Purpose Pedicle screw loosening is a frequent complication in lumbar spine fixation, most commonly among patients with poor bone quality. Determining patients at high risk for insufficient implant stability would allow clinicians to adapt the treatment accordingly. The aim of this study was to develop a computational model for quantitative and reliable assessment of the risk of screw loosening. Methods A cohort of patient vertebrae with diagnosed screw loosening was juxtaposed to a control

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... with stable fusion. Imaging data from the two cohorts were used to generate patient-specific biomechanical models of lumbar instrumented vertebral bodies. Single-level finite element models loading the screw in axial or caudo-cranial direction were generated. Further, multi-level models incorporating individualized joint loading were created. Results The simulation results indicate that there is no association between screw pull-out strength and the manifestation of implant loosening (p = 0.8). For patient models incorporating multiple instrumented vertebrae, CT-values and stress in the bone were significantly different between loose screws and non-loose screws (p = 0.017 and p = 0.029, for CT-values and stress, respectively). However, very high distinction (p = 0.001) and predictability (R 2 Pseudo = 0.358, AUC = 0.85) were achieved when considering the relationship between local bone strength and the predicted stress (loading factor). Screws surrounded by bone with a loading factor higher than 25% were likely to be loose, while the chances of screw loosening were close to 0 with a loading factor below 15%. Conclusion The use of a biomechanics-based score for risk assessment of implant fixation failure might represent a paradigm shift in addressing screw loosening after spondylodesis surgery.