Arista Hemostatic Powder for Total Knee Post Operative Outcomes Study

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

To examine in Arista hemostatic powder results in less post-total knee arthroplasty blood loss, hematoma formation, and improved range of motion when compared to patients who did not receive the product.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Virtua Health, Inc.
• Collaborator: Becton, Dickinson and Company

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.