Comparison of Clinical Outcomes of Fixation with Proximal Femoral Nail (PFN) vs Proximal Femoral Nail-Antirotation 2(PFN A2) In Unstable Intertrochanteric Fractures of the Femur: A Randomised Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Intraoperative C arm shoots
研究概览
简要总结
Objective: This open-label randomized comparative study aimed to assess the efficacy and outcomes of two different intramedullary implants, Proximal Femoral Nail (PFN) and PFN-A2, in the surgical management of acute, unstable intertrochanteric femur fractures.
Study Design and Setting: Conducted at All India Institute of Medical Scinces, Nagpur, the study includes patients presenting with hip pain due to trauma, such as Road Traffic Accidents or falls, in the Orthopaedics OPD or Emergency Department. Eligible patients will undergo randomization to receive either PFN or PFN-A2 implants.
Methods: Patients aged 50-80 years with acute, unilateral, closed intertrochanteric femur fractures (AO31A2, AO31A3) and independently ambulatory before the injury will be included. Surgical procedures will be performed under various forms of anesthesia, and outcomes will be evaluated through clinical, radiological assessments, and functional scores (Parker Palmer Mobility Score, Harris Hip Score) at 6-month follow-up.
Findings: Demographic data, surgical parameters (perioperative time, C-arm exposures), and postoperative outcomes (reduction quality, complication rates) will be analyzed.
Significance: This study provides valuable insights into choosing the appropriate implant for treating unstable intertrochanteric femur fractures, aiding orthopedic surgeons in decision-making and optimizing patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with acute, unilateral, closed Intertrochanteric fractures of the femur, belonging to the unstable type (AO31A2, AO31A3).
- •Patients with mature skeleton
- •Patients aged between 50-80 years.
- •Patients who were independently ambulatory before the injury event
- •Willingness to participate in the study and forgo any other concomitant treatment modality with written informed consent.
排除标准
- •Immature skeleton
- •Pathological fractures
- •Open fractures
- •Inability to mobilize independently prior to injury event
- •Preexisting neuromuscular disorder
- •Patients unfit for undergoing surgery
- •Intracapsular fractures of the femur
- •Subtrochanteric fractures of the femur
- •Concomitant injuries, e.g., Head injury, other fractures etc.
- •Stable type of IT fractures of the femur 11.
结局指标
主要结局
Intraoperative C arm shoots
时间窗: 2 weeks, 6 weeks, 3 months and 6 months post-surgery
Perioperative time
时间窗: 2 weeks, 6 weeks, 3 months and 6 months post-surgery
Blood loss
时间窗: 2 weeks, 6 weeks, 3 months and 6 months post-surgery
Reduction quality
时间窗: 2 weeks, 6 weeks, 3 months and 6 months post-surgery
Placement of screw/ blade
时间窗: 2 weeks, 6 weeks, 3 months and 6 months post-surgery
Post op functional status using Parker Palmer Mobility Score and Harris Hip Score
时间窗: 2 weeks, 6 weeks, 3 months and 6 months post-surgery
次要结局
- Complications associated with either implant(2 weeks, 6 weeks, 3 months and 6 months post-surgery)
研究者
Deepanjan Das
All India Institute of Medical Sciences, Nagpur