Uncoated Versus Antibiotic Coated Intramedullary Interlocking Nail in Open Tibial Shaft Fractures –A Prospective Radndomised Study of Clinical Outcomes and Complications

Background: Open tibial shaft fractures are associated with a high risk of infection, delayed union, non-union, and repeated surgical procedures. Antibiotic-coated intramedullary nails provide stable fixation together with local antibiotic delivery and may improve treatment outcomes. The objective is to compare clinical outcomes, fracture healing, infection rates, secondary procedures, and functional recovery between uncoated and antibiotic-coated intramedullary interlocking nails in open tibial shaft fractures. Material and Methods: This prospective randomized study included 50 adults with open tibial shaft fractures treated at Basaveshwara Medical College Hospital and Research Centre from May 2023 to January 2025. Patients were allocated equally to uncoated and antibiotic-coated nail groups. The coated nails were prepared using polymethylmethacrylate cement containing vancomycin and gentamicin. Infection, wound complications, union time, delayed union, non-union, secondary procedures, hospital stay, SF-36 scores, and Lysholm scores were compared. Results: Infection occurred in 48% of the uncoated group and 12% of the coated group (p=0.007). No osteomyelitis occurred in the coated group. Mean union time was significantly shorter with coated nails (7.1 versus 9.2 months, p<0.0001). Delayed union occurred in 20% versus 60%, while non-union occurred in 4% versus 28% in the coated and uncoated groups, respectively. Repeat debridement, dynamization, bone grafting, and revision surgery were significantly less frequent in the coated group. Mean hospital stay was 15 days with coated nails and 26 days with uncoated nails. SF-36 and Lysholm scores were significantly better in the coated group at all follow-ups. Conclusion: Antibiotic-coated intramedullary nails significantly reduced infection and secondary procedures, promoted faster union, shortened hospitalization, and improved functional recovery compared with uncoated nails in open tibial shaft fractures.

Keywords: Open tibial fracture, antibiotic-coated nail, intramedullary nailing, gentamicin, vancomycin, and infection, non-union.