Nathaniel R. Ordway

Characteristics of unicortical and bicortical lateral mass screws in the cervical spine

STUDY DESIGN A biomechanical study evaluating the safety and efficacy of unicortical versus bicortical lateral mass screws in the cervical spine. OBJECTIVES To analyze the safety, pullout strength and radiographic characteristics of unicortical and bicortical screws placed in cadaveric spines and to evaluate the influence of level of training on the positioning of these screws. SUMMARY OF BACKGROUND DATA Lateral mass plating for posterior cervical spine fusion is an effective method for the treatment of traumatic and degenerative instability. The initial description of the technique included bicortical screw purchase. The added benefit of bicortical purchase must be weighed against the increased risk of injury to nerve roots and the vertebral artery. METHODS In 21 cadaveric spines (mean age 78.9 years), 3.5-mm anterior oblique lateral mass screws were placed bilaterally from C3 to C6 (n = 168) using a modification of the Magerl technique. In the right side (unicortical) only 14-mm screws (effective length of 11 mm) were used, whereas on the left side, bicortical purchase was obtained. All screws were evaluated clinically and radiographically for safety and zone placement. Pullout force was determined for all screws. RESULTS Most screws (92.8%) were rated satisfactory. There were no injuries to the spinal cord. On the right side (14 mm) 98.9% of the screws were satisfactory, and on the left side (bicortical) 68.1% were satisfactory. There was a 5.8% incidence of direct artery injury (compression of vessel wall) and a 17.4% incidence of direct nerve root injury by the bicortical screws. There were no direct injuries with the unicortical screws. Most of the direct-injury bicortical screws were placed by the surgeon with the least experience. The mean pullout force for all screws was 542.9 +/- 296.6 N. There was no statistically significant difference between the pullout force for unicortical (519.9 +/- 286.9 N) and bicortical (565.2 +/- 306 N) screws (P < 0.05). There were no significant differences in pullout strengths in association with zone placement. CONCLUSIONS Fourteen-millimeter lateral mass screws (effective length, 11 mm) placed in a superolateral trajectory in the adult cervical spine provide an equivalent strength with a much lower risk of injury than the longer bicortical screws placed in a similar orientation.

Comparison Between the C-leg® Microprocessor-Controlled Prosthetic Knee and Non-Microprocessor Control Prosthetic Knees: A Preliminary Study of Energy Expenditure, Obstacle Course Performance, and Quality of Life Survey

This study investigated energy expenditure and obstacle course negotiation between the C-leg® and various non-microprocessor control (NMC) prosthetic knees and compared a quality of life survey (SF-36v2™) of use of the C-leg® to national norms. Thirteen subjects with unilateral limb loss (12 with trans-femoral and one with a knee disarticulation amputation) participated in the study. The mean age was 46 years, range 30 – 75. Energy expenditure using both the NMC and C-leg® prostheses was measured at self-selected typical and fast walking paces on a motorized treadmill. Subjects were also asked to walk through a standardized walking obstacle course carrying a 4.5 kg (10 lb) basket and with hands free. Finally, the SF-36v2™ was completed for subjects while using the C-leg®. Statistically significant differences were found in oxygen consumption between prostheses at both typical and fast paces with the C-leg® showing decreased values. Use of the C-leg® resulted in a statistically significant decrease in the number of steps and time to complete the obstacle course. Scores on a quality of life index for subjects using the C-leg® were above the mean for norms for limitation in the use of an arm or leg, equal to the mean for the general United States population for the physical component score and were above this mean for the mental component score. Based on oxygen consumption and obstacle course findings, the C-leg® when compared to the NMC prostheses may provide increased functional mobility and ease of performance in the home and community environment. Questionnaire results suggest a minimal quality of life impairment when using a C-leg® for this cohort of individuals with amputation.

