跳至主要内容
临床试验/CTRI/2025/03/082370
CTRI/2025/03/082370尚未招募不适用

Surgical Efficiency and Outcomes of Femur Nailing in Lateral versus Supine Position - A Randomized Controlled Trial

AIIMS Patna1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
64
试验地点
1
主要终点
This study aims to assess a broader spectrum of outcomes, including surgical

研究概览

简要总结

Femoral shaft fractures are among the most common long bone fractures, often occurring most frequently in young males after high-energy trauma such as motor vehicle accidents and in elderly females after falls from standing. Incidences of such fractures have been found to be increased due to increasing population and use of motor vehicles. The majority of adult femur fractures are treated surgically with intramedullary nailing regarded as the gold standard treatment for management. Despite its widespread use, the success of femoral nailing procedures is influenced by several factors, including the patient’s positioning during surgery.

Two primary positions are commonly employed during femoral nailing: the lateral decubitus position and the supine position. Each position has its advantages and disadvantages. The supine position is favoured for familiarity among surgical teams. Conversely, the lateral position is preferred by some surgeons for its potential benefits in specific fracture patterns, such as proximal or distal femur fractures, due to improved mechanical alignment and access. In the lateral decubitus position, finding the trochanteric entry site, ensuring reduction, and placing the apical and distal locking screws can be done more easily and quickly. Lateral positioning is preferred in sub-trochanteric femur fracture and in obese patients for the ease of reduction and making entry. Since it can be done on simple OT table, hence cost effective and can be done at any centre where they lack fracture table.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • Patients diagnosed with femur fractures requiring nailing.
  • Age [18-60 years].
  • Fit for general/spinal anaesthesia.

排除标准

  • Open fractures.
  • Patients with comorbidities/conditions impacting surgery.
  • Previous femur surgeries.
  • Intertrochanteric femur fracture
  • Polytrauma.

结局指标

主要结局

This study aims to assess a broader spectrum of outcomes, including surgical

时间窗: Baseline | At 4 Weeks, 8 Weeks, 12 Weeks

efficiency ( setup time, operative time), intraoperative imaging quality, surgeon ergonomics.

时间窗: Baseline | At 4 Weeks, 8 Weeks, 12 Weeks

次要结局

  • patient-centric outcomes ( functional recovery, complication rates).(Baseline)

研究者

发起方
AIIMS Patna
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Saket Prakash

AIIMS Patna

研究点 (1)

Loading locations...

相似试验