Concentration of prophylactic intraosseous regional vancomycin administration prior to total knee arthroplasty in the obese patient
Randomized controlled trial of intraosseous regional vancomycin prior to total knee arthroplasty in the obese population compared with systemic vancomycin administration with the primary outcome of tissue concentration
Seung Joon Chin
22 participants
Dec 15, 2014
Interventional
Conditions
Summary
The aim of the proposed study is to assess the concentration of vancomycin for prophylactic total knee arthroplasty in the obese patient. Infection remains a devastating complication to total knee joint arthroplasty. Obesity (BMI>30) has been shown in a meta-analysis of 150000 patients to have a significantly higher incidence of deep and superficial infections with an odds ratio of 2.4 and 2.2 respectively. Intraosseous regional administration (IORA) has been validated to produce higher tissue concentration of vancomycin compared to systemic administration in a study performed by the project leader that recently received the Mark Coventry Award. The pathophysiology of obesity alters the pharmacokinetics of vancomycin with a higher volume of distribution and a shorter elimination half-life. Thus the systemic dose of vancomycin increases according to body weight. The significance of this for regional antibiotics is unknown.
Eligibility
Inclusion Criteria5
- Undergoing primary total knee replacement
- Informed consent given
- Age>55
- Age<85
- BMI greater than or equal to 35
Exclusion Criteria5
- Previous compartment syndrome
- Allergy to antibiotics used in the study
- Abnormal cardiac, renal or liver function
- Concurrent nephrotoxic medications
- BMI <35
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Interventions
Patients would be randomised to two groups. Both groups would receive 1g systemic IV cefazolin 15 minutes prior to tourniquet inflation. This ensures all patients in the study receive effective antibiotic prophylaxis regardless of randomisation. Both groups of patients would then undergo routine prep and draping prior to exsanguination and inflation of an above knee tourniquet to 300mmHg. Immediately following inflation, the intervention group would receive 500mg of vancomycin via an EZ-IO (Vidacare, San Antonio, Texas) intraosseous cannula.
Locations(1)
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ACTRN12614001297617