NCT04401462招募中不适用
SCORE Trial - Scandinavian Olecranon Research in the Elderly
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 5
- 主要终点
- the Disabilities of Arm, Shoulder and Hand (DASH)
研究概览
简要总结
This study is designed to study the difference between operative treatment, either with tension band wiring or plate fixation, and conservative treatment of traumatic, displaced olecranon fractures in elderly population in a non-inferiority study setting.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Radiologically (standard AP and lateral radiographs) confirmed, displaced (≥2mm dislocation of the joint surface) fracture of the olecranon
- •Age of patient is 75 years or over at the time of the injury
排除标准
- •A delay more than 2 weeks after traumatic event to the day of intervention
- •Mayo type 3 fracture
- •Fracture continuation distal to coronoideus
- •Other acute fracture or nerve damage of the ipsilateral upper limb
- •Old fracture (<6 months) or pseudoarthrosis or unhealed nerve injury of the ipsilateral upper limb
- •Open fracture
- •Pathological fracture
- •History of alcoholism, drug abuse, psychological or other emotional problems likely to jeopardize informed consent
- •Patient's inability to understand written and spoken Finnish or Swedish or Danish
- •Patient's denial for participation or cognitive incapability to provide consent
- •Patient physically unfit for surgery
结局指标
主要结局
the Disabilities of Arm, Shoulder and Hand (DASH)
时间窗: 1 year
Minimum value 0, maximum value 100. Higher scores mean worse outcome.
次要结局
- Patient Rated Elbow Evaluation (PREE) Finnish, Swedish and Danish versions(3 and 12 months)
- Pain, visual analogue scale (VAS)(3 and 12 months)
- Adverse events(up to 12 months)
- the Disabilities of Arm, Shoulder and Hand (DASH)(3 months)
- Satisfaction, visual analogue scale (VAS)(3 and 12 months)
- Range of elbow motion.(3 and 12 months)
- Elbow X-rays(post-operatively, 2 weeks, 3 and 12 months)
- Comparison of extension strength between injured and healthy elbow.(12 months)
研究者
研究点 (5)
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