Clinical Outcomes and Safety After Tibial Fracture Fixation Using the Tibia Nail

Abstract

Background: Tibial fractures are common long-bone injuries that may cause pain, loss of mobility, prolonged functional limitation, and complications related to fracture healing. Intramedullary nailing is a widely used method of internal fixation for tibial shaft fractures because it provides load-sharing stabilization while limiting disruption of the surrounding soft tissues. This study evaluated the clinical outcomes and safety of tibial fracture fixation using the Auxein Tibia Nail. Methods: Clinical data from 32 patients treated with the Tibia Nail between January 2018 and December 2020 were evaluated. Patients were 20 to 68 years of age, with a mean age of 44.52 years. The study population included 18 males and 14 females; 15 patients had right-leg involvement and 17 had left-leg involvement. Follow-up was 12 months. Available outcome variables included pain assessed using the Visual Analogue Scale (VAS), implant failure, reoperation, device-related complications, surgery-related complications, and other clinically recorded abnormalities. Results: At the recorded follow-up assessment, the mean/recorded VAS score was 2. No implant failure, reoperation, device-related complication, surgery-related complication, or other abnormality was reported in the available dataset during the 12-month follow-up period. Conclusion: Within the limitations of this 32-patient clinical dataset, fixation using the Tibia Nail was associated with a low recorded pain score and no reported implant failure, reoperation, device-related complications, or surgery-related complications over 12 months. These findings support a favorable observed safety and clinical performance profile in this cohort.