Electromagnetic Field-Based Image-Guided Spine Surgery Part One : Results of a Cadaveric Study Evaluating Lumbar Pedicle Screw Placement

Study Design. Human cadaveric. Objectives. Compare the accuracy of electromagnetic field (EMF)-based image-guided lumbar pedicle screw insertion to conventional techniques using anatomic landmarks, and fluoroscopy. Background. Image-guided surgical systems that aid in spinal instrumentation seek to minimize radiation exposure and improve accuracy. EMF tracking-based image-guidance was developed in the hopes of eliminating line-of-sight restrictions seen with other systems. Materials and Methods. Sixteen fresh-frozen human cadavers were randomly allocated into three groups. Pedicle screws were inserted from L1 to L5 using only anatomic landmarks in group 1, fluoroscopy in group 2, and image-guidance in group 3. Insertion and total fluoroscopic time were recorded. Anatomic dissections were performed to assess screw placement. Results. Accuracy was 83%, 78%, and 95% for groups 1, 2, and 3, respectively. However, image-guided pedicle screw placement resulted in a 5% critical perforation rate whereas anatomic and fluoroscopic placement resulted in a 15% and 22% critical perforation rate, respectively. The average degree of perforation was 1.5 mm with image guidance, and 3.8 mm with fluoroscopic guidance (P < 0.05). Fluoroscopy time and insertion time per screw were not improved using image guidance. Conclusions. Our study has shown that when EMF tracking was used for image-guided lumbar pedicle screw placement, accuracy was improved and the incidence and degree of cortical perforations that may place neurovascular structures at risk was also reduced. Current system requirements for set-up and image acquisition, however, do add time to the procedure, and when factored in, do not yet result in a decrease in the use of fluoroscopy or screw insertion time.

Posterior Lumbar Interbody Fusion Using Posterolateral Placement of a Single Cylindrical Threaded Cage

STUDY DESIGN An in vitro biomechanical study of posterior lumbar interbody fusion (PLIF) with threaded cages was performed on 18 bovine lumbar functional spinal units. OBJECTIVES To compare the segmental stiffness among PLIF with a single long posterolateral cage, PLIF with a single long posterolateral cage and simultaneous facet joint fixation, and PLIF with two posterior cages. SUMMARY OF BACKGROUND DATA In most cases, PLIF with threaded cage techniques needs bilateral facetectomy, extensive exposure, and retraction of the cauda equina. Posterior element deficiency is detrimental to postoperative segmental stiffness. METHODS All specimens were tested intact and with cage insertion. Group 1 (n = 12) had a long threaded cage (15 x 36 mm) inserted posterolaterally and oriented counter anterolaterally on the left side by posterior approach with left unilateral facetectomy. Group 2 (n = 6) had two regular-length cages (15 x 24 mm) inserted posteriorly with bilateral facetectomy. Six specimens from Group 1 were then retested after unilateral facet joint screw fixation in neutral (Group 3). Similarly, the other six specimens from Group 1 were retested after fixation with a facet joint screw in an extended position (Group 4). Nondestructive tests were performed in pure compression, flexion, extension, lateral bending, and torsion. RESULTS The PLIF procedure involving a single cage (Group 1) had a significantly higher stiffness than PLIF with two cages (Group 2) in left and right torsion (P < 0.05). Group 1 had higher stiffness values than Group 2 in pure compression, flexion, and left and right bending, but differences were not significant. Group 3 had a significant increase in stiffness in comparison with Group 1 for pure compression, extension, left bending, and right torsion (P < 0.05). For Group 4, the stiffness significantly increased in comparison with Group 1 for extension, flexion, and right torsion (P < 0.05). Although there was no significant difference between Groups 3 and 4, Group 4 had increased stiffness in extension, flexion, right bending, and torsion. CONCLUSIONS Posterior lumbar interbody fusion with a single posterolateral long threaded cage with unilateral facetectomy enabled sufficient decompression while maintaining most of the posterior elements. In combination with a facet joint screw, adequate postoperative stability was achieved.

Loss of cervical endplate integrity following minimal surface preparation.

