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

NCT02425917 | Withdrawn

• 1 other identifier: FKD-IPC-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Total Hip Replacement

Outcome Measures

Primary Outcomes (1)

• Ultra sound measurements of haemodynamics

  10mins

Secondary Outcomes (2)

• Adverse event rate

  3 hrs

• patient rated tolerability

  3 hrs

Study Arms (2)

geko

EXPERIMENTAL

Device: geko

ipc-calf

ACTIVE COMPARATOR

intermittent pneumatic compression of the calf

Device: IPC-Calf

Interventions

geko DEVICE

neuromuscular electrostimulator

geko

IPC-Calf DEVICE

IPC used on calf with or without geko

ipc-calf

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female
• Aged over 18-80 years
• Be in good general health and fitness other than the clinical requirement for a planned hip replacement.
• Free of significant abnormal findings as determined by medical history (specifically an absence of DVT or haematological disorders.
• No history or signs of drug abuse (including alcohol), licit or illicit.
• 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.
• Able to understand the Patient Information Sheet and willing to sign the written Informed Consent Form.
• Able and willing to follow the protocol requirements.

You may not qualify if:

• Are requiring hip revision surgery
• History or signs of significant haematological disorders (especially in relation to clotting or coagulation or previous deep or superficial vein thrombosis/pulmonary embolism).
• Significant Peripheral arterial disease (ABPI \< 0.8), 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 ix. Haematological conditions i.e. coagulation disorders, sickle cell disease
• 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.
• Any significant illness during the four (4) weeks preceding the hip replacement surgery.
• Participation in any clinical study during the eight (8) weeks preceding the screening period

Sponsors & Collaborators

• Firstkind Ltd: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 24, 2015
• Study Start: June 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: July 21, 2017

Record last verified: 2017-05