NCT00707018已完成不适用
Immobilization in External Rotation After First Time Anterior Shoulder Dislocation: A Prospective Randomized Study
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
- 50
- 试验地点
- 8
- 主要终点
- Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation.
研究概览
简要总结
Comparison of immobilization in internal versus external rotation after first time anterior shoulder dislocation.
详细描述
The purpose of this study is to compare immobilization in internal versus external rotation after first time anterior shoulder dislocation, and thereby increase our knowledge about the best standard of care.
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
- 14 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •14 to 30 years of age
- •Willing to participate in follow-up for at least two years
- •Acute, first-time, traumatic, isolated anterior dislocation of the shoulder
排除标准
- •Previous instability of the affected shoulder
- •A history of significant ligamentous laxity or demonstrated multi-directional instability of the opposite shoulder
- •Inability or unwillingness to comply with sling immobilization, rehabilitative protocol, or required follow-up assessments
- •Incompetent or unwilling to consent
- •A medical condition making the patient unable to wear a sling
- •Significant associated fracture (Exception Hill Sachs of >20% or bony Bankart lesions>10%)
- •Neurovascular compromise of the affected limb
- •Concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program.
研究组 & 干预措施
External rotation shoulder sling
Experimental
External rotation shoulder sling
干预措施: External rotation shoulder sling (Device)
Internal rotation shoulder sling
Active Comparator
Internal rotation shoulder sling
干预措施: Internal rotation shoulder sling (Device)
结局指标
主要结局
Recurrent instability consisting of a documented episode of anterior shoulder dislocation or multiple episodes of shoulder subluxation.
时间窗: 24 months
次要结局
- Patient self reported outcome measures(24 Months)
- Time to return to work or sport(24 Months)
研究者
研究点 (8)
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