Multimodal DVT Protocol in Tourniquet-less Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Deep Vein Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Aspirin only

Patients receive aspirin therapy

Group Type PLACEBO_COMPARATOR

Aspirin

Intervention Type OTHER

standard therapy of aspirin

extended compression

aspirin and extended compression therapy in combination

Group Type EXPERIMENTAL

extended compression

Intervention Type DEVICE

Home use of extended compression therapy and aspirin

Interventions

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extended compression

Home use of extended compression therapy and aspirin

Intervention Type DEVICE

Aspirin

standard therapy of aspirin

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No