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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medical Compression Systems
ClinicalTrials.gov Identifier:
NCT01984190
First received: November 7, 2013
Last updated: September 3, 2014
Last verified: November 2013
  Purpose

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
Venous Thromboembolism

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: ActiveCare+S.F.T® Outcomes Registry (ACOR)

Resource links provided by NLM:


Further study details as provided by Medical Compression Systems:

Primary Outcome Measures:
  • Incidence of deep venous thrombosis or pulmonary emboli [ Time Frame: Within 3 months post operatively ] [ Designated as safety issue: No ]

Enrollment: 411
Study Start Date: April 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984190

Locations
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
Investigators
Principal Investigator: Clifford W Colwell, Jr., MD Shiley Center for Orthopaedic Research and Education at Scripps Clinic
  More Information

Publications:
Responsible Party: Medical Compression Systems
ClinicalTrials.gov Identifier: NCT01984190     History of Changes
Other Study ID Numbers: Version date: 9 -8 -10
Study First Received: November 7, 2013
Last Updated: September 3, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 20, 2014