Clinical trial NCT05522153
Conditions: Blood Loss, Surgical
Sponsor: Virtua Health, Inc.
Start date: 2021-05-01; Completion date: 2023-06-08
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

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.

Arms: arm 1: 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 arm 2: this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision
Interventions: intervention 1: Arista
Intervention descriptions: intervention 1: hemostatic powder

Protocol documents:
ICF_001.pdf: 











Prot_000.pdf: 
Research Protocol Proposal: 
Title:  A Single Blinded Randomized Control Trial Comparing the Use of ARISTA 
Polysaccharide Hemostat in Total Knee Arthroplasty (TKA) 
Version: August 13, 2020 
NCT05522153 
Investigators: 
Sean Mc Millan, DO FAOAO 
Chief of Orthopedics 
Virtua Burlington and Camden Campuses 
Burlington, NJ 08016 
 
Michael Ast, MD 
Adult Reconstruction and Joint Replacement Service 
Hospital for Special Surgery 
New York, NY 10021 
Purpose: 
To determine if there is a benefit to overall reduction of blood loss, hematoma formation 
and outcomes in patients who undergo a primary unilateral TKA utilizing Arista MPH ® 
for hemostatic control. 
Objectives: 
The objectives of this study are to examine the effects of specific metrics in patients 
undergoing TKA with and without the utilization of Arista MPH® as a hemostatic 
adjunct.  
These outcome metrics include direct comparison of: 
- 
Blood loss (primary outcome) 
- 
Transfusion rates (secondary outcome) 
- 
Pre- and Post-operative thigh circumference 
- 
Post-operative range of motion 
- 
Adverse patient events within 90 days post-operatively 
Number of Participants: 
60 total patients (30 per group) 
Methods:   


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. 
Inclusion/Exclusion Criteria 
Patients will be included if: 
• 
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 
 
Patients will be excluded from the study if any of the following exist: 
• 
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 Results 
 
 
 
 
TABLE 1: DEMOGRAPHIC DATA (ALL PATIENTS OVER COURSE OF STUDY)  
Number of Subjects Screened 
 
Number of Patients Enrolled:  
 
Age 
Average ± SD (Range) 
Gender 
Male:Female 
Number of Withdrawn: 
 
 
Table 2: (ALL PATIENTS IN  STUDY) 
 
PreOp 
IntraOp 
6Hrs 
IV Fluids 
Y/N 
Y/N 
Y/N 
Hemoglobin 
Average ± SD 
(Range) 
 
Average ± SD 
(Range) 


Hematocrit 
Average ± SD 
(Range) 
 
Average ± SD 
(Range) 
Thigh circumference 
Average ± SD 
(Range) 
 
Average ± SD 
(Range) 
KSS 
Average ± SD 
(Range) 
 
 
PT 
Average ± SD 
(Range) 
 
 
PTT 
Average ± SD 
(Range) 
 
 
INR 
Average ± SD 
(Range) 
 
 
Blood products 
administered? 
 
Y/N (count) 
Y/N (count) 
Adverse Events 
 
Y/N (count) 
Y/N (count)  
 
 
Table 5: Additional data elements for all patients in study.  
 
 
24hrs 
48hrs 
28 days 
90days 
IV Fluids 
Y/N 
 
 
 
Hemoglobin 
Average ± SD 
(Range) 
 
 
 
Hematocrit 
Average ± SD 
(Range) 
 
 
 
Thigh Circumference 
Average ± SD 
(Range) 
Average ± SD 
(Range) 
 
 
Blood products 
administered? 
Y/N (count) 
Y/N (count) 
Y/N (count) Y/N (count) 
Adverse Events 
Y/N (count) 
Y/N (count)  
Y/N (count) Y/N (count) 
 
 


Attachment 9A 
 
Interim Report 
 
 
TABLE 1: DEMOGRAPHIC DATA (SINCE LAST REPORT “SLR”) 
Number of Subjects Screened SLR 
 
Number of Subjects enrolled SLR 
 
Age (SLR) 
Average ± SD (Range) 
Gender (SLR) 
Male:Female 
Number of Withdrawn: (SLR) 
 
 
 
TABLE 2: DEMOGRAPHIC DATA FOR ALL PATIENTS TO DATE 
Number of Subjects Screened 
 
Number of Patients Enrolled:  
 
Age 
Average ± SD (Range) 
Gender 
Male:Female 
Number of Withdrawn: