NCT00196560已完成3 期
A Randomized Evaluation of Immobilization in External Rotation in the Management of Acute Anterior Dislocations of the Shoulder
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Recurrent Instability at 24 months
研究概览
简要总结
The purpose of this study is to determine whether immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditional internal rotation) reduces the rate of recurrent dislocations experienced in 24 months.
详细描述
Immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditional internal rotation)should reduce the rate of recurrent dislocations experienced in 24 months.
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
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •skeletally mature patients less than 30 years of age
- •sustained an acute, first-time, traumatic anterior dislocation of the shoulder as defined by; i. Mechanism of abduction, external rotation ii. Sudden pain in the shoulder iii. Manipulative reduction required or iv. Radiograph documenting a dislocated joint
- •willing to participate in follow-up for at least two years
排除标准
- •incompetent or unwilling to consent
- •inability or unwillingness to comply with rehabilitative protocol or required follow-up assessments
- •previous instability of the affected shoulder
- •significant associated fracture (exception Hill Sachs or Bankart lesions)
- •concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program
- •a history of significant ligamentous laxity or demonstrated multi-directional instability of the contralateral shoulder
- •neurovascular compromise of the affected limb
- •a medical condition making the patient unable to wear a brace or sling
结局指标
主要结局
Recurrent Instability at 24 months
次要结局
- Western Ontario Shoulder Instability index (WOSI)
- Complications (resulting from immobilization)
- Compliance with immobilization protocol
- American Shoulder and Elbow Surgeons questionnaire (ASES)
- Time (weeks) to return to work and time(weeks) to return to sport
研究者
Sharon Griffin
Research Coordinator
Fowler Kennedy Sport Medicine Clinic
研究点 (2)
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