Biomechanical evaluation of stand-alone lumbar polyether-ether-ketone interbody cage with integrated screws

BACKGROUND CONTEXT: Stand-alone interbody cages with integrated screws potentially provide a biomechanically stable solution for anterior lumbar interbody fusion (ALIF) that alleviates the need for additional exposure for supplemental fixation, thereby reducing the chance of additional complications and morbidity. PURPOSE: To compare the stability of a stand-alone anterior interbody fusion system with integrated fixation screws against traditional supplemental fixation methods and to evaluate the difference between three and four fixation screws in the stand-alone cage. STUDY DESIGN: In vitro cadaveric biomechanical study. METHODS: Eight cadaveric lumbar spines (L2-sacrum) were tested using a flexibility protocol consisting of three cycles to +/- 7.5 Nm in flexion-extension, lateral bending, and axial rotation. The conditions evaluated were intact spine; polyether-ether-ketone cage (zero integrated screws) at L4-L5; cage (zero screws) + bilateral pedicle screws (PS); cage (three screws); cage (four screws); cage (zero screws) + anterior plate; and cage (three screws) + spinous process plate. Motion at the index level was assessed using an optoelectronic system. RESULTS: The cage without integrated screws reduced the motion in flexion-extension and lateral bending (p < .001) compared with that in the intact spine. In axial rotation, mean range of motion (ROM) was 8% greater than in intact spine (p > .962). The addition of three integrated screws reduced ROM significantly compared with the cage without screws in all motion planes (p < .001). A fourth screw had no statistically significant effect on the ROM, although there was a trend toward less motion with four screws compared with three. In flexion-extension, the cage with three integrated screws and the spinous process plate was the most rigid condition. There was no significant difference from the bilateral PS (p = .537); however, this was more rigid than all other conditions (p < .024). The most stable condition in lateral bending and axial rotation was the cage with bilateral PS. In lateral bending, the cage (three or four screws) was not significantly different from the cage with anterior plate or the cage (three screws) with spinous process plate fixation; however, only the latter condition was statistically comparable with bilateral PS. In axial rotation, there were no significant differences between the conditions that included integrated screws or supplemental fixation (p > .081). CONCLUSIONS: Biomechanical testing revealed that the stand-alone cage with integrated screws provides more immediate stability than a cage alone and provides equivalent stability to ALIF constructs with supplemental fixation in lateral bending and axial rotation. Additional flexion-extension rigidity of the anterior cage maybe realized by the addition of a spinous process plate that was found to be as stable as supplemental bilateral PS. (C) 2013 Elsevier Inc. All rights reserved.