Phase 3 N=22 Randomized Treatment

Regional Prophylactic Vancomycin in Revision Total Knee Replacement

Arthropathy of Knee Joint

Bottom Line

View on ClinicalTrials.gov: NCT02020031 ↗

Enrolled (actual)

Serious AEs

20.0%

Results posted

Nov 2016

Primary outcome: Primary: Mean Concentration of Vancomycin in Subcutaneous Fat — 94.1; 3.2; 88.3; 5.0 µg/g — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Vancomycin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Concentration of Vancomycin in Subcutaneous Fat	94.1; 3.2; 88.3; 5.0; 69.4; 4.2	<0.0001 sig
PRIMARY Mean Concentration of Vancomycin in Bone Samples	90.7; 7.9; 193; 8.6; 59.8; 5.0	—

Summary

The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (the knee joint) is more effective at preventing infection than the current standard dose which is given intravenously (IV) through a wrist vein.

Eligibility Criteria

Inclusion Criteria

Revision total knee arthroplasty
Informed consent given

Exclusion Criteria

Current treatment with IV Vancomycin within the preceding 7 days
Previous hypersensitivity to vancomycin
Significant cardiac or respiratory abnormality
Contraindications to using the intraosseous vascular access system (EZ-IO)
Sepsis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02020031). 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.