The relative influence of model parameters on finite element analysis simulations of intervertebral body fusion device static compression performance.

Non-clinical mechanical performance testing is a critical aspect of intervertebral body fusion device (IBFD) development and regulatory evaluation. Recently, stakeholders have begun leveraging computational modeling and simulations such as finite element analysis (FEA) in addition to traditional bench testing. FEA offers advantages such as reduced experiment time, lower costs associated with elimination of bench testing (e.g. specimen manufacture and test execution), and elucidating quantities of interest that traditional testing cannot provide (e.g. stress and strain distributions). However, best practices for FEA of IBFDs are not well defined, and modeler decision making can significantly influence simulation setup and results. Therefore, the goal of this study was to determine the relative influence of modeling parameters when using FEA to assess non-clinical mechanical performance of IBFDs. FEA was used to conduct a series of IBFD static uniaxial compression simulations. Several parameters relating to implant geometry, loading/boundary conditions, and material properties were carefully controlled to assess their relative influence on two output variables (IBFD stiffness and yield load). Results were most influenced by device geometry, while the effects of boundary conditions and material properties were more significant within IBFDs of identical or similar geometries. These results will aid stakeholders in the development of standardized best practices for using FEA to assess non-clinical mechanical performance of IBFDs.

Development of an in vitro test method to simulate intra-operative impaction loading on lumbar intervertebral body fusion devices.

Intervertebral body fusion devices (IBFDs) are commonly used in the treatment of various spinal pathologies. Intra-operative fractures of polyether-ether-ketone (PEEK) implants have been reported in the literature and to the FDA as device-related adverse events. The device and/or implant inserter failures typically occur during device impaction into the disc space and require implant removal and replacement. These additional steps may cause further complications along with increased surgical time and cost. Currently, there are no standardized test methods that evaluate clinically relevant impaction loading conditions on IBFDs. This study aims to develop an in vitro test method that would evaluate implant resistance to failure during intra-operative impaction. To achieve this, (1) surgical implantations of IBFDs were simulated in nine lumbar cadaver specimens by three different orthopedic spine surgeons (n = 3/surgeon). Impact force and mallet speed data were acquired for each surgeon. (2) Based on the acquired surgeon data, a benchtop mechanical test setup was developed to differentiate between two TLIF IBFD designs and two inserter designs (for a total of four IBFD-inserter combinations) under impaction loading. During implant insertion, impact force measurements indicated that lumbar IBFDs are subjected to high energy forces that may exceed their mechanical strength. Our test method successfully replicated clinically-relevant loading conditions and was effective at differentiating failure parameters between different implant and inserter instrument designs. The mechanical test method developed shows promise in its ability to assess impaction resistance of IBFD/inserter designs and evaluate potential risks of device failure during intraoperative loading.

Assessing the use of finite element analysis for mechanical performance evaluation of intervertebral body fusion devices.

BACKGROUND: Intervertebral body fusion devices (IBFDs) are a widely used type of spinal implant placed between two vertebral bodies to stabilize the spine for fusion in the treatment of spinal pathologies. Assessing mechanical performance of these devices is critical during the design, verification, and regulatory evaluation phases of development. While traditionally evaluated with physical bench testing, empirical assessments are at times supplemented with computational models and simulations such as finite element analysis (FEA). However, unlike many mechanical bench tests, FEA lacks standardized practices and consistency of implementation. OBJECTIVES: The objectives of this study were twofold. First, to identify IBFD 510(k) submissions containing FEA and conduct a comprehensive review of the elements provided in the FEA reports. Second, to engage with spinal device manufacturers through an anonymous survey and assess their practices for implementing FEA. METHODS: First, a retrospective analysis of 510(k) submissions for IBFDs cleared by the FDA between 2013 and 2017 was performed. The contents of FEA test reports were quantified according to FDA guidance. Second, a survey inquiring about the use of FEA was distributed to industry and academic stakeholders. The survey asked up to 20 questions relating to modeler experience and modeling practices. RESULTS: Significant gaps were present in model test reports that deemed the data unreliable and, therefore, unusable for regulatory decision-making in a high percentage of submissions. Nonetheless, the industry survey revealed most stakeholders employ FEA during device evaluation and are interested in more prescriptive guidelines for executing IBFD models. CONCLUSIONS: This study showed that while inconsistencies and gaps in FEA execution do exist within the spinal device community, the stakeholders are eager to work together in developing standardized approaches for executing computational models to support mechanical performance assessment of spinal devices in regulatory submissions.

FDA public workshop: Orthopaedic sensing, measuring, and advanced reporting technology (SMART) devices.

