Antibotics in Cementless Knees
Conditions
Brief summary
The purpose of the study is to determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty and determine the serum concentrations of these antibiotics postoperatively.
Detailed description
Patients will be identified by medical record review to make sure they meet inclusion and exclusion criteria. Patients that qualify and sign consent will have tobramycin and vancomycin antibiotic powder placed into the knee during surgery. Postoperative drain fluid from the knee will be collected.
Interventions
Everyone gets tobramycin powder.
DEVICEVancomyscin
Everyone gets the vancomyscin powder.
Sponsors
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age over 18 2. Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis
Exclusion criteria
1. Diminished mental capacity 2. Vancomycin allergy 3. Tobramycin allergy 4. Chronic kidney disease stage III and stage IV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Antibiotics in Cementless Knees Post op | 1 hour, 4 hours, and 24 hours | 1\. Determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. | 1 hour, 4 hours, and 24 hours | 2\. Determine the serum concentrations of these antibiotics postoperatively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Vancomycin | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 13 Participants | — |
| Age, Categorical Between 18 and 65 years | 7 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
| Vancomycin | 20 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Concentration of Antibiotics in Cementless Knees Post op
1\. Determine the intra-articular concentration of vancomycin and tobramycin after administration of vancomycin and tobramycin powder in primary cementless total knee arthroplasty.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intraarticular Concentrations of Tobramycin and Vancomycin | Concentration of Antibiotics in Cementless Knees Post op | 1 hour Vancomycin Intraarticular concentration | 1702.5 micrograms per milliliter |
| Intraarticular Concentrations of Tobramycin and Vancomycin | Concentration of Antibiotics in Cementless Knees Post op | 4 hour Vancomycin Intraarticular concentration | 582.5 micrograms per milliliter |
| Intraarticular Concentrations of Tobramycin and Vancomycin | Concentration of Antibiotics in Cementless Knees Post op | 24 hour Vancomycin Intraarticular concentration | 56.1 micrograms per milliliter |
| Intraarticular Concentrations of Tobramycin and Vancomycin | Concentration of Antibiotics in Cementless Knees Post op | 1 hour tobramycin Intraarticular concentration | 1943 micrograms per milliliter |
| Intraarticular Concentrations of Tobramycin and Vancomycin | Concentration of Antibiotics in Cementless Knees Post op | 4 hour tobramycin Intraarticular concentration | 345 micrograms per milliliter |
| Intraarticular Concentrations of Tobramycin and Vancomycin | Concentration of Antibiotics in Cementless Knees Post op | 24 hour tobramycin Intraarticular concentration | 8.7 micrograms per milliliter |
Secondary
Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours.
2\. Determine the serum concentrations of these antibiotics postoperatively
Time frame: 1 hour, 4 hours, and 24 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Intraarticular Concentrations of Tobramycin and Vancomycin | Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. | 1 hour vancomycin serum concentration | 2.3 micrograms per milliliter |
| Intraarticular Concentrations of Tobramycin and Vancomycin | Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. | 4 hour vancomycin serum concentration | 4.6 micrograms per milliliter |
| Intraarticular Concentrations of Tobramycin and Vancomycin | Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. | 24 hour vancomycin serum concentration | 3.1 micrograms per milliliter |
| Intraarticular Concentrations of Tobramycin and Vancomycin | Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. | 1 hour tobramycin serum concentration | 6.3 micrograms per milliliter |
| Intraarticular Concentrations of Tobramycin and Vancomycin | Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. | 4 tobramycin | 8 micrograms per milliliter |
| Intraarticular Concentrations of Tobramycin and Vancomycin | Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours. | 24 hour tobramycin | .8 micrograms per milliliter |