Background: The TomoFix plate has been extensively used in high tibial osteotomy surgery to stabilize the distracted tibial bones. However, distal pain related to plate irritation was considered one of the most relevant complications for this fixation device. This study aimed to correlate reports of distal pain with the profiles of the distracted tibia and initial plate and plate contour. Methods: This study used the finite-element method to investigate the profile-, distraction-, and contour-induced effects on stress distribution of the distal tibia-plate contact. The associations of two tibia profiles (normal and concave), distraction angles, and two plate profiles (contoured and non-contoured) were discussed in this study. The areas and stresses of the distal tibia-plate contact were chosen as comparison indices. Findings: Before weight-bearing, the non-contoured plates of the normal and concave tibia profiles consistently showed less contact area at the distal tibia-plate region. Consequently, the physiological loads make the non-contoured plate subject to more concentrated bone stresses and thus may induce more pain at the distal tibia-plate region than a contoured plate. When the distraction angle decreases, the tibia-plate gap increases. Prior to fixation, the tibia-plate gap can be evaluated by the profiles of the distracted tibia and non-contoured plate by use of anteroposterior radiograph and computer-aided simulation. Interpretation: In the situations of a lower distraction angle or a large tibia-plate gap, the use of a plate bender or a lag screw is recommended in order to contour the plate for reducing the concentrated stress at the distal tibia-plate region.
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