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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001297617

Enrollment

Registered

2014-12-11

Start date

2014-12-15

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 (Vi

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

55 Years to 85 Years

Healthy volunteers

Inclusion criteria

Undergoing primary total knee replacement Informed consent given Age>55 Age<85 BMI greater than or equal to 35

Exclusion criteria

Previous compartment syndrome Allergy to antibiotics used in the study Abnormal cardiac, renal or liver function Concurrent nephrotoxic medications BMI <35

Outcome results