Multicenter Registry for Effectiveness Analysis of ActiveCare+S.F.T® Mobile Compression Device for Thrombosis Prevention in Hip and Knee Arthroplasty

Completed

Conditions studied: Venous Thromboembolism

In brief

Venous thromboembolic events (VTE), either deep vein thromboses or pulmonary emboli, are important complications in patients undergoing knee or hip arthroplasty. This multicenter Clinical Registry is aimed at collecting large volume clinical effectiveness data of ActiveCare+S.F.T® mobile compression device +/- aspirin in lowering the potential risk of venous thromboembolism (VTE) prophylaxis in patients undergoing primary lower extremity total joint arthroplasty. The results can then be compared to pharmacology protocols.

Key facts

Study ID

NCT01984190

Run by

Medical Compression Systems

People needed

411

Starts

2011-04-01

Expected to finish

2011-10-01

Last updated by the study team

2014-09-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients (Age >18 yrs).
• Patient intended to undergo elective primary unilateral total hip arthroplasty (THA) or total knee arthroplasty (TKA), or unicondylar knee arthroplasty (UKA).
• Patient is using only ActiveCare+S.F.T® +/- aspirin for venous thromboembolism (VTE) prevention(Aspirin (ASA) can be prescribed at the discretion of the surgeon).

You may not qualify if…

• Patient with known coagulation disorder
• Patient currently treated with anticoagulant medications.
• Patients with current signs and symptoms of or history of deep vein thrombosis(DVT) or pulmonary embolism (PE).
• Patients currently suffering from a solid tumor malignancy.
• Patients who underwent major surgery procedure within 3 months prior to participation in the registry

Where it is running

• Arkansas Specialty Orthopaedics — Little Rock, Alaska, United States
• Shiley Center for Orthopaedic Research and Education at Scripps Clinic — La Jolla, California, United States
• VA Palo Alto Health Care System — Menlo Park, California, United States
• Rubin Institute for Advanced Orthopedics, — Baltimore, Maryland, United States
• Twin Cities Orthopaedics — Edina, Minnesota, United States
• Washington University School of Medicine, Department of Orthopaedic Surgery — St Louis, Missouri, United States
• Hospital for Special Surgery — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• The Center Orthopedic & Neurosurgical Care &Research — Bend, Oregon, United States
• Anderson Orthopaedic Clinic — Alexandria, Virginia, United States

Full record on ClinicalTrials.gov

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