The Use of a Vancomycin-Eluting Calcium Sulfate and Hydroxyapatite Composite for Dead Space Management in a Fracture-Related Infection (FRI): A Retrospective Case Series

Abstract

Background Cerament V (CV) is a bioactive bone graft substitute with vancomycin as an antimicrobial agent designed for the management of bone defects and infections. In this retrospective case series, we aim to evaluate the clinical outcomes of patients treated with CV for fracture-related infections (FRI). Methods All patients who received treatment for FRI and whose dead space and bone reconstruction management was solely done utilizing CV were included. The patients were recruited between September 2015 and September 2022. Data including patient demographics, primary diagnosis, surgical procedure, antibiotic therapy, microbiological results, complications, and follow-ups were recorded. Outcomes were assessed, including the percentage of bone void filling on radiographs, infection resolution, adverse effects, and patient-reported outcome measures by EQ-5D-5L. Results We present in this retrospective case series seven patients (three female) with a mean age of 56.86 ± 16.27 years. All patients underwent surgical debridement and bone grafting using CV. Antibiotic therapy was tailored to the specific pathogens isolated in each case. Infection eradication was achieved in five patients. On average, new bone formation was 81% at six months and 99% at 12 months. Patient-reported outcome parameters (PROMs) utilizing the EQ-5D-5L questionnaire were recorded at a mean follow-up of 42.00 ± 27.97 months with a median EQ-5D-5L index of 0.541 (range: 0.459 - 0.97) and a mean EQ-5D-Visual Analogue Scale (VAS) score of 62.20 ± 24.68. No major adverse events related to CV were reported. Conclusion This retrospective case series demonstrates the potential efficacy of CV in managing FRIs. The bioactive and antibiotic properties of CV appear to facilitate infection resolution and bone healing, with an advantageous safety profile. Larger prospective studies are needed to further investigate the utility of CV in orthopedic practice.