Midds Ankle Fracture | NCT02841007

Studies
Midds Ankle Fracture

NCT02841007

Sponsor

Firstkind Ltd

Status

Completed

Last Update Posted

Apr 13, 2017Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Ankle Fracture Requiring Internal Fixation

Interventions

geko neuromuscular electrostimulation device

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Feb 2017Actual

Completion Date

Feb 2017Actual

First Submitted Date

Jul 15, 2016

First Submission Date that Met QC Criteria

Jul 20, 2016

First Posted Date

Jul 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2017

Last Update Posted Date

Apr 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Device: geko neuromuscular electrostimulation device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
geko neuromuscular electrostimulation device	Device		geko device arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Oedema reduction in prospective geko™ subjects prior to surgery, by two circumferential measures using tape measures built into the patients plaster cast		0-~7days
Adverse events, including the need for secondary surgery or additional treatment, serious adverse events

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
James Cook Hospital		Middlesbrough		TS4 3BW	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided