Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2016-07-31
2017-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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geko device arm
Patients consenting to take part will receive the geko device prior to surgery to internally fixate their fractured ankle, to reduce and prevent oedema
geko neuromuscular electrostimulation device
Interventions
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geko neuromuscular electrostimulation device
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
60 Years
ALL
No
Sponsors
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Firstkind Ltd
INDUSTRY
Responsible Party
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Locations
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James Cook Hospital
Middlesbrough, , United Kingdom
Countries
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Other Identifiers
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FKD-LOS-001
Identifier Type: -
Identifier Source: org_study_id
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