Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 主要终点
- Harris Hip Score
研究概览
简要总结
An estimated 1.6 million patients sustain a hip fracture every year, about half of these are intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for any patient, and the risk of disability, increased dependence and death is substantial. The main treatment options for displaced femoral neck fractures are internal fixation and arthroplasty. It is established that there are more complications and reoperations after internal fixation, and better short term clinical results with arthroplasty, but knowledge about long term results is lacking.
详细描述
Patients were included from 2002-2004. Two years follow up was finished by 2006. Patients with displaced intracapsular femoral neck fractures were included and randomized by means of closed numbered envelopes to operation groups:
- Two parallel screws (Olmed).
- Hemiarthroplasty with Charnley/ Hastings prosthesis.
A priori one would expect that there would be less morbidity and mortality with the less extensive and quicker operation with parallel screw and that a faster and better rehabilitation would be achieved with hemiarthroplasty.
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 femoral neck fracture
- •Age 60 or above
- •Able to walk (any aids allowed)
排除标准
- •Anesthesiologically unfit for arthroplasty surgery
- •Previous symptomatic hip pathology (i.e. arthritis)
- •Pathological fracture
- •Delay of more than 96 hours from injury to treatment
- •Not living in hospital area
结局指标
主要结局
Harris Hip Score
时间窗: 5-6 years
次要结局
- Eq-5d(5-6 years)
- Reoperations and complications(5-6 years)
- Barthel Index(5-6 years)