Influence of the screw augmentation technique and a diameter increase on pedicle screw fixation in the osteoporotic spine: pullout versus fatigue testing

For posterior spinal stabilization, loosening of pedicle screws at the bone-screw interface is a clinical complication, especially in the osteoporotic population. Axial pullout testing is the standard pre-clinical testing method for new screw designs although it has questioned clinical relevance. The aim of this study was to determine the fixation strength of three current osteoporotic fixation techniques and to investigate whether or not pullout testing results can directly relate to those of the more physiologic fatigue testing. Thirty-nine osteoporotic, human lumbar vertebrae were instrumented with pedicle screws according to four treatment groups: (1) screw only (control), (2) prefilled augmentation, (3) screw injected augmentation, and (4) unaugmented screws with an increased diameter. Toggle testing was first performed on one pedicle, using a cranial-caudal sinusoidal, cyclic (1.0 Hz) fatigue loading applied at the screw head. The initial compressive forces ranged from 25 to 75 N. Peak force increased stepwise by 25 N every 250 cycles until a 5.4-mm screw head displacement. The contralateral screw then underwent pure axial pullout (5 mm/min). When compared to the control group, screw injected augmentation increased fatigue force (27 %, p = 0.045) while prefilled augmentation reduced fatigue force (-7 %, p = 0.73). Both augmentation techniques increased pullout force compared to the control (ps < 0.04). Increasing the screw diameter by 1 mm increased pullout force (24 %, p = 0.19), fatigue force (5 %, p = 0.73), and induced the least stiffness loss (-29 %) from control. For the osteoporotic spine, screw injected augmentation showed the best biomechanical stability. Although pullout testing was more sensitive, the differences observed were not reflected in the more physiological fatigue testing, thus casting further doubt on the clinical relevance of pullout testing.