Management of Traumatic Bone Defects in Tibial Plateau Fractures with Antibiotic-Impregnated Biodegradable Calcium Sulfate Beads: A Prospective Clinical Trial

Abstract

Objectives: The purpose of this study was to assess adverse events and resorption of antibiotic-impregnated calcium sulfate beads used as a nonstructural void filler in tibia plateau fractures. This device may be more adaptable to a specific bacterium than vancomycin powder as it allows the mixtures of specific bactericidal antibiotics to treat bacterium with specific sensitivities. Design: A multicenter, non-randomized, uncontrolled prospective cohort study. Setting: Five level 1 trauma centers. Participants: Thirty adults with an acute closed tibia plateau fracture, OTA 41B and 41C fractures, requiring operative fixation. Intervention: After fracture fixation, the subchondral bone void was filled with the study device. Main Outcome Measures: Local wound reaction to the device was assessed and resorption of the calcium sulfate was measured on serial x-rays. Follow-up assessments occurred at six weeks, three months, six months and one year, with a CT scan performed at six months to determine resorption of the device. Results: Thirteen male and 17 female participants were recruited with a mean age of 53.3 ± 12.8 years. The median age was 55 years with a range of 29 to 78 years of age. Two participants reported serous drainage: one resolved without treatment, the other was diagnosed as a deep infection and required plate removal and oral antibiotics. There were no local or systemic allergic reactions. Resorption of the material averaged 70% by three months, 87% at six months, and 100% at one year. Conclusions: This device performed as anticipated and completely resorbed without any unexpected adverse events. It allowed for personalizing antibiotic choice with better reported elutional characteristics than vancomycin powder over two weeks and six weeks. Surgical site drainage was low, and 97% union rate was achieved. This is a safe surgical augment for local release of a chosen antibiotic into a contained subchondral defect in a periarticular fracture.