Prospective Randomised Controlled Trial of Unipolar vs Bipolar Hemiarthroplasty for Patients With an Intracapsular Hip Fracture
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- NHS Lothian
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
The purpose of this study is to determine whether significant functional benefits are seen in patients who have a bipolar hemiarthroplasty as treatment for hip fracture compared to those who have a unipolar hemiarthroplasty.
详细描述
Proposed study design
Randomized controlled trial of unipolar vs bipolar hip hemiarthroplasty for intracapsular fracture of the femoral neck
The trial will be conducted in accordance with the GCP (Good Clinical Practice) guidelines and will be reported in line with the CONSORT statement
Study Centre
The Royal Infirmary of Edinburgh admits 1000 patients a year with a hip fracture; the largest number in any one centre in Scotland. Of these, 500 have intracapsular fractures, which is the type addressed in this study. Some patients will be better suited to a total hip replacement (5-10% of this group), and others may refuse to consent to the trial (previous experience has suggested a rate of 15-20%). Investigators therefore expect just over 300 patients to be recruitable each year, and so plan to allow up to two years for recruitment, and two years to complete follow up of the last patient
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted with an intracapsular fracture of the femoral neck who are suitable for a hemiarthroplasty.
排除标准
- •Patients deemed suitable for a total hip arthroplasty, patients with a high energy fracture.
结局指标
主要结局
Pain
时间窗: 1 year
visual analogue scale pain score ( on a 10cm baseline fro 'no pain' to 'worst pain imaginable'
次要结局
- Complications(up to 2 years)
- Function and self care(2 years)
- Function and general health(2 years)
- Pain(2 years)
- Radiographic assessment(1 year)
- complications(up to 2 years)
- complication(up to 2 years)
- Complication(up to 2 years)
- Function(2 years)