Multimodal DVT Protocol in Tourniquet-less Total Knee Arthroplasty

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 100
• Participant gender: Both

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TriHealth Inc.
• Treatments: Aspirin
• Last Updated: 2015-10-20

Criteria

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