Study Design. In vitro biomechanical study. Objectives. This biomechanical study was designed to evaluate the loss of endplate integrity with incremental removal of the endplate. Summary of Background Data. The position of the anterior cervical motion preserving prosthesis is very important. Unlike interbody bone graft, where a certain amount of settling is tolerable and potentially advantageous with respect to the fusion rate, a settled total disc replacement will not function properly and may dislodge. Partial or aggressive endplate removal may be a factor resulting in subsidence of an interbody device. This study was designed to precisely examine the change of endplate strength following precise burring of the surface. Methods. Eight human cadaver cervical spines (C3–C7) were dissected and 6 locations on the endplates from each vertebra were biomechanically tested using an indentation test protocol. Pairs of locations were randomly assigned to be burred to the depth of 0 mm (intact), 1 mm, or 2 mm before the testing using a flat 3-mm end mill. Strength of the endplate was statistically analyzed to examine the effect of the depth of the burr and any regional variations. Results. Significant differences (P < 0.0001) in endplate strength was noted between the intact endplate (106 ± 86 N) and burred endplates (1 mm depth, 59 ± 49 N; 2 mm depth, 51 ± 46 N). No significant differences existed between the burr depths of 1 and 2 mm (P = 0.21). The posterior endplate was significantly stronger than the anterior endplate irrespective of depth of burr. Conclusion. There is a significant loss of endplate integrity when 1 mm of endplate (44% loss) or 2 mm of endplate (52% loss) is removed. Although the implant interface plays an important role in the magnitude of the subsidence of a device, this study in general shows that the endplate is important in terms of maximizing the strength of a construct.

Factors Affecting Dimensional Accuracy of 3-D Printed Anatomical Structures Derived from CT Data

Additive manufacturing and bio-printing, with the potential for direct fabrication of complex patient-specific anatomies derived from medical scan data, are having an ever-increasing impact on the practice of medicine. Anatomic structures are typically derived from CT or MRI scans, and there are multiple steps in the model derivation process that influence the geometric accuracy of the printed constructs. In this work, we compare the dimensional accuracy of 3-D printed constructs of an L1 vertebra derived from CT data for an ex vivo cadaver T-L spine with the original vertebra. Processing of segmented structures using binary median filters and various surface extraction algorithms is evaluated for the effect on model dimensions. We investigate the effects of changing CT reconstruction kernels by scanning simple geometric objects and measuring the impact on the derived model dimensions. We also investigate if there are significant differences between physical and virtual model measurements. The 3-D models were printed using a commercial 3-D printer, the Replicator 2 (MakerBot, Brooklyn, NY) using polylactic acid (PLA) filament. We found that changing parameters during the scan reconstruction, segmentation, filtering, and surface extraction steps will have an effect on the dimensions of the final model. These effects need to be quantified for specific situations that rely on the accuracy of 3-D printed models used in medicine or tissue engineering applications.

Radiostereometric Analysis of Postoperative Motion After Application of Dynesys Dynamic Posterior Stabilization System for Treatment of Degenerative Spondylolisthesis

Study Design Prospective case series Objective This was designed to precisely measure motion after posterior dynamic stabilization using Dynesys instrumentation. Summary of Background Data The Dynesys posterior dynamic stabilization system, which stabilizes the spinal segment while potentially decreasing the risk of adjacent segment disease, is undergoing evaluation by the US Food and Drug Administration for treatment of degenerative spondylolisthesis without fusion. Evaluation of adjacent segment disease requires precise characterization of motion on the surgical level. Unfortunately, routine clinical radiographic techniques are imprecise and unreliable for full characterization of spinal segment motion. Radiostereometric analysis, which is very precise and reliable for in vivo measurement of motion, was used to examine spinal segment motion after dynamic stabilization with Dynesys. Methods Six patients (age 59±7 y) underwent posterior decompression followed by posterior stabilization using Dynesys instrumentation (4 one-level, 2 two-levels). Three to 5 tantalum beads were placed in each vertebral body. Postoperative biplanar radiographs were obtained in flexion, extension, right, and left lateral bending, and 3-dimensional reconstruction was performed using radiostereometric analysis at 3, 6, 12, and 24 months postoperatively. The translations and rotations of the superior vertebral body were measured relative to the inferior vertebral body. Results Over the 24-month follow-up period, mean flexion, extension, left, and right lateral bending of the motion segments were noted to be 1.0 degrees, 2.4 degrees, 0.6 degrees, and 0.6 degrees or less, respectively. There were no statistically significant changes in the degree of motion. During follow-up, no significant changes in neutral position of the device were noted in any of the 3 planes, and minimal translation was noted in the postoperative period. Conclusions The Dynesys dynamic instrumentation system seems to stabilize degenerative spondylolisthesis. As expected in the degenerative lumbar spine, the segmental motion of the implanted level in this study was limited and considerably less than normal spinal motion.

