NCT00872105已完成不适用
A Multicentre, Randomized Trial of Conservative Treatment Versus Operative Plate Fixation for Acute, Displaced Fractures of the Distal Clavicle
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- The primary outcome measurement will be patient DASH (Disabilities of the Arm, Shoulder and Hand Instrument) scores. The DASH is a patient-oriented, limb-specific, functional measurement questionnaire.
研究概览
简要总结
This is a multicentre randomized clinical trial prospectively comparing operative treatment versus conservative (nonoperative) care in the management of displaced distal (Type II) clavicle fractures.
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
- 16 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 16 to 60 years of age
- •Completely displaced (no cortical contact), closed fracture of the distal 3rd of the clavicle (Type II) confirmed by radiograph
- •Fractures within 28 days post injury
- •Provision of informed consent
排除标准
- •Pathological fractures
- •Non-displaced (cortical contact) distal clavicle fractures
- •Open clavicle fractures
- •Presence of vascular injury
- •Fractures more than 28 days post-injury
- •Limited life expectancy due to significant medical co-morbidity
- •Medical contraindication to surgery
- •Inability to comply with rehabilitation or form completion
- •Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, patients not mentally competent to give consent, etc.)
研究组 & 干预措施
Non-operative treatment
Other
The first treatment strategy will involve conservative (nonoperative) management of the clavicle fracture.
干预措施: Non-operative Treatment (Procedure)
Operative treatment
Active Comparator
The second treatment strategy will involve operative fixation (i.e. ORIF) of the fracture with a plate and screws.
干预措施: Operative Treatment (Procedure)
结局指标
主要结局
The primary outcome measurement will be patient DASH (Disabilities of the Arm, Shoulder and Hand Instrument) scores. The DASH is a patient-oriented, limb-specific, functional measurement questionnaire.
时间窗: 2 years
次要结局
- The secondary outcome measurement patients' functional shoulder scores as defined by Constant's Shoulder Score (i.e. pain, activities of daily living, range of motion and power).(2 years)
研究者
研究点 (1)
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