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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01984190
Recruitment Status : Completed
First Posted : November 14, 2013
Last Update Posted : September 4, 2014
Information provided by (Responsible Party):
Medical Compression Systems

Brief Summary:
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.

Condition or disease
Venous Thromboembolism

  Show Detailed Description

Study Type : Observational [Patient Registry]
Actual Enrollment : 411 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: ActiveCare+S.F.T® Outcomes Registry (ACOR)
Study Start Date : April 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots
U.S. FDA Resources

Lower Extremity Joint Arthroplasty
Postoperative venous thromboembolism incidence in lower extremity joint arthroplasty using only the mobile compression device with or without aspirin for venous thromboembolism prevention. Sub-analysis of Total Hip Arthroplasty and Total Knee Arthroplasty will be included.

Primary Outcome Measures :
  1. Incidence of deep venous thrombosis or pulmonary emboli [ Time Frame: Within 3 months post operatively ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The registry will include all Adult patients scheduled for elective unilateral total hip arthroplasty (THA) or total knee arthroplasty (TKA), or unicondylar knee arthroplasty (UKA), where the orthopaedic surgeon is using the ActiveCare+S.F.T® mobile compression device as a monotherapy for venous thromboembolism prevention.

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01984190

United States, Alaska
Arkansas Specialty Orthopaedics
Little Rock, Alaska, United States, 72205
United States, California
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, United States, 92037
VA Palo Alto Health Care System
Menlo Park, California, United States, 94025
United States, Maryland
Rubin Institute for Advanced Orthopedics,
Baltimore, Maryland, United States, 21215
United States, Minnesota
Twin Cities Orthopaedics
Edina, Minnesota, United States, 55435
United States, Missouri
Washington University School of Medicine, Department of Orthopaedic Surgery
St. Louis, Missouri, United States, 63310
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
The Center Orthopedic & Neurosurgical Care &Research
Bend, Oregon, United States, 97710
United States, Virginia
Anderson Orthopaedic Clinic
Alexandria, Virginia, United States, 22306
Sponsors and Collaborators
Medical Compression Systems
Principal Investigator: Clifford W Colwell, Jr., MD Shiley Center for Orthopaedic Research and Education at Scripps Clinic

Publications of Results:
Other Publications:
Responsible Party: Medical Compression Systems Identifier: NCT01984190     History of Changes
Other Study ID Numbers: Version date: 9 -8 -10
First Posted: November 14, 2013    Key Record Dates
Last Update Posted: September 4, 2014
Last Verified: November 2013

Keywords provided by Medical Compression Systems:
venous thromboembolism
deep vein thrombosis
pulmonary emboli
hip arthroplasty
knee arthroplasty
mobile compression device
mechanical device

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases