Status:
COMPLETED
Lower Limb Blood Flow Geko vs Foot Pump
Lead Sponsor:
Hampshire Hospitals NHS Foundation Trust
Collaborating Sponsors:
Firstkind Ltd
Conditions:
Venous Thrombosis
Arthroplasty, Replacement, Hip
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of this pilot study was to assess venous flow parameters in patients following total hip arthroplasty, comparing an intermittent pneumatic compression foot device with a portable neuromuscular...
Detailed Description
Ethical approval was obtained from the National Research Ethics Service (Edgbaston), reference 13/WM/0139. Upon admission to hospital for THA, eligible patients were invited to participate in the stud...
Eligibility Criteria
Inclusion
- patients undergoing primary THA,
- in good general health and fitness,
- age 18 years or over
- able to provide written informed consent.
Exclusion
- Are requiring hip revision surgery
- Previous or current diagnosis of deep vein thrombosis (DVT) or pulmonary embolism (PE).
- History or signs of significant haematological disorders (especially in relation to clotting or coagulation) or thrombophlebitis.
- Peripheral arterial disease, clinically significant 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
- On LMWH/Heparin (Prophylactic/therapeutic doses) or Warfarin or warfarin stopped recently and replaced by LMWH/ Heparin
- Long term steroid use with dermatological changes
- 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.
- Participation in any clinical study during the eight (8) weeks preceding the screening period
- THR done for hip fracture
Key Trial Info
Start Date :
July 24 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03317145
Start Date
July 24 2013
End Date
February 19 2014
Last Update
September 21 2021
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