Foot and Ankle Post-operative Oedema Management Using Geko™

Firstkind Ltd123 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

123

Conditions

Surgery Edema

Interventions

geko™ therapyDEVICE

Neuro-muscular electrical stimulation of the peroneal nerve

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Golden State Orthopedics and Spine

Capitola, California, United States

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Maidstone and Tunbridge Wells NHS Trust

Royal Tunbridge Wells, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: From pre-surgery assessment until up to 90 days post-surgery

Secondary Outcomes

Incidence of Adverse Events in each group

Time frame: 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)

Time frame: 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.

Data from ClinicalTrials.gov

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