Phase 4 N=20 Treatment

Intraarticular Antibiotic in TKA

Antibotics in Cementless Knees

Bottom Line

View on ClinicalTrials.gov: NCT04297631 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Concentration of Antibiotics in Cementless Knees Post op — 1702.5; 582.5; 56.1; 1943 micrograms per milliliter

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Tobramycin Powder (Drug); Vancomyscin (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Concentration of Antibiotics in Cementless Knees Post op	1702.5; 582.5; 56.1; 1943; 345; 8.7	—
SECONDARY Serum Concentrations of Vancomycin and Tobramycin at 1, 4, and 24 Hours.	2.3; 4.6; 3.1; 6.3; 8; .8	—

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.

Eligibility Criteria

Inclusion Criteria

Age over 18
Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis

Exclusion Criteria

Diminished mental capacity
Vancomycin allergy
Tobramycin allergy
Chronic kidney disease stage III and stage IV

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04297631). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.