Plain English Summary
Background and study aims
There has been a recent trend amongst athletes to use peroneal (leg) nerve stimulators to reduce swelling after training or competition. The Geko peroneal nerve stimulator is a piece of equipment that sits on the skin at the side of the leg and sends electrical impulses through the skin so that the leg muscles can be stimulated to different levels. There is evidence that these nerve stimulators reduce the rates of leg clots and improves the circulation to the leg. The aims of this study are to find out if the Geko peroneal nerve stimulator reduces the rate of leg clots and improves the bone healing in patients who have had their ankles fixed after fracture.
Who can participate?
Adults both male and female, with closed ankle fractures who present to Wirral University Hospital.
What does the study involve?
The study participants would be approached by a member of the clinical team and the research team and then after the appropriate consent is obtained, they would be included into the trial. Each patient would then be randomised into one of two groups i.e. those who receive the stimulator for a two week period post operative period and those who do not. The treatment of patients will not be affected by this trial. Patients in the treatment group would receive the stimulator for 2 weeks after being counselled by the research team. At the normal two week follow up patients in both groups will have their leg circumference measured and a vascular ultrasound performed to exclude the presence of a leg clot. Normal follow up is then at the six week period where X rays are taken and leg circumference is yet again measured. At the three month period patients answer a questionnaire.
What are the possible benefits and risks of participating?
The benefits of participating in the study would include a reduction in post operative swelling, time to healing and rates of leg clots. The possible risks include minor discomfort from the stimulator or allergic reaction to the stimulator pad, a delay in healing of the bone.
Where is the study run from?
Wirral University Teaching Hospital (UK)
When is the study starting and how long is it expected to run for?
The study started in November 2012 and is expected to run until we have enough patients in each group or run out of Geko stimulators.
Who is funding the study?
The study is being funded by Wirral University Hospital primarily. Skymed Limited are providing the Geko stimulators for free and we are applying from external funding from the British Orthopaedic Foot and Ankle Association (BOFAS) for the ultrasound funding.
Who is the main contact?
1. Mr Michael Hennessy (Consultant Orthopaedic Surgeon), mchenno@btinternet.com
2. Mr Peter Kenyon (Specialist Registrar), dr_kenyon@hotmail.com
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
12/NW/0083
Study information
Scientific title
A randomised controlled trial investigating the effect of the Geko nerve stimulator to reduce DVT rates and improve healing in ankle fractures
Acronym
Study hypothesis
The null hypothesis is that there is no alteration in the rates of DVT or the time to clinical and radiological union following open reduction and internal fixation of the ankle when using the Geko peroneal nerve stimulator.
Ethics approval
NRES Committee North West - Liverpool Central, 02/04/2012, ref: 12/NW/0083
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Ankle fracture
Intervention
Each patient randomised into one of two groups i.e. those who receive the stimulator for a two week period post operative period and those who do not.
The treatment of patients will not be affected by this trial. Patients in the treatment group would receive the stimulator for 2 weeks after being counselled by the research team. At the normal two week follow up patients in both groups will have their leg circumference measured and a vascular ultrasound performed to exclude the presence of a leg clot. Normal follow up is then at the six week period where x rays are taken and leg circumference is yet again measured. At the three month period patients answer a Manchester - Oxford Foot and Ankle Questionnaire.
Intervention type
Device
Phase
Drug names
Primary outcome measure
1. DVT rate
2. Time to Union
Secondary outcome measures
1. Manchester - Oxford Foot and ankle questionnaire at end of 3 months
2. Time to return work
Overall trial start date
01/11/2012
Overall trial end date
01/11/2013
Reason abandoned (if study stopped)
Trial did not start
Eligibility
Participant inclusion criteria
1. Adults aged 18 years or older, either sex
2. Patients with closed ankle fractures that have required open reduction and internal fixation
3. Patients who are able to consent for themselves
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Open fractures
2. Diabetics
3. Those with peripheral neuropathy, metabolic bone disorders and immunological disorders
4. Patients undergoing revision procedures
5. Patients with syndesmotic injury requiring screw removal prior to mobilisation
6. Those unable to use the Geko device
Recruitment start date
01/11/2012
Recruitment end date
01/11/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wirral University Teaching Hospital
Merseyside
CH49 5PE
United Kingdom
Sponsor information
Organisation
Wirral University Teaching Hospital (UK)
Sponsor details
Arrowe Park Road
Upton Wirral
Merseyside
L176GD
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Skymed Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list