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

Total Hip Replacement Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02425917
• Other study ID #: FKD-IPC-002
• Status: Withdrawn
• Phase: N/A
• First received: April 14, 2015
• Last updated: July 18, 2017
• Start date: June 2017
• Est. completion date: January 2018

Study information

• Verified date: May 2017
• Source: Firstkind Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Hip Replacement

Intervention

Device:
• geko
neuromuscular electrostimulator
• IPC-Calf
IPC used on calf with or without geko

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Firstkind Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultra sound measurements of haemodynamics		10mins
Secondary	Adverse event rate		3 hrs
Secondary	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