Back to resultsMidds Ankle Fracture
Primary Purpose
Ankle Fracture Requiring Internal Fixation
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
geko neuromuscular electrostimulation device
Sponsored by
About this trial
This is an interventional other trial for Ankle Fracture Requiring Internal Fixation
Eligibility Criteria
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
Sites / Locations
- James Cook Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
geko device arm
Arm 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
Outcomes
Primary Outcome Measures
Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months
Time to readiness for surgery
Secondary Outcome Measures
Oedema reduction in prospective geko™ subjects prior to surgery, by two circumferential measures using tape measures built into the patients plaster cast
Adverse events, including the need for secondary surgery or additional treatment, serious adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02841007
Brief Title
Midds Ankle Fracture
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Firstkind Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Fracture Requiring Internal Fixation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
geko device arm
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
geko neuromuscular electrostimulation device
Primary Outcome Measure Information:
Title
Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months
Time Frame
4 months
Title
Time to readiness for surgery
Time Frame
0-~7days
Secondary Outcome Measure Information:
Title
Oedema reduction in prospective geko™ subjects prior to surgery, by two circumferential measures using tape measures built into the patients plaster cast
Time Frame
0-~7days
Title
Adverse events, including the need for secondary surgery or additional treatment, serious adverse events
Time Frame
study duration up to ~14days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
James Cook Hospital
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Midds Ankle Fracture
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