In Vitro Comparison of Dynesys, PEEK, and Titanium Constructs in the Lumbar Spine.

Introduction. Pedicle based posterior dynamic stabilization systems aim to stabilize the pathologic spine while also allowing sufficient motion to mitigate adjacent level effects. Two flexible constructs that have been proposed to act in such a manner, the Dynesys Dynamic Stabilization System and PEEK rod, have yet to be directly compared in vitro to a rigid Titanium rod. Methods. Human lumbar specimens were tested in flexion extension, lateral bending, and axial torsion to evaluate the following conditions at L4-L5: Intact, Dynesys, PEEK rod, Titanium rod, and Destabilized. Intervertebral range of motion, interpedicular travel, and interpedicular displacement metrics were evaluated from 3rd-cycle data using an optoelectric tracking system. Results. Statistically significant decreases in ROM compared to Intact and Destabilized conditions were detected for the instrumented conditions during flexion extension and lateral bending. AT ROM was significantly less than Destabilized but not the Intact condition. Similar trends were found for interpedicular displacement in all modes of loading; however, interpedicular travel trends were less consistent. More importantly, no metrics under any mode of loading revealed significant differences between Dynesys, PEEK, and Titanium. Conclusion. The results of this study support previous findings that Dynesys and PEEK constructs behave similarly to a Titanium rod in vitro.

Comparison of Intervertebral ROM in Multi-Level Cadaveric Lumbar Spines Using Distinct Pure Moment Loading Approaches.

BACKGROUND: Pure-moment loading is the test method of choice for spinal implant evaluation. However, the apparatuses and boundary conditions employed by laboratories in performing spine flexibility testing vary. The purpose of this study was to quantify the differences, if they exist, in intervertebral range of motion (ROM) resulting from different pure-moment loading apparatuses used in two laboratories. METHODS: Twenty-four (laboratory A) and forty-two (laboratory B) intact L1-S1 specimens were loaded using pure moments (±7.5 Nm) in flexion-extension (FE), lateral bending (LB) and axial torsion (AT). At laboratory A, pure moments were applied using a system of cables, pulleys and suspended weights in 1.5 Nm increments. At laboratory B, specimens were loaded in a pneumatic biaxial test frame mounted with counteracting stepper-motor-driven biaxial gimbals. ROM was obtained in both labs using identical optoelectronic systems and compared. RESULTS: In FE, total L1-L5 ROM was similar, on average, between the two laboratories (lab A: 37.4° ± 9.1°; lab B: 35.0° ± 8.9°, p=0.289). Larger apparent differences, on average, were noted between labs in AT (lab A: 19.4° ± 7.3°; lab B: 15.7° ± 7.1°, p=0.074), and this finding was significant for combined right and left LB (lab A: 45.5° ± 11.4°; lab B: 35.3° ± 8.5°, p < 0.001). CONCLUSIONS: To our knowledge, this is the first study comparing ROM of multi-segment lumbar spines between laboratories utilizing different apparatuses. The results of this study show that intervertebral ROM in multi-segment lumbar spine constructs are markedly similar in FE loading. Differences in boundary conditions are likely the source of small and sometimes statistically significant differences between the two techniques in LB and AT ROM. The relative merits of each testing strategy with regard to the physiologic conditions that are to be simulated should be considered in the design of a study including LB and AT modes of loading. An understanding of these differences also serves as important information when comparing study results across different laboratories.

Effect of TLIF Cage Placement on In Vivo Kinematics.

