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This study was designed as proof of principle and safety test of the novel technique, the Immediate Stabilization System (ISS). The technique is designed to immediately stabilize polymer-augmented pedicle screws (PAS) in deficient bone and avoid complications of loosening pedicle screws at the bone-screw interface, especially in osteoporotic patients. A polymer sleeve was designed as augmentation to improve screw anchorage after drilling the screw hole. By applying ultrasonic energy, the polymeric tube was molded into the pores of the host bone forming a strong and uniform bond with the adjacent bone. The original screw was then implanted into the denser bony environment leading to an enhanced immediate stability. The ISS-treated implants were compared to conventionally placed pedicle screws in ex-vivo cadaver bones (2 sheep spines, n = 6 implants per spine, total 12 screws) and in-vivo in a spinal sheep model (Swiss alpine sheep, n = 5, 4 implants per animal, total 20 screws). The primary stability of ISS-treated pedicle screws was increased in ex-vivo bone (+24% insertion torque (IT)) and in-vivo (+32.9% IT) in sheep spine. Removal torque (RT) was lower in the in PAS tested for 8 weeks in-vivo. The ISS technology demonstrated improved anchorage of pedicle screws in ex-vivo cadaver bones as well as in-vivo studies in sheep spine.

Abstract Background C ement augmentation of pedicle screws to prevent screw loosening is associated with significant complications, such as cement leakage or bone necrosis. Therefore, an alternative strategy to improve pedicle screw anchorage has been recently developed: Polymer reinforcement of pedicle screws uses an in situ melted polymer sleeve in order to enhance screw anchorage. This biomechanical study evaluated the effect of polymer-reinforcement by comparing polymer-reinforced pedicle screws to non-augmented as well as cement-augmented screws under cyclic loading. Methods For each of the two comparisons (polymer-reinforced vs. non-augmented screws and polymer-reinforced vs. cement-augmented screws), polymer-reinforced screws and control screws were placed into the left and right pedicle of seven vertebrae (mean age: 74.0 (SD 9.3) years) to allow for pairwise left–right comparisons. Each screw was subjected to cyclic cranio-caudal loading with an initial load ranging from −50 N to +50 N and with stepwise increasing compressive loads (5 N every 100 cycles) until screw loosening. Findings Polymer-reinforced pedicle screws resisted a higher number of load cycles until loosening than the contralateral non-augmented control screws (4300 SD 2018 vs. 2457 SD 1116 load cycles, p = 0.015). Screw anchorage of polymer-reinforced pedicle screws was comparable to that of cement augmented control screws (3857 (SD2085) vs. 4300 (SD1257) load cycles until failure, p = 0.64). Interpretation Our findings indicate that polymer-reinforcement significantly enhances pedicle screw anchorage in low quality bone and that its effect is similar in size than that of cement augmentation. Highlights • Cyclic loading in cranio-caudal direction to investigate pedicle screw anchorage was applied. • Reinforcement with a polymer sleeve improved pedicle screws anchorage compared to control. • Compared to cement-augmentation reinforcement with a polymer sleeve showed no difference. [ABSTRACT FROM AUTHOR]

