Midds Ankle Fracture

Firstkind Ltd20 enrolled

Overview

The geko™ device is indicated for the prevention and treatment of oedema. The aim of this study is to show that recruiting, and performing study assessments in ankle fracture patients requiring surgery to fix their ankle attending the James Cook Hospital is feasible, and to obtain data to support the powering of a larger study to demonstrate the effectiveness of the geko™ device at reducing length of stay for this population of patients. This study will also allow us to assess the acceptability, tolerability and compliance of treatment with the geko device.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Ankle Fracture Requiring Internal Fixation

Interventions

geko neuromuscular electrostimulation deviceDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18-60 years old 2. Clinically and radiologically diagnosed acute ankle fracture that, in the opinion of the treating surgeon, requires operative fixation 3. Able to understand the Patient Information Sheet (PIS) and willing to sign the written Informed Consent Form. 4. Able and willing to follow the protocol requirements. Exclusion Criteria: 1. Has a pacemaker 2. Morbid Obesity (BMI Index \>40kg/m2). 3. Patients who on presentation to hospital are known to be pregnant. 4. Clinically significant co-morbidities that need to be treated prior to surgical intervention and could therefore impact upon time to theatre 5. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism. 6. Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted 7. Diabetic 8. Already taking part in a clinical study, or has so within the last 8 weeks 9. None responder to geko™ device

Locations (1)

James Cook Hospital

Middlesbrough, United Kingdom

Outcomes

Primary Outcomes

Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months

Time frame: 4 months

Time to readiness for surgery

Time frame: 0-~7days

Secondary Outcomes

Oedema reduction in prospective geko™ subjects prior to surgery, by two circumferential measures using tape measures built into the patients plaster cast

Time frame: 0-~7days

Adverse events, including the need for secondary surgery or additional treatment, serious adverse events

Time frame: study duration up to ~14days

Data from ClinicalTrials.gov

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