N/A
N=80
Evaluating the Need for Pneumatic Compression Devices
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02641080 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Participants With Venous Thromboembolism — 0; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aspirin (Drug); Portable Compression Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- West Virginia University
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Venous Thromboembolism |
0; 3 | — |
| SECONDARY Aspirin Usage Over 6 Week Post op Period |
2; 1 | — |
| SECONDARY Compression Pump Compliance Over 2 Weeks Post op |
10 | — |
| SECONDARY Overall Pump Experience After 2 Weeks |
0.36; 0.26; 0.11; -0.22; -0.25; -0.12 | — |
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%.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02641080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.