Pulsed Electromagnetic Fields in the Treatment of Fresh Distal Radius Fractures. A Prospective, Double Blind, Placebo Controlled, Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Change from baseline in radiographic fracture healing
研究概览
简要总结
Distal radial fractures (DRF) are the most common fractures encountered in health care. Annualized estimates in the United States alone suggest an incidence of approximately 640,000 cases, and rising, per year. Most fractures may be treated in a plaster cast, but unstable fractures tend to displace without a surgical procedure. 1
Pulsed electromagnetic field (PEMF) is one modality commonly used to stimulate bone generation throughout various clinical settings including orthoapedic surgery. PEMF has been shown to primarily effect vascular generation, formation and neovascularization2,3. This may help decrease time to healing and allow patients to return to normal activities sooner.
Additional study demonstrated that PEMF exposure increased cell proliferation, adhesion and the osteogenic commitment of MSCs, even in inflammatory conditions. In this in-vitro model PEMFs increased the expression of anti-inflammatory cytokines, such as IL-10, and reduced the expression of the pro-inflammatory cytokine IL-1 4.
The distal radius fracture was chosen as the model to test the effects of PEMF treatment because it includes both trabecular and cortical bone, is accessible for radiographs, has little soft tissue that can distort the radiograph, and is amenable to multiple functional endpoints.
The purpose of the study is to determine whether the use of FHP by means of pulsed electromagnetic fields in acute distal radius fractures will accelerate healing both clinically and radiotralogically
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)
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
- •Subjects with closed unilateral dorsally angulated fracture of the distal radius (Colles') visible by x-ray.
- •Subjects treated conservatively by immobilization ± closed reduction
- •Age >18 years
- •Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
排除标准
- •Subjects with intra articular fracture or extra-articular fracture that meets the criteria for operative fracture fixation.
- •Subjects with pins or plates in the wrist
- •Sustained previous fractures or bone surgery in the currently fractured distal forearm
- •Synovial pseudarthrosis
- •Subjects with multiple trauma (several fractures at once)
- •Subjects suffering from joint diseases that affect the function of the wrist and/or hand of the injured arm.
- •Women who are breast-feeding.
- •Women of childbearing potential and not using a medically accepted form of contraception when sexually active.
- •presence of a life supporting implanted electronical device
结局指标
主要结局
Change from baseline in radiographic fracture healing
时间窗: Radiographic images (X-ray) will be performed for each subject from day 0 and onward: week 2,4, 6 and 12.
Change from baseline in radiographic fracture healing will be measured. Radiographic healing will be defined as the interval in days between the occurrence of the fracture and the time when bridging in three of four cortices is seen on X-ray images. A measurement will be made at each follow up evaluation by using Radius Union Scoring System (RUSS) score
次要结局
- Change from baseline in improvement of function(Functional assessment will be performed at 4, 6 and 12 weeks from treatment)
研究者
michal roll
Head of Research and Developement Department
Tel-Aviv Sourasky Medical Center