BACKGROUND: The influence of interbody cage positioning on clinical outcomes following lumbar interbody fusion is not well understood, though it has been hypothesized to play a significant role in stability of the treated level. The purpose of this study was to evaluate any correlations between cage placement in TLIF procedures and post-operative kinematics. METHODS: Thirteen patients who had previously undergone a TLIF procedure were evaluated using the Vertebral Motion Analysis (VMA) system, an automated fluoroscopic method of tracking kinematics in vivo. Upright and recumbent bending platforms were used to guide patients through a set range of motion (ROM) standing up and lying down, respectively, in both flexion-extension (FE) and lateral bending (LB). Intervertebral ROM was measured via fluoroscopic images captured sequentially throughout the movement. DICOM images acquired by the VMA system were used to calculate cage positioning. Intra-rater and inter-rater reliability of TLIF cage position were also assessed. RESULTS: Statistically significant correlations were noted between sagittal cage position and lying LB (r = -0.583, p = 0.047), and coronal cage positioning with both standing (r = 0.672, p = 0.012) and lying LB (r = 0.632, p = 0.027). Additionally, the correlation between sagittal cage position and standing FE was trending towards significance (r = -0.542, p = 0.055). CONCLUSIONS: The intuitive correlation between coronal cage position and both standing and lying lateral bending ROM is supported by the data from this study, suggesting placement closer to midline is optimal for stability. Additionally, the VMA system appears to be a sensitive and repeatable means to obtain information on postoperative kinematic outcomes. Further work to establish the relationship between cage placement, these kinematic outcomes and, potentially, functional pain outcomes seems to be warranted based on the results obtained here.

Anterior lumbar interbody fusion with integrated fixation and adjunctive posterior stabilization: A comparative biomechanical analysis.

BACKGROUND: Interbody fusion cages with integrated fixation components have become of interest due to their ability to provide enhanced post-operative stability and mitigate device migration. A recently approved anterior lumbar interbody fusion cage with integrated fixation anchors has yet to be compared in vitro to a standard polyetheretherketone cage when used in combination with an interspinous process clamp. METHODS: Twelve human cadaveric lumbar segments were implanted at L4-L5 with a Solus interbody cage (n=6) or standard polyetheretherketone cage (n=6) following Intact testing and discectomy. Each cage was subsequently evaluated in all primary modes of loading after supplementation with the following posterior constructs: interspinous process clamp, bilateral transfacet screws, unilateral transfacet screw with contralateral pedicle screws, and bilateral pedicle screws. Range of motion results were normalized to Intact, and a two-way mixed analysis of variance was utilized to detect statistical differences. FINDINGS: The Solus cage in combination with all posterior constructs provided significant fixation compared to Intact in all loading conditions. The polyetheretherketone cage also provided significant fixation when combined with all screw based treatments, however when used with the interspinous process clamp a significant reduction was not observed in lateral bending or axial torsion. INTERPRETATION: Interbody cages with integrated fixation components enhance post-operative stability within the intervertebral space, thus affording clinicians the potential to utilize less invasive methods of posterior stabilization when seeking circumferential fusion. Interspinous process clamps, in particular, may reduce peri-operative and post-operative comorbidities compared to screw based constructs. Further study is necessary to corroborate their effectiveness in vivo.

Stability and Load Sharing Characteristics of a Posterior Dynamic Stabilization Device.

BACKGROUND: Lumbar interbody fusion is a common treatment for a variety of spinal pathologies. It has been hypothesized that insufficient mechanical loading of the interbody graft can prevent proper fusion of the joint. The purpose of this study was to evaluate the mechanical stability and anterior column loading sharing characteristics of a posterior dynamic system compared to titanium rods in an anterior lumbar interbody fusion (ALIF) model. METHODS: Range of motion, interpedicular kinematics and interbody graft loading were measured in human cadaveric lumbar segments tested under a pure moment flexibility testing protocol. RESULTS: Both systems provided significant fixation compared to the intact condition and to an interbody spacer alone in flexion extension and lateral bending. No significant differences in fixation were detected between the devices. A significant decrease in graft loading was detected in flexion for the titanium rod treatment compared to spacer alone. No significant differences in graft loading were detected between the spacer alone and posterior dynamic system or between the posterior dynamic system and the titanium rod. CONCLUSIONS: The results of this study indicate that the posterior dynamic system provides similar fixation compared to that of a titanium rod, however, studies designed to evaluate the efficacy of fixation in a cadaver model may not be sufficiently powered to establish differences in load sharing using the techniques described here.

