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Midds Ankle Fracture

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ClinicalTrials.gov Identifier: NCT02841007
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):
Firstkind Ltd

Brief 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 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.

Condition or disease Intervention/treatment
Ankle Fracture Requiring Internal Fixation Device: geko neuromuscular electrostimulation device

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Study Start Date : July 2016
Primary Completion Date : February 2017
Study Completion Date : February 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02841007


Locations
United Kingdom
James Cook Hospital
Middlesbrough, United Kingdom, TS4 3BW
Sponsors and Collaborators
Firstkind Ltd

Responsible Party: Firstkind Ltd
ClinicalTrials.gov Identifier: NCT02841007     History of Changes
Other Study ID Numbers: FKD-LOS-001
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fractures, Bone
Ankle Fractures
Wounds and Injuries