Condition category
Injury, Occupational Diseases, Poisoning
Date applied
17/07/2012
Date assigned
07/01/2013
Last edited
20/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

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

Contact information

Type

Scientific

Primary contact

Mr Michael Hennessy

ORCID ID

Contact details

Wirral University Teaching Hospital
Arrowe Park Road
Upton
Wirral
Merseyside
CH49 5PE
United Kingdom

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 measures

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

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

http://www.whnt.nhs.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/05/2016: trial status updated to 'Stopped'.