Traditional orthopaedic devices do not communicate with physicians or patients post-operatively. After implantation, follow-up of traditional orthopaedic devices is generally limited to episodic monitoring. However, the orthopaedic community may be shifting towards incorporation of smart technology. Smart technology in orthopaedics is a term that encompasses a wide range of potential applications. Smart orthopaedic implants offer the possibility of gathering data and exchanging it with an external reader. They incorporate technology that enables automated sensing, measuring, processing, and reporting of patient or device parameters at or near the implant. While including advanced technology in orthopaedic devices has the potential to benefit patients, physicians, and the scientific community, it may also increase the patient risks associated with the implants. Understanding the benefit-risk profile of new smart orthopaedic devices is critical to ensuring their safety and effectiveness. The 2018 FDA public workshop on orthopaedic sensing, measuring, and advanced reporting technology (SMART) devices was held on April 30, 2018, at the FDA White Oak Campus in Silver Spring, MD with the goal of fostering a collaborative dialogue amongst the orthopaedic community. Workshop attendees discussed four key areas related to smart orthopaedic devices: engineering and technology considerations, clinical and patient perspectives, cybersecurity, and regulatory considerations. The workshop presentations and associated discussions highlighted the need for the orthopaedic community to collectively craft a responsible path for incorporating smart technology in musculoskeletal disease care.

Mechanical performance of lumbar intervertebral body fusion devices: An analysis of data submitted to the Food and Drug Administration.

Lumbar intervertebral body fusion devices (L-IBFDs) are intended to provide stability to promote fusion in patients with a variety of lumbar pathologies. Different L-IBFD designs have been developed to accommodate various surgical approaches for lumbar interbody fusion procedures including anterior, lateral, posterior, and transforaminal lumbar interbody fusions (ALIF, LLIF, PLIF, and TLIF, respectively). Due to design differences, there is a potential for mechanical performance differences between ALIF, LLIF, PLIF, and TLIF devices. To evaluate this, mechanical performance and device dimension data were collected from 124 Traditional 510(k) submissions to the FDA for L-IBFDs cleared for marketing from 2007 through 2016. From these submissions, mechanical test results were aggregated for seven commonly performed tests: static and dynamic axial compression, compression-shear, and torsion testing per ASTM F2077, and subsidence testing per ASTM F2267. The Kruskal-Wallis test and Wilcoxon signed-rank test were used to determine if device type (ALIF, LLIF, PLIF, TLIF) had a significant effect on mechanical performance parameters (static testing: stiffness and yield strength; dynamic testing: runout load; subsidence testing: stiffness [Kp]). Generally, ALIFs and LLIFs were found to be stiffer, stronger, and had higher subsidence resistance than PLIF and TLIF designs. These results are likely due to the larger footprints of the ALIF and LLIF devices. The relative mechanical performance and subsidence resistance can be considered when determining the appropriate surgical approach and implant for a given patient. Overall, the mechanical performance data presented here can be utilized for future L-IBFD development and design verification.

Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration.

Cervical intervertebral body fusion devices (IBFDs) are utilized to provide stability while fusion occurs in patients with cervical pathology. For a manufacturer to market a new cervical IBFD in the United States, substantial equivalence to a cervical IBFD previously cleared by FDA must be established through the 510(k) regulatory pathway. Mechanical performance data are typically provided as part of the 510(k) process for IBFDs. We reviewed all Traditional 510(k) submissions for cervical IBFDs deemed substantially equivalent and cleared for marketing from 2007 through 2014. To reduce sources of variability in test methods and results, analysis was restricted to cervical IBFD designs without integrated fixation, coatings, or expandable features. Mechanical testing reports were analyzed and results were aggregated for seven commonly performed tests (static and dynamic axial compression, compression-shear, and torsion testing per ASTM F2077, and subsidence testing per ASTM F2267), and percentile distributions of performance measurements were calculated. Eighty-three (83) submissions met the criteria for inclusion in this analysis. The median device yield strength was 10,117N for static axial compression, 3680N for static compression-shear, and 8.6Nm for static torsion. Median runout load was 2600N for dynamic axial compression, 1400N for dynamic compression-shear, and ±1.5Nm for dynamic torsion. In subsidence testing, median block stiffness (Kp) was 424N/mm. The mechanical performance data presented here will aid in the development of future cervical IBFDs by providing a means for comparison for design verification purposes.

Bone morphogenetic protein-2-mediated pain and inflammation in a rat model of posterolateral arthrodesis.

BACKGROUND: Bone morphogenetic protein-2 (BMP-2) is a pleiotropic, secreted molecule with diverse effects. The potent ability of BMP-2 to stimulate bone growth prompted its widespread clinical use for arthrodesis (spine fusion). However, elevated post-operative pain in patients treated with BMP-2 has been increasingly reported. Determining whether BMP-2 induces pain directly or whether it induces neuroinflammation, which could lower the threshold for pain, is important for developing therapeutic interventions. We therefore modeled the clinical use of BMP-2 for posterior lumbar fusion by implanting absorbable collagen sponges soaked with either recombinant human BMP-2 (rhBMP-2) or vehicle above the L4-L5 transverse processes of rat spine. RESULTS: Using microarray analysis we found that implantation of rhBMP-2-soaked absorbable collagen sponges resulted in altered expression of numerous pro-inflammatory genes in the adjacent dorsal root ganglia (DRG) showing that implantation of rhBMP-2/absorbable collagen sponges triggers potent neuroinflammatory responses in the DRG-2. Interestingly, direct BMP-2 treatment of DRG explants resulted in changes in gene expression that were not specifically pro-inflammatory. Rats implanted with rhBMP-2 in absorbable collagen sponges also exhibited a transient change in thermal and mechanical sensitivity indicating that rhBMP-2 applied to the lumbar spine could increase pain sensitivity. Immunohistochemical analysis indicated macrophage infiltration in the DRG and spinal nerve in rats implanted with rhBMP-2/absorbable collagen sponges or absorbable collagen sponges alone, but not in rats that underwent surgery without implantation of the absorbable collagen sponges suggesting that the sponges contributed to the biological response. Indeed, analysis of DRGs taken from rats implanted with absorbable collagen sponges without rhBMP-2 showed a significant change in gene expression distinct from DRGs from rats undergoing surgery only. CONCLUSIONS: Our data indicate that implantation of rhBMP-2/absorbable collagen sponges on the lumbar spine triggers potent neuroinflammatory responses in the DRG. Importantly, however, these BMP-2 effects may be partially mediated through a response to the absorbable collagen sponges.

