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OpenTrials
Completed

NCT Number: NCT02841007

Midds Ankle Fracture

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.

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Key information

Conditions

Ankle Fracture Requiring Internal Fixation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

James Cook Hospital

Middlesbrough, TS4 3BW, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Diabetic
  • Already taking part in a clinical study, or has so within the last 8 weeks
  • None responder to geko™ device

Treatment and study plan

geko neuromuscular electrostimulation device

Device

Primary outcomes

  1. Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months

    Time frame: 4 months

  2. Time to readiness for surgery

    Time frame: 0-~7days

Secondary outcomes

  1. 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

  2. Adverse events, including the need for secondary surgery or additional treatment, serious adverse events

    Time frame: study duration up to ~14days

Sponsors and collaborators

Lead sponsor

Firstkind Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 21, 2016
Registry last updated
Apr 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.