The Management of Intracapsular Fractures of the Proximal Femur. A Prospective, Randomized Trial of Two Parallel Screws and Hemiarthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Harris Hip Score at 4, 12 and 24 months
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, but there is no consensus about which procedure that gives best functional results.
详细描述
We plan to include patients with displaced intracapsular femoral neck fractures. The patients will be 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
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 at 4, 12 and 24 months
Barthel ADL Index at 4, 12 and 24 months
Eq-5d (Euroqol) at 4, 12 and 24 months
次要结局
- Mortality
- Re-operations
- Complications
- Morbidity