跳至主要内容
临床试验/CTRI/2022/10/046918
CTRI/2022/10/046918尚未招募不适用

"Clinical and radiological assessment of patients with intertrochanteric fracturemanaged with proximal femoral nail with helical blade- A Cohart study

Rohilkhand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2022年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
62
试验地点
1
主要终点
To study the clinical and radiological outcome of proximal femoral nail with helical blade in the management of patients with intertrochanteric fractures.

研究概览

简要总结

Intertrochanteric fracture is one of the most common fractures in Orthopaedics, particularly in the geriatric age group. Majority of the elderly population is osteoporotic, so they are generally more prone and can sustain the fracture even with a minor fall.

Trochanteric fractures unite readily, but if there is failure in maintaining the alignment these can malunite. Surgical treatment has been accepted as the standard protocol of management of intertrochanteric fractures throughout the world.

DHS (Dynamic Hip Screw) is the most commonly used extramedullary implant. It has stood the test of time and has continued to be the gold standard in the management of intertrochanteric fractures, especially stable fractures.

Introduction of intra-medullary concept and devices, Gamma nail in 1988 & later proximal femoral nail (PFN) in 1996 by AO/ASIF group, the intramedullary devices have gained attention and popularity globally.

PFN (Proximal Femoral Nail) is an intramedullary device, it was designed to overcome the implant related complications of DHS and to facilitate the surgical management of unstable intertrochanteric fractures. Advantages  are – better biomechanical strength, shorter duration of surgery, preservation of fracture biology, earlier weight bearing, smaller incision and less wound related complications.

With time implant underwent more changes and finally Proximal Femoral Nail with Helical Blade was introduced in 2003. The helical blade of PFN achieves better cancellous bone compaction in femoral neck (particularly in osteoporotics), thereby decreasing the risk of secondary displacement, and it has superior resistance to rotation and varus collapse as compared to conventional PFN. The new PFNA device ensures reliable fixation with low mechanical complications.

A study is however needed to confirm the superior biomechanical performance of PFN with helical blade (PFNA) by assessing the functional outcomes, clinical and radiological results in the patients with intertrochanteric fractures.

In our study we will assess functional outcome using radiological and clinical evaluation at our centre i.e. RMCH, Bareilly , U.P.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Patients with trochanteric fracture of femur .
  • •Patient with inter-trochanteric fracture with sub-trochanteric extensio.

排除标准

  • •Open fractures.
  • •Pure sub-trochanteric fracture femur.
  • •Patients who are medically not fit for anaesthesia or surgery.

结局指标

主要结局

To study the clinical and radiological outcome of proximal femoral nail with helical blade in the management of patients with intertrochanteric fractures.

时间窗: During post operative phase

次要结局

  • To evaluate clinical and radiological outcome at 6,12 and 24 weeks.
  • To evaluate clinical outcome using Modified Harris Hip Score after surgery.(During post operative phase)

研究者

发起方
Rohilkhand Medical College and Hospital
申办方类型
Private medical college

研究点 (1)

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