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Lower Limb Blood Flow Geko vs Foot Pump

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ClinicalTrials.gov Identifier: NCT03317145
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : October 23, 2017
Sponsor:
Collaborator:
Firstkind Ltd
Information provided by (Responsible Party):
Hampshire Hospitals NHS Foundation Trust

Brief Summary:
The aim of this pilot study was to assess venous flow parameters in patients following total hip arthroplasty, comparing an intermittent pneumatic compression foot device with a portable neuromuscular electrostimulator device. Assessments were performed in a single sitting before hospital discharge, between days 1 to 4 post operatively. The total duration of participation for each patient who completed the study was approximately 2.5 hours.

Condition or disease Intervention/treatment Phase
Venous Thrombosis Arthroplasty, Replacement, Hip Device: Neuromuscular electrostimulation (NMES) device Device: Intermittent pneumatic compression (IPC) device Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Patients who have had a total hip replacement will be randomised to wear either a foot compression (IPC) device or a neuromuscular electrostimulation (NMES) device (gekoTM) first. Blood flow will be measured using both devices on the same patient in sequence. The blood flow measurements will be done by ultrasound. Each ultrasound assessment will take approximately 30 minutes in total. Baseline blood flow measurements will be taken initially. The first device will then be fitted and allowed to operate for 10 minutes before ultrasound measurements are taken. After a rest period of 30 minutes, the second device is then fitted and allowed to operate for 10 minutes, following which blood flow measurements are repeated. Patients will then be asked to complete a questionnaire to assess the comfort of each device.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intermittent Pneumatic Compression (IPC) of the Foot Versus Geko™ Neuromuscular Electrostimulation (NMES): Comparison of Lower Limb Circulation Following Elective Total Hip Replacement (THR)
Actual Study Start Date : July 24, 2013
Actual Primary Completion Date : February 19, 2014
Actual Study Completion Date : February 19, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm A (NMES followed by IPC)
Arm A (NMES followed by IPC). Following baseline blood flow measurements using ultrasound, the neuromuscular electrostimulation (NMES) device will be fitted and allowed to operate for 10 minutes. Blood flow measurements will then be repeated. The NMES device will be removed. After a 30 minute rest period, the intermittent pneumatic compression (IPC) device will be fitted, activated for 10 minutes and then blood flow measurements repeated.
Device: Neuromuscular electrostimulation (NMES) device
A mobile peroneal nerve stimulator
Other Name: Geko T-1

Device: Intermittent pneumatic compression (IPC) device
A foot pump or foot compression device
Other Name: Vadoplex

Active Comparator: Arm B (IPC followed by NMES)
Arm B (IPC followed by NMES). Following baseline blood flow measurements using ultrasound, the intermittent pneumatic compression device (IPC) will be fitted and allowed to operate for 10 minutes. Blood flow measurements will then be repeated. The IPC device will be removed. After a 30 minute rest period, the neuromuscular electrostimulation (NMES) device will then be fitted, activated for 10 minutes and then blood flow measurements repeated
Device: Neuromuscular electrostimulation (NMES) device
A mobile peroneal nerve stimulator
Other Name: Geko T-1

Device: Intermittent pneumatic compression (IPC) device
A foot pump or foot compression device
Other Name: Vadoplex




Primary Outcome Measures :
  1. Venous flow at baseline [ Time Frame: "t0" - 30 minutes to include the ultrasound assessment, performed between days 1 and 4 post operatively ]
    Measured within the superficial femoral vein using ultrasound

  2. Venous flow after application of device 1 [ Time Frame: "t1" - 90 minutes to include the ultrasound assessment ]
    Measured within the superficial femoral vein using ultrasound

  3. Venous flow after application of device 2 [ Time Frame: "t2" - 150 minutes to include the ultrasound assessment ]
    Measured within the superficial femoral vein using ultrasound


Secondary Outcome Measures :
  1. Patient satisfaction with device 1 [ Time Frame: Immediately after completion of the ultrasound assessment for device 1, at "t1" - 90 minutes ]
    verbal rating score: 1 extremely comfortable, 2 comfortable, 3 uncomfortable, 4 very uncomfortable, 5 extremely uncomfortable.

  2. Patient satisfaction with device 2 [ Time Frame: Immediately after completion of the ultrasound assessment for device 2, at "t2" - 150 minutes ]
    verbal rating score: 1 extremely comfortable, 2 comfortable, 3 uncomfortable, 4 very uncomfortable, 5 extremely uncomfortable.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing primary THA,
  • in good general health and fitness,
  • age 18 years or over
  • able to provide written informed consent.

Exclusion Criteria:

  • Are requiring hip revision surgery
  • Previous or current diagnosis of deep vein thrombosis (DVT) or pulmonary embolism (PE).
  • History or signs of significant haematological disorders (especially in relation to clotting or coagulation) or thrombophlebitis.
  • Peripheral arterial disease, clinically significant varicose veins or lower limb ulceration or ischemia.
  • Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
  • Recent trauma to lower limb.
  • Chronic Obesity (BMI Index >40kg/m2).
  • Pregnancy.
  • 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. Renal: Moderate to severely impaired renal function vi. Hepatic: Moderate to severely impaired hepatic function vii. Psychiatric disorders viii. Dermatological conditions affecting lower limbs
  • On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin
  • Long term steroid use with dermatological changes
  • A pulse rate of less than 40 beats/minute
  • A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.
  • Participation in any clinical study during the eight (8) weeks preceding the screening period
  • THR done for hip fracture

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): NCT03317145


Sponsors and Collaborators
Hampshire Hospitals NHS Foundation Trust
Firstkind Ltd
Investigators
Principal Investigator: Geoff Stranks, FRCS North Hampshire Hospital, Basingstoke

Publications:
Responsible Party: Hampshire Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03317145     History of Changes
Other Study ID Numbers: FSK-FP-001
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We would be happy to share individual participant data if requested by other researchers although have no formal plans to publish this at present. All data shared would be anonymised.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hampshire Hospitals NHS Foundation Trust:
venous thromboembolism
deep vein thrombosis
pulmonary embolism
neuromuscular electrostimulation
foot compression
hip replacement

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases