Postoperative Oedema Management Following Neuromuscular Electro- Stimulation of the Peroneal Nerve Using the gekoTM Device After Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The primary objective of the study is to assess the post-operative effect of gekoTM on formation of oedema following Total Knee Arthroplasty (TKA)
研究概览
简要总结
This study will investigate whether the recovery of muscle function of total knee arthroplasty is accelerated with the use of the gekoTM device along with its effect on reducing symptoms such as oedema and inhibition of the muscle function.
详细描述
This study will investigate total knee arthroplasty patients:
- One group gets standard of care (i.e. performing exercises & guidance by a physiotherapist via a CE-marked mobile application, called moveUP)
- Second group gets standard of care + GekoTM device (i.e. non-invasive neuromuscular electrostimulation applied at the peroneal nerve for 10 days after the operation date.)
The primary objective of the study is to assess the post-operative effect of gekoTM on formation of oedema (measured by perometer).
The effect of the gekoTM device on the muscle function & the overall recovery will be also investigated.
To collect parameters, the patient will be asked to complete questionnaires, including the following patient reported outcomes (PROMs): Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS), Euroqol Health questionnaire EQ5D, Forgotten Joint Score (FJS), Oxford Knee Score (OKS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary TKA planned for degenerative OA
- •Subjects must be discharged to home environment and be able to independently perform the activities of daily life
- •Obtain a written informed consent
排除标准
- •TED stockings, Dauerbinde, other compressive bandages
- •Mechanical foot pump
- •Cooling device type 'Game Ready'
- •Posttraumatic OA of the knee
- •History of DVT / Flebitis / Pulmonary embolism
- •Surgical treatment of venous insufficiency <1y prior to TKA surgery
- •Neurological deficit of lower limbs
- •Current sciatic irradiating pain in lower limbs
- •History of lumbar fusion
- •Knee Arthroscopy of the involved limb <6m prior to TKA surgery
- •Any per-operative complication related to the TKA procedure (bleeding, fracture, vascular injury, cardiac complication, pulmonary complication)
- •In case of a release during the TKA procedure
- •Any per-operative (e.g. epidural catheter, urethral catheter, intra articular catheter) or post-operative procedure that might interfere with the rehabilitation during and after hospitalization
- •Any scheduled surgery in the 3 months following the reference surgery;
- •Any significant medical condition (e.g. Parkinson's disease, multiple sclerosis, cerebral vascular accident) that might interfere with the rehabilitation
- •Any significant psychiatric disorders, active alcohol/drug abuse
- •Subject is either pregnant or interested in becoming pregnant during the duration of the study
- •Subjects who are currently involved in any investigational drug or device study or have been enrolled in such study within the last 3 months
结局指标
主要结局
The primary objective of the study is to assess the post-operative effect of gekoTM on formation of oedema following Total Knee Arthroplasty (TKA)
时间窗: until end of rehabilitation (+- 3 months after TKA operation)
This is measured by the use of a perometer. For each patient, change in limb volume shall be calculated as a percentage of original limb volume. Shapiro-Wilk test shall be used to test whether there is a significant (p\<0.05) departure from normal distribution in either group.
次要结局
- Incidence of Device Deficiency(during 10 days after TKA operation)
- Sleep quality(2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation))
- Number of days of crutches use(until end of rehabilitation (+- 3 months after TKA operation))
- Oedema measurements - photographic evaluation(until end of rehabilitation (+- 3 months after TKA operation))
- Pain level(2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation))
- Number of days of NSAID intake(2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation))
- Recovery of physical activity (PA)(2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation))
- Incidence of Adverse Events(until end of rehabilitation (+- 3 months after TKA operation))
- Oedema measurements - subjective slider(until end of rehabilitation (+- 3 months after TKA operation))
- Dosage Painkiller intake(2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation))
- Dosage NSAID intake(2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation))
- Resume driving a car(until end of rehabilitation (+- 3 months after TKA operation))
- Number of days of Painkiller intake(2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation))
- Sleep duration(2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation))
- Satisfaction and feedback on the geko device (only for patients using the geko)(during 10 days after TKA operation)
- Overall Net Promotor Score (NPS) of the rehabilitation in general(2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation))
- Patient Reported Outcome Measures (PROM's)(2 weeks pre-operative until end of rehabilitation (+- 3 months after TKA operation))