Multimodal DVT Protocol in Tourniquet-less Total Knee Arthroplasty

NCT02102828 | Completed

• 1 other identifier: 14045-14-008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Deep Vein Thrombosis

Keywords

DVT; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• DVT Occurence

  DVT Occurence measured by physical assessment and duplex ultrasound images for DVT detection

  3 weeks

Secondary Outcomes (2)

• Patient Satisfaction

  10 days

• Mobilization

  10 days

Study Arms (2)

Aspirin only

PLACEBO COMPARATOR

Patients receive aspirin therapy

Other: Aspirin

extended compression

EXPERIMENTAL

aspirin and extended compression therapy in combination

Device: extended compression

Interventions

extended compression DEVICE

Home use of extended compression therapy and aspirin

extended compression

Aspirin OTHER

standard therapy of aspirin

Aspirin only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Good Samaritan Hosptial

Cincinnati, Ohio, 45220, United States

Location

Related Publications (1)

• Snyder MA, Sympson AN, Scheuerman CM, Gregg JL, Hussain LR. Efficacy in Deep Vein Thrombosis Prevention With Extended Mechanical Compression Device Therapy and Prophylactic Aspirin Following Total Knee Arthroplasty: A Randomized Control Trial. J Arthroplasty. 2017 May;32(5):1478-1482. doi: 10.1016/j.arth.2016.12.027. Epub 2016 Dec 23.

  PMID: 28159420 DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Mark A Snyder, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 3, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 10, 2019

Record last verified: 2015-10

Locations

US (1)