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

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)

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.

Study Overview

• Status: Withdrawn
• Conditions: Total Hip Replacement
• Intervention / Treatment: Device: geko; Device: IPC-Calf

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ultra sound measurements of haemodynamics	10mins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event rate		3 hrs
patient rated tolerability	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	3 hrs

Collaborators and Investigators

• Sponsor: Firstkind Ltd

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2017
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: April 14, 2015
• First Submitted That Met QC Criteria: April 23, 2015
• First Posted (Estimate): April 24, 2015

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: FKD-IPC-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No