Prospective Randomized Study Investigating the Characterization of Antibiotics From Antibiotic Impregnated Cement After Total Knee Arthroplasty
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
patient will not know which antibiotic cement group they are in
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Pre-mixed tobramycin
patients will receive pre-mixed tobramycin cement
Intervention: pre-mixed tobramycin (Device)
hand mixed tobramycin
patients will receive hand mixed tobramycin cement
Intervention: hand mixed tobramycin (Drug)
hand mixed vancomycin
patients will receive hand mixed vancomycin cement
Intervention: hand mixed vancomycin (Drug)
hand-mixed vancomycin and tobramycin
patients will receive hand mixed vancomycin and tobramycin
Intervention: hand mixed vancomycin (Drug)
hand-mixed vancomycin and tobramycin
patients will receive hand mixed vancomycin and tobramycin
Intervention: hand mixed tobramycin (Drug)
Outcomes
Primary Outcomes
Amount of Vancomycin and Tobramycin Eluted From Hand Mixed Cement With Both Antibiotics After Total Knee Arthroplasty
Time Frame: 24 hours
We wanted to measure the effect of elution level of vancomycin and tobramycin together
Secondary Outcomes
No secondary outcomes reported