Ankle Fracture Requiring Internal FixationNCT02841007
Midds Ankle Fracture
A study testing geko neuromuscular electrostimulation device in people with Ankle Fracture Requiring Internal Fixation, run by Firstkind Ltd at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ankle Fracture Requiring Internal Fixation
- What is being tested?
- geko neuromuscular electrostimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- Diabetic
- Already taking part in a clinical study, or has so within the last 8 weeks
- None responder to geko™ device
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- geko neuromuscular electrostimulation device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
geko neuromuscular electrostimulation deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| geko device arm | Experimental | Patients consenting to take part will receive the geko device prior to surgery to internally fixate their fractured ankle, to reduce and prevent oedema Receives: Device: geko neuromuscular electrostimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months
Measured: 4 months
Time to readiness for surgery
Measured: 0-~7days
Secondary outcomes (2)
Oedema reduction in prospective geko™ subjects prior to surgery, by two circumferential measures using tape measures built into the patients plaster cast
Measured: 0-~7days
Adverse events, including the need for secondary surgery or additional treatment, serious adverse events
Measured: study duration up to ~14days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle Fracture Requiring Internal FixationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firstkind Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841007
- Sponsor's protocol ID
- FKD-LOS-001
- Status last verified
- Jul 2016
- First submitted
- 15 Jul 2016
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02841007
- Acronym / sponsor ID
- FKD-LOS-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Firstkind LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| geko device arm | Experimental | Device: geko neuromuscular electrostimulation devicePatients consenting to take part will receive the geko device prior to surgery to internally fixate their fractured ankle, to reduce and prevent oedema |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| geko neuromuscular electrostimulation device | Device | geko device arm |
Primary outcome
Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months
Time frame: 4 months
Time to readiness for surgery
Time frame: 0-~7days
2 secondary outcomes
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
Adverse events, including the need for secondary surgery or additional treatment, serious adverse events
Time frame: study duration up to ~14days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing geko neuromuscular electrostimulation device in people with Ankle Fracture Requiring Internal Fixation, run by Firstkind Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.