Biomechanical stability of transverse connectors in the setting of a thoracic pedicle subtraction osteotomy.

BACKGROUND CONTEXT: Transverse connectors (TCs) are often used to improve the rigidity of posterior spinal instrumentation as previous investigations have suggested that TCs enhance torsional rigidity in long-segment thoracic constructs. Posterior osteotomies, such as pedicle subtraction osteotomy (PSO), are used in severe thoracic deformities and provide a significant amount of correction; as a consequence, however, PSOs also induce three-column spinal instability. In theory, augmentation of longitudinal constructs with TC after a thoracic PSO may provide additional rigidity, but the concept has not been previously evaluated. PURPOSE: To evaluate the biomechanical contribution of TC to the rigidity of a long-segment pedicle screw-rod construct after a thoracic PSO. STUDY DESIGN: An in vitro fresh-frozen human cadaveric biomechanical analysis. METHODS: Seven human cadaveric thoracic spines were prepared and instrumented from T4-T10 with bilateral pedicle screws/rods and a PSO was performed at T7. Intact range of motion (ROM) testing was performed with nondestructive loading and analyzed by loading modality (axial rotation [AR], flexion/extension [FE], and lateral bending [LB]). Range of motion analysis was performed in the unaugmented construct, the construct augmented with one TC, and the construct augmented with two TCs. RESULTS: After PSO and an unaugmented longitudinal pedicle screw-rod construct, T4-T10 (overall construct) and T6-T8 (PSO site) ROMs were significantly reduced in all planes of motion compared with intact condition (AR: 11.8° vs. 31.7°; FE: 2.4° vs. 12.3°; 3.4° vs. 17.9°, respectively, p<.05). Augmentation of longitudinal construct with either one or two TCs did not significantly increase construct rigidity in FE or LB compared with the unaugmented construct (p>.05). In contrast, during AR, global ROM was significantly reduced by 43% and 48% at T6-T8 (1.7° and 1.2° vs. 2.38°, respectively) after addition of one and two TCs (p<.05), respectively. One TC did not significantly reduce torsional ROM from the intact state. CONCLUSIONS: Two TCs significantly improved torsional rigidity of the entire construct and at the PSO site, with no differences in rigidity for FE and LB or with the addition of only one TC. In the setting of a PSO and long-segment pedicle screw-rod construct, augmentation with at least two TCs should be considered to improve torsional rigidity.

Effects of rod reduction on pedicle screw fixation strength in the setting of Ponte osteotomies.

BACKGROUND CONTEXT: The use of a rod reduction device can have deleterious consequences on pedicle screw pullout strength (POS) in the thoracic spine. However, posterior-only osteotomies in the thoracic spine are often performed to improve flexibility of the spine and offset forces of deformity correction maneuvers. PURPOSE: To investigate the effect on pedicle screw POS caused by the rod reduction technique in the presence of facet osteotomies in the thoracic spine. STUDY DESIGN/SETTING: The study is a biomechanical study using human cadaveric spine specimens. METHODS: Thoracic Ponte osteotomies were performed on 3 thoracic levels in 15 cadaveric specimens. The right rod was contoured with a 5-mm residual gap at the middle level and was reduced using a rod reduction device. On the left side (paired control), a rod with no mismatch was placed. Biomechanical testing was performed with tensile load to failure "in line" with the screw axis and POS measured in Newtons (N). RESULTS: After rod reduction, thoracic pedicle screw POS was significantly decreased (40%) compared with the control (419±426 N vs. 708±462 N, p=.002) and remained statistically significant after adjusting for bone mineral density (BMD) (p=.05). Eleven (73%) of the pedicle screws had visible pullout/failure during the reduction attempt and occurred irrespective of BMD. CONCLUSIONS: Despite thoracic Ponte osteotomies and increased flexibility of the spinal segments, the rod reduction device still significantly decreased pedicle screw POS, typically resulting in outright failure of the screw-bone interface. Therefore, rod reduction technique of any kind should be performed with caution as it frequently results in suboptimal pedicle screw fixation.

