Multimodal DVT Protocol in Tourniquet-less Total Knee Arthroplasty

Deep Vein Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102828
• Other study ID #: 14045-14-008
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Device:
• extended compression
Home use of extended compression therapy and aspirin

Other:
• Aspirin
standard therapy of aspirin

Locations

Country	Name	City	State
United States	Good Samaritan Hosptial	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DVT Occurence	DVT Occurence measured by physical assessment and duplex ultrasound images for DVT detection	3 weeks
Secondary	Patient Satisfaction	Patient satisfaction will be measured 10 days postop using the EuroQol standardized instrument	10 days
Secondary	Mobilization	Patient activity level will be measured using the standardized UCLA Activity Score	10 days