Proximal Femoral Nailing in Unstable Intertrochanteric Fractures: Lateral Decubitus Position Versus Supine Position on Traction Table.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Quality of radiographic reduction
研究概览
简要总结
This study is designed to compare two positions in the management of unstable intertrochanteric femur fractures. It's to compare the traditional supine position using a traction table and lateral decubitus. This study is designed to Compare between The accuracy of reduction In both methods, in addition,the radiological exposure and other secondary outcomes, like the blood loss, are compared.
详细描述
To compare the fluoroscopic exposure time, quality of radiographic reduction, intra operative blood loss, setup time and surgical time between the lateral decubitus position and the use of a traction table in supine position in fixation of unstable intertrochanteric femur fractures by proximal femoral nail.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Skeletally mature patients
- •Unstable intertrochanteric fracture ( AO/OTA type 31A2 & 31A3 )
排除标准
- •Patients unfit for surgery
- •Revision cases
- •Patients with multiple or pathological, neglected or open fractures.
研究组 & 干预措施
Lateral postion during proximal femoral nailing for unstable intertrochnateric femur fractures
Proximal femoral nailing in lateral decubitus position
干预措施: lateral decubitus postion during proximal femoral nailing for unstable intertrochnateric femur fractures (Procedure)
Supine postion using traction table in proximal femoral nailing intertrochanteric femur fractures
Proximal femoral nailing in supine position using traction table
干预措施: Proximal femoral nailing for unstable intertrochnateric femur fractures in supine psoition using traction table (Procedure)
结局指标
主要结局
Quality of radiographic reduction
时间窗: immediate postoperative
Optimum Tip-to-apex distance (TAD) is 25mm or less. * Normal femoral neck shaft angle between 125 and 145 degree. * The Baumgartner reduction quality criteria : - 1. Criterion one (alignment) : 1. Anterior posterior view : normal or slight valgus neck shaft angle 2. lateral view : less than 20 degree of angulation (Slight valgus means a valgus of no more 10 degrees) 2. Criterion two (displacement) : 1. Anterior posterior view: less than 4 mm of displacement of any fragment. 2. Lateral view: less than 4 mm of displacement of any fragment. 3. The reduction will be categorized as good if both criteria were met, acceptable if only one criterion was met, and poor if Neither criterion was met.
Fluoroscopic exposure time
时间窗: intraoperative
The fluoroscopic exposure time is defined as: The total duration of fluoroscopy use in minutes during the set up and the surgical procedure.
次要结局
- Setup time(Intraoperative)
- Surgical time(Intraoperative)