Conservative Treatment Versus Plate Osteosynthesis Using Angular Stabile Screws and Precontoured Plates in Displaced Midshaft Clavicular Fractures. A Prospective Randomized Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Disabilities of the Arm, Shoulder and Hand (DASH) Score
研究概览
简要总结
This study will compare non-operative treatment of displaced midshaft collarbone fractures with operative treatment using a precontoured titanium plate and screws.
The study hypothesis is that operation will provide better pain relief, faster return to activities, better function of the involved upper limb, and lower the risk of a non healing fracture (non union).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fracture located to the mid third of the collar bone where there is no contact between the fractured surface of the main fragments on x-ray in one or two of two levels.
排除标准
- •bilateral fracture
- •imminent skin perforation
- •open fracture
- •associated neurovascular effect
- •unstable fracture of neck of scapula "floating shoulder"
- •fracture of coincidental upper extremity distal for the shoulder
- •pathologic fracture
- •the patient states that there was a unilateral or bilateral shoulder problem before the fracture
- •fracture realized more than 14 days after it arose
- •circumstances which make it impossible to carry out one of the two regimes, i.e. mental illness and abuse
- •circumstances which make follow-up impossible, i.e. address far from the including departments and stays abroad of long duration
- •medical contraindication against surgery or general anaesthesia
- •former participation in the trial
- •former fracture contra/ipsilateral at the age of 15 or older
结局指标
主要结局
Disabilities of the Arm, Shoulder and Hand (DASH) Score
时间窗: 6 weeks, 3 months, 6 months, 1 year
The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. The tool gives clinicians and researchers the advantage of having a single, reliable instrument that can be used to assess any or all joints in the upper extremity.
次要结局
- Constant-Murley Score(6 weeks, 3 months, 6 months, 1 year)