Study Design: Biomechanical investigation.Purpose: Cervical two-level corpectomies with anterior-only instrumentation are associated with a high rate of implant-related complications. These procedures, therefore, often require an additional dorsal instrumentation to prevent screw loosening. Cement augmentation of the anterior screws in two-level corpectomies might stabilize the construct, so that a second dorsal procedure could be avoided. To evaluate the screw anchorage in cervical anterior-only procedures, an ex vivo evaluation of the range of motion (ROM) in two-level corpectomies (C4 and C5), with and without cement augmentation of the anterior screws, was carried out in this study.Methods: Twelve human cervical cadaveric spines (C2-T1) were divided into two groups of six specimens each. Corpectomies were performed in C4 and C5, with grafting and anterior instrumentation with and without cement augmentation of the anterior screw-and-plate system (0.3-0.5 mL cement/screw). Flexibility tests with pure moments (1.5 Nm) were carried out before and after three cyclic loading periods of 5000 cycles with increasing eccentric forces (100, 200, and 300 N).Results: After corpectomy and instrumentation, the control group and the augmented group showed a significant reduction in ROM in comparison with the native states with average ROMs of 49% (±17%) and 24% (±10%), respectively (P = 0.006). The ROM in the control group increased significantly in all motion directions in the course of cyclic loading and approached native values after the third cyclic loading period, with an overall ROM of 78% (±22%). In contrast, the augmented group maintained a significantly decreased ROM in all motion directions during cyclic loading, with a final ROM of 32% (±14%) after the third period of cyclic testing. Inter-group comparison demonstrated a significant difference between the two groups in the course of cyclic loading. The cement-augmented group outperformed the control group in all motion directions, with a significantly lower ROM after all three cyclic loading periods.Conclusions: A two-level corpectomy with cement-augmentation results in a significantly reduced ROM. In comparison with the conventional anterior screw-and-plate fixation, it represents a significantly stabilized two-level anterior construct. This might be a treatment option for patients with a two-level corpectomy associated with reduced bone mineral density, to avoid an additional dorsal instrumentation. [ABSTRACT FROM AUTHOR]

Background Screw anchorage in osteoporotic bone is still limited and makes treatment of osteoporotic fractures challenging for surgeons. Conventional screws fail in poor bone quality due to loosening at the screw–bone interface. A new technology should help to improve this interface. In a novel constant amelioration process technique, a polymer sleeve is melted by ultrasound in the predrilled screw hole prior to screw insertion. The purpose of this study was to investigate in vitro the effect of the constant amelioration process platform technology on primary screw anchorage. Methods Fresh frozen femoral heads ( n = 6) and vertebrae ( n = 6) were used to measure the maximum screw insertion torque of reference and constant amelioration process augmented screws. Specimens were cut in cranio-caudal direction, and the screws (reference and constant amelioration process) were implanted in predrilled holes in the trabecular structure on both sides of the cross section. This allowed the pairwise comparison of insertion torque for constant amelioration process and reference screws (femoral heads n = 18, vertebrae n = 12). Prior to screw insertion, a micro-CT scan was made to ensure comparable bone quality at the screw placement location. Findings The mean insertion torque for the constant amelioration process augmented screws in both, the femoral heads (44.2 Ncm, SD 14.7) and the vertebral bodies (13.5 Ncm, SD 6.3) was significantly higher than for the reference screws of the femoral heads (31.7 Ncm, SD 9.6, p < 0.001) and the vertebral bodies (7.1 Ncm, SD 4.5, p < 0.001). Interpretation The interconnection of the melted polymer sleeve with the surrounding trabecular bone in the constant amelioration process technique resulted in a higher screw insertion torque and can improve screw anchorage in osteoporotic trabecular bone. [ABSTRACT FROM AUTHOR]

Fracture fixation in severe osteoporotic bone by means of implants that rely on screw anchorage is still a clinical problem. So far, a sufficiently accurate prediction of the holding capacity of screws as a function of local bone morphology has not been obtained. In this study the ultimate pullout loads of screws in the epi-, meta-, and diaphyseal regions of human tibiae were correlated to the cortical thicknesses and cancellous bone mineral densities at the screw axes determined from QCT densitometric data. Stepwise multiple linear regression showed that in regions with cortical thicknesses below 1.5 mm, cancellous density determined the ultimate pullout load (R2=0.85, p<0.001), while in regions with cortices above 1.5 mm, cortical thickness alone significantly influenced the holding capacity of a screw (R2=0.90, p<0.001). The findings of this study provide a basis for a bone morphology-related pre-operative estimation of the holding capacity of screws, which could help to improve their proper application in osteoporotic bone. [ABSTRACT FROM AUTHOR]