Multimodal DVT Protocol in Tourniquet-less Total Knee Arthroplasty



Status:Completed
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2014
End Date:March 2015

Use our guide to learn which trials are right for you!

Efficacy of Prolonged Distal Calf Compression as Part of a Multimodal DVT Protocol in Tourniquet-less Total Knee Arthroplasty: a Randomized Clinical Trial in 100 Patients

The Cothera VPulse(tm) mechanical compression device (MCD) combines rapid intermittent
sequential compression with cold therapy and is designed for single patient use in the home.
Additionally, it can track patient compliance. This study will examine if there is a
difference in deep vein thrombosis (DVT) occurrence over 3 weeks after tourniquet-less total
knee arthroplasty (TKA) and multimodal prophylaxis with or without extended MCD use in a
cooling device/MCD system.

In recent years there has been significant progress towards more effective and practical
thromboprophylaxis in joint replacement surgeries. Since Aspirin 325mg twice daily has been
recently included as a nationally approved venous thromboembolism (VTE) prophylaxis in the
Surgical Care Improvement Project (SCIP) protocols for low risk total knee arthroplasty
(TKA) patients, it is necessary to optimize multimodal prophylaxis methods. These include
reduced tourniquet time, early mobilization, and mechanical compression devices (MCDs). MCDs
are commonly used as part of the in-hospital VTE prophylaxis measures; however, it has not
been demonstrated in clinical trials that optimal prophylaxis methods would be enhanced by
prolonged use of a MCD after discharge. In order to achieve this, a potentially valuable
solution has recently been made available to the outpatient population. The Cothera
VPulse(tm) is a MCD that combines rapid intermittent sequential compression with cold
therapy. It is designed for single patient use in the home and includes technology to track
patient compliance. The purpose of this study is to examine if there is a difference in DVT
occurrence over 3 weeks after tourniquet-less TKA and multimodal prophylaxis with or without
extended MCD use in a cooling device/MCD system.

Inclusion Criteria:

- TKA candidacy, osteoarthritis, patients able to understand study intent, and agree to
study participation

Exclusion Criteria:

- Subjects with personal or family history of DVT, currently taking
antiplatelet/anticoagulant drugs, genetic risk factor positive for VTE, pronounced
thrombocytopenia, GI bleed within 6 months of surgery, NSAID intolerance, orthopaedic
and medical co-morbidities that would prevent postoperative rapid mobilization and
compliance with MCD such as extra-articular pathology with referred pain to the knee
(spinal stenosis, neuropathy, ipsilateral hip disease), severe knee deformity,
post-traumatic and inflammatory arthritis, BMI above 40, active knee sepsis, remote
sites of active infection, ASA class > lll, cardiac disease failing medical
clearance, severe liver disease, peripheral artery disease, seizure disorder, alcohol
abuse, smoking abuse
We found this trial at
1
site
Cincinnati, Ohio 45220
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials