Midds Ankle Fracture

Not Applicable

Completed

• Conditions: Ankle Fracture Requiring Internal Fixation
• Interventions: Device: geko neuromuscular electrostimulation device

• Registration Number: NCT02841007
• Lead Sponsor: Firstkind Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-07
• Study Start: 2016-07
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-21
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
geko device arm	geko neuromuscular electrostimulation device	Patients consenting to take part will receive the geko device prior to surgery to internally fixate their fractured ankle, to reduce and prevent oedema

Primary Outcome Measures

Name	Time	Method
Time to readiness for surgery	0-~7days
Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months	4 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

James Cook Hospital; 🇬🇧 Middlesbrough, United Kingdom