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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-mixed tobramycin | Active Comparator | patients will receive pre-mixed tobramycin cement |
|
| hand mixed tobramycin | Active Comparator | patients will receive hand mixed tobramycin cement |
|
| hand mixed vancomycin | Active Comparator | patients will receive hand mixed vancomycin cement |
|
| hand-mixed vancomycin and tobramycin | Experimental | patients will receive hand mixed vancomycin and tobramycin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hand mixed vancomycin | Drug | hand mixed vancomycin powder into cement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours |
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Inclusion Criteria:
Age over 18
Total knee arthroplasty for primary osteoarthritis performed by Dr. Rick Wright.
Primary diagnosis of knee osteoarthritis
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
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| Name | Affiliation | Role |
|---|---|---|
| Charles Lawrie, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University Orthopedics | St Louis | Missouri | 63019 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pre-mixed Tobramycin | patients will receive pre-mixed tobramycin cement pre-mixed tobramycin: this cement is already pre-mixed with tobramycin |
| FG001 | Hand Mixed Tobramycin | patients will receive hand mixed tobramycin cement hand mixed tobramycin: hand mixed tobramycin into cement |
| FG002 | Hand Mixed Vancomycin | patients will receive hand mixed vancomycin cement hand mixed vancomycin: hand mixed vancomycin powder into cement |
| FG003 | 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 |
| FG004 | Intra-articular Vancomycin | Patients will receive powdered vancomycin antibiotic into a cementless total knee in wound prior to closure |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pre-mixed Tobramycin | patients will receive pre-mixed tobramycin cement pre-mixed tobramycin: this cement is already pre-mixed with tobramycin |
| BG001 | Hand Mixed Tobramycin | patients will receive hand mixed tobramycin cement hand mixed tobramycin: hand mixed tobramycin into cement |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Inter-Quartile Range | mg/mL | 24 hours |
|
Adverse event data was collected within 4-6 weeks after surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pre-mixed Tobramycin | patients will receive pre-mixed tobramycin cement pre-mixed tobramycin: this cement is already pre-mixed with tobramycin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Venessa Riegler | Washington University | 314-362-1721 | rieglerv@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2019 | Oct 8, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| D014031 | Tobramycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
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patient will not know which antibiotic cement group they are in
| hand mixed tobramycin | Drug | hand mixed tobramycin into cement |
|
|
| pre-mixed tobramycin | Device | this cement is already pre-mixed with tobramycin |
|
|
| BG002 | Hand Mixed Vancomycin | patients will receive hand mixed vancomycin cement hand mixed vancomycin: hand mixed vancomycin powder into cement |
| BG003 | 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 |
| BG004 | Intr-articular Vancomycin | Patients will receive powdered vancomycin antibiotic into a cementless total knee in wound prior to closure |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hand Mixed Vancomycin |
patients will receive hand mixed vancomycin cement hand mixed vancomycin: hand mixed vancomycin powder into cement |
| OG003 | 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 |
| OG004 | Intr-articular Vancomycin | Patients will receive powdered vancomycin antibiotic into a cementless total knee in wound prior to closure |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Hand Mixed Tobramycin | patients will receive hand mixed tobramycin cement hand mixed tobramycin: hand mixed tobramycin into cement | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Hand Mixed Vancomycin | patients will receive hand mixed vancomycin cement hand mixed vancomycin: hand mixed vancomycin powder into cement | 0 | 12 | 0 | 12 | 0 | 12 |
| EG003 | 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 | 0 | 12 | 0 | 12 | 0 | 12 |
| EG004 | Intra-articular Vancomycin | patients will receive powdered vancomycin into the wound before closure | 0 | 12 | 0 | 12 | 0 | 12 |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D009328 | Nebramycin |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|