Forcefully engaging rods into tulips with gap discrepancy leading to pedicle screw loosening-a biomechanical analysis using long porcine spine segments.

BACKGROUND CONTEXT: Long-segment pedicle screw instrumentation is widely used to treat complex spinal disorders. Rods are routinely precontoured to maximize assistance on the correcting side of the deformity, but there often exists a residual gap discrepancy between the precontoured rods and screw tulips. No previous research has investigated the diminished pullout strength of the most proximal or distal pedicle screw resulting from a mismatched rod in long-segment pedicle screw instrumentation. PURPOSE: The present study aimed to investigate the decreased pullout force of pedicle screws affected by the gap discrepancy when forcefully engaging a mismatched rod into a tulip in a normal-density porcine spine. STUDY DESIGN: The pedicle screw fixation strength under axial pullout force was compared among three different gap discrepancies between rods and tulips using long porcine spine segments. METHODS: Twelve porcine lumbar vertebrae (L3-L6) were implanted with pedicle screws and rods. Screws on one side had no gap between the tulip and rod (0-mm group), while the most proximal screw on the other side had an intentional gap of 3 mm (3-mm group) or 6 mm (6-mm group). Three hours after forcefully engaging the rod into the tulips at room temperature, the set screws in all specimens were loosened, and each specimen was dissected into individual vertebrae for subsequent pullout testing. RESULTS: The control group exhibited significantly greater pullout strength (1987.68 ± 126.80 N) than the groups from different rod-tulip configurations (p<.05), with significantly greater strength in the 3-mm group (945.62 ± 97.43 N) than the 6-mm group (655.30 ± 194.49 N) (p<.05). Only 47.6% and 33.0% of the pullout strength was retained in the 3-mm and 6-mm groups, respectively, compared to the control group. CONCLUSIONS: Gap discrepancies between rods and tulips can significantly reduce pedicle screw pullout strength, with a correlation between decreased strength and increased gaps. Surgeons should avoid forcefully engaging mismatched rods and consider well-fitted contoured rods in spinal surgery to minimize the risk of screw loosening. CLINICAL SIGNIFICANCE: The gap discrepancy between rod and tulip significantly affected pullout strength, with greater gaps leading to reduced strength. Forcefully engaging mismatched rods into tulips in degenerative spinal surgery should be avoided to minimize the risk of early screw pullout.

Influence of various pilot hole profiles on pedicle screw fixation strength in minimally invasive and traditional spinal surgery: a comparative biomechanical study.

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.

Finite element analysis of optimized novel additively manufactured non-articulating prostheses for cervical total disc replacement.

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.

Biomechanical evaluation of pedicle screw stability after 360-degree turnback from full insertion: effects of screw shape, pilot hole profile and bone density.

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.

Biomechanical evaluation of position and bicortical fixation of anterior lateral vertebral screws in a porcine model.

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 < 0.05), and there was no significant differences between the central and lower positions. The maximal pullout forces from the same screw positions in unicortical fixation modalities were all significantly lower, decreases that ranged from 32.7 to 74%, than those in bicortical fixation modalities. Our study using porcine vertebrae showed that screws in the middle or posterior position of the lateral vertebral body had a higher pullout performance than those in the anterior position. Posteriorly positioned lateral vertebral screws with unicortical fixation provided better stability than anteriorly positioned screws with bicortical fixation.

Biomechanical comparison of different combinations of hook and screw in one spine motion unit--an experiment in porcine model.

BACKGROUND: The biomechanical performance of the hooks and screws in spinal posterior instrumentation is not well-characterized. Screw-bone interface failure at the uppermost and lowermost vertebrae is not uncommon. Some have advocated for the use of supplement hooks to prevent screw loosening. However, studies describing methods for combined hook and screw systems that fully address the benefits of these systems are lacking. Thus, the choice of which implant to use in a given case is often based solely on a surgeon's experience instead of on the biomechanical features and advantages of each device. METHODS: We conducted a biomechanical comparison of devices instrumented with different combinations of hooks and screws. Thirty-six fresh low thoracic porcine spines were assigned to three groups (12 per group) according to the configuration used for of fixation: (1) pedicle screw; (2) lamina hook and (3) combination of pedicle screw and lamina hook. Axial pullout tests backward on transverse plane in the direction normal to the rods were performed using a material testing machine and a specially designed grip with self-aligned function. RESULTS: The pullout force for the pedicle screws group was significantly greater than for the hooks and the combination (p < 0.05). However, no significant difference was found between the hooks and the combination (p > 0.05). CONCLUSIONS: Pedicle screws achieve the maximal pullout strength for spinal posterior instrumentation.

Pullout strength of pedicle screws with cement augmentation in severe osteoporosis: a comparative study between cannulated screws with cement injection and solid screws with cement pre-filling.

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. CONCLUSIONS: Solid screws with retrograde cement pre-filling offer improved initial fixation strength when compared to that of cannulated screws with cement injection through perforation for both the conically and cylindrically shaped screw. Our results also suggest that the fixation screws can be backed out by 360 degrees for intra-operative adjustment without the loss of fixation strength.

Pullout strength for cannulated pedicle screws with bone cement augmentation in severely osteoporotic bone: influences of radial hole and pilot hole tapping.

BACKGROUND: Pedicle screw fixation in a severely osteoporotic spine remains a challenge for orthopedic surgeons. The previous literature does not adequately address the effects of radial holes for cannulated screws with cement injection and pilot hole tapping on the bone/screw interfacial strength. METHODS: Specially designed cannulated pedicle screws, with or without radial holes, were installed in tapped and untapped pilot holes and then injected with cement. A uniform synthetic bone (test block) was used to provide a platform for each screw design. Specimens with inserted screws were then tested for axial pullout failure. FINDINGS: (1) Cannulated screws with cement augmentation significantly increased the pullout strength in comparison to solid screws. Additionally, the amount of cement exuded from the cannulated screws increased with an increasing number of radial holes, leading to an increase in the average ultimate pullout strength for cannulated screws with a large number of radial holes. (2) Radiological examination indicated that the cement was exuded from the most proximal holes at the very beginning of its flow path, whereas no cement exudation was found at the remaining distal holes. (3) Cement exudation from the holes of cannulated screws into the open cell of the test block led to a composite (cement/bone) structure at the area of cement exudation. Observations of the failed specimens indicated that failure occurred at the composite/bone interface, while the composite was well bonded to the screws. This implies that the screw/composite interfacial strength was much higher than the composite/bone interfacial strength. (4) Tapping pilot holes decreased the pullout strength of the screws. Generally, larger standard deviations were found for the tapped cases, implying that untapped cases results are more repeatable than tapped cases results. INTERPRETATION: Cannulated pedicle screws with radial holes combined with PMMA cement augmentation but without tapping may be a viable clinical option for achieving fixation in severely osteoporotic bone.