Clinical Efficacy of Three-Dimensional-Printed Pure Titanium Fracture Plates with Locking Screw Systems in Distal Tibia Fractures.

Distal tibia fractures are high-energy injuries characterized by a mismatch between standard plate designs and the patient's specific anatomical bone structure, which can lead to severe soft tissue damage. Recent advancements have focused on the development of customized metal plates using three-dimensional (3D) printing technology. However, 3D-printed metal plates using titanium alloys have not incorporated a locking system due to the brittleness of these alloys. Therefore, this study aimed to determine whether a locking mechanism can be effectively implemented using 3D-printed pure titanium and further evaluate the clinical outcomes of such implants in patients with distal tibia fractures. : Between March 2021 and June 2022, nine patients who underwent open reduction and internal fixation for distal tibia fractures using 3D-printed pure titanium plates were enrolled. Pure titanium powder (Ti Gr.2, Type A, 3D Systems, USA) was spread to a thickness of 30 μm and partially sintered using a 500 W laser to produce the 3D-printed metal plates. The locking screws were fabricated using a milling process. Open reduction and internal fixation were performed on the nine patients using 10 customized plates. The clinical efficacy was analyzed using the union rate, and complications, such as infection and skin irritation, were evaluated to ensure a comprehensive outcome assessment. Surgical treatment was successfully performed on nine patients, with nine of ten plates remaining stable and undamaged. However, one patient with neurofibromatosis experienced a fractured metal plate, which necessitated revision surgery using a metal rod. No screw loosening or surgical wound complications occurred. This study showed that 3D-printed pure titanium plates with integrated locking screw systems provide a viable and effective solution for managing distal tibia fractures. Three-dimensional printing and pure titanium show promise for orthopedic advancements.