A Double Blind Randomised Controlled Trial of Pulsed Electromagnetic Field (PEMF) Stimulation in Acute Tibial Shaft Fractures
试验速览
- 阶段
- 2 期
- 入组人数
- 340
- 试验地点
- 9
- 主要终点
- Surgical revision rate in the 12 months after fracture
研究概览
简要总结
Fractures of the tibial shaft (diaphysis) are some of the most common long bone fractures. They most frequently occur in males less than 40 years of age. Despite advancements in the surgical management of these fractures, the precarious blood supply and lack of soft-tissue cover of the shaft of the tibia make these fractures vulnerable to non-union and infection. These complications often require multiple procedures, extended time off of work, and can result in ongoing poor mobility. This is reflected in the surgical revision rate that the scientific literature has recorded as being between 20 and 30%.
Pulsed electromagnetic field (PEMF) stimulation has been shown to be a safe and effective treatment for non-unions of the tibia. These are fractures in which the bone has failed to unite and the healing process has ceased. The PEMF is delivered via a device such as the EBI Bone Healing System®, which straps onto the limb overlying the fracture. It is lightweight and portable using a rechargeable battery for power. It is compatible with internal and external fixation and may also be worn over a plaster or fibreglass cast. It is usually kept in place for ten hours per day and used for a period of three months or until the fracture unites. In animal models, PEMF stimulation has been demonstrated to improve the time to fracture healing in acute fractures. There have been no demonstrated side effects of the therapy.
The study hypothesis is that PEMF stimulation during the first twelve weeks after fracture, in addition to normal surgical care, will increase the union rate for these fractures and thereby significantly reduce the surgical revision rate within the first twelve months following fracture.
详细描述
Study Objectives:
This is a randomized controlled study whose objective is to determine whether PEMF stimulation as an adjunct therapy has a clinically significant effect on the morbidity associated with tibial shaft fractures.
It is a two-armed study. The active treatment arm involves participants with acute tibial shaft fractures who have been randomized to receive a PEMF stimulation device to be worn over the fracture site for 10 hours per day during the first twelve weeks after injury. The control arm involves participants with acute tibial shaft fractures who have been randomized to receive a placebo device to be worn over the fracture site for 10 hours per day during the first twelve weeks after injury.
Primary Aim:
- To determine whether the use of a PEMF stimulation device as adjunct therapy for acute tibial shaft fractures reduces the surgical revision rate in the 12 months after injury.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Acute diaphyseal fracture of the tibia (AO classification 42)
排除标准
- •Pathological fracture secondary to tumours.
- •Pregnant patients.
- •Patients with permanent pacemakers or defibrillators.
- •If the device is unable to be applied by 14 days post fracture.
- •Patients who lack the cognitive ability to consent.
结局指标
主要结局
Surgical revision rate in the 12 months after fracture
次要结局
- Fracture union rate at 12, 26 and 52 weeks after fracture
- General health score and lower extremity functional score at 12, 26 and 52 weeks after fracture