Clinical trial NCT02425917: IPC-CALF Versus GEKO in Post-op Total Hip Patients
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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Total Hip Replacement
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
First posted: 2015-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Ultra sound measurements of haemodynamics
timeFrame: 10mins
Secondary outcomes:
measure: Adverse event rate
timeFrame: 3 hrs
measure: patient rated tolerability
timeFrame: 3 hrs
Other outcomes:
Locations:
Study officials:
References: