Feasibility and Mechanical Strength Evaluation of New Customized Implants for Tibial Plateau Fractures Fixation.

BACKGROUND AND OBJECTIVE

Customized implants could improve the capture of fracture fragments for strengthened stability of tibial plateau fractures (TPFs) fixation. This study aimed to validate the feasibility of customized implants through optimized manufacturing within a clinically acceptable timeframe and evaluate the mechanical strength of customized internal implants through finite element analysis.

METHODS

A retrospective was conducted. From May 1, 2023, to June 1, 2023, 10 patients with TPFs were treated at our hospital using various new internal fixation systems combined with customized technology. The indicators of patients characteristics, operation, and follow-up were collected, such as the cause of trauma, fresh or old, fracture classification, blood loss, Lysholm score, EQ-5D-3L score, and so on. Additionally, we created a Schatzker IV TPF model with two separated fragments in the medial to compare the biomechanical strength and directional deformation between standard medial dual plates (MDPs) and medial customized plate (MCP).

RESULTS

The study found that the entire process of implant fabrication can be completed within a clinically acceptable timeframe of 3-4 days. We designed specific types of plates for different types of fractures, such as semi-circumferential plates for lateral TPFs, γ-type plates for medial TPFs, and pistol-type and wing-type plates for posterior TPFs. Follow-up analysis showed operative times of 1.37 ± 0.58 h, intraoperative blood loss of 260 ± 179.20 mL, and favorable functional outcomes: Lysholm score 88.6 ± 4.93, knee ROM 103.5° ± 11.56°, and EQ-5D-3L score 0.87 ± 0.47. Additionally, the γ-type plate showed comparable strength to the MDPs system via finite element analysis and demonstrated a more vital ability to resist the separation of fracture fragments, with the maximum displacement of MDPs (0.61878 mm) 2.4 times higher than that of MCP (0.26124 mm).

CONCLUSIONS

Using customized internal fixation systems provided solutions to challenges of complex fractures, within a clinically acceptable timeframe of 3-4 days. Notably, the study showed that the strength of customized internal fixation systems of γ-shaped plate was comparable to that of conventional implants. This innovative approach offered a new avenue for managing TPFs and even complex limb fractures.