Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

IPC-CALF Versus GEKO in Post-op Total Hip Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02425917
Recruitment Status : Withdrawn (not relevant to the sponsor)
First Posted : April 24, 2015
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Firstkind Ltd

Brief Summary:
This study is designed to compare the effect of IPC on post-operative circulation in lower limbs with gekoTM device after total hip replacement procedure.

Condition or disease Intervention/treatment Phase
Total Hip Replacement Device: geko Device: IPC-Calf Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparison of Intermittent Pneumatic Compression (IPC) of the Calf and gekoTM Neuromuscular Electrostimulation (NMES) Device on Lower Limb Circulation Following Elective Total Hip Replacement (THR)
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hip Replacement

Arm Intervention/treatment
Experimental: geko Device: geko
neuromuscular electrostimulator

Active Comparator: ipc-calf
intermittent pneumatic compression of the calf
Device: IPC-Calf
IPC used on calf with or without geko




Primary Outcome Measures :
  1. Ultra sound measurements of haemodynamics [ Time Frame: 10mins ]

Secondary Outcome Measures :
  1. Adverse event rate [ Time Frame: 3 hrs ]
  2. patient rated tolerability [ Time Frame: 3 hrs ]
    A questionnaire has been designed to record the opinion of the patient with regard to both devices, in particular how comfortable the devices were to wear. The patient will be asked to rate how comfortable the devices are to wear on a scale of 1-5, 1 being very comfortable and 5 being extremely uncomfortable



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and Female
  2. Aged over 18-80 years
  3. Be in good general health and fitness other than the clinical requirement for a planned hip replacement.
  4. Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders.
  5. No history or signs of drug abuse (including alcohol), licit or illicit.
  6. Has not used any medications (prescribed or over-the-counter including herbal remedies) judged to be significant by the Principal Investigator (PI) during the thirty (30) days preceding the study.
  7. Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
  8. Able and willing to follow the protocol requirements.

Exclusion Criteria:

  1. Are requiring hip revision surgery
  2. History or signs of significant haematological disorders (especially in relation to clotting or coagulation or previous deep or superficial vein thrombosis/pulmonary embolism).
  3. Significant Peripheral arterial disease (ABPI < 0.8), varicose veins or lower limb ulceration or ischemia.
  4. Recent surgery within the last 3 months (such as abdominal, gynaecological, hip or knee replacement).
  5. Recent trauma to lower limb.
  6. Chronic Obesity (BMI Index >40kg/m2).
  7. Pregnancy.
  8. 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 ix. Haematological conditions i.e. coagulation disorders, sickle cell disease
  9. A pulse rate of less than 40 beats/minute
  10. A sitting systolic blood pressure >180 and <100 mmHg and/or a sitting diastolic pressure of >100 mmHg.
  11. Any significant illness during the four (4) weeks preceding the hip replacement surgery.
  12. Participation in any clinical study during the eight (8) weeks preceding the screening period

Layout table for additonal information
Responsible Party: Firstkind Ltd
ClinicalTrials.gov Identifier: NCT02425917     History of Changes
Other Study ID Numbers: FKD-IPC-002
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: May 2017

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No