The immediate ex vivo covering and filling characteristics of antibiotic-loaded resorbable calcium sulfate paste around intramedullary nails.

Background: Antibiotic-laden polymethyl methacrylate (PMMA)-coated intramedullary nails (IMNs) are an effective treatment for osteomyelitis, but they pose multiple disadvantages. Antibiotic-loaded resorbable calcium sulfate (ARCS) paste is an alternative option to deliver a local antibiotic depot around IMNs, but such use has been minimally investigated. This study aimed to define the immediate covering and filling characteristics of ARCS around IMNs by using anatomic bone models. Method: Five tibia models (foam with cortical shell) were prepared by reaming a uniform 13 mm cylindrical path. Three 40 cc kits of ARCS (STIMULAN, Biocomposites Ltd, Keele, UK) were mixed with 3 g vancomycin and 1.2 g tobramycin powder and injected into the intramedullary canal while wet, completely filling the canal. A 10 mm $\times$ 345 mm tibial IMN was immediately inserted without interlocking screws and allowed to completely cure for 2 h. The models were then longitudinally cut without disrupting the dry ARCS covering on the nail. The ARCS was removed from the nail at five equidistant locations along the nail. The thickness of the ARCS was measured with a caliper. A repeated-measures ANOVA test was used to compare the mean width of each segment for each model. Results: In all five trials, the tibial canal volume surrounding the nail remained completely filled. The ARCS paste was confluent along the length of the IMN. There were no gaps or air pockets between the paste and reamed model bone. There was no statistically significant difference among the five samples at each location ( $p=0.913$ ) or among the five locations along the bone ( $p=0.210$ ). Conclusion: In a model setting, ARCS fully fills the intramedullary canal of a tibia and covers an IMN uniformly. Study of the in vivo material properties of ARCS may further elucidate the bone penetration as well as the clinical utility of this antibiotic depot technique.