A Phase 4 interventional study of hand mixed vancomycin and hand mixed tobramycin in Total Knee Replacement, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-02.
Sponsored by Washington University School of Medicine · Phase 4, Interventional, and Treatment
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.
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.
Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
patients will receive pre-mixed tobramycin cement
Device: pre-mixed tobramycin
patients will receive hand mixed tobramycin cement
Drug: hand mixed tobramycin
patients will receive hand mixed vancomycin cement
Drug: hand mixed vancomycin
patients will receive hand mixed vancomycin and tobramycin
Drug: hand mixed vancomycin · Drug: hand mixed tobramycin
hand mixed vancomycin powder into cement
Also known as: Vancomycin
hand mixed tobramycin into cement
Also known as: Tobramycin
this cement is already pre-mixed with tobramycin
Also known as: Antibiotic PMMA bone cement
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
| Milestone | Pre-mixed Tobramycin | Hand Mixed Tobramycin | Hand Mixed Vancomycin | Hand-mixed Vancomycin and Tobramycin | Intra-articular Vancomycin |
|---|---|---|---|---|---|
| Started | 12 | 12 | 12 | 12 | 12 |
| Completed | 12 | 12 | 12 | 12 | 12 |
| Not completed | 0 | 0 | 0 | 0 | 0 |
We wanted to measure the effect of elution level of vancomycin and tobramycin together
| mg/mL | Pre-mixed Tobramycin | Hand Mixed Tobramycin | Hand Mixed Vancomycin | Hand-mixed Vancomycin and Tobramycin | Intr-articular Vancomycin |
|---|---|---|---|---|---|
| Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty | 23.9 (9.8 to 125.4) | 30.6 (8.6 to 81.0) | 12.6 (2.0 to 72.6) | 16.2 (.3 to 47.3) | 1315 (429 to 2324.8) |
Collected over Adverse event data was collected within 4-6 weeks after surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-mixed Tobramycin | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Hand Mixed Tobramycin | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Hand Mixed Vancomycin | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Hand-mixed Vancomycin and Tobramycin | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Intra-articular Vancomycin | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Pre-mixed Tobramycin | Hand Mixed Tobramycin | Hand Mixed Vancomycin | Hand-mixed Vancomycin and Tobramycin | Intr-articular Vancomycin | Total |
|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 3 | 6 | 3 | 7 | 23 |
| >=65 years | 8 | 9 | 6 | 9 | 5 | 37 |
| Sex: Female, Male(Participants) | Pre-mixed Tobramycin | Hand Mixed Tobramycin | Hand Mixed Vancomycin | Hand-mixed Vancomycin and Tobramycin | Intr-articular Vancomycin | Total |
|---|---|---|---|---|---|---|
| Female | 8 | 4 | 6 | 6 | 7 | 31 |
| Male | 4 | 8 | 6 | 6 | 5 | 29 |
| Race and Ethnicity Not Collected(Participants) | Pre-mixed Tobramycin | Hand Mixed Tobramycin | Hand Mixed Vancomycin | Hand-mixed Vancomycin and Tobramycin | Intr-articular Vancomycin | Total |
|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | 0 |
| Region of Enrollment(participants) | Pre-mixed Tobramycin | Hand Mixed Tobramycin | Hand Mixed Vancomycin | Hand-mixed Vancomycin and Tobramycin | Intr-articular Vancomycin | Total |
|---|---|---|---|---|---|---|
| United States | 12 | 12 | 12 | 12 | 12 | 60 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Washington University School of Medicine