Clinical trial NCT02641080: Evaluating the Need for Pneumatic Compression Devices
Official title: Evaluating the Need for Pneumatic Compression Devices: A Randomized-controlled Trial (RCT) of Aspirin Versus Aspirin and Pneumatic Compression Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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%.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Primary replacements and revisions.
3. Weight bearing as tolerated postoperatively.

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants With Venous Thromboembolism
timeFrame: 90 days
Secondary outcomes:
measure: Aspirin Usage Over 6 Week Post op Period
timeFrame: 6 week post op
measure: Compression Pump Compliance Over 2 Weeks Post op
timeFrame: 14 days post operative
measure: Overall Pump Experience After 2 Weeks
timeFrame: 2 weeks post op
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: WVU Medicine Department of Orthopaedics
state: West Virginia
Study officials:
affiliation: West Virginia University
name: Matthew J Dietz, MD
role: PRINCIPAL_INVESTIGATOR
References: