Decrease in acute periprosthetic joint infections incidence with vancomycin-loaded calcium sulfate beads in patients with non-modifiable risk factors. A randomized clinical trial.

OBJECTIVES

The influence of local antibiotic therapy in orthopedic surgery remains unclear. In this trial, we evaluated the incidence of periprosthetic joint infections (PJI), after local or intravenous (IV) antibiotic prophylaxis. The aim of this intervention was to compare the PJI incidence in a population with non-modifiable risk factors after local prophylaxis with vancomycin-loaded calcium sulfate beads versus a control group.

METHODS

A total of 83 subjects were evaluated, inclusion criteria included participants over 60 years of age, with at least one main risk factor for PJI who underwent total hip or knee joint replacement between June 2019 and May 2020. Cases were randomized, and the intervention group received local prophylactic antibiotic therapy with calcium sulfate beads impregnated with vancomycin; conventional IV prophylactic antibiotic therapy was administered for the control group. C-reactive protein (CRP) and erythrocyte sedimentation rate (ERS) serum biomarkers were analyzed on the day 5 and weeks 4, 8, and 12. When needed, the synovial fluid sample was obtained and cultured for the early acute PJI diagnosis.

RESULTS

Acute PJI was found in 27 patients (67.5%) in the control group and 4 (9.3%) in the intervention group. The variable analysis identified that local prophylaxis with calcium sulfate beads reduces the incidence of acute knee or hip PJI in patients with non-modifiable risk factors compared to conventional prophylaxis (p < 0.0001) with a relative risk of 0.13 (CI:0.05-0.35). Length of hospital stay was also shorter in the intervention group at 4.6 days, compared to 15.25 days in the control group; p < 0.001.

CONCLUSIONS

Local antibiotic prophylaxis in patients with non-modifiable risk factors undergoing hip or knee replacement reduces the incidence of acute PJI compared to IV antibiotics.

CLINICAL TRIALS: NCT03976466 (clnicaltrials.gov) LEVEL OF EVIDENCE: II.