Trial record 2 of 9 for:    fkd

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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Firstkind Ltd
ClinicalTrials.gov Identifier:
NCT02425917
First received: April 14, 2015
Last updated: March 8, 2016
Last verified: March 2016
  Purpose
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 Intervention Phase
Total Hip Replacement
Device: geko
Device: IPC-Calf
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Firstkind Ltd:

Primary Outcome Measures:
  • Ultra sound measurements of haemodynamics [ Time Frame: 10mins ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse event rate [ Time Frame: 3 hrs ] [ Designated as safety issue: Yes ]
  • patient rated tolerability [ Time Frame: 3 hrs ] [ Designated as safety issue: No ]
    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


Enrollment: 0
Study Start Date: May 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: geko Device: geko
neuromuscular electrostimulator
Active Comparator: ipc-calf
intermittent pneumatic compression of the calf
Device: IPC-Calf

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Firstkind Ltd
ClinicalTrials.gov Identifier: NCT02425917     History of Changes
Other Study ID Numbers: FKD-IPC-002 
Study First Received: April 14, 2015
Last Updated: March 8, 2016
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on August 25, 2016