing two different conservative treatment options in patients with proximal phalanx fractures.
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, while patients in the study group will receive the lucerne cast. Both groups will receive the allocated cast for 4 weeks. 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
- •Proximal phalanx fracture in the fingers (II - V)
- •Patient age between 18 and 70 years
排除标准
- •Condylar fracture
- •Avulsions of the collateral ligament
- •Pathologic fracture
- •Intraarticular fracture
- •Patients unable to consent
- •Polytraumatized patients
- •Patients initially presenting more than 7 days after injury
- •Pregnancy
- •Compound fractures
- •Multiple hand injuries
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
- Treatment Failure(at 1, 2, 4 and 12 weeks)
研究者
Paul L Hoppe
M.D.
Medical University of Vienna