Comparing Locking compression plating and Retrograde intramedullary nailing in the treatment of extraarticular fractures of the distal femur: A Randomised controlled study
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Surgical outcome- Surgical duration and blood loss
研究概览
简要总结
The two surgical techniques which are commonly used are extra medullary fixation with an anatomical locking compression plate (LCP) or intramedullary fixation with retrograde nail
LCP offers anatomical fixation and has been used since long for fixation of these fractures. But open reduction hampers the natural process of fracture healing and is associated with higher rates of infection and non union
Retrograde IMIL nail has a mechanical advantage of an intramedullary device that is close to the axis of the femur and has biological advantage of minimal disruption of blood supply
Several studies have compared the outcomes between the two surgical techniques and showed that IMIL nailing is better than LCP in terms of infection rates and also IMIL nailing causes stimulation of blood supply aided by reaming. The need for the study is to evaluate the differences in clinical, surgical and radiological outcomes between the 2 surgical techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Extra articular distal femur fractures ( AO type A1,A2,A3) -Gustilo Anderson classification grade I and grade II.
排除标准
- •Gustilo Anderson classification grade III.
- •Distal femur fracture AO type B and C.
- •Associated vascular injury.
- •Periprosthetic fracture.
- •Pathological fracture.
结局指标
主要结局
Surgical outcome- Surgical duration and blood loss
时间窗: 3 months
Functional outcome - VAS, SANDERS scale, LYSHOLM knee score.
时间窗: 3 months
次要结局
- Functional outcome - VAS, SANDERS scale, LYSHOLM KNEE score
研究者
Dr Rohit Raj R
SRM medical college hospital and research centre