NCT01725997已完成不适用
Operative or Conservative Treatment of Acute Acromioclavicular Joint Dislocation Rockwood Grade III and V - a Prospective Randomized Study
St Goran's Hospital2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2012年11月14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
- 124
- 试验地点
- 2
- 主要终点
- Constant Score
研究概览
简要总结
The study aims to answer if surgery with hook plate for acute dislocation of the acromioclavicular joint (AC joint) grade III and V according to Rockwood is superior to conservative treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AC joint dislocation grade III according to Rockwood with at least half a clavicular bone width above the acromion or grade V according to Rockwood
- •men and women 18-65 years and able to work
- •understand spoken and/or written Swedish or English language
- •be able to start treatment within 3 weeks from trauma
- •consent form signed
排除标准
- •earlier injury to, or surgery of either of the shoulders
- •simultaneous fracture of the clavicle or acromion
- •associates neurovascular injury
- •severe osteoporosis
- •open dislocation
- •open growth plate of the acromion
- •local skin damage
结局指标
主要结局
Constant Score
时间窗: change from Baseline in Constant Score at 24 months
次要结局
- Disabilities of Arm, Shoulder and Hand function (QuickDASH)(change from Baseline in QuickDASH at 24 months)
研究者
Helena Boström Windhamre
MD
St Goran's Hospital
研究点 (2)
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