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Background: The study aimed to (1) create a series of pedicle injectors with different number of holes on the sheath especially for the Chinese elderly patients and (2) further investigate the effects of the injectors on the augmentation of pedicle screw among osteoporotic lumbar pedicle channel.Methods: This study used the biomechanical test module of polyurethane (Pacific Research Laboratory Corp, USA) to simulate the mechanical properties of human osteoporotic cancellous bone. The bone cement injectors were invented based on anatomical parameters of lumbar pedicle in Chinese elderly patients. Mechanical test experiments were performed on the bone cement injectors according to the three groups, namely, a local augmentation group, a full-length augmentation group, and a control group. The local augmentation group included three subgroups including 4-hole group, 6-hole group, and 8-hole group. All holes were laterally placed. The full-length augmentation group was a straight-hole injector. The control group was defined that pedicle screws were inserted without any cement augmentation. Six screws were inserted in each group and the maximum insertion torque was recorded. After 24 h of injecting acrylic bone cement, routine X-ray and CT examinations were performed to evaluate the distribution of bone cement. The axial pull-out force of screws was tested with the help of the material testing system 858 (MTS-858) mechanical tester.Results: The bone cement injectors were consisted of the sheaths and the steel rods and the sheaths had different number of lateral holes. The control group had the lowest maximum insertion torque as compared with the 4-hole, 6-hole, 8-hole, and straight pore groups (P < 0.01), but the differences between the 4-hole, 6-hole, 8-hole, and straight pore groups were no statistical significance. The control group had the lowest maximum axial pull-out force as compared with the other four groups (P < 0.01). Subgroup analysis showed the 8-hole group (161.35 ± 27.17 N) had the lower maximum axial pull-out force as compared with the 4-hole group (217.29 ± 49.68 N), 6-hole group (228.39 ± 57.83 N), and straight pore group (237.55 ± 35.96 N) (P < 0.01). Bone cement was mainly distributed in 1/3 of the distal end of the screw among the 4-hole group, in the middle 1/3 and distal end of the screw among the 6-hole group, in the proximal 1/3 of the screw among the 8-hole group, and along the long axis of the whole screw body in the straight pore group. It might indicate that the 8-hole and straight-hole groups were more vulnerable to spinal canal cement leakage. After pullout, bone cement was also closely connected with the screw without any looseness or fragmentation.Conclusions: The bone cement injectors with different number of holes can be used to augment the pedicle screw channel. The pedicle screw augmented by the 4-hole or 6-hole sheath may have similar effects to the straight pore injector. However, the 8-hole injector may result in relatively lower pull-out strength and the straight pore injector has the risks of cement leakage as well as cement solidarization near the screw head. [ABSTRACT FROM AUTHOR]

Study Design. A finite element analysis was used. Objective. To evaluate the feasibility of using the Ti-24Nb-4Zr-7.9Sn (Ti2448) pedicle screw system to augment single-level posterior lumbar interbody fusion (PLIF). Summary of Background Data. The Ti-6AI-4V pedicle screw system increases the risk of adjacent disc degeneration and stress-shielding effect due to enormous rigidity. A titanium alloy with much lower elastic modulus, Ti2448, may help to resolve the complications. Methods. A finite element model of intact L3-S1 was established and then validated. Single-level PLIF at L4-L5 with or without a supplementary titanium-alloy pedicle screw system was simulated. A pure moment of 7.6 Nm and a 400 N preload was applied to the finite element model of PLIF, PLIF with the Ti-6AI-4V screw system, and PLIF with the Ti2448 screw system in flexion, extension, axial rotation, and lateral bending. Results. The axial displacement at the fusion level decreased to 64%, 72%, 84%, and 92% of screw-free status in flexion, extension, axial rotation, and lateral bending, respectively, after augmentation of the Ti2448 screw system, which was 1% to 3% lower than the performance of the Ti-6AI-4V system. The angular displacement at the fusion level with the Ti2448 system was similar to that of the Ti-6AI-4V system, only 2% lower in flexion. Compared with theTi-6AI-4V system, the Ti2448 system suppressed the increase of intradiscal pressures at the upper adjacent disc in all bending directions, but only in extension and axial rotation at the lower adjacent disc; the maximum stress experienced by cages and screws was higher in all bending directions when augmented with the Ti2448 system. Conclusion. Using the Ti2448 screw system is suggested for augmenting single-level PLIF because it induces less disc intradiscal pressure at adjacent levels and the stress-shielding effect at implant-bone surface with stabilization performance compared with the Ti-6AI-4V screw system. [ABSTRACT FROM AUTHOR]

Transpedicular fixation can be challenging in the osteoporotic spine as reduced bone mineral density compromises the mechanical stability of the pedicle screw. Here, we sought to investigate the biomechanical and histological properties of stabilization of expandable pedicle screw (EPS) in the osteoporotic spine in sheep. EPSs and standard pedicle screws, SINO screws, were inserted on the vertebral bodies in four female ovariectomized sheep. Pull-out and cyclic bending resistance test were performed to compare the holding strength of these pedicle screws. High-resolution micro-computed tomography (CT) was performed for three-dimensional image reconstruction. We found that the EPSs provided a 59.6% increase in the pull-out strength over the SINO screws. Moreover, the EPSs withstood a greater number of cycles or load with less displacement before loosening. Micro-CT image reconstruction showed that the tissue mineral density, bone volume fraction, bone surface/bone volume ratio, trabecular thickness, and trabecular separation were significantly better in the expandable portion of the EPSs than those in the anterior portion of the SINO screws ( P < 0.05). Furthermore, the trabecular architecture in the screw-bone interface was denser in the expandable portion of the EPS than that in the anterior portion of the SINO screw. Histologically, newly formed bone tissues grew into the center of EPS and were in close contact with the EPS. Our results show that the EPS demonstrates improved biomechanical and histological properties over the standard screw in the osteoporotic spine. The EPS may be of value in treating patients with osteoporosis and warrants further clinical studies. [ABSTRACT FROM AUTHOR]