Effect of Osteosynthesis, Primary Hemi-arthroplasty, and Non-surgical Management for Displaced Four-part Fractures of the Proximal Humerus in Elderly: a Multi-centre, Randomised Clinical Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Constant Disability Scale
研究概览
简要总结
Displaced four-part fractures are among the most severe injuries of the proximal humerus. The optimal treatment is disputed and published data are inadequate for evidence-based decision making.
The investigators aim to: 1) compare the effect of angle-stable plate osteosynthesis and non-surgical management, 2) compare the effect of primary hemiarthroplasty with both osteosynthesis and non-surgical management, 3) study prognostic differences between 'valgus impacted' and 'classical' four-part fracture patterns.
The investigators will conduct a randomised, multi-centre, clinical trial including patients from ten national shoulder units within a two year period. Patients will be randomised to non-surgical treatment, hemiarthroplasty or angle-stable plate osteosynthesis. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy. Patients will be followed at least one year and will be assessed blindly according to a standardised evaluation protocol including Constant Disability Scale, Oxford Shoulder Score, and Short Form-36.
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
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Displaced four-part fracture of the proximal humerus
- •Mentally alert
- •Physically fit for surgery and rehabilitation (ASA-group 1-3)
- •Informed written consent
- •Operation can be conducted within 2 weeks of injury
排除标准
- •Fracture-dislocations
- •Head-splitting fractures
- •Previous shoulder surgery on injured side
- •Chronic shoulder pain
- •Abuse problems
- •Patients unable to understand instructions in Danish
结局指标
主要结局
Constant Disability Scale
时间窗: 3 years
次要结局
- Oxford Shoulder Score, Short Form-36(3 years)