Range of motion of the intact lumbar segment: a multivariate study of 42 lumbar spines.

BACKGROUND: A thorough understanding of the biomechanical characteristics of the healthy human spine is critical in furthering the treatment of spinal pathology. The goal of this study was to investigate the motion of the intact lumbar spine segment as measured by range of motion (ROM), and to investigate the dependencies thereof on gender and intervertebral level. MATERIALS AND METHODS: Kinematic data was obtained for 42 human lumbar segments (L1-S1) in response to a pure-moment loading protocol in flexion extension (FE), lateral bending (LB) and axial torsion (AT). Data was obtained for 204 individual functional spinal units (91 female, 113 male). Multivariate analysis of variance was conducted to detect differences between genders and intervertebral levels in each mode of loading. Correlations between ROM and donor demographics, including height, weight, and age, were conducted. RESULTS: ROM was significantly greater for females than for males in FE, LB and AT (p<0.001). ROM tended to increase down the vertebral column in FE. L3-4 FE ROM was significantly greater than L1-2 (p=0.024), and L4-5 and L5-S1 FE ROM were significantly greater than for every other level (p<0.003). LB ROM tended to be greater toward the center of the segment with L2-3, L3-4 and L4-5 ROM being significantly greater than both L1-2 (p<0.001) and L5-S1 (p=0.006, p<0.001, p=0.043, respectively). A similar trend was found for AT, however only L1-2 was significantly less than all other levels (p=0.042, p<0.001, p<0.001, and p=0.034 for L2-3, L3-4, L4-5, and L5-S1 respectively). CONCLUSION: The significant differences in lumbar ROM between male and female spine segments and between the intervertebral levels must be taken into account in study design in order to prevent biases in outcomes. The significant differences in ROM between levels may also have critical implications in the design of spinal implants, particularly those designed to maintain or restore healthy motion.

Lumbar intrafacet bone dowel fixation.

BACKGROUND: The efficacy of intrafacet bone dowels in promoting lumbar fusion has not been established. A recently published study indicates a low fusion rate, along with device migration. OBJECTIVE: To evaluate the mechanical stability of 2 lumbar facet fixation technologies before and after repeated cyclic loading. METHODS: Six human lumbar specimens were implanted with both types of allograft, one at L2-3 and the other at L4-5, on a randomized basis. All specimens were subjected to pure-moment flexibility testing before and after implantation and after 2500 and 5000 cycles of flexion-extension bending. Each specimen was scanned with computed tomography before and after cyclic loading to measure device migration. RESULTS: Only dowel 1 resulted in a statistically significant reduction in flexion-extension range of motion at the treatment level. This reduction was significant at baseline testing (P = .03) and after 2500 cycles of flexion-extension loading (P = .048) but was not significant after 5000 cycles of loading. One of the bone dowels extruded posteriorly out of the joint space during baseline axial torsion flexibility testing, which was before any cyclic loading. CONCLUSION: The data obtained in this study do not indicate efficacy of fixation for cylindrical bone dowels in the lumbar facet joint. Significant fixation was detected only for one of the devices and was no longer present after a relatively short duration of repeated loading. Furthermore, considerable magnitudes of device migration were detected.

Quantitative analysis of the nonlinear displacement-load behavior of the lumbar spine.

