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

NCT ID: NCT02425917

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2018-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

geko

Group Type: EXPERIMENTAL

geko

Intervention Type: DEVICE

neuromuscular electrostimulator

ipc-calf

intermittent pneumatic compression of the calf

Group Type: ACTIVE_COMPARATOR

IPC-Calf

Intervention Type: DEVICE

IPC used on calf with or without geko

Interventions

geko

neuromuscular electrostimulator

Intervention Type: DEVICE

IPC-Calf

IPC used on calf with or without geko

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Firstkind Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

FKD-IPC-002

Identifier Type: -

Identifier Source: org_study_id