Correlation of Radiostereometric Measured Cervical Range of Motion With Clinical Radiographic Findings After Anterior Cervical Discectomy and Fusion

Study Design. Prospective clinical study. Objective. To evaluate the correlation between clinical radiographic findings and sagittal range of motion (ROM) measured using radiostereometric analysis (RSA) after anterior cervical discectomy and fusion (ACDF). Summary of Background Data. Evaluation of fusion after ACDF continues to be difficult. Radiographic films including flexion/extension views are routinely used for this purpose. Unfortunately, routine radiographs are insensitive in demonstrating pseudarthrosis. RSA is an accurate technique that can be used in evaluation of segmental motion in vivo and can potentially be used in evaluation of spinal fusion. Methods. Sixteen patients who underwent multi-level ACDF were enrolled in this study. The procedure was performed in the routine fashion; cervical plates were utilized in each case. Intraoperatively, 3 to 5 tantalum beads were inserted into each vertebral body. At the 1-year follow-up period, sagittal ROM of the operated segments was measured with RSA. In addition, each segment was clinically evaluated for evidence of radiographic fusion by using a 3-point grading system (fused, uncertain, pseudarthrosis) and by measuring the interspinous widening on flexion/extension films. The correlation between the radiographic findings and RSA measured sagittal ROM was evaluated. Results. Fourteen 2-level and two 3-level procedures representing 31 motion segments were analyzed. The average sagittal ROM of all segments as measured by RSA was 1.3 ± 1.4°. The sagittal ROM of the segments with less than 2 mm of interspinous widening on clinical flexion/extension radiographs was measured at 1.1° ± 1.0° with RSA, whereas the sagittal ROM of the segments with greater than 2 mm of interspinous widening was measured at 3.4° ± 2.9°; a significant correlation was noted between the 2-point grading method and the sagittal ROM (Pearson coefficient, r = 0.504, P = 0.004). Using the 3-point grading system, there were 20 levels graded as fused (0.8° ± 0.9°), 6 levels were graded as uncertain (1.7° ± 1.0°), and 4 levels were graded as pseudarthrosis (3.5° ± 2.7°). The pseudarthrosis group showed significantly greater motion than the fusion group (P = 0.005); a significant correlation was noted between the 3-point grading method and the sagittal ROM (Pearson coefficient, r = 0.561, P = 0.001). Conclusion. In this study, we evaluated the utility of RSA in evaluating segmental motion after ACDF and demonstrated a significant difference between segments that demonstrated radiographic evidence of fusion when compared with segments that demonstrated evidence of pseudarthrosis. RSA appears to be a quantitative technique capable of assisting in the evaluation of fusion.

Anterior cervical interbody constructs: effect of a repetitive compressive force on the endplate

Graft subsidence following anterior cervical reconstruction can result in the loss of sagittal balance and recurring foraminal stenosis. This study examined the implant–endplate interface using a cyclic fatigue loading protocol in an attempt to model the subsidence seen in vivo. The superior endplate from 30 cervical vertebrae (C3 to T1) were harvested and biomechanically tested in axial compression with one of three implants: Fibular allograft; titanium mesh cage packed with cancellous chips; and trabecular metal. Each construct was cyclically loaded from 50 to 250 N for 10,000 cycles. Nondestructive cyclic loading of the cervical endplate–implant construct resulted in a stiffer construct independent of the type of the interbody implant tested. The trabecular metal construct demonstrated significantly more axial stability and significantly less subsidence in comparison to the titanium mesh construct. Although the allograft construct resulted in more subsidence than the trabecular metal construct, the difference was not significant and no difference was found when comparing axial stability. For all constructs, the majority of the subsidence during the cyclic testing occurred during the first 500 cycles and was followed by a more gradual settling in the remaining 9,500 cycles.

Mechanical and Biomechanical Characterization of a Polyurethane Nucleus Replacement Device Injected and Cured In Situ Within a Balloon

Background The DASCOR device has recently been introduced as an innovative nucleus replacement alternative for the treatment of low-back pain caused by degenerative intervertebral disc disease. The purpose