There is currently no universal model or fitting method to characterize the visco-elastic behavior of the lumbar spine observed in displacement versus load hysteresis loops. In this study, proposed methods for fitting these loops, along with the metrics obtained, were thoroughly analyzed. A spline fitting technique was shown to provide a consistent approximation of spinal kinetic behavior that can be differentiated and integrated. Using this tool, previously established metrics were analyzed using data from two separate studies evaluating different motion preservation technologies. Many of the metrics, however, provided no significant differences beyond range of motion analysis. Particular attention was paid to how different definitions of the neutral zone capture the high-flexibility region often seen in lumbar hysteresis loops. As a result, the maximum slope was introduced and shown to be well defined. This new parameter offers promise as a descriptive measurement of spinal instability in vitro and may have future implications in clinical diagnosis and treatment of spinal instability. In particular, it could help in assigning treatments to specific stabilizing effects in the lumbar spine.

Reliability of computer-assisted lumbar intervertebral measurements using a novel vertebral motion analysis system.

BACKGROUND CONTEXT: Traditional methods for the evaluation of in vivo spine kinematics introduce significant measurement variability. Digital videofluoroscopic techniques coupled with computer-assisted measurements have been shown to reduce such error, as well as provide detailed information about spinal motion otherwise unobtainable by standard roentgenograms. Studies have evaluated the precision of computer-assisted fluoroscopic measurements; however, a formal clinical evaluation and comparison with manual methods is unavailable. Further, it is essential to establish reliability of novel measurements systems compared with standard techniques. PURPOSE: To determine the repeatability and reproducibility of sagittal lumbar intervertebral measurements using a new system for the evaluation of lumbar spine motion. STUDY DESIGN: Reliability evaluation of digitized manual versus computer-assisted measurements of the lumbar spine using motion sequences from a videofluoroscopic technique. PATIENT SAMPLE: A total of 205 intervertebral levels from 61 patients were retrospectively evaluated in this study. OUTCOME MEASURES: Coefficient of repeatability (CR), limits of agreement (LOA), intraclass correlation coefficient (ICC; type 3,1), and standard error of measurement. METHODS: Intervertebral rotations and translations (IVR and IVT) were each measured twice by three physicians using the KineGraph vertebral motion analysis (VMA) system and twice by three different physicians using a digitized manual technique. Each observer evaluated all images independently. Intra- and interobserver statistics were compiled based on the methods of Bland-Altman (CR, LOA) and Shrout-Fleiss (ICC, standard error of measurement). RESULTS: The VMA measurements demonstrated substantially more precision compared with the manual technique. Intraobserver measurements were the most reliable, with a CR of 1.53 (manual, 8.28) for IVR, and 2.20 (manual, 11.75) for IVT. The least reliable measurements were interobserver IVR and IVT, with a CR of 2.15 (manual, 9.88) and 3.90 (manual, 12.43), respectively. The ICCs and standard error results followed the same pattern. CONCLUSIONS: The VMA system markedly reduced variability of lumbar intervertebral measurements compared with a digitized manual analysis. Further, computer-assisted fluoroscopic imaging techniques demonstrate precision within the range of computer-assisted X-ray analysis techniques.

Erratum to 'Variability of manual lumbar spine segmentation' [International Journal of Spine Surgery 6 (2012) 167-173].

[This corrects the article DOI: 10.1016/j.ijsp.2012.04.002.].

Interpedicular travel in the evaluation of spinal implants: an application in posterior dynamic stabilization.

