Arista Hemostatic Powder for Total Knee Post Operative Outcomes Study

Launched by VIRTUA HEALTH, INC. · Aug 26, 2022

Keywords

ClinConnect Summary

Patients will be recruited from the Hospital for Special Surgery and Our Lady of Lourdes Programs. Patients will be prospectively enrolled when Institutional Review Board (IRB) approval is obtained. All patients will be undergoing a primary unilateral total knee arthroplasty for a diagnosis of osteoarthritis. Once enrolled in the study, each patient will be randomized into one of two groups. Group A will undergo a TKA utilizing Arista MPH ® intra-operatively. Group B will undergo a TKA without Arista MPH ®. All patients will receive a baseline IV dose of tranexamic acid per weight based gui...

Gender

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Eligibility criteria

• Inclusion Criteria:
• • • They willingly desire to participate and signed the informed consent
• • Are between the ages of 18 and 100 years of age
• • Have the mental capacity to provide consent
• • Are undergoing a primary unilateral total knee arthroplasty
• Exclusion Criteria:
• • • allergy to Arista MPH®
• • allergy to tranexamic acid
• • preoperative hepatic or renal dysfunction
• • serious cardiac or respiratory disease including coronary artery stent placement
• • congenital or acquired coagulopathy as evidence by INR \> 1.4 or PTT \> 1.4 times normal
• • thrombocytopenia as identified by a preoperative platelet count of \< 150,000/mm3
• • history of thromboembolic disease
• • pregnant or breast feeding
• • donated preoperative autologous blood
• • diagnosis of inflammatory arthritis
• • a preoperative hemoglobin \< 10 g/dL.