Arista Hemostatic Powder for Total Knee Post Operative Outcomes Study

A Single Blinded Randomized Control Trial Comparing the Use of ARISTA Polysaccharide Hemostat in Total Knee Arthroplasty (TKA)

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Drug: Arista

Detailed Description

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 guidelines prior to incision.

A thigh tourniquet will be utilized from prior to incision until wound closure is complete. Arista MPH ® will be used intra-operatively. A 5 gram vial of Arista MPH will be the standard of use. ARISTA will be used in accordance with the instructions for use. Additional need for Arista MPH ® usage during the case will be permitted and recorded. Standard electrocautory will be permitted, however additional thermal devices intended for hemostatic control will not be utilized.

Pre-operative hemoglobin, hematocrit, PT, PTT, and INR will be per standard institutional protocol within 30 days of surgery. The hemoglobin and hematocrit will be repeated 24 hours after the procedure per standard physician protocol. IV fluids administered pre-op, intra-op and post op for the first 24 hours will be recorded. Administration of any blood products from the time of incision until 90 days post-op will be recorded. Blood loss will be calculated via standard HSS. Drains will not be utilized.

The transfusion criteria is: a hemoglobin level of <8 g/dL or a hemoglobin level of <10 g/dL in a patient with symptomatic anemia or deemed at high risk because of notable underlying cardiac comorbidities. Blood will be administered 1 unit at a time, and the presence of symptoms or signs was reassessed.

Pre-operative thigh circumference will be measured on the day of the surgery. For standardization, the circumference will be recorded 15 cm proximal to the superior pole of the patella. Post-operatively the thigh circumference will be measured at 24 hours, post-operative day 14 +/- 4 days, and post operatively at 3 months +/- 1 week.

Post-operative knee range of motion will be recorded at 24 hours, post-operative day 14 +/- 4 days, and post-operatively at 3 months +/- 1 week.

Pre-operative and post-operative day 14 (+/- 4 days) and post-operative 3 months (+/- 1 week) knee society short form scores will be collected All post-operative adverse events related to the procedure will be recorded. These invents include, but are not limited to: readmission, infection, prosthesis loosening, wound dehiscence, and wound drainage.

All data will be de-identified and securely maintained in an IRB approved manner.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: sean mcmillan, DO; Phone Number: 6097479200; Email: smcmillan@virtua.org

Study Locations

• United States
  • New Jersey
    • Marlton, New Jersey, United States, 08053-9697
      • Recruiting
      • Virtua Health System
      • Contact: Kristin Broderick; Phone Number: 856-355-1225; Email: KBroderick@virtua.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arista group; this group of randomized patients will receive 5 grams of arista hemostatic powder intra-operatively in their wound in addition to 1 gram of IV transexemic acid prior to incision	Drug: Arista; hemostatic powder
No Intervention: control group; this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Loss	Calculated on standard hospital protocol	Time of incision until 90 days post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hematoma formation	Thigh circumference measurement 15 cm above the top of the patella	preoperatively, 24 hours postop, 14 days postop, 3 months post op
Range of motion	Measured in degrees	24 hours postop, 14 days postop, 3 months post op

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): March 17, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Blood Loss, Surgical
• Other Study ID Numbers: virtuamcmillan1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No