Bilateral pedicle screw fixation provides superior biomechanical stability in transforaminal lumbar interbody fusion: a finite element study.

BACKGROUND CONTEXT: Transforaminal lumbar interbody fusion (TLIF) is increasingly popular for the surgical treatment of degenerative lumbar disease. The optimal construct for segmental stability remains unknown. PURPOSE: To compare the stability of fusion constructs using standard (C) and crescent-shaped (CC) polyetheretherketone TLIF cages with unilateral (UPS) or bilateral (BPS) posterior instrumentation. STUDY DESIGN: Five TLIF fusion constructs were compared using finite element (FE) analysis. METHODS: A previously validated L3-L5 FE model was modified to simulate decompression and fusion at L4-L5. This model was used to analyze the biomechanics of various unilateral and bilateral TLIF constructs. The inferior surface of the L5 vertebra remained immobilized throughout the load simulation, and a bending moment of 10 Nm was applied on the L3 vertebra to recreate flexion, extension, lateral bending, and axial rotation. Various biomechanical parameters were evaluated for intact and implanted models in all loading planes. RESULTS: All reconstructive conditions displayed decreased motion at L4-L5. Bilateral posterior fixation conferred greater stability when compared with unilateral fixation in left lateral bending. More than 50% of intact motion remained in the left lateral bending with unilateral posterior fixation compared with less than 10% when bilateral pedicle screw fixation was used. Posterior implant stresses for unilateral fixation were six times greater in flexion and up to four times greater in left lateral bending compared with bilateral fixation. No effects on segmental stability or posterior implant stresses were found. An obliquely-placed, single standard cage generated the lowest cage-end plate stress. CONCLUSIONS: Transforaminal lumbar interbody fusion augmentation with bilateral posterior fixation increases fusion construct stability and decreases posterior instrumentation stress. The shape or number of interbody implants does not appear to impact the segmental stability when bilateral pedicle screws are used. Increased posterior instrumentation stresses were observed in all loading modes with unilateral pedicle screw/rod fixation, which may theoretically accelerate implant loosening or increase the risk of construct failure.

Pedicle screw reinsertion using previous pilot hole and trajectory does not reduce fixation strength.

STUDY DESIGN: Fresh-frozen human cadaveric biomechanical study. OBJECTIVE: To evaluate the biomechanical consequence of pedicle screw reinsertion in the thoracic spine. SUMMARY OF BACKGROUND DATA: During pedicle screw instrumentation, abnormal appearance on fluoroscopic imaging or low current reading with intraoperatively evoked electromyographic stimulation of a pedicle screw warrants complete removal to reassess for pedicle wall violation or screw malposition. However, screw fixation strength has never been evaluated biomechanically after reinsertion using a previous pilot hole and trajectory. METHODS: Thirty-one thoracic individual fresh-frozen human cadaveric vertebral levels were instrumented bilaterally with 5.5-mm titanium polyaxial pedicle screws, and insertional torque (IT) was measured with each revolution. A paired comparison was performed for each level. Screw reinsertion was performed by completely removing the pedicle screw, palpating the tract, and then reinserting along the same trajectory. Screws were tensile loaded to failure "in-line" with the screw axis. RESULTS: There was no significant difference for pedicle screw pullout strength (POS) between reinserted and control screws (732 ± 307 N vs. 742 ± 320 N, respectively; P = 0.78). There was no significant difference in IT between initial insertion for the test group (INI) (0.82 ± 0.40 N·m) and control (0.87 ± 0.50 N·m) (P = 0.33). IT for reinserted screws (0.58 ± 0.47 N·m) had significantly decreased compared with INI and control screws (29% decrease, P = 0.00; 33% decrease, P = 0.00, respectively). The test group screws in the thoracic spine had significant correlations between initial IT and POS (r = 0.79, P = 0.00), and moderate correlations between reinsertion IT and POS in the thoracic spine (r = 0.56, P = 0.00). CONCLUSION: Despite a significant reduction in pedicle screw IT, there was no significant difference in pedicle screw POS with reinsertion. Therefore, when surgeons must completely remove a pedicle screw for tract inspection, reinsertion along the same trajectory may be performed without significantly compromising fixation strength. LEVEL OF EVIDENCE: N/A.

The effect of cervical posterior foraminotomy on segmental range of motion in the setting of total disc arthroplasty.

