Evaluation of instrumentation and pedicle screw design for posterior lumbar fixation: A pre-clinical in vivo/ex vivo ovine model

Background: Stabilization procedures of the lumbar spine are routinely performed for various conditions, such as spondylolisthesis and scoliosis. Spine surgery has become even more common, with the incidence rates increasing similar to 30% between 2004 and 2015. Various solutions to increase the success of lumbar stabilization procedures have been proposed, ranging from the device's geometrical configuration to bone quality enhancement via grafting and, recently, through modified drilling instrumentation. Conventional (manual) instrumentation renders the excavated bony fragments ineffective, whereas the "additive" osseodensification rotary drilling compacts the bone fragments into the osteotomy walls, creating nucleating sites for regeneration. Methods: This study aimed to compare both manual versus rotary Osseodensification (OD) instrumentation as well as two different pedicle screw thread designs in a controlled split animal model in posterior lumbar stabilization to determine the feasibility and potential advantages of each variable with respect to mechanical stability and histomorphology. A total of 164 single thread (82 per thread configuration), pedicle screws (4.5 x 35 mm) were used for the study. Each animal received eight pedicles (four per thread design) screws, which were placed in the lumbar spine of 21 adult sheep. One side of the lumbar spine underwent rotary osseodensification instrumentation, while the contralateral underwent conventional, hand, instrumentation. The animals were euthanized after 6- and 24-weeks of healing, and the vertebrae were removed for biomechanical and histomorphometric analyses. Pullout strength and histologic analysis were performed on all harvested samples. Results: The rotary instrumentation yielded statistically (p = 0.026) greater pullout strength (1060.6 N +/- 181) relative to hand instrumentation (769.3 N +/- 181) at the 24-week healing time point. Histomorphometric analysis exhibited significantly higher degrees of bone to implant contact for the rotary instrumentation only at the early healing time point (6 weeks), whereas bone area fraction occupancy was statistically higher for rotary instrumentation at both healing times. The levels of soft tissue infiltration were lower for pedicle screws placed in osteotomies prepared using OD instrumentation relative to hand instrumentation, independent of healing time. Conclusion: The rotary instrumentation yielded enhanced mechanical and histologic results relative to the conventional hand instrumentation in this lumbar spine stabilization model.