Pinloc Versus Hansson Pins in the Treatment of Femoral Neck Fractures: A Prospective Randomized Study of 500 Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 537
- 试验地点
- 11
- 主要终点
- Failure of fracture treatment
研究概览
简要总结
A prospective randomized study comparing a new implant with three interlocked pins for internal fixation of femoral neck fractures (Hansson Pinloc System, Swemac Linköping, Sweden) versus 2 parallel pins with hooks (Hansson Pins, Swemac Linköping, Sweden).
详细描述
Patients, who are to be treated with internal fixation due to a femoral neck fracture, will be randomized by the surgeon to Pinloc or Hansson Pins using an on-line randomization system.
The patients will be followed up at open visits at 3 months and 1 year. At two years the patients will be contacted by phone and medical records studied in order to detect any fracture complications.
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
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Femoral neck fractures where the preferred treatment is internal fixation.
排除标准
- •Unwilling to participate.
研究组 & 干预措施
Pinloc
Plate and 3 interlocked pins. A new device for fixation of femoral neck fractures.
干预措施: Pinloc (Device)
LIH (Hansson pins)
2 pins. An established method for fixation of femoral neck fractures.
干预措施: Hansson Pins (LIH) (Device)
结局指标
主要结局
Failure of fracture treatment
时间窗: Within 2 years postoperatively
Failure is defined as non-union or avascular necrosis.
次要结局
- Quality of life (EQ-5D)(At 3 months and 1 year postoperatively)
- Pain (Visual analogue scale)(At 3 months and 1 year postoperatively)
- WOMAC (An established hip score)(At 3 months and 1 year postoperatively)
- Timed-up and go test(At 3 months and 1 year postoperatively)
研究者
Torsten Johansson
MD (Orthopedic surgeon), Associate professor
University Hospital, Linkoeping