STUDY DESIGN: Human cadaveric biomechanical analysis. OBJECTIVE: To investigate the effect on cervical spine segmental stability that results from a posterior foraminotomy after cervical disc arthroplasty (CDA). SUMMARY OF BACKGROUND DATA: Posterior foraminotomy offers the ability to decompress cervical nerves roots while avoiding the need to extend a previous fusion or revise an arthroplasty to a fusion. However, the safety of a foraminotomy in the setting of CDA is unknown. METHODS: Segmental nondestructive range of motion (ROM) was analyzed in 9 human cadaveric cervical spine specimens. After intact testing, each specimen was sequentially tested according to the following 4 experimental groups: group 1=C5-C6 CDA, group 2=C5-C6 CDA with unilateral C5-C6 foraminotomy, group 3=C5-C6 CDA with bilateral C5-C6 foraminotomy, and group 4=C5-C6 CDA with C5-C6 and C4-C5 bilateral foraminotomy. RESULTS: No differences in ROM were found between the intact, CDA, and foraminotomy specimens at C4-C5 or C6-C7. There was a step-wise increase in C5-C6 axial rotation from the intact state (8°) to group 4 (12°), although the difference did not reach statistical significance. At C5-C6, the degree of lateral bending remained relatively constant. Flexion and extension at C5-C6 was significantly higher in the foraminotomy specimens, groups 2 (18.1°), 3 (18.6°), and 4 (18.2°), compared with the intact state, 11.2°. However, no ROM difference was found within foraminotomy groups (2-4) or between the foraminotomy groups and the CDA group (group 1), 15.3°. CONCLUSION: Our results indicate that cervical stability is not significantly decreased by the presence, number, or level of posterior foraminotomies in the setting of CDA. The addition of foraminotomies to specimens with a pre-existing CDA resulted in small and insignificant increases in segmental ROM. Therefore, biomechanically, posterior foraminotomy/foraminotomies may be considered a safe and viable option in the setting of recurrent or adjacent level radiculopathy after cervical disc replacement. LEVEL OF EVIDENCE: N/A.

Pedicle screw "hubbing" in the immature thoracic spine: a biomechanical and micro-computed tomography evaluation.

BACKGROUND: A previous biomechanical study using adult thoracic vertebrae (both normal and osteoporotic bone density) demonstrated the deleterious effect of the pedicle screw hubbing technique. Pedicle screw "hubbing" involves seating and engaging the ventral aspect of the screw head onto the dorsal lamina cortex. This technique is postulated to provide a load-sharing effect by improving pullout resistance, as well as decreasing cephalocaudad toggling and implant loosening. We hypothesized the elastic properties of immature bone may mitigate, and perhaps enhance the purported benefits of the hubbing technique. We set out to evaluate pullout strength of fixed-head pedicle screws after hubbing versus standard insertion in the immature thoracic calf spine. METHODS: Twenty-two (n=22) single-level disarticulated fresh-frozen immature calf thoracic vertebra specimens (ranging from T2 to T13) were prepared. Twelve specimens were instrumented with pedicle screws in group I (nonhubbed) and group II (hubbed) in the opposite pedicle. Cyclic loading in a cephalocaudad direction was applied for 2000 cycles at a rate of 1 Hz. Pullout testing was performed in-line with the midline of the vertebra and peak pullout strength was measured in Newtons. Ten different specimens underwent micro-computed tomography evaluation to assess for trabecular architecture and incidence of iatrogenic microfractures. RESULTS: Hubbed screws resulted in significantly lower pullout strength (747±197 vs. 922±112 N, P=0.01). With the hubbing technique, the dorsal cortex demonstrated plastic deformation and conformed to the screw head in 83% of cases compared with no visible plastic deformation in the control group. Micro-computed tomography demonstrated microfractures of the dorsal cortex in 10/10 for the hubbed group compared with 1/10 for the control group. CONCLUSIONS: This is the largest study ever performed on immature thoracic vertebra to evaluate this topic. Hubbed pedicle screws have significantly decreased pullout strength and frequently cause iatrogenic microfractures of the dorsal cortex. The unique ability of immature bone to exhibit plastic deformation did not provide a protective effect on immediate fixation strength, and the increased insertional torque during the hubbing technique should not give a false sense of added fixation. This study, along with our adult study, provides critical information to the surgeon to avoid this common misunderstanding with screw insertion technique. CLINICAL RELEVANCE: In vitro fresh-frozen immature calf spine study.

Do stand-alone interbody spacers with integrated screws provide adequate segmental stability for multilevel cervical arthrodesis?

BACKGROUND CONTEXT: Some postoperative complications after anterior cervical fusions have been attributed to anterior cervical plate (ACP) profiles and the necessary wide operative exposure for their insertion. Consequently, low-profile stand-alone interbody spacers with integrated screws (SIS) have been developed. Although SIS constructs have demonstrated similar biomechanical stability to the ACP in single-level fusions, their role as a stand-alone device in multilevel reconstructions has not been thoroughly evaluated. PURPOSE: To evaluate the acute segmental stability afforded by an SIS device compared with the traditional ACP in the setting of a multilevel cervical arthrodesis. STUDY DESIGN: In vitro human cadaveric biomechanical analysis. METHODS: Thirteen human cadaveric cervical spines (C2-T1) were nondestructively tested with a custom 6 df spine simulator under axial rotation, flexion-extension, and lateral bending loading. After intact analysis, eight single-levels (C4-C5/C6-C7) from four specimens were instrumented and tested with ACP and SIS. Nine specimens were tested with C5-C7 SIS, C5-C7 ACP, C4-C7 ACP, C4-C7 ACP+posterior fixation, C4-C7 SIS, and C4-C7 SIS+posterior fixation. Testing order was randomized with each additional level instrumented. Full range of motion (ROM) data were obtained and analyzed by each loading modality, using mean comparisons with repeated measures analysis of variance. Paired t tests were used for post hoc analysis with Sidak correction for multiple comparisons. RESULTS: No significant difference in ROM was noted between the ACP and SIS for single-level fixation (p>.05). For multisegment reconstructions (two and three levels), the ACP proved superior to SIS and intact condition, with significantly lower ROM in all planes (p<.05). When either the three-level SIS or ACP constructs were supplemented with posterior lateral mass fixation, there was a greater than 80% reduction in ROM under all testing modalities (p<.05), with no significant difference between the ACP and SIS constructs (p>.05). CONCLUSIONS: The SIS device may be a reasonable option as a stand-alone device for single-level fixation. However, SIS devices should be used with careful consideration in the setting of multilevel cervical fusion. However, when supplemented with posterior fixation, SIS devices are a sound biomechanical alternative to ACP for multilevel fusion constructs.

