Total Knee Replacement
Conditions
Brief summary
The purpose of the study is to characterize and quantify the level of antibiotics eluted from antibiotic laden cement after primary cemented total knee arthroplasty. Patients will be identified by medical record review to make sure they meet inclusion and exclusion criteria. Patients that qualify and sign consent will be randomized to 1 of 4 antibiotic cement groups which are pre-mixed tobramycin, hand-mixed tobramycin, hand mixed vancomycin, and hand-mixed tobramycin and hand mixed vancomycin. Study patients will be blinded to their study group. Intraoperative fluid from the knee prior to surgery and postoperative drain fluid from the knee postoperatively will be collected as well.
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 be randomized to 1 of 4 antibiotic cement groups which are pre-mixed tobramycin, hand-mixed tobramycin, hand mixed vancomycin, and hand-mixed tobramycin and hand mixed vancomycin. Study patients will be blinded to their study group. Intraoperative fluid from the knee prior to surgery and postoperative drain fluid from the knee postoperatively will be collected as well.
Interventions
DRUGhand mixed vancomycin
hand mixed vancomycin powder into cement
DRUGhand mixed tobramycin
hand mixed tobramycin into cement
DEVICEpre-mixed tobramycin
this cement is already pre-mixed with tobramycin
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
patient will not know which antibiotic cement group they are in
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 * Total knee arthroplasty for primary osteoarthritis performed by Dr. Rick Wright. * Primary diagnosis of knee osteoarthritis *
Exclusion criteria
* Diminished mental capacity * Vancomycin allergy * Tobramycin allergy * Patient history requiring IV administration of vancomycin or tobramycin perioperatively * Chronic kidney disease stage III and stage IV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty | 24 hours | We wanted to measure the effect of elution level of vancomycin and tobramycin together |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pre-mixed Tobramycin patients will receive pre-mixed tobramycin cement
pre-mixed tobramycin: this cement is already pre-mixed with tobramycin | 12 |
| Hand Mixed Tobramycin patients will receive hand mixed tobramycin cement
hand mixed tobramycin: hand mixed tobramycin into cement | 12 |
| Hand Mixed Vancomycin patients will receive hand mixed vancomycin cement
hand mixed vancomycin: hand mixed vancomycin powder into cement | 12 |
| Hand-mixed Vancomycin and Tobramycin patients will receive hand mixed vancomycin and tobramycin
hand mixed vancomycin: hand mixed vancomycin powder into cement
hand mixed tobramycin: hand mixed tobramycin into cement | 12 |
| Intr-articular Vancomycin Patients will receive powdered vancomycin antibiotic into a cementless total knee in wound prior to closure | 12 |
| Total | 60 |
Baseline characteristics
| Characteristic | Total | Hand Mixed Tobramycin | Hand Mixed Vancomycin | Hand-mixed Vancomycin and Tobramycin | Pre-mixed Tobramycin | Intr-articular Vancomycin |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 37 Participants | 9 Participants | 6 Participants | 9 Participants | 8 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 3 Participants | 6 Participants | 3 Participants | 4 Participants | 7 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — | — | — | — |
| Region of Enrollment United States | 60 participants | 12 participants | 12 participants | 12 participants | 12 participants | 12 participants |
| Sex: Female, Male Female | 31 Participants | 4 Participants | 6 Participants | 6 Participants | 8 Participants | 7 Participants |
| Sex: Female, Male Male | 29 Participants | 8 Participants | 6 Participants | 6 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty
We wanted to measure the effect of elution level of vancomycin and tobramycin together
Time frame: 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pre-mixed Tobramycin | Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty | 23.9 mg/mL |
| Hand Mixed Tobramycin | Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty | 30.6 mg/mL |
| Hand Mixed Vancomycin | Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty | 12.6 mg/mL |
| Hand-mixed Vancomycin and Tobramycin | Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty | 16.2 mg/mL |
| Intr-articular Vancomycin | Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty | 1315 mg/mL |