Midds Ankle Fracture

April 12, 2017 updated by: Firstkind Ltd

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Middlesbrough, United Kingdom, TS4 3BW
        • James Cook Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: geko device arm
Patients consenting to take part will receive the geko device prior to surgery to internally fixate their fractured ankle, to reduce and prevent oedema
Device: geko neuromuscular electrostimulation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months
Time Frame: 4 months
4 months
Time to readiness for surgery
Time Frame: 0-~7days
0-~7days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
0-~7days
Adverse events, including the need for secondary surgery or additional treatment, serious adverse events
Time Frame: study duration up to ~14days
study duration up to ~14days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Firstkind Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 12, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKD-LOS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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