Clinical trial NCT01935414: Geko Neuromuscular Stimulator vs Thromboembolism Deterrent Stockings (TEDS): DVT Prevention Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Vein Thrombosis
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
First posted: 2013-09-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Presence of asymptomatic DVT assessed by Duplex Ultrasound
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Poole
country: United Kingdom
facility: BMI The Harbour Hospital
state: Dorset
Study officials:
References: