NCT01139528已完成不适用
Conservative Treatment Versus Operative Treatment of Extra-articular Fractures in the Neck of the 5th Metacarpal Bone- A Prospective Randomized Trial
Oslo University Hospital2 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2010年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Quick-DASH
研究概览
简要总结
A multi-site randomized controlled trial where patients are allocated to operative treatment or conservative treatment of fractures of the neck of the 5th metacarpal bone. The study goal is to identify which degree of angular displacement in the fracture that requires operative intervention.
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
- •Patients over 18 years of age with fractures of the neck of the 5th metacarpal bone
排除标准
- •Less than 30 degrees of volar angulation in the fracture
- •rotational deformity
- •pseudoclawing
- •intra-articular involvement
- •ad latus displacement more than one half of a bone width
- •concomitant fractures or soft tissue damage
- •admittance more than 14 days after injury
- •non-compliant patient (language, drugs, tourist)
- •patient who refuses to participate in the study
结局指标
主要结局
Quick-DASH
时间窗: 6 weeks, 3 months, 1 year, 2 years
Validated hand function score
次要结局
- Grip strength(3 months, 1 year, 2 years)
- Complications(1 week, 6 weeks, 3 months, 1 year, 2 years)
- Patient satisfaction(6 weeks, 3 months, 1 year, 2 years)
- Eq-5d(6 weeks, 3 months, 1 year, 2 years)
- Range of motion in the joints in the 5th finger measured by hand therapist(3 months, 1 year, 2 years)
- Pain(1 week, 6 weeks, 3 months, 1 year, 2 years)
- Sick-leave(1 week, 6 weeks, 3 months (1 year, 2 years))
- Angular displacement in fracture measured in lateral x-ray, and shortening in fracture measured in AP view, of the 5th ray of the hand(6 weeks, 1 year)
研究者
Ida Neergård Sletten
Consultant orthopaedic surgeon
Oslo University Hospital
研究点 (2)
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