Ankle Fracture Requiring Internal Fixation Clinical Trial
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
| Verified date | July 2016 |
| Source | Firstkind Ltd |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | February 2017 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | James Cook Hospital | Middlesbrough |
| Lead Sponsor | Collaborator |
|---|---|
| Firstkind Ltd |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months | 4 months | ||
| Primary | Time to readiness for surgery | 0-~7days | ||
| Secondary | Oedema reduction in prospective geko™ subjects prior to surgery, by two circumferential measures using tape measures built into the patients plaster cast | 0-~7days | ||
| Secondary | Adverse events, including the need for secondary surgery or additional treatment, serious adverse events | study duration up to ~14days |