Evaluating the Need for Pneumatic Compression Devices

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641080
• Other study ID #: 1508807749
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: October 2016

Study information

• Verified date: November 2020
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• Aspirin
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.

Device:
• Portable Compression 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.

Locations

Country	Name	City	State
United States	WVU Medicine Department of Orthopaedics	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Venous Thromboembolism	Patients clinically diagnosed with a DVT or PE during the immediate 90 days post operative.	90 days
Secondary	Aspirin Usage Over 6 Week Post op Period	Number of Participants Taking aspirin over the 6 week post op period	6 week post op
Secondary	Compression Pump Compliance Over 2 Weeks Post op	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.	14 days post operative
Secondary	Overall Pump Experience After 2 Weeks	Correlation of Recorded Pump Compliance with perceived Patient Factors	2 weeks post op