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临床试验/NCT00686023
NCT00686023Unknown不适用

Comparing Surgical Techniques for CRIF of Pertrochanteric Fractures

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
death within 1 year of operation

研究概览

简要总结

Hypothesis: Inflatable intra medullary femoral nailing is superior to DHS in terms of blood loss, operative complications and postoperative rehabilitation in the management of pertrochanteric femur neck fractures.

详细描述

patients with pertrochanteric fractures of the femur will be randomly assigned to one of 2 groups.

group 1 will undergo internal fixation using a DHS device. group 2 will undergo internal fixation using an inflatable intramedullary femoral nail device post operative care will be the same including DVT prophylaxis, early mobilization.

weight baring will be aloud in cases of a stable fracture (EVANS 1-3) non weight bearing until callus bridge in patients with unstable fractures (EVANS 4-6)

outcomes: death within first year

postoperative complications length of hospitalization time to mobilization functional score reontgenic evaluation

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pertrochanteric femur fracture
  • Unilateral
  • Age over 60 years
  • Low energy trauma
  • ASA score 0-3

排除标准

  • Reverse oblique fractures
  • Pathological fractures
  • Severe osteoarthritis of the hip joint
  • Previous operations on same leg
  • ASA score 4-5

结局指标

主要结局

death within 1 year of operation

时间窗: 4 years

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (1)

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