Stabilization of Tibial Fractures at Risk of Complications With the Bactiguard Intramedullary Nail: Early to Medium Results With a Novel Metal-Coated Device

Abstract

Objectives: The purpose of this study was to investigate the safety and early clinical results from the use of a novel, noble metal-coated titanium tibial nail for the definite stabilization of tibial shaft fractures at risk of developing complications. Design: This is a retrospective case series with prospectively collected data. Setting: Level I Trauma Centre in the United Kingdom. Patients and Intervention: Thirty-one patients who were managed with the Bactiguard-coated Natural Nail and achieved a minimum of a 12-month follow-up. Main Outcome Measurements: The main outcomes of this study were the incidence of adverse events (related to implant safety), complications (particularly infection), and reinterventions. Results: Thirty-one patients with a mean age of 41.6 years were included in this study. Active heavy smokers or intravenous drug users were 25.8% and 9.7% of them were diabetic. Five fractures were open while 13 had concomitant soft-tissue involvement (Tscherne grade 1 or 2). Twenty-seven patients healed with no further intervention in a mean time of 3.3 months. Three patients developed nonunion and required further intervention. The overall union rate was 96.7%. One patient developed deep infection after union (infection incidence 3.2%). Six patients (6/31; [19.3%]) required reinterventions [2 for the treatment of nonunion, 3 for removal of screws soft-tissue irritation, and 1 for the management of infection). Conclusions: The management of tibial shaft fractures with a noble metal-coated titanium tibial nail demonstrates encouraging outcomes. Further studies are desirable to gather more evidence in the performance of this innovative implant. Level of Evidence: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.