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Abstract Objective Combining oblique lumbar interbody fusion (OLIF) with posterior pedicle screw fixation (PPSF) has been proposed to reduce cage subsidence, especially in osteoporotic spines. Recently, anterolateral screw-rod fixation has gained interest as it allows direct pathology observation and avoids a posterior approach. However, controversies exist between anterolateral screw fixation systems and traditional PPSF due to variations in osteoporotic vertebral mineral density, screw fixation positions, and fixation methods (bicortical vs. unicortical). This study aimed to investigate the biomechanical impact of fixation position and method in osteoporotic spine. Methods Seventy-two fresh‑frozen porcine vertebrae (L1–6) were decalcified using 0.5 M EDTA and divided into two groups based on fixation method: bicortical or unicortical. Six groups for each method were created according to the screw position in the lateral vertebral body, with six specimens in each group: anterior, central, and posterior in the middle body and para-endplate regions. Correlations among screw position, fixation method and axial pullout strength were analyzed. Results A 4-week decalcification process, bone mineral density in the porcine vertebrae decreased to approximately 48% (p

Despite advancements in pedicle screw design and surgical techniques, the standard steps for inserting pedicle screws still need to follow a set of fixed procedures. The first step, known as establishing a pilot hole, also referred to as a pre-drilled hole, is crucial for ensuring screw insertion accuracy. In different surgical approaches, such as minimally invasive or traditional surgery, the method of creating pilot holes varies, resulting in different pilot hole profiles, including variations in size and shape. The aim of this study is to evaluate the biomechanical properties of different pilot hole profiles corresponding to various surgical approaches. Commercially available synthetic L4 vertebrae with a density of 0.16 g/cc were utilized as substitutes for human bone. Four different pilot hole profiles were created using a 3.0 mm cylindrical bone biopsy needle, 3.6 mm cylindrical drill, 3.2–5.0 mm conical drill, and 3.2–5.0 mm conical curette for simulating various minimally invasive and traditional spinal surgeries. Two frequently employed screw shapes, namely, cylindrical and conical, were selected. Following specimen preparation, screw pullout tests were performed using a material test machine, and statistical analysis was applied to compare the mean maximal pullout strength of each configuration. Conical and cylindrical screws in these four pilot hole configurations showed similar trends, with the mean maximal pullout strength ranking from high to low as follows: 3.0 mm cylindrical biopsy needle, 3.6 mm cylindrical drill bit, 3.2–5.0 mm conical curette, and 3.2–5.0 mm conical drill bit. Conical screws generally exhibited a greater mean maximal pullout strength than cylindrical screws in three of the four different pilot hole configurations. In the groups with conical pilot holes, created with a 3.2–5.0 mm drill bit and 3.2–5.0 mm curette, both conical screws exhibited a greater mean maximal pullout strength than did cylindrical screws. The strength of this study lies in its comprehensive comparison of the impact of various pilot hole profiles commonly used in clinical procedures on screw fixation stability, a topic rarely reported in the literature. Our results demonstrated that pilot holes created for minimally invasive surgery using image-guided techniques exhibit superior pullout strength compared to those utilized in traditional surgery. Therefore, we recommend prioritizing minimally invasive surgery when screw implantation is anticipated to be difficult or there is a specific need for stronger screw fixation. When opting for traditional surgery, image-guided methods may help establish smaller pilot holes and increase screw fixation strength.