The biomechanical consequences of rod reduction on pedicle screws: should it be avoided?

BACKGROUND CONTEXT: Rod contouring is frequently required to allow for appropriate alignment of pedicle screw-rod constructs. When residual mismatch is still present, a rod persuasion device is often used to achieve further rod reduction. Despite its popularity and widespread use, the biomechanical consequences of this technique have not been evaluated. PURPOSE: To evaluate the biomechanical fixation strength of pedicle screws after attempted reduction of a rod-pedicle screw mismatch using a rod persuasion device. METHODS: Fifteen 3-level, human cadaveric thoracic specimens were prepared and scanned for bone mineral density. Osteoporotic (n=6) and normal (n=9) specimens were instrumented with 5.0-mm-diameter pedicle screws; for each pair of comparison level tested, the bilateral screws were equal in length, and the screw length was determined by the thoracic level and size of the vertebra (35 to 45 mm). Titanium 5.5-mm rods were contoured and secured to the pedicle screws at the proximal and distal levels. For the middle segment, the rod on the right side was intentionally contoured to create a 5-mm residual gap between the inner bushing of the pedicle screw and the rod. A rod persuasion device was then used to engage the setscrew. The left side served as a control with perfect screw/rod alignment. After 30 minutes, constructs were disassembled and vertebrae individually potted. The implants were pulled in-line with the screw axis with peak pullout strength (POS) measured in Newton (N). For the proximal and distal segments, pedicle screws on the right side were taken out and reinserted through the same trajectory to simulate screw depth adjustment as an alternative to rod reduction. RESULTS: Pedicle screws reduced to the rod generated a 48% lower mean POS (495±379 N) relative to the controls (954±237 N) (p<.05) and significantly decreased work energy to failure (p<.05). Nearly half (n=7) of the pedicle screws had failed during the reduction attempt with visible pullout of the screw. After reduction, decreased POS was observed in both normal (p<.05) and osteoporotic (p<.05) bone. Back out and reinsertion of the screw resulted in no significant difference in mean POS, stiffness, and work energy to failure (p>.05). CONCLUSIONS: In circumstances where a rod is not fully seated within the pedicle screw, the use of a rod persuasion device decreases the overall POS and work energy to failure of the screw or results in outright failure. Further rod contouring or correction of pedicle screw depth of insertion may be warranted to allow for appropriate alignment of the longitudinal rods.

Tapping insertional torque allows prediction for better pedicle screw fixation and optimal screw size selection.

