Foot and Ankle Post-operative Oedema Management Using Geko™

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Postoperative Oedema Management of Foot and Ankle Patients With Neuromuscular Electro-stimulation of the Peroneal Nerve Using Geko™

Conditions
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Surgery, Edema

Intervention / Treatment
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* Device: geko™ therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Pregnant 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Standard block randomisation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard of care + geko™ Therapy<br>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) | Device: geko™ therapy<br>* Neuro-muscular electrical stimulation of the peroneal nerve<br>* Other names: NMES;|
| No Intervention: Standard of care<br>Patients will receive their standard of care as per hospital practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of post-operative oedema formation using the figure-of-eight tape measurement | 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 | From pre-surgery assessment until up to 90 days post-surgery | 
| Assessment of post-operative oedema formation using the pitting oedema scale | 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. | From pre-surgery assessment until up to 90 days post-surgery | 
| Assessment of post-operative oedema formation using bioimpedance analysis (US sites only) | 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. | From pre-surgery assessment until up to 90 days post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events in each group |  | From pre-surgery assessment until up to 90 days post-surgery | 
| Incidence of device deficiencies | To assess the number of geko device deficiencies (if any) | 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 | Assessing pain levels using a visual analogue scale (VAS) score, where 0 means no pain and 100 is the worst pain possible. | From pre-surgery assessment until up to 90 days post-surgery | 
| Incidence of surgical wound healing | Visually assessing the surgical wound healing status as either healed/progressing/static/deteriorating/severe. | From surgery until up to 90 days post-surgery | 
| Change in analgesia dosage | Assessing changes in dosage of recorded analgesic medication taken by the patient | From pre-surgery assessment until up to 90 days post-surgery | 
| Change in analgesia frequency | Assessing changes of frequency of recorded analgesic medication taken by the patient | From pre-surgery assessment until up to 90 days post-surgery | 
| Change in patient reported outcomes via Manchester-Oxford Foot & Ankle Questionnaire (MOxFQ) | Domains that are assessed in this questionnaire include walking/standing, pain and social interaction. Scores will range from 0 to 100, where 100 is most severe. | From pre-surgery assessment until up to 90 days post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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geko, foot surgery, ankle surgery, oedema management, post-operative oedema