Two-Year Follow-Up Shows Gentamicin-Coated Tibial Nails Reduce Infection Rates in Open Tibial Fractures

Introduction: Open tibial fractures carry a high risk of fracture-related infection (FRI), and prevention typically relies on early antibiotics and debridement. However, achieving optimum local antibiotic concentration remains challenging. Gentamicin-coated intramedullary nails (GCN) have been developed to prevent biofilm formation, showing short-term efficacy without interfering with fracture healing. Medium- and long-term data on GCN use are limited. This study aimed to assess the effectiveness and safety of GCN in medium-term follow-up. Methods: A prospective cohort study of patients with open tibial fractures was treated with GCN under a standardized protocol, with a minimum follow-up of 24 months. Patients with traumatic amputations, protocol infringement, or loss of follow-up were excluded. The analysis assessed overall FRI incidence by Gustilo-Anderson (GA) classification. Results: Of 907 patients, 139 were included, with 2 lost to follow-up. The overall FRI incidence was 8.8%, the average healing time was 34.3 weeks, and the non-union rate was 2.2%. FRI incidence by GA classification was 0% in GA I, 2.9% in GA II, 2.9% in GA IIIA, 44.4% in GA IIIB, and 33.3% in GA IIIC. External fixation (EF) was required in 45.2% of cases, with 16.1% developing FRI (14.3% in GA II, 2.8% in GA IIIA, 50% in GA IIIB, and 33.3% in GA IIIC). In non-EF cases, FRI occurred in 2.7% of patients (2.9% in GA IIIA and 25% in GA IIIB). No adverse effects were reported due to locally administered gentamicin. Conclusions: In the medium term, GCN has consistently demonstrated safety and efficacy in preventing FRI in open tibial fractures, particularly in GA IIIA cases, even with the use of temporary EF. These findings highlight its potential as a valuable tool in managing open tibial fractures. However, further studies with long-term outcomes are needed to evaluate its effectiveness in GA IIIB and IIIC fractures.