Trial Outcomes & Findings for Arista Hemostatic Powder for Total Knee Post Operative Outcomes Study (NCT NCT05522153)

NCT ID: NCT05522153

Last Updated: 2024-09-19

Results Overview

Calculated on standard hospital protocol

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 61 participants
• Primary outcome timeframe: Time of incision until 90 days post-op
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	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 Arista: hemostatic powder	Control Group this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision
Overall Study STARTED	31	30
Overall Study COMPLETED	31	28
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Arista Hemostatic Powder for Total Knee Post Operative Outcomes Study

Baseline characteristics by cohort

Measure	Arista Group n=31 Participants 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 Arista: hemostatic powder	Control Group n=30 Participants this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision	Total n=61 Participants Total of all reporting groups
Age, Continuous	66.7 years STANDARD_DEVIATION 8.0 • n=5 Participants	65.9 years STANDARD_DEVIATION 8.4 • n=7 Participants	66.31 years STANDARD_DEVIATION 8.1 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	20 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	20 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	30 participants n=7 Participants	61 participants n=5 Participants

PRIMARY outcome

Timeframe: Time of incision until 90 days post-op

Calculated on standard hospital protocol

Outcome measures

Measure	Arista Group n=31 Participants 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 Arista: hemostatic powder	Control Group n=30 Participants this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision
Blood Loss	122.6 cubic centimeters Standard Deviation 25.3	133.3 cubic centimeters Standard Deviation 42.2

SECONDARY outcome

Timeframe: 3 months post op

Population: 61 patients were consented however some did not continue to the 3 month post op timepoint and therefore their data was not collected or analyzed.

Thigh circumference measurement 15 cm above the top of the patella

Outcome measures

Measure	Arista Group n=30 Participants 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 Arista: hemostatic powder	Control Group n=26 Participants this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision
Thigh Circumference	50.6 centimeters Standard Deviation 6.7	54 centimeters Standard Deviation 6.9

SECONDARY outcome

Timeframe: 3 months post op

Population: 61 patients were consented however some did not continue to the 3 month post op timepoint and therefore their data was not collected or analyzed.

Measured in degrees

Outcome measures

Measure	Arista Group n=30 Participants 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 Arista: hemostatic powder	Control Group n=24 Participants this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision
Range of Motion	117.8 Degrees Standard Deviation 9.6	114.3 Degrees Standard Deviation 11.7

Adverse Events

Arista Group

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Control Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arista Group n=31 participants at risk 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 Arista: hemostatic powder	Control Group n=28 participants at risk this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision
Musculoskeletal and connective tissue disorders Readmission due to pain	9.7% 3/31 • Number of events 3 • Enrollment to 90 Days post-op	7.1% 2/28 • Number of events 2 • Enrollment to 90 Days post-op

Other adverse events

Measure	Arista Group n=31 participants at risk 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 Arista: hemostatic powder	Control Group n=28 participants at risk this group of randomized patients will receive just the 1 gram of IV transexemic acid prior to incision
Infections and infestations Infection	6.5% 2/31 • Number of events 2 • Enrollment to 90 Days post-op	0.00% 0/28 • Enrollment to 90 Days post-op

Additional Information

Sean McMillan

Virtua Medical Group, PA

Phone: 908-812-7542

Email: smcmillan@virtua.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place