Abstract Although an anterior approach with anterior lateral screw fixation has been developed for stabilizing the thoracolumbar spine clinically, screw loosening still occurs. In this novel in vitro study, we attempted to elucidate the optimal screw position in the lateral lumbar vertebra and the effect of bicortical fixation. A total of 72 fresh-frozen lumbar vertebrae from L1–6 were harvested from 12 mature pigs and randomly assigned to two modalities: bicortical fixation (n = 36) and unicortical fixation (n = 36). Six groups of screw positions in the lateral vertebral body in each modality were designated as central-anterior, central-middle, central-posterior, lower-anterior, lower-middle, and lower- posterior; 6 specimens were used in each group. The correlations between screw fixation modalities, screw positions and axial pullout strength were analyzed. An appropriate screw trajectory and insertional depth were confirmed using axial and sagittal X-ray imaging prior to pullout testing. In both bicortical and unicortical fixation modalities, the screw pullout force was significantly higher in the posterior or middle position than in the anterior position (p

Ball-and-socket designs of cervical total disc replacement (TDR) have been popular in recent years despite the disadvantages of polyethylene wear, heterotrophic ossification, increased facet contact force, and implant subsidence. In this study, a non-articulating, additively manufactured hybrid TDR with an ultra-high molecular weight polyethylene core and polycarbonate urethane (PCU) fiber jacket, was designed to mimic the motion of normal discs. A finite element (FE) study was conducted to optimize the lattice structure and assess the biomechanical performance of this new generation TDR with an intact disc and a commercial ball-and-socket Baguera®C TDR (Spineart SA, Geneva, Switzerland) on an intact C5-6 cervical spinal model. The lattice structure of the PCU fiber was constructed using the Tesseract or the Cross structures from the IntraLattice model in the Rhino software (McNeel North America, Seattle, WA) to create the hybrid I and hybrid II groups, respectively. The circumferential area of the PCU fiber was divided into three regions (anterior, lateral and posterior), and the cellular structures were adjusted. Optimal cellular distributions and structures were A2L5P2 in the hybrid I and A2L7P3 in the hybrid II groups. All but one of the maximum von Mises stresses were within the yield strength of the PCU material. The range of motions, facet joint stress, C6 vertebral superior endplate stress and path of instantaneous center of rotation of the hybrid I and II groups were closer to those of the intact group than those of the Baguera®C group under 100 N follower load and pure moment of 1.5 Nm in four different planar motions. Restoration of normal cervical spinal kinematics and prevention of implant subsidence could be observed from the FE analysis results. Superior stress distribution in the PCU fiber and core in the hybrid II group revealed that the Cross lattice structure of a PCU fiber jacket could be a choice for a next-generation TDR. This promising outcome suggests the feasibility of implanting an additively manufactured multi-material artificial disc that allows for better physiological motion than the current ball-and-socket design.

Intraoperative pedicle screw depth adjustment after initial insertion, including both forward and backward adjustments, is sometimes necessary to facilitate rod application and ensure that the screw is in the correct position, which is determined by intraoperative fluoroscopy. Adjusting the screw with forward turns has no negative influence on the screw fixation stability; however, screw turnback may weaken the fixation stability. The aim of this study is to evaluate the biomechanical properties of screw turnback and demonstrate the reduction in the fixation stability after the screw is turned 360° from its full insertion position. Commercially available synthetic closed-cell polyurethane foams with three different densities simulating various degrees of bone density were utilized as substitutes for human bone. Two different screw shapes (cylindrical and conical) together with two different pilot hole profiles (cylindrical and conical) were tested. Following specimen preparation, screw pullout tests were conducted using a material test machine. The mean maximal pullout strength between full insertion and 360-degree turnback from full insertion in each setting was statistically analyzed. The mean maximal pullout strength after 360-degree turnback from full insertion was generally lower than that at full insertion. The reduced mean maximal pullout strength after turnback increased with decreasing bone density. Conical screws had significantly lower pullout strength after 360-degree turnback than cylindrical screws. The mean maximal pullout strength was reduced by up to approximately 27% after 360-degree turnback when using a conical screw in a low bone density specimen. Additionally, specimens treated with a conical pilot hole presented a less reduction in pullout strength after screw turnback as compared to those with a cylindrical pilot hole. The strength of our study was that we systematically investigated the effects of various bone densities and screw shapes on screw stability after turnback, which has rarely been reported in the literature. Our study suggests that pedicle screw turnback after full insertion should be reduced in spinal surgeries, particularly procedures that use conical screws in osteoporotic bone. Pedicle screw secured with a conical pilot hole might be beneficial for screw adjustment.

