NCT02841007已完成不适用
gekoTM Neuromuscular Electrostimulation (NMES) Device, Pilot Feasibility Study Looking at Time to Surgery Study in Patients Requiring Ankle Fixation Following Fracture, Comparison to Matched Retrospective Controls
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Time to readiness for surgery
研究概览
简要总结
The geko™ device is indicated for the prevention and treatment of oedema. The aim of this study is to show that recruiting, and performing study assessments in ankle fracture patients requiring surgery to fix their ankle attending the James Cook Hospital is feasible, and to obtain data to support the powering of a larger study to demonstrate the effectiveness of the geko™ device at reducing length of stay for this population of patients. This study will also allow us to assess the acceptability, tolerability and compliance of treatment with the geko device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Aged 18-60 years old
- •Clinically and radiologically diagnosed acute ankle fracture that, in the opinion of the treating surgeon, requires operative fixation
- •Able to understand the Patient Information Sheet (PIS) and willing to sign the written Informed Consent Form.
- •Able and willing to follow the protocol requirements.
排除标准
- •Has a pacemaker
- •Morbid Obesity (BMI Index >40kg/m2).
- •Patients who on presentation to hospital are known to be pregnant.
- •Clinically significant co-morbidities that need to be treated prior to surgical intervention and could therefore impact upon time to theatre
- •History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
- •Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted
- •Already taking part in a clinical study, or has so within the last 8 weeks
- •None responder to geko™ device
结局指标
主要结局
Time to readiness for surgery
时间窗: 0-~7days
Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months
时间窗: 4 months
次要结局
- Oedema reduction in prospective geko™ subjects prior to surgery, by two circumferential measures using tape measures built into the patients plaster cast(0-~7days)
- Adverse events, including the need for secondary surgery or additional treatment, serious adverse events(study duration up to ~14days)
研究者
研究点 (2)
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