Design and development of a novel expanding flexible rod device (FRD) for stability in the lumbar spine: A finite-element study.

The aim of this study is to design a novel expanding flexible rod device, for pedicle screw fixation to provide dynamic stability, based on strength and flexibility. Three-dimensional finite-element models of lumbar spine (L1-S) with flexible rod device on L3-L4-L5 levels are developed. The implant material is taken to be Ti-6Al-4V. The models are simulated under different boundary conditions, and the results are compared with intact model. In natural model, total range of motion under 10 Nm moment were found 66.7°, 24.3° and 13.59°, respectively during flexion-extension, lateral bending and axial rotation. The von Mises stress at intact bone was 4 ± 2 MPa and at bone, adjacent to the screw in the implanted bone, was 6 ± 3 MPa. The von Mises stress of disc of intact bone varied from 0.36 to 2.13 MPa while that of the disc between the fixed vertebra of the fixation model reduced by approximately 10% for flexion and 25% for extension compared to intact model. The von Mises stresses of pedicle screw were 120, 135, 110 and 90 MPa during flexion, extension, lateral bending, and axial rotation, respectively. All the stress values were within the safe limit of the material. Using the flexible rod device, flexibility was significantly increased in flexion/extension but not in axial rotation and lateral bending. The results suggest that dynamic stabilization system with respect to fusion is more effective for homogenizing the range of motion of the spine.