Does the Geko nerve stimulator reduce Deep Vein Thrombosis (DVT) and improve healing in ankle fractures?
| ISRCTN | ISRCTN95441725 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95441725 |
| Secondary identifying numbers | 12/NW/0083 |
- Submission date
- 17/07/2012
- Registration date
- 07/01/2013
- Last edited
- 20/05/2016
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
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
Contact information
Scientific
Wirral University Teaching Hospital
Arrowe Park Road
Upton
Wirral
Merseyside
CH49 5PE
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial investigating the effect of the Geko nerve stimulator to reduce DVT rates and improve healing in ankle fractures |
| Study objectives | 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(s) | NRES Committee North West - Liverpool Central, 02/04/2012, ref: 12/NW/0083 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/11/2012 |
| Completion date | 01/11/2013 |
| Reason abandoned (if study stopped) | Trial did not start |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2012 |
| Date of final enrolment | 01/11/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
CH49 5PE
United Kingdom
Sponsor information
Hospital/treatment centre
Arrowe Park Road
Upton Wirral
Merseyside
L176GD
England
United Kingdom
| Website | http://www.whnt.nhs.uk |
|---|---|
"ROR" |
https://ror.org/05cv4zg26 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
20/05/2016: trial status updated to 'Stopped'.