Unacceptable sagittal alignment and cement leakage are major concerns of percutaneous vertebroplasty when treating patients with painful vertebral osteoporotic compression fractures. To maintain the restored vertebral height and reduce the reliance on cement as the major stabilizer, an expandable vertebral augment system (EVA®) made of titanium alloy consisting of a rigid tube encased by a barrel with an anterior expansion mechanism was developed. The aim of the current study was to determine whether this novel design is as effective as existing procedures in terms of height restoration and biomechanical performance. Eight osteoporotic vertebrae (T12-L3) confirmed by dual-energy X-ray absorptiometry from two fresh-frozen human cadavers (70- and 72-year-old females) were used. Twenty-five percent reduced anterior wedge vertebral compression fractures were created using a material testing machine. Four randomized specimens were augmented with EVA® (Chang Gu Biotechnology Co. Ltd., Taipei city, Taiwan), and another four randomized specimens were augmented with OsseoFix® (AlphaTec Spine Inc., Carlsbad, CA, USA). The implant size and cement volume were controlled. The anterior vertebral body height (VBH) ratio and pre/postaugmented ultimate strength and stiffness were measured and compared. The mean anterior VBH restoration ratio was 8.54% in the EVA® group and 8.26% in the OsseoFix® groups. A significant difference from augmentation was measured in both groups (p < 0.05), but there was no significant difference between the EVA® and OsseoFix® groups in anterior VBH restoration. The ultimate strengths of the EVA® and OsseoFix® groups were 6071.4 ± 352.6 N and 6262.9 ± 529.2 N, respectively, both of which were statistically significantly higher than that of the intact group (4589.9 ± 474.6 N) (p < 0.05). The stiffnesses of the EVA®, OsseoFix®, and intact groups were 1087.2 ± 176.9, 1154.9 ± 168.9, and 1637.3 ± 340.8 N/mm, respectively, indicating that the stiffness was significantly higher in the intact group than in both the EVA® and OsseoFix® groups (p < 0.05). No significant differences were observed between the two augmentation procedures in height restoration or ultimate strength and stiffness. This novel EVA® system showed comparable height restoration and biomechanical performance to those of existing implants for human cadaveric osteoporotic compression fractures. Potential advantages of preventing cement posterior leakage and promoting cement interdigitation are expected with this ameliorated design.

Allograft bone particles, hydroxyapatite/β-hydroxyapatite-tricalcium phosphate (HA/β-TCP), calcium sulfate (CS), and polymethylmethacrylate (PMMA) bone cement are biomaterials clinically used to fill defective pedicles for pedicle screw augmentation. Few studies have systematically investigated the effects of various biomaterials utilized for salvage screw stabilization. The aim of this study was to evaluate the biomechanical properties of screws augmented with these four different materials and the effect of different pilot hole sizes and bone densities on screw fixation strength. Commercially available synthetic bones with three different densities (7.5 pcf, 15pcf, 30 pcf) simulating different degrees of bone density were utilized as substitutes for human bone. Two different pilot hole sizes (3.2 mm and 7.0 mm in diameter) were prepared on test blocks to simulate primary and revision pedicle screw fixation, respectively. Following separate specimen preparation with these four different filling biomaterials, a screw pullout test was conducted using a material test machine, and the average maximal screw pullout strength was compared among groups. The average maximal pullout strength of the materials, presented in descending order, was as follows: bone cement, calcium sulfate, HA/β-TCP, allograft bone chips and the control. In samples in both the 3.2 mm pilot-hole and 7.0 mm pilot-hole groups, the average maximal pullout strength of these four materials increased with increasing bone density. The average maximal pullout strength of the bone cement augmented salvage screw (7.0 mm) was apparently elevated in the 7.5 pcf test block. Salvage pedicle screw augmentation with allograft bone chips, HA/β-TCP, calcium sulfate, and bone cement are all feasible methods and can offer better pullout strength than materials in the non-augmentation group. Bone cement provides the most significantly augmented effect in each pilot hole size and bone density setting and could be considered preferentially to achieve larger initial stability during revision surgery, especially for bones with osteoporotic quality.

