Trial Outcomes & Findings for Intraarticular Antibiotic in TKA (NCT NCT04297631)

NCT ID: NCT04297631

Last Updated: 2021-10-05

Results Overview

1\. Determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 20 participants
• Primary outcome timeframe: 1 hour, 4 hours, and 24 hours
• Results posted on: 2021-10-05

Participant Flow

Participant milestones

Measure	Vancomycin All patients getting vancomycin and tobramycin to see concentration after 24hrs in knee drain and serum levels. Vancomyscin: Everyone gets the vancomyscin powder. Tobramycin Powder: Everyone gets tobramycin powder.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Vancomycin n=20 Participants All patients getting vancomycin and tobramycin to see concentration after 24hrs in knee drain and serum levels. Vancomyscin: Everyone gets the vancomyscin powder. Tobramycin Powder: Everyone gets tobramycin powder.
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=20 Participants
Age, Categorical >=65 years	13 Participants n=20 Participants
Sex: Female, Male Female	8 Participants n=20 Participants
Sex: Female, Male Male	12 Participants n=20 Participants
Vancomycin	20 Participants n=20 Participants

PRIMARY outcome

Timeframe: 1 hour, 4 hours, and 24 hours

Population: All primary cementless TKA two surgeons at a single institution over a 4-week period were assessed preoperatively for study inclusion.

1. Determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty.

Outcome measures

Measure	Intraarticular Concentrations of Tobramycin and Vancomycin n=20 Participants All patients getting vancomycin and tobramycin to see serum concentration after 24hrs in knee drain and serum levels. Vancomyscin: Everyone gets the vancomyscin powder. Tobramycin Powder: Everyone gets tobramycin powder.
Concentration of Antibiotics in Cementless Knees Post op 1 hour Vancomycin Intraarticular concentration	1702.5 micrograms per milliliter Interval 440.0 to 4000.0
Concentration of Antibiotics in Cementless Knees Post op 4 hour Vancomycin Intraarticular concentration	582.5 micrograms per milliliter Interval 61.0 to 2400.0
Concentration of Antibiotics in Cementless Knees Post op 24 hour Vancomycin Intraarticular concentration	56.1 micrograms per milliliter Interval 12.4 to 290.0
Concentration of Antibiotics in Cementless Knees Post op 1 hour tobramycin Intraarticular concentration	1943 micrograms per milliliter Interval 345.0 to 7850.0
Concentration of Antibiotics in Cementless Knees Post op 4 hour tobramycin Intraarticular concentration	345 micrograms per milliliter Interval 31.8 to 1150.0
Concentration of Antibiotics in Cementless Knees Post op 24 hour tobramycin Intraarticular concentration	8.7 micrograms per milliliter Interval 1.5 to 358.0

SECONDARY outcome

Timeframe: 1 hour, 4 hours, and 24 hours

2. Determine the serum concentrations of these antibiotics postoperatively

Outcome measures

Measure	Intraarticular Concentrations of Tobramycin and Vancomycin n=20 Participants All patients getting vancomycin and tobramycin to see serum concentration after 24hrs in knee drain and serum levels. Vancomyscin: Everyone gets the vancomyscin powder. Tobramycin Powder: Everyone gets tobramycin powder.
Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. 1 hour vancomycin serum concentration	2.3 micrograms per milliliter Interval 0.0 to 3.9
Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. 4 hour vancomycin serum concentration	4.6 micrograms per milliliter Interval 0.0 to 6.8
Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. 4 tobramycin	8 micrograms per milliliter Interval 3.1 to 10.5
Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. 24 hour vancomycin serum concentration	3.1 micrograms per milliliter Interval 0.0 to 5.8
Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. 1 hour tobramycin serum concentration	6.3 micrograms per milliliter Interval 3.2 to 8.4
Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. 24 hour tobramycin	.8 micrograms per milliliter Interval 0.5 to 2.0

Adverse Events

Intraarticular Concentrations of Tobramycin and Vancomycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Venessa Riegler

Washington University

Phone: 3143621721

Email: rieglerv@wustl.edu

Results disclosure agreements

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