BACKGROUND CONTEXT: There is currently no reliable technique for intraoperative assessment of pedicle screw fixation strength and optimal screw size. Several studies have evaluated pedicle screw insertional torque (IT) and its direct correlation with pullout strength. However, there is limited clinical application with pedicle screw IT as it must be measured during screw placement and rarely causes the spine surgeon to change screw size. To date, no study has evaluated tapping IT, which precedes screw insertion, and its ability to predict pedicle screw pullout strength. PURPOSE: The objective of this study was to investigate tapping IT and its ability to predict pedicle screw pullout strength and optimal screw size. STUDY DESIGN: In vitro human cadaveric biomechanical analysis. METHODS: Twenty fresh-frozen human cadaveric thoracic vertebral levels were prepared and dual-energy radiographic absorptiometry scanned for bone mineral density (BMD). All specimens were osteoporotic with a mean BMD of 0.60 ± 0.07 g/cm(2). Five specimens (n=10) were used to perform a pilot study, as there were no previously established values for optimal tapping IT. Each pedicle during the pilot study was measured using a digital caliper as well as computed tomography measurements, and the optimal screw size was determined to be equal to or the first size smaller than the pedicle diameter. The optimal tap size was then selected as the tap diameter 1 mm smaller than the optimal screw size. During optimal tap size insertion, all peak tapping IT values were found to be between 2 in-lbs and 3 in-lbs. Therefore, the threshold tapping IT value for optimal pedicle screw and tap size was determined to be 2.5 in-lbs, and a comparison tapping IT value of 1.5 in-lbs was selected. Next, 15 test specimens (n=30) were measured with digital calipers, probed, tapped, and instrumented using a paired comparison between the two threshold tapping IT values (Group 1: 1.5 in-lbs; Group 2: 2.5 in-lbs), randomly assigned to the left or right pedicle on each specimen. Each pedicle was incrementally tapped to increasing size (3.75, 4.00, 4.50, and 5.50 mm) until the threshold value was reached based on the assigned group. Pedicle screw size was determined by adding 1 mm to the tap size that crossed the threshold torque value. Torque measurements were recorded with each revolution during tap and pedicle screw insertion. Each specimen was then individually potted and pedicle screws pulled out "in-line" with the screw axis at a rate of 0.25 mm/sec. Peak pullout strength (POS) was measured in Newtons (N). RESULTS: The peak tapping IT was significantly increased (50%) in Group 2 (3.23 ± 0.65 in-lbs) compared with Group 1 (2.15 ± 0.56 in-lbs) (p=.0005). The peak screw IT was also significantly increased (19%) in Group 2 (8.99 ± 2.27 in-lbs) compared with Group 1 (7.52 ± 2.96 in-lbs) (p=.02). The pedicle screw pullout strength was also significantly increased (23%) in Group 2 (877.9 ± 235.2 N) compared with Group 1 (712.3 ± 223.1 N) (p=.017). The mean pedicle screw diameter was significantly increased in Group 2 (5.70 ± 1.05 mm) compared with Group 1 (5.00 ± 0.80 mm) (p=.0002). There was also an increased rate of optimal pedicle screw size selection in Group 2 with 9 of 15 (60%) pedicle screws compared with Group 1 with 4 of 15 (26.7%) pedicle screws within 1 mm of the measured pedicle width. There was a moderate correlation for tapping IT with both screw IT (r=0.54; p=.002) and pedicle screw POS (r=0.55; p=.002). CONCLUSIONS: Our findings suggest that tapping IT directly correlates with pedicle screw IT, pedicle screw pullout strength, and optimal pedicle screw size. Therefore, tapping IT may be used during thoracic pedicle screw instrumentation as an adjunct to preoperative imaging and clinical experience to maximize fixation strength and optimize pedicle "fit and fill" with the largest screw possible. However, further prospective, in vivo studies are necessary to evaluate the intraoperative use of tapping IT to predict screw loosening/complications.

What is the best way to optimize thoracic kyphosis correction? A micro-CT and biomechanical analysis of pedicle morphology and screw failure.

STUDY DESIGN: A human cadaveric biomechanical analysis. OBJECTIVE: The purpose of this study was to evaluate the bone density/trabecular width of the thoracic pedicle and correlate that with its resistance against compressive loading used during correction maneuvers in the thoracic spine (i.e., cantilever bending). SUMMARY OF BACKGROUND DATA: As surgeons perform cantilever correction maneuvers in the spine, it is common to have pedicle screws pullout or displace while placing corrective forces on the construct. Currently, surgeons either compress against the cephalad aspect of the pedicle or vice versa. We set out to establish which aspect of the pedicle was the most dense and to determine the optimal direction for screw compression during kyphosis/deformity correction. METHODS: Fifteen fresh-frozen cadaveric vertebrae (n = 15) were examined by micro-computed tomography to determine percent bone volume/total volume (%BV/TV) within the cephalad and caudad aspects of the pedicle. Specimens were sectioned in the sagittal plane. Pedicles were instrumented according to the straightforward trajectory on both sides. Specimens were then mounted and loading to failure was performed perpendicular to the screw axis (either the cephalad or the caudad aspect of the pedicle). RESULTS: Mean failure when loading against the caudad aspect of the pedicle was statistically, significantly greater (454.5 ± 241.3 N vs. 334.79 1 ± 158.435 N) than for the cephalad pedicle (P < 0.001). In concordance with failure data, more trabecular and cortical bones were observed within the caudad half of the pedicle compared with the cephalad half (P < 0.001). CONCLUSION: Our results suggest that the caudad half of the pedicle is denser and withstands higher forces compared with the cephalad aspect. In turn, the incidence of intraoperative screw loosening and/or pedicle fracture may be reduced if the compressive forces (cantilever bending during deformity correction) placed upon the construct are applied against the caudad portion of the pedicle.

The biomechanical effect of pedicle screw hubbing on pullout resistance in the thoracic spine.

