Evaluating the Need for Pneumatic Compression Devices

NCT02641080 | Completed Results DMC

• 1 other identifier: 1508807749
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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%.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Venous Thromboembolism

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

  90 days

Secondary Outcomes (3)

• Aspirin Usage Over 6 Week Post op Period

  6 week post op

• Compression Pump Compliance Over 2 Weeks Post op

  14 days post operative

• Overall Pump Experience After 2 Weeks

  2 weeks post op

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

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

Drug: Aspirin

Aspirin with portable Compression Device

ACTIVE COMPARATOR

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.

Drug: Aspirin; Device: Portable Compression Device

Interventions

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.

Also known as: ASA

Aspirin; Aspirin with portable Compression Device

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.

Aspirin with portable Compression Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

WVU Medicine Department of Orthopaedics

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Matthew J. Dietz, MD
• Organization: West Virginia University Department of Orthopaedics

mdietz@hsc.wvu.edu

304-285-7445

Study Officials

• Matthew J Dietz, MD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 29, 2015
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 6, 2020
• Results First Posted: November 6, 2020

Record last verified: 2020-11

Locations

US (1)