Conservative Treatment of Rockwood Type III Acromioclavicular Dislocation With Two Different Types of Braces: a Comparative Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Shoulder function
研究概览
简要总结
In a randomised prospective comparative Trial the investigators aim to compare the conservative Treatment of acromioclavicular dislocations (Rockwood III) with a conventional sling versus a Acromion 2.0 brace, which exerts a direct Reposition force on the Joint.
The sling/brace will be worn for 6 weeks and the patients will be regularly checked clinically and radiologically.The investigators are interested in differences of shoulder function, Patient satisfaction as well as cosmetic and radiological results.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •First acute acromioclavicular dislocation Rockwood Type III
排除标准
- •Previous injury to acromioclavicular Joint
- •Previous surgery of acromioclavicular Joint
- •Known hypersensitivity or allergy to fabric of investigational product
- •Pregnancy
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
研究组 & 干预措施
Mitella Sling
干预措施: Acromion 2.0 Brace (Device)
Acromion 2.0 Brace
干预措施: Acromion 2.0 Brace (Device)
结局指标
主要结局
Shoulder function
时间窗: at 12 weeks
Constant-Score
Shoulder function
时间窗: at 6 weeks
Constant-Score
Shoulder function
时间窗: at 1 week
ASES-Score (American Shoulder and Elbow Score)
次要结局
- Degree of lateral clavicle dislocation(at 12 weeks)
- Degree of lateral clavicle dislocation(at initial presentation)
- Degree of lateral clavicle dislocation(at 6 weeks)
研究者
Michael Finsterwald
Dr. med. Michael Finsterwald
Bürgerspital Solothurn