Replacement with larger diameter screws is always used in pedicle screw loosening but carries a risk of pedicle wall violation. A pedicle screw with more preserved bone stock is the preferred primary fixation choice. The purpose of this study was to evaluate whether a newly designed proximal-conical dual-thread screw with less bone occupancy provides fixation strength comparable to that of a traditional screw. Six types of pedicle screws based on three different shapes (cylindrical, conical, and proximal-conical) and two thread profiles (single-thread and dual-thread) were grouped. Conical and proximal-conical screws differed mainly in the slope of the outer diameter from the hub to the tip. Conical screws had an outer diameter (6.5 mm) that differed from the hub and tapered by 30% to an outer diameter (4.5 mm) at the tip and proximal-conical screws had the same outer diameter from the hub and tapered by 30% (4.5 mm) at 20 mm from the hub and then maintained the outer diameter (45 mm) to the tip. A total of 36 L4 Sawbones® vertebrae were used in the study and six trials for each screw group. The results of the imaging, screw volume in bone, insertion torque, and pullout force were analyzed. For screws with the same shape, insertion torque and pullout force were significantly higher for those in the dual-thread groups than for those in the single-thread groups (p < 0.05). For screws with the same thread profile, there was no significant difference in either biomechanical test between the different screw shapes (p > 0.05). Our results demonstrated that these proximal-conical dual-thread screws, with the property of relative bone stock preservation, display a comparable biomechanical performance to traditional dual-thread screws and a better performance than single-thread screws. This screw design could serve as the primary pedicle screw choice to reduce revision difficulty.

Background: Pedicle screws with PMMA cement augmentation have been shown to significantly improve the fixation strength in a severely osteoporotic spine. However, the efficacy of screw fixation for different cement augmentation techniques, namely solid screws with retrograde cement pre-filling versus cannulated screws with cement injection through perforation, remains unknown. This study aimed to determine the difference in pullout strength between conical and cylindrical screws based on the aforementioned cement augmentation techniques. The potential loss of fixation upon partial screw removal after screw insertion was also examined. Method: The Taguchi method with an L8 array was employed to determine the significance of design factors. Conical and cylindrical pedicle screws with solid or cannulated designs were installed using two different screw augmentation techniques: solid screws with retrograde cement pre-filling and cannulated screws with cement injection through perforation. Uniform synthetic bones (test block) simulating severe osteoporosis were used to provide a platform for each screw design and cement augmentation technique. Pedicle screws at full insertion and after a 360-degree back-out from full insertion were then tested for axial pullout failure using a mechanical testing machine. Results: The results revealed the following 1) Regardless of the screw outer geometry (conical or cylindrical), solid screws with retrograde cement pre-filling exhibited significantly higher pullout strength than did cannulated screws with cement injection through perforation (p = 0.0129 for conical screws; p = 0.005 for cylindrical screws). 2) For a given cement augmentation technique (screws without cement augmentation, cannulated screws with cement injection or solid screws with cement pre-filling), no significant difference in pullout strength was found between conical and cylindrical screws (p >0.05). 3) Cement infiltration into the open cell of the test block led to the formation of a cement/bone composite structure. Observations of the failed specimens indicated that failure occurred at the composite/bone interface, whereas the composite remained well bonded to the screws. This result implies that the screw/composite interfacial strength was much higher than the composite/bone interfacial strength. 4) The back-out of the screw by 360 degrees from full insertion did not decrease the pullout strength in any of the studied cases. 5) Generally, larger standard deviations were found for the screw back-out cases, implying that the results of full insertion cases are more repeatable than those of the back-out cases. [ABSTRACT FROM AUTHOR]