Clinical trial NCT04927234: Foot and Ankle Post-operative Oedema Management Using Geko™
Official title: Postoperative Oedema Management of Foot and Ankle Patients With Neuromuscular Electro-stimulation of the Peroneal Nerve Using Geko™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Edema
Keywords: geko
foot surgery
ankle surgery
oedema management
post-operative oedema
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
First posted: 2021-06-15
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Standard block randomisation
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessment of post-operative oedema formation using the figure-of-eight tape measurement
timeFrame: From pre-surgery assessment until up to 90 days post-surgery
measure: Assessment of post-operative oedema formation using the pitting oedema scale
timeFrame: From pre-surgery assessment until up to 90 days post-surgery
measure: Assessment of post-operative oedema formation using bioimpedance analysis (US sites only)
timeFrame: From pre-surgery assessment until up to 90 days post-surgery
Secondary outcomes:
measure: Incidence of Adverse Events in each group
timeFrame: From pre-surgery assessment until up to 90 days post-surgery
measure: Incidence of device deficiencies
timeFrame: from start of geko treatment (immediately post-surgery) until up to 90 days post-surgery
measure: Change in pain level using a visual analogue scale (VAS) score
timeFrame: From pre-surgery assessment until up to 90 days post-surgery
measure: Incidence of surgical wound healing
timeFrame: From surgery until up to 90 days post-surgery
measure: Change in analgesia dosage
timeFrame: From pre-surgery assessment until up to 90 days post-surgery
measure: Change in analgesia frequency
timeFrame: From pre-surgery assessment until up to 90 days post-surgery
measure: Change in patient reported outcomes via Manchester-Oxford Foot & Ankle Questionnaire (MOxFQ)
timeFrame: From pre-surgery assessment until up to 90 days post-surgery
Other outcomes:
Locations:
city: Capitola
country: United States
facility: Golden State Orthopedics and Spine
state: California
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Stanmore
country: United Kingdom
facility: The Royal National Orthopaedic Hospital NHS Trust
city: Tunbridge Wells
country: United Kingdom
facility: Maidstone and Tunbridge Wells NHS Trust
Study officials:
affiliation: Royal National Orthopaedic Hospital
name: Shelain Patel, MB BS BSc(Hons) FRCS
role: PRINCIPAL_INVESTIGATOR
References: