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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  < 0.05) of the original value, categorizing them as osteoporotic. Bicortical fixation showed significantly greater pullout forces than unicortical fixation, with differences ranging from 82 to 273%. Notably, central or posterior screws outperformed anterior screws in pullout strength. Conclusion Bicortical fixation exhibited significantly greater pullout forces than unicortical fixation. We suggest positioning screws in the central or posterior region of the middle body with bicortical fixation in osteoporotic vertebrae.

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.

Three key factors are responsible for the biomechanical performance of pedicle screw fixation: screw mechanical characteristics, bone quality and insertion techniques. To the best of the authors’ knowledge, no study has directly compared the biomechanical performance among three trajectories, i.e., the traditional trajectory (TT), modified trajectory (MT) and cortical bone trajectory (CBT), in a porcine model. This study compared the pullout strength and insertion torque of three trajectory methods in single vertebrae, the pullout strength and fixation stiffness including flexion, extension, and lateral bending in a one-level instrumented functional spinal unit (FSU) that mimics the in vivo configuration were clarified. A total of 18 single vertebrae and 18 FSUs were randomly assigned into three screw insertion methods ( n = 6 in each trajectory group). In the TT group, the screw converged from its entry point, passed completely inside the pedicle, was parallel to the superior endplate, was located in the superior third of the vertebral body and reached to at least the anterior third of the vertebral body. In the MT group, the convergent angle was similar to that of the TT method but directed caudally to the anterior inferior margin of the vertebral body. The results of insertion torque and pullout strength in single vertebrae were analyzed; in addition, the stiffness and pullout strength in the one-level FSU were also investigated. This study demonstrated that, in single vertebrae, the insertion torque was significantly higher in CBT groups than in TT and MT groups ( p < 0.05). The maximal pullout strength was significantly higher in MT groups than in TT and CBT groups ( p < 0.05). There was no significant difference in stiffness in the three motions among all groups. The maximal pullout strength in FSUs of MT and CBT groups were significantly higher than the TT groups ( p < 0.05). We concluded that either MT or CBT provides better biomechanical performance than TT in single vertebrae or FSUs. The lack of significance of stiffness in FSUs among three methods suggested that MT or CBT could be a reasonable alternative to TT if the traditional trajectory was not feasible.

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.

Study Design: Biomechanical study. Objective: Cross-links are a type of common clinical spinal instrumentation. However, the effects of the position and number of cross-links have never been investigated in long-segment spinal fixation, and the variables have not been optimized. We conducted an in vitro biomechanical study by using a porcine long-segment spinal model with 5 different crosslink configurations to determine the optimal construct for clinical practice. Methods: Five modalities with paired segmental screws from T15-L5 were tested in 20 porcine spines. The spines without cross-links composed the control group, Group A; those with a single cross-link from L2-3 composed Group B; those with 2 cross-links from L1-2 and L3-4 composed Group C; those with 2 cross-links from T15-L1 and L4-5 composed Group D; and those with 3 cross-links from T15-L1, L2-3 and L4-5 composed Group E. Spinal stiffnesses in flexion, extension, lateral bending, and axial rotation were compared among 5 different cross-link configurations in 5-level porcine spinal units. Results: Flexional, extensional and lateral bending stiffnesses did not significantly change with an increasing number of cross-links or positions in the construct. Axial stiffness was significantly increased with 2 cross-links compared to one (P < 0.05) and with placement more distant from the center of the long spinal fixation construct (P < 0.05). Conclusions: Two cross-links individually placed proximal and distal from the center of a construct is an optimal and efficient configuration to achieve biomechanical stability in non-rigid lumbar spines undergoing long-level fixation.

Background/Objectives: The pullout failure of conventional locking screws (LSs, screws with a locking mechanism) may occur in patients with osteoporosis, particularly when inserted near joints or across periarticular fractures (e.g., proximal humerus). The two-part locking cancellous screw modification (TP-LCS, screws composed of two parts) in metaphyseal cancellous bone is hypothesized to increase bone purchase and holding power. This study aimed to test the hypothesized advantages of TP-LCS over LSs. Methods: An MTS 370 series frame with an axial/torsional load cell was used to test driving torque and axial pullout strength, following ASTM F543-07 standards. The TP-LCS group featured a newly modified screw design made from titanium alloy (Ti6Al4V), while conventional LSs (Synthes) were used for the control group. Statistical significance was assessed for selected comparisons relevant to the research objectives, including driving torque and axial pullout strength. Results: The driving torque test showed that TP-LCS had a significantly higher maximum insertion torque (4.9 ± 0.4 N·cm) compared to LSs (4.2 ± 0.4 N·cm) (p = 0.0269), although no significant difference was found in maximum removal torque (p = 0.1046). The axial pullout test revealed that TP-LCS had significantly higher pullout strength (223.5 ± 12.2 N) compared to LSs (203.5 ± 11.5 N) (p = 0.0284). Failure during the axial pullout test often involved cracking of the test block material around the screw threads, causing the screw to pull out. Conclusions: These results support the hypothesis that TP-LCS may offer improved axial pullout resistance compared to LSs, making it a potentially beneficial modification for LSs in osteoporotic metaphyseal regions or near joints. This study provides biomechanical insights into the advantages of the modified screw design over conventional LSs.

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.

With regard to the sustainability and biological origin of plastic components, regenerated cellulose fiber (RCF)-reinforced polymers are expected to replace other composites in the future. For use under severe conditions, for example, as a housing in the engine compartment, the resistance of the composites and the impact on the fiber and fiber-matrix adhesion must be investigated. Composites of bio-polyamide with a reinforcement of 20 wt.% RCF were compounded using a twin-screw extruder. The test specimens were manufactured with an injection molding machine and aged under conditions of high humidity at 90% r. H, a high temperature of 70 °C, and water storage using a water temperature of 23 °C for 504 h. Mechanical tests, single-fiber tensile tests (SFTT), single-fibre pull-out tests (SFPT), and optical characterization revealed significant changes in the properties of the composites. The results of the SFPT show that accelerated aging had a significant effect on the bio-polymer and an even stronger effect on the fiber, as the single-fiber tensile strength decreased by 27.5%. Supplementary notched impact strength tests revealed a correlation of the impact strength and the accelerated aging of the RCF-reinforced composites. In addition, it could be verified that the tensile strength also decreased at about 37% due to the aging effect on the RCF and a lowered fiber-matrix adhesion. The largest aging impact was on the Young’s modulus with a decrease of 45% due to the accelerated aging. In summary, the results show that the strengthening effect with 20 wt.% RCF was highly decreased subsequent to the accelerated aging due to hydrolysis and debonding because of the shrinkage and swelling of the matrix and fiber. These scientific findings are essential, as it is important to ensure that this bio-based material used in the automotive sector can withstand these stresses without severe degradation. This study provides information about the aging behavior of RCF-reinforced bio-based polyamide, which provides fundamental insights for future research.

Screw loosening can threaten pedicle screw fixation of the spine. Conical screws can improve the bending strength, but studies of their pullout strength as compared with that of cylindrical screws have shown wide variation. In the present study, polyurethane foam with two different densities (0.32 and 0.16 gm/cm 3) was used to compare the pullout strength and stripping torque among three kinds of pedicle screws with different degrees of core tapering. Three-dimensional finite element models were also developed to compare the structural performance of these screws and to predict their pullout strength. In the mechanical tests, pullout strength was consistently higher in the higher density foam and was closely related to screw insertion torque ( r = 0.87 and 0.81 for the high and low density foam, respectively) and stripping torque ( r = 0.92 and 0.78, respectively). Conical core screws with effective foam compaction had significantly higher pullout strength and insertion torque than cylindrical core screws ( p < 0.05). The results of finite element analyses were closely related to those of the mechanical tests in both situations with or without foam compaction. This study led to three conclusions: polyurethane foam bone yielded consistent experimental results; screws with a conical core could significantly increase pullout strength and insertion torque over cylindrical; and finite element models could reliably reflect the results of mechanical tests.

To evaluate mechanical performance properties of various types of cortical bone screw, cancellous bone screw, and locking bolt, we conducted torsional breaking and durability tests, screw driving torque tests into bone models, and screw pullout tests (crosshead speed: 10 mm/min) after driving torque tests. The 2° proof and rupture torques of a screw, which were estimated from torque versus rotational angle curves, increased with increasing core diameter of the screw. The durability limit of metallic screws obtained by four-point bending durability tests increased with increasing core diameter. The compressive, tensile, and shear strengths of the bone models used for the mechanical testing of orthopedic devices increased with increasing density of the bone model. The strength and modulus obtained for solid rigid polyurethane foam (SRPF) and cellular rigid polyurethane foam (CRPF) lay on the same straight line. Among the three strengths, the rate of increase in compressive strength with the increase in density was the highest. The maximum torque obtained by screw driving torque tests for up to 8.3 rotations (3000°) into the bone models tended to increase with increasing core diameter. In particular, the maximum torque increased linearly with increasing effective surface area of the screw, as newly defined in this work. The maximum pullout load increased linearly with increasing number of rotations and mechanical strength of the bone model. Screws with low driving torque and high pullout load were considered to have excellent fixation and are a target for development.