Edema, Surgery
Conditions
Keywords
geko, foot surgery, ankle surgery, oedema management, post-operative oedema
Brief summary
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
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.
Interventions
DEVICEgeko™ therapy
Neuro-muscular electrical stimulation of the peroneal nerve
Sponsors
Firstkind Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Standard block randomisation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of post-operative oedema formation using the figure-of-eight tape measurement | 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 the pitting oedema scale | 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. |
| Assessment of post-operative oedema formation using bioimpedance analysis (US sites only) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of surgical wound healing | From surgery until up to 90 days post-surgery | Visually assessing the surgical wound healing status as either healed/progressing/static/deteriorating/severe. |
| Change in analgesia dosage | From pre-surgery assessment until up to 90 days post-surgery | Assessing changes in dosage of recorded analgesic medication taken by the patient |
| Incidence of Adverse Events in each group | 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 | 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. |
| Change in analgesia frequency | From pre-surgery assessment until up to 90 days post-surgery | Assessing changes of frequency of recorded analgesic medication taken by the patient |
| Incidence of device deficiencies | from start of geko treatment (immediately post-surgery) until up to 90 days post-surgery | To assess the number of geko device deficiencies (if any) |
| Change in pain level using a visual analogue scale (VAS) score | From pre-surgery assessment until up to 90 days post-surgery | Assessing pain levels using a visual analogue scale (VAS) score, where 0 means no pain and 100 is the worst pain possible. |
Countries
Spain, United Kingdom, United States
Outcome results
None listed