Comparative Study Between (MIPO)Submuscular Plate Fixation of Fracture Femur and Conservative Management With Thomas Splint in Children From 5 to 8 Years Old: A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Bony union
研究概览
简要总结
This randomized clinical study compares the outcomes of two treatment methods for femur fractures in children aged 5 to 8 years: Minimally Invasive Plate Osteosynthesis (MIPO) using submuscular plate fixation and conservative management using a Thomas splint. The study evaluates the efficacy, safety, and recovery outcomes of both techniques. Key parameters include healing time, functional outcomes, complication rates, and patient and caregiver satisfaction. The findings aim to provide evidence-based recommendations for the optimal management of femur fractures in young children, balancing the benefits and risks of surgical versus non-surgical approaches.
详细描述
Introduction:
Femur fractures are common pediatric injuries that require effective treatment to ensure proper healing and prevent long-term complications. While conservative management with a Thomas splint is a traditional method, Minimally Invasive Plate Osteosynthesis (MIPO) using submuscular plate fixation has gained popularity due to its potential for faster recovery and reduced complications. This study aims to compare the outcomes of these two treatment modalities in children aged 5 to 8 years.
Objectives:
To compare the healing time between MIPO submuscular plate fixation and conservative management with Thomas splint.
To assess the functional outcomes of both treatment methods. To evaluate the complication rates associated with each treatment. To measure patient and caregiver satisfaction with each treatment approach.
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
- None
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 5 to 8 years.
- •Patients with midshaft or distal shaft femur fracture.
- •Fracture pattern: transverse - oblique - spiral.
- •Children must be < 45 KG.
排除标准
- •Open fracture
- •Any associated fracture in the same limb or in contralateral limb
- •Associated serious internal organ injury or vascular injury
- •Proximal, distal physeal femur fracture.
- •Patient with pathological bone disease as osteogenesis imperfecta.
结局指标
主要结局
Bony union
时间窗: 6 weeks and 12 weeks
we do sequential xrays until we can see a bony union
次要结局
- Any associated complications(6 weeks and 12 weeks)
研究者
Ahmed Omar Sabry
Dr.
Kasr El Aini Hospital