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

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.