Multicenter Registry for Effectiveness Analysis of ActiveCare+S.F.T® Mobile Compression Device for Thrombosis Prevention in Hip and Knee Arthroplasty
ACOR
ActiveCare+S.F.T® Outcomes Registry (ACOR)
1 other identifier
observational
411
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2011
Shorter than P25 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 7, 2013
CompletedFirst Posted
Study publicly available on registry
November 14, 2013
CompletedSeptember 4, 2014
November 1, 2013
6 months
November 7, 2013
September 3, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of deep venous thrombosis or pulmonary emboli
Within 3 months post operatively
Study Arms (1)
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.
Eligibility Criteria
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.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Arkansas Specialty Orthopaedics
Little Rock, Alaska, 72205, United States
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, 92037, United States
VA Palo Alto Health Care System
Menlo Park, California, 94025, United States
Rubin Institute for Advanced Orthopedics,
Baltimore, Maryland, 21215, United States
Twin Cities Orthopaedics
Edina, Minnesota, 55435, United States
Washington University School of Medicine, Department of Orthopaedic Surgery
St Louis, Missouri, 63310, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Center Orthopedic & Neurosurgical Care &Research
Bend, Oregon, 97710, United States
Anderson Orthopaedic Clinic
Alexandria, Virginia, 22306, United States
Related Publications (2)
Colwell CW Jr, Froimson MI, Mont MA, Ritter MA, Trousdale RT, Buehler KC, Spitzer A, Donaldson TK, Padgett DE. Thrombosis prevention after total hip arthroplasty: a prospective, randomized trial comparing a mobile compression device with low-molecular-weight heparin. J Bone Joint Surg Am. 2010 Mar;92(3):527-35. doi: 10.2106/JBJS.I.00047.
PMID: 20194309BACKGROUNDColwell CW Jr, Froimson MI, Anseth SD, Giori NJ, Hamilton WG, Barrack RL, Buehler KC, Mont MA, Padgett DE, Pulido PA, Barnes CL. A mobile compression device for thrombosis prevention in hip and knee arthroplasty. J Bone Joint Surg Am. 2014 Feb 5;96(3):177-83. doi: 10.2106/JBJS.L.01031.
PMID: 24500578RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Clifford W Colwell, Jr., MD
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2013
First Posted
November 14, 2013
Study Start
April 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
September 4, 2014
Record last verified: 2013-11