Tibial Fractures at High Risk of Infection Treated with Intramedullary Nailing: Do Nails with Antibacterial Coatings Make a Difference?

Background: Tibial fractures represent the most common model for studying complications of long-bone fracture treatment, particularly fracture-related infections (FRIs). One of the recently emerging FRI prevention strategies has been the use of coated intramedullary nails. The aim of this study was to evaluate the clinical effectiveness of 2 commercially available coated tibial nails (the ETN PROtect and the ZNN Bactiguard) in comparison with standard noncoated nails in clinical scenarios of high FRI risk. Methods: In-hospital and follow-up data for a minimum of 12 months were collected. High risk was defined as open injuries, fasciotomies, and fractures treated initially with a bridging external fixator or Oestern-Tscherne grade 2/3 soft tissue trauma. Statistical analysis was performed using Stata, with a significance level of p < 0.05. Results: Two hundred thirty-four high-risk tibial fractures were operated in different periods by the same team of senior surgeons. The PROtect nail was used in 102 fractures, the Bactiguard in 41, and the noncoated standard nail in 92. There were no statistically significant differences in epidemiological and comorbidity characteristics, severity of associated injuries, fracture types, severity of soft tissue trauma, time-to-definitive fixation, or soft tissue management between the coated nail groups. Overall, the incidence of FRIs was 9.4%: for the PROtect nails, 7.8%; for the Bactiguard nails, 4.9%; and 13.2% for the noncoated nails (p = 0.167). Staphylococcus was the most common species, whereas 11 (50%) samples were polymicrobial, and 18.8% were multidrug-resistant species. Uncomplicated union within 6 months was recorded in 64.7% vs. 65.9% vs. 53.8% and unplanned secondary interventions in 26.5% vs. 22% vs. 41.8%, respectively, (p = 0.009). Conclusions: The incidence of FRIs in these high-risk tibial fractures was 9.4%. Compared with noncoated intramedullary implants, both types of coated nails achieved a lower incidence of FRI. Larger-scale studies would provide more robust evidence to inform patient care and validate the role of coated implants in preventing FRI. Level of Evidence: Level III, cohort study (nonrandomized comparative study). See Instructions for Authors for a complete description of levels of evidence.