Antibiofilm-coated intramedullary nailing for tibial and femoral diaphyseal fractures at high-risk infection: outcomes of 103 consecutive patients

Abstract Background Fracture-related infection (FRI) is a devastating complication of intramedullary nailing of tibial and femoral diaphyseal fractures. The present study evaluates the clinical efficacy of an antibacterially coated intramedullary nail in patients with high-risk tibial and femoral diaphyseal fractures. Open fractures, fractures requiring fasciotomy or closed fractures with Tscherne grade II or III soft-tissue damage were considered fractures at high risk of infection. Methods A single-centre observational study was conducted between January 2022 and December 2024, in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. Patients who underwent definitive intramedullary nailing with Bactiguard (Bactiguard AB, Tullinge, Sweden)-coated Natural Nail (Zimmer Biomet, Warsaw, IN, USA) for tibial or femoral diaphyseal fractures at high risk of infection were included. The primary outcome was the incidence of FRI, defined according to the internationally validated consensus criteria. Secondary outcomes included time to union, rates of nonunion, malunion, unplanned secondary procedures and functional outcomes at a minimum follow-up of 12 months. Results A total of 103 patients were enrolled: 55 with tibial fractures and 48 with femoral fractures. The combined cohort comprised 90 males and 13 females, with a median age of 40 years (tibial) and 32.5 years (femoral). Open fractures accounted for 38.2% and 16.7% of tibial and femoral cases, respectively; the remaining patients presented closed fractures with severe soft-tissue involvement (Tscherne grade II–III). FRI was diagnosed in 6 of 103 patients (5.8%): 4 of 55 in the tibial cohort (7.3%) and 2 of 48 in the femoral cohort (4.2%). All FRI cases were successfully managed without sepsis or limb amputation. Fracture union was achieved in 94.5% of tibial and 95.8% of femoral cases, with mean times to union of 9.8 ± 3.2 and 8.4 ± 2.3 months, respectively. No malunion was recorded in either cohort. Open reduction was significantly associated with FRI in both the tibial ( p = 0.001) and femoral ( p = 0.03) cohorts; articular extension of the fracture was associated with FRI in femoral fractures ( p = 0.01). Conclusions Intramedullary nailing with a Bactiguard-coated implant yielded an overall FRI rate of 5.8% in a consecutive series of 103 high-risk tibial and femoral diaphyseal fractures. Open reduction was identified as a significant independent risk factor for FRI in both cohorts. These findings are hypothesis-generating and support the rationale for prospective, controlled studies to establish the efficacy of biofilm-inhibiting coatings in orthopaedic trauma.