Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study

A Multicentre Randomised Controlled Trial Comparing the Incidence of Asymptomatic and Symptomatic Deep Vein Thrombosis Between the gekoTM Device and Thromboembolism Deterrent Stockings in Patients Recovering From Total Hip Replacement Surgery

This study hypothesises that the geko™ device is more efficient than TEDS in preventing the formation of symptomatic/asymptomatic Deep Vein Thrombosis (DVTs), post-surgery.

Study Overview

• Status: Completed
• Conditions: Deep Vein Thrombosis
• Intervention / Treatment: Device: geko™ post-surgery for 48hrs then 4hrs/day until discharge.; Device: TEDS post-surgery for 48hrs then 4hrs/day until discharge.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Dorset
    • Poole, Dorset, United Kingdom, BH15 2BH
      • BMI The Harbour Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged 18 years of age and over
2. Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders).
3. Has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator during the ten (10) days preceding enrolment.
4. Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
5. Able and willing to follow the protocol requirements.

Exclusion Criteria:

1. Are requiring hip revision surgery
2. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
3. Evidence of asymptomatic DVT by Duplex Ultrasound
4. Peripheral arterial disease (ABPI < 0.8), varicose veins or lower limb ulceration or ischemia.
5. Significant varicose veins, phlebitis or lower limb ulceration or ischemia. CEAP Grade 4-6. See Appendix 2
6. Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
7. Recent trauma to lower limb.
8. Chronic Obesity (BMI Index >40kg/m2).
9. Pregnancy.

10. Significant history of following diseases I. Cardiovascular: Recent MI (< 6 months) II. Percutaneous Coronary Intervention (PCI) with stent (< 3 months for Bare Metal Stent (BMS) and < 12 months for Drug Eluding Stent (DES) III. Moderate to severe CCF, uncontrolled AF IV. Neurological: Stroke, Hemiplegia/Paraplegia, Myopathies V. Significant dermatological conditions affecting lower limbs resulting in broken or inflamed skin particularly at the site where the device is to be fitted.

    VI. Clinically significant haematological conditions i.e. coagulation disorders, sickle cell disease VII. Psychiatric disorders

11. On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin
12. Long term steroid with dermatological changes
13. A pulse rate of less than 40 beats/minute
14. A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.
15. Any significant illness during the four (4) weeks preceding the hip replacement surgery.
16. Participation in any clinical study during the eight (8) weeks preceding the screening period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: geko™; geko™ use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge	Device: geko™ post-surgery for 48hrs then 4hrs/day until discharge.
Active Comparator: TEDS stockings; TEDS use continually post-surgery for 48hrs and then a minimum of 4hrs/day until discharge	Device: TEDS post-surgery for 48hrs then 4hrs/day until discharge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence of asymptomatic DVT assessed by Duplex Ultrasound	6 weeks

Collaborators and Investigators

• Sponsor: Firstkind Ltd

Publications and helpful links

Helpful Links

• Company website

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2013
• Primary Completion (Actual): November 16, 2016
• Study Completion (Actual): November 16, 2016

Study Registration Dates

• First Submitted: August 28, 2013
• First Submitted That Met QC Criteria: August 30, 2013
• First Posted (Estimate): September 5, 2013

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Thromboembolism
• Other Study ID Numbers: FKD-TEDS-001