STUDY DESIGN: In vitro flexibility testing of the lumbar spine. OBJECTIVE: The goal of this study was to evaluate a motion-preserving posterior dynamic stabilization (PDS) implant based on newly defined parameters describing interpedicular kinematics. SUMMARY OF BACKGROUND DATA: PDS implants have been designed as either motion-preserving or adjunct-to-fusion devices to treat various degenerative spinal pathologies. The ambiguity of design and evaluation goals and the inability of traditional biomechanical parameters to appropriately describe the behavior of PDS devices in vitro have served as the impetus to develop kinematic parameters more specific to this class of device. METHODS: Flexibility testing of 6 fresh-frozen human lumbar spines was conducted before and after destabilization of the index level (L4-L5). Testing under the same protocol was repeated after treatment at the index level with a 1-level PDS device, extension of the device to the adjacent inferior level (L5-S1), and treatment with a hybrid construct consisting of the PDS implant at L4-L5 and rigid fixation at L5-S1. The kinematic response was recorded using an optoelectric tracking system and reported in terms of intervertebral range of motion (ROM) and newly developed parameters describing interpedicular motion. RESULTS: Based on ROM and interpedicular kinematics, the devices implanted at L4-L5 provide significant but not differing stabilization in flexion-extension with implantation after a significant destabilization procedure. Interpedicular kinematic results indicate that the 2-level construct contributes to significantly more motion at L5-S1 compared with rigid fixation. This result was not detected when evaluated by the ROM metric. CONCLUSION: Those involved in the design and evaluation of PDS devices may benefit from evaluation of interpedicular kinematics. Evaluating intervertebral motion from the perspective of the pedicle screw allows for a direct and intuitive translation between in vitro test results and design parameters. Furthermore, these parameters may provide additional clinical insight into the biomechanics of the healthy and pathological spine. The study presented indicates that this approach may be more sensitive in detecting differences in implant motion between PDS devices.

Verification of pure moment testing in a multi-degree of freedom spine testing apparatus.

BACKGROUND: Pure moment testing is a common method used in cadaveric spine testing. The fundamental basis for the widespread acceptance of applying a pure moment is uniform loading along the column of the spine. To our knowledge, this protocol has not been experimentally verified on a multi-degree of freedom testing apparatus. Given its ubiquitous use in spine biomechanics laboratories, confirmation of this comparative cadaveric test protocol is paramount. METHODS: Group A specimens (n =13) were used to test the pure moment protocol, by use of 3 constructs that changed the number of involved vertebrae, orientation, and rigidity of the spine construct. Group B specimens (n = 6) were used to determine whether potting orientation, testing order, or degradation affected the range of motion (ROM) by use of 8 constructs. Each group was subjected to 3 cycles of flexion-extension, lateral bending, and axial torsion. The data from the third cycle were used to calculate the ROM for each method. RESULTS: Group A testing resulted in significant differences in ROM across the 3 constructs for lateral bending and axial torsion (P < .02) and trended toward a difference for flexion-extension (P = .055). Group B testing showed an increase in ROM across 8 constructs (P < .04) but no significant difference due to the orientation change. CONCLUSION: The increased ROM across constructs observed in both groups indicates that the cause is likely the testing order or degradation of the specimens, with orientation having no observed effect. The data do not invalidate pure moment testing, and its use should persist.

Variability of manual lumbar spine segmentation.

BACKGROUND: The application of kinematic data acquired during biomechanical testing to specimen-specific, three-dimensional models of the spine has emerged as a useful tool in spine biomechanics research. However, the development of these models is subject to segmentation error because of complex morphology and pathologic changes of the spine. This error has not been previously characterized. METHODS: Eight cadaveric lumbar spines were prepared and underwent computed tomography (CT) scanning. After disarticulation and soft-tissue removal, 5 individual vertebrae from these specimens were scanned a second time. The CT images of the full lumbar specimens were segmented twice each by 2 operators, and the images of the individual vertebrae with soft tissue removed were segmented as well. The solid models derived from these differing segmentation sessions were registered, and the distribution of distances between nearest neighboring points was calculated to evaluate the accuracy and precision of the segmentation technique. RESULTS: Manual segmentation yielded root-mean-square errors below 0.39 mm for accuracy, 0.33 mm for intrauser precision, and 0.35 mm for interuser precision. Furthermore, the 95th percentile of all distances was below 0.75 mm for all analyses of accuracy and precision. CONCLUSIONS: These findings indicate that such models are highly accurate and that a high level of intrauser and interuser precision can be achieved. The magnitude of the error presented here should inform the design and interpretation of future studies using manual segmentation techniques to derive models of the lumbar spine.