Background: We conducted a finite element study to assess the effectiveness of a novel pedicle screw design with two alterations in the distal and proximal portions. Methods: Finite element (FE) models of 24 vertebrae were constructed using computed tomographic data. Pull-out strength of 4 different pedicle screws were compared. The basic screw design was a dual threaded one (PS0), in which the proximal portion is double-threaded (cortical thread), and the distal portion is single-threaded (cancellous thread). In PS1, the inter-thread double-core shape was added to PS0 in the distal portion. Compared to PS0, in PS2, the proximal portion was elongated by 5 mm. PS3 had both PS1 and PS2 features. In addition, the 24 vertebrae were classified into 3 groups based on volumetric bone mineral density (vBMD) of the vertebral body: low <120 mg/cm3, moderate 120–170 mg/cm3, and high >170 mg/cm3. Results: The mean pull-out strengths (±SD) were 1137 ± 500 N, 1188 ± 520 N, 1191 ± 512 N, and 1242 ± 538 N for PS0, PS1, PS2, and PS3, respectively. In PS1, there was significant difference in the incremental ratio of pull-out strength to PS0 between the low and high vBMD groups (3.7 ± 1.6% vs. 5.0 ± 1.0%, p = 0.006). In PS2, there was a significant difference in the incremental ratio to PS0 between the moderate and high vBMD groups (7.6 ± 4.0% vs. 3.3 ± 1.8%, p < 0.001). In PS3, there was a significant difference in the incremental ratio to PS0 between the moderate and high vBMD groups (12.1 ± 4.8% vs. 8.5 ± 2.1%, p = 0.003). Conclusions: The two design alterations showed the combined additive effect in the PS3 design. The moderate vBMD group has a balanced bone property to reflect the combined effects of the PS1 and PS2 design alterations.
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