Ankle Fracture Requiring Internal Fixation
Conditions
Brief summary
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.
Interventions
DEVICEgeko neuromuscular electrostimulation device
Sponsors
Firstkind Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United Kingdom
Outcome results
None listed