BACKGROUND CONTEXT: The biomechanical fixation strength afforded by pedicle screws has been strongly correlated with bone mineral density. It has been postulated that "hubbing" the head of the pedicle screw against the dorsal laminar cortex provides a load-sharing effect, thereby limiting cephalocaudad toggling and improving the pullout resistance of the pedicle screw. PURPOSE: To evaluate the pullout strength (POS) of monoaxial hubbed pedicle screws versus standard fixation in the thoracic spine. STUDY DESIGN: Biomechanical investigation. METHODS: Twenty-two human cadaveric thoracic vertebrae were acquired and dual-energy X-ray absorptiometry scanned. Osteoporotic (n = 16) and normal (n = 6) specimens were instrumented with a 5.0 × 35-mm pedicle screw on one side in a standard fashion. In the contralateral pedicle, 5.0 × 30-mm screw was inserted with hubbing of the screw into the dorsal lamina. A difference in screw length was used to achieve equivalent depth of insertion. After 2,000 cycles of cephalocaudad toggling, screws were pulled out with the tensile force oriented to the midline of the spine and peak POS measured in newtons (N). Four additional specimens were subjected to microcomputed tomography (micro-CT) analysis to evaluate internal pedicle architecture after screw insertion. RESULTS: Hubbed screws resulted in significantly lower POS (290.5 ± 142.4 N) compared with standard pedicle screws (511.5 ± 242.8 N; p = .00). This finding was evident in both normal and osteoporotic vertebrae based on independent subgroup post hoc analyses (p<.05). As a result of hubbing, half of the specimens fractured through the lamina or superior articular facet (SAF). No fractures occurred on the control side. There was no difference in mean POS for hubbed screws with and without fracture; however, further micro-CT analysis revealed the presence of internal fracture propagation for those specimens that did not have any external signs of failure. CONCLUSIONS: Hubbing pedicle screws results in significantly decreased POS compared with conventional pedicle screws. Hubbing predisposes toward iatrogenic fracture of the dorsal lamina, transverse process, or SAF during insertion.

Biomechanical analysis of the C2 intralaminar fixation technique using a cross-link and offset connector for an unstable atlantoaxial joint.

BACKGROUND CONTEXT: C2 intralaminar screws offer the advantage of avoiding the vertebral artery; however, biomechanical studies have demonstrated inferiority of C2 intralaminar screw fixation compared with C2 intrapedicular fixation in the presence of an odontoid fracture. Addition of a transverse cross-link may improve stability afforded by the lamina screws but will require the use of offset connectors to complete the construct. PURPOSE: The aims of this project were to evaluate whether transverse cross-links can add adequate stability to atlantoaxial constructs using C1 lateral mass and C2 intralaminar screw fixation. The secondary objective was to determine the biomechanical contribution of the C2 offset connectors. STUDY DESIGN: In vitro human cadaveric biomechanical study. METHODS: Ten cadaveric specimens were obtained and instrumented with C1 lateral mass, C2 pedicle, and C2 intralaminar screws. After intact spine testing, each C1-C2 construct was nondestructively evaluated under axial rotation (AR), flexion extension (FE), and lateral bending (LB). Intralaminar fixation was tested with and without offset connectors, which allowed for cross-link addition to the construct. After normal state evaluation, the odontoid was resected and analyses were repeated. RESULTS: Postreconstruction range of motion in AR, FE, and LB showed no significant differences between the four fixation constructs in the stable specimens. Transpedicular fixation at C2 proved superior to intralaminar techniques without a cross-link in AR and LB after destabilization with an odontoidectomy. The addition of a cross-link to the intralaminar construct improved segmental AR and LB stability to the level afforded by the transpedicular fixation. Offset connectors appeared to marginally weaken the intralaminar fixation, but the findings were not significant. CONCLUSIONS: Coupled with an offset connector and a cross-link, C2 intralaminar screws offer similar segmental stability to intrapedicular fixation in the presence of an unstable dens fracture. Lateral offset connectors at C2 do not significantly compromise stability of C1 lateral mass-C2 intralaminar fixation.

Alterations in recovery from spinal cord injury in rats treated with recombinant human bone morphogenetic protein-2 for posterolateral arthrodesis.

BACKGROUND: Treatment of trauma-related spinal instability with use of recombinant human bone morphogenetic protein-2 (rhBMP-2) may appear as a viable option, but little is known of the direct effects of rhBMP-2 on the injured spinal cord. In the current study, we investigated the acute and long-term effects of using rhBMP-2 in the posterolateral spine at the level of a spinal cord injury in rats. METHODS: Fifty-two rats underwent a T10 dorsal hemisection and were assigned to one of two groups: the vehicle control group (twenty-four rats) or the rhBMP-2 group (twenty-four rats). Within each group, animals were further subdivided according to the follow-up period: one week and six weeks after the lesion. For the acute phase, an additional group of four rats received recombinant human albumin, to account for the cross-species inflammatory response. Postoperatively, locomotor function was assessed on a weekly basis with use of an open field scale and digital footprint analysis. After the animals were killed, they were perfused and the spinal cords analyzed for inflammatory markers, gliosis, and extracellular matrix proteins with use of immunohistochemistry. RESULTS: At one week, there was a significant increase in reactive astrocyte, macrophage-microglia, and fibroblast immunoreactivity around the lesion in the rhBMP-2-treated rats relative to controls. Additionally, there was increased staining for chondroitin sulfate proteoglycans. Similar intergroup morphologic differences persisted at six weeks. Functionally, in the acute phase, rhBMP-2-treated animals demonstrated more open field and fine motor control deficits relative to the controls. By six weeks, both groups had equivalent functional scores, but those treated with rhBMP-2 retained significantly greater paw angle changes than the control animals. CONCLUSIONS: Our findings indicate that in a rat model, rhBMP-2 use in the vicinity of a penetrating spinal cord injury triggers detrimental changes in the morphology of the spinal cord lesion and alters functional recovery.