Foot and Ankle Post-operative Oedema Management Using Geko™
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|ClinicalTrials.gov Identifier: NCT04927234|
Recruitment Status : Not yet recruiting
First Posted : June 15, 2021
Last Update Posted : August 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Surgery Edema||Device: geko™ therapy||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Standard block randomisation|
|Masking:||None (Open Label)|
|Official Title:||Postoperative Oedema Management of Foot and Ankle Patients With Neuromuscular Electro-stimulation of the Peroneal Nerve Using Geko™|
|Estimated Study Start Date :||September 2022|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||September 2024|
Experimental: Standard of care + 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)
Device: geko™ therapy
Neuro-muscular electrical stimulation of the peroneal nerve
No Intervention: Standard of care
Patients will receive their standard of care as per hospital practice.
- Assessment of post-operative oedema formation using the figure-of-eight tape measurement [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Incidence of Adverse Events in each group [ Time Frame: From pre-surgery assessment until up to 90 days post-surgery ]
- Incidence of device deficiencies [ Time Frame: 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 [ Time Frame: 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.
- Incidence of surgical wound healing [ Time Frame: 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 [ Time Frame: 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 analgesia frequency [ Time Frame: From pre-surgery assessment until up to 90 days post-surgery ]Assessing changes of frequency of recorded analgesic medication taken by the patient
- Change in patient reported outcomes via Manchester-Oxford Foot & Ankle Questionnaire (MOxFQ) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04927234
|Contact: Kieron Day, DPhil||+44 (0) 7921 106253||Kieron.Day@firstkindmedical.com|
|Contact: Marie-Therese Targett, PhD||+44 (0) email@example.com|
|United States, California|
|Golden State Orthopedics and Spine|
|Capitola, California, United States, 95010|
|Contact: Rich Anderson firstname.lastname@example.org|
|Principal Investigator: Nicholas Abidi|
|The Royal National Orthopaedic Hospital NHS Trust|
|Stanmore, United Kingdom, HA7 4LP|
|Contact: Nana Okine email@example.com|
|Principal Investigator: Shelain Patel|
|Principal Investigator:||Heath P Taylor, MB BS BSc(Hons) FRCS||University Hospitals Dorset NHS Foundation Trust|