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Completed

NCT Number: NCT02641080

Evaluating the Need for Pneumatic Compression Devices

For patients undergoing total hip and knee arthroplasty, does the use of Aspirin alone compared to using Aspirin along with a mobile compression device provide equivocal results for preventing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE) after total joint arthroplasty? The investigator will evaluate the prevention of DVT/PE after total hip and knee arthroplasty will be evaluated to see if there is a decreased risk of bleeding while continuing to prevent thromboembolic disease. The equivalency of using the mobile compression devices with aspirin compared to aspirin alone in patients undergoing total hip and knee arthroplasty will be evaluated. A previous study has shown that patient compliance with the pneumatic compression device is less than 80%.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WVU Medicine Department of Orthopaedics

Morgantown, West Virginia, 26506, United States

About this study

The research question is: does the use of Aspirin alone compared to using Aspirin along with a mobile compression device provide equivocal results for preventing Deep Vein Thrombosis (DVT) and pulmonary embolism (PE) after total joint arthroplasty? Participants were randomized to either receive aspirin and mobile pneumatic compression devices or aspirin alone as outpatient DVT prophylaxis as their standard of care after primary total hip and total knee arthroplasty. Participants randomized to the compression device group were asked to wear the compression devices for 20 hours a day for 2 weeks along with taking an aspirin (325mg once a day), per standard of care. Participants randomized to aspirin alone took 325 mg per day. Participant usage information from Active Care +S.F.T. mobile devices was collected. The information was recorded at the participant's first follow up visit occurring between 7-21 days post-surgery. All of the participants were asked to keep a checklist indicating aspirin intake compliance each day, which was returned at their first follow up visit. Participants randomized to mobile pneumatic compression device and aspirin (325 mg) were asked to complete a satisfaction questionnaire about the compression device at their first follow up visit. Participants received a phone call from a member of the research team approximately 90 days post-op. The call was necessary to assess if any participants have been diagnosed with DVT at another hospital.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients, 18+ years of age, scheduled at WVU Medicine Center for Joint Replacement for a History and Physical visit to undergo a total hip or knee surgery.
  • Primary replacements and revisions.
  • Weight bearing as tolerated postoperatively.

Exclusion criteria

  • History of DVT/PE
  • History of hypercoagulable disorder
  • Currently on other blood thinning medication with the exception of aspirin (Plavix, Coumadin, xarelto, pradaxa, lovenox, heparin, other Factor Xa inhibitors).
  • Patients less than 18 years of age.

Treatment and study plan

Aspirin

Drug

If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, this could lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device.

Other names: ASA

Portable Compression Device

Device

If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, there could be lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device.

Primary outcomes

  1. Number of Participants With Venous Thromboembolism

    Time frame: 90 days

    Patients clinically diagnosed with a DVT or PE during the immediate 90 days post operative.

Secondary outcomes

  1. Aspirin Usage Over 6 Week Post op Period

    Time frame: 6 week post op

    Number of Participants Taking aspirin over the 6 week post op period

  2. Compression Pump Compliance Over 2 Weeks Post op

    Time frame: 14 days post operative

    Patients found to be compliant with recommended pump use over the course of two weeks. Compliance is defined as the recommended dose of 20 hours during the recommend course of prophylaxis.

  3. Overall Pump Experience After 2 Weeks

    Time frame: 2 weeks post op

    Correlation of Recorded Pump Compliance with perceived Patient Factors

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

Evaluating the Need for Pneumatic Compression Devices: A Randomized-controlled Trial (RCT) of Aspirin Versus Aspirin and Pneumatic Compression Devices

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 29, 2015
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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