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临床试验/NCT03911180
NCT03911180Unknown不适用

Pertrochanteric Fracture Fixation In Elderly Adults Using Proximal Femoral Nail Anti-rotation (HERACLES) With a T-shaped Parallel Blade: A New Design

Ilocos Training and Regional Medical Center0 个研究点目标入组 40 人开始时间: 2019年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
主要终点
Time to Clinical Union

研究概览

简要总结

This is a prospective case series of elderly adult patients sustaining pertrochanteric fractures who will be treated by a proximal femoral nail with a non-helical (straight) blade. This study seeks to observe and evaluate the outcomes, advantages and complication rates in using the HERACLES PFN with a non-helical (T-shaped parallel) blade.

详细描述

The trochanteric area is defined by AO as the area bordered by the tip of the greater trochanter, extracapsular portion of the femoral neck extending to a line parallel to the inferior most border of the lesser trochanter.

Pertrochanteric fracture is a fracture is of the trochanteric area which is usually reducible. Unstable pertrochanteric fracture is defined as AO-31A2 or AO-31A3. Instability arises from the degree of comminution, the presence, and comminution of the posteromedial fragment and lastly, lateral wall involvement The ideal implant for fixation of this kind of fractures is still under debate, but intramedullary implants are preferred than extramedullary implants in these unstable fractures. On the other hand, unique fracture configurations predispose to instability such as reverse obliquity fractures and fractures extending to the subtrochanteric area.

Proximal femoral locking plate as used in unstable pertrochanteric fracture has a high complication rate. In one study in 2014, there is up to 41.4% failure rate due to the proud plate, screw malposition, too rigid construct when used as a bridge plate.

Intramedullary implants specifically cephalomedullary nails has been the mainstay of treatment in unstable pertrochanteric fractures primarily because of the short moment arm and load-sharing properties. It employs relative stability and can be applied in a minimally invasive manner.

In 1997, the AO/ASIF group developed the proximal femoral nail. The proximal femoral nail has two proximal screws that traverse the neck to the femoral head. The inferior screw is the load-bearing screw, and the superior screw is the anti-rotation screw. Good to excellent results were observed using this implant compared to previous implant designs, but complications still exist.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who sustained stable pertrochanteric fracture (AO31A.1)
  • Patients who sustained unstable pertrochanteric fracture (AO31A.2 or AO31A.)

排除标准

  • Patients who are bedridden
  • Patients with a neurologic/psychiatric disorder (previous or present)
  • Patients with severe dementia/Alzheimer's disease
  • Patient with a history of hip dislocation (whether reduced or unreduced)
  • Patient who underwent previous operation on the hip
  • Patient with amputation of one or both legs
  • Patient with segmental fractures involving the ipsilateral femoral shaft/metaphysis
  • Patient with pathologic fractures, e.g. secondary to metastatic bone disease/ metabolic bone disease
  • Patient presenting with an infection
  • Patient who sustained multiple injuries from other body systems

研究组 & 干预措施

PFN straight parallel blade

Experimental

All patients with pertrochanteric fracture that is eligible will undergo PFNA with straight parallel blade.

干预措施: Proximal femoral nail with straight parallel blade (Device)

结局指标

主要结局

Time to Clinical Union

时间窗: 2 months to 4 months

Weeks until Union Clinical Union - fracture site becomes stable and pain-free

Time to full weightbearing

时间窗: 4-6 months

weeks until full weight bearing without pain

次要结局

  • Quality and Maintenance of Reduction(up to 2 years)
  • Tip-Apex Distance(up to 2 years)
  • Blood Loss(Taken immediately postop)
  • Fluoroscopy time(Intraoperative measurement)
  • Mobility scale(up to 2 years)
  • Social dependence scale(up to 2 years)
  • Pain scale(Postop up to 2 years)
  • Radiographic Union Score for the Hip(up to 2 years)
  • Radiation load(Intraoperative measurement)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Lou Mervyn Tec

Orthopedic Resident Year Level IV

Ilocos Training and Regional Medical Center

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