Midds Ankle Fracture

Firstkind

Status: Completed

Conditions: Ankle Fracture Requiring Internal Fixation

Treatments: Device: geko neuromuscular electrostimulation device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02841007

FKD-LOS-001

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

geko device arm

Experimental group

Description:

Patients consenting to take part will receive the geko device prior to surgery to internally fixate their fractured ankle, to reduce and prevent oedema

Treatment:

Device: geko neuromuscular electrostimulation device