Midds Ankle Fracture

Study Overview
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Brief Summary
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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.

Official Title
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gekoTM Neuromuscular Electrostimulation (NMES) Device, Pilot Feasibility Study Looking at Time to Surgery Study in Patients Requiring Ankle Fixation Following Fracture, Comparison to Matched Retrospective Controls

Conditions
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Ankle Fracture Requiring Internal Fixation

Intervention / Treatment
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* Device: geko neuromuscular electrostimulation device


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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: geko device arm<br>Patients consenting to take part will receive the geko device prior to surgery to internally fixate their fractured ankle, to reduce and prevent oedema | Device: geko neuromuscular electrostimulation device<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months |  | 4 months | 
| Time to readiness for surgery |  | 0- 7days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oedema reduction in prospective geko™ subjects prior to surgery, by two circumferential measures using tape measures built into the patients plaster cast |  | 0- 7days | 
| Adverse events, including the need for secondary surgery or additional treatment, serious adverse events |  | study duration up to  14days |