Electromagnetic Stimulation as Coadjuvant in the Healing of Diaphyseal Femoral Fractures: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Fracture healing
研究概览
简要总结
This study specifically evaluates the effects of electromagnetic stimulation for diaphyseal femur fractures using a device developed by the investigators.
The hypothesis is that patients with femoral diaphysis treated with the electromagnetic stimulation have less non-union after six months than patients treated with a placebo device.
详细描述
The inclusion criteria were: patients of any sex, age between 18 and 60 years, with a closed fracture in their femoral diaphysis or an open fracture secondary to a low-speed bullet; treated with open or closed reduction and intramedullary reamed blocked nail.
Patients were excluded if they had a pathological fracture, an open fracture from another etiology, or if they were treated after 10 days from the day of fracture.
64 patients were included.
Randomization took place six weeks after fracture day, allocating participants to either one of two groups: group A (electromagnetic stimulation) or group B (placebo).
Each group had a device exactly the same. Patients used the device during one hour every day for eight weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sham electromagnetic device
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of any sex,
- •age between 18 and 60 years, with a closed fracture in their femoral diaphysis or an open fracture secondary to a low-speed bullet;
- •treated with open or closed reduction and intramedullary reamed blocked nail.
排除标准
- •Patients were excluded if they had a pathological fracture,
- •an open fracture from another etiology, or if they were treated after 10 days from the day of fracture.
结局指标
主要结局
Fracture healing
时间窗: up to 18 weerks
Percentage (%) of patients with their fracture healed six months after the fracture day and 18 weeks after treatment began.
次要结局
- Infection(6 months)
研究者
Juan Pablo Martinez
Medical doctor
Fundacion Clinica Valle del Lili