Postoperative Oedema Management of Foot and Ankle Patients with Neuromuscular Electro-stimulation of the Peroneal Nerve Using Geko™
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 5
- 主要终点
- Assessment of post-operative oedema formation using the figure-of-eight tape measurement
研究概览
简要总结
The multicentre randomised geko™ Foot and Ankle Trial will prospectively and systematically collect clinical data on patients randomised, on a 1:1 basis, to either standard care or standard care plus geko™ therapy to assess oedema management and patient outcomes during a follow-up period of up to three months post-surgery.
详细描述
The geko™ device has a wide range of clinical applications including the post-operative management of oedema.
Although many short-term acute studies have been completed using the device, little clinical data has been collected on the effect of geko™ use in current standard care pathways for oedema management on patient outcomes during long term follow-up after surgery.
This study is an open label, multi-centre prospective randomised study. The study patient population will be randomised on a 1:1 basis into two groups of 61 patients each. These groups are defined as Group A patients who receive geko™ therapy and SC i.e. the intervention group and Group B patients who receive Standard Care (SC) only i.e. no intervention. The participants will be assessed pre-surgery and up to 90 days post-surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years
- •Intact healthy skin at the site of geko™ device application.
- •Patients that have been listed for forefoot and / or hindfoot surgery
- •Patient understands and is willing to participate in the study and can comply with study procedures
- •Patient is willing and able to give written informed consent
排除标准
- •Use of any other neuro-modulation device.
- •Trauma to the lower limbs that would prevent geko™ from stimulating the common peroneal nerve.
- •No response to geko™ therapy i.e. no involuntary rhythmic upward and outward movement of the foot (dorsiflexion) at the maximum tolerable device setting
- •Participation in any other clinical study that may interfere with the outcome of either study
研究组 & 干预措施
Standard of care + geko™ Therapy
In addition to their standard of care, for patients randomised to the intervention arm, geko™ therapy will be applied immediately post-surgery on the operated leg and administered for 24 hours / day whilst the patient remains in hospital, after which geko™ therapy will then be applied for 12hrs / day until the patient returns for their first post-operative follow-up visit (Day 14 ± 2 days post-surgery)
干预措施: geko™ therapy (Device)
Standard of care
Patients will receive their standard of care as per hospital practice.
结局指标
主要结局
Assessment of post-operative oedema formation using the figure-of-eight tape measurement
时间窗: From pre-surgery assessment until up to 90 days post-surgery
To assess the effect of geko™ therapy on oedema formation following foot and / or ankle surgery. This will be done using the figure of eight tape measurement method
Assessment of post-operative oedema formation using bioimpedance analysis (US sites only)
时间窗: From pre-surgery assessment until up to 90 days post-surgery
To assess the effect of geko™ therapy on oedema formation following foot and / or ankle surgery using a bioimpedance device to measure resistance to electrical current in both legs and calculating the percentage difference between the operated leg and the contralateral limb.
Assessment of post-operative oedema formation using the pitting oedema scale
时间窗: From pre-surgery assessment until up to 90 days post-surgery
To assess the effect of geko™ therapy on oedema formation following foot and / or ankle surgery using the pitting oedema scale, where following a 2 second firm thumb press, 0 (min) indicates no oedema and 4 (max) is a very deep pit.
次要结局
- Incidence of surgical wound healing(From surgery until up to 90 days post-surgery)
- Change in analgesia frequency(From pre-surgery assessment until up to 90 days post-surgery)
- Incidence of Adverse Events in each group(From pre-surgery assessment until up to 90 days post-surgery)
- Incidence of device deficiencies(from start of geko treatment (immediately post-surgery) until up to 90 days post-surgery)
- Change in pain level using a visual analogue scale (VAS) score(From pre-surgery assessment until up to 90 days post-surgery)
- Change in analgesia dosage(From pre-surgery assessment until up to 90 days post-surgery)
- Change in patient reported outcomes via Manchester-Oxford Foot & Ankle Questionnaire (MOxFQ)(From pre-surgery assessment until up to 90 days post-surgery)