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临床试验/NCT04306198
NCT04306198Unknown不适用

Helical Blade vs Lag Screw Fixation for Cephalomedullary Nailing of Low Energy Intertrochanteric Hip Fractures: Are There Differences in the Failure Rate? A Prospective, Randomized Study

Instituto Traumatologico Dr. Teodoro Gebauer Weisser0 个研究点目标入组 200 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
Implant Failure

研究概览

简要总结

The purpose of this study will be to compare the failure and complications rates of and orthopedic implant (Cephalomedullary Nail) fixed with two different options actually available: lag screw or helical blade.

The study population will be patient who have been diagnosed with an intertrochanteric hip fracture.

Hypothesis: Our hypothesis is that the helical blade will have a higher failure rate compared to the lag screw

详细描述

Hip fractures in the elderly are recognized worldwide as a major public health problem, its incidence is increasing and it is expected to have 6,26 million cases per year worldwide by 2050.

Surgical treatment is recognized as the best option in these patients because it allows early rehabilitation and decreases mortality and complications.

Currently, the fixation with a cephalomedullary nail is the most commonly used treatment, since it has some mechanical advantages compared to other fixation methods and achieves adequate stability allowing early weight bearing and rehabilitation with low failure rates.

Changes in the design of these implants have tried to reduce the failure rate. The main change has been the introduction of the helical blade for cephalic fixation, instead of a lag screw. The concept behind this modification is that the blade would have greater fixation to the bone and less risk of cut out, because it is supposed to compact the bone around the helical blade instead of removing it.

In spite of some biomechanical studies in cadaveric or artificial models validating this biomechanical advantage, clinical series have shown controversial results. Recently, retrospective clinical studies have shown similar results with the use of the helical blade, and even some studies have shown a higher failure rate compared to the sliding screw.

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

入选标准

  • Low Energy Mechanism
  • Hip fracture classified as 31.A1.2 - 31 A1.3 and 31.A2 in the AO classification (year 2018)

排除标准

  • Medical contraindication to surgery
  • A fracture due to malignancy
  • Peri implant fractures
  • Inability to walk before the fracture
  • An inability to comply with rehabilitation
  • Non-ambulatory pre-fracture

结局指标

主要结局

Implant Failure

时间窗: 6 months

Rate of cut out , cut through, varus collapse

次要结局

  • Complications(3 weeks, 3 months , 6 months)
  • Parker Mobility score(3 months , 6 months)

研究者

发起方
Instituto Traumatologico Dr. Teodoro Gebauer Weisser
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomas Amenabar MD

Tomas Amenabar Vial , Head of hip and pelvis department.

Instituto Traumatologico Dr. Teodoro Gebauer Weisser

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