Evaluating the Need for Pneumatic Compression Devices

NCT ID: NCT02641080

Last Updated: 2020-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-10-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Aspirin

Participants randomized to aspirin alone will be advised to take a 325mg per day as their outpatient DVT/PE prophylaxis.

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: 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.

Aspirin with portable Compression Device

Participants randomized to the compression device group are asked to wear the compression devices for 20 hours a day for 2 weeks along with taking an 325mg aspirin per day as their outpatient DVT/PE prophylaxis.

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: 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.

Portable Compression Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Other Intervention Names

ASA

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Matthew Dietz, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew J Dietz, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

WVU Medicine Department of Orthopaedics

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

1508807749

Identifier Type: -

Identifier Source: org_study_id