Foot and Ankle Post-operative Oedema Management Using Geko™
- Conditions
- EdemaSurgery
- Interventions
- Device: geko™ therapy
- Registration Number
- NCT04927234
- Lead Sponsor
- Firstkind Ltd
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of care + geko™ Therapy 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)
- Primary Outcome Measures
Name Time Method 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 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.
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.
- Secondary Outcome Measures
Name Time Method 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 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 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 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.
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
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.
Trial Locations
- Locations (5)
Hospital Clinic Barcelona
🇪🇸Barcelona, Spain
Maidstone and Tunbridge Wells NHS Trust
🇬🇧Tunbridge Wells, United Kingdom
The Royal National Orthopaedic Hospital NHS Trust
🇬🇧Stanmore, United Kingdom
Golden State Orthopedics and Spine
🇺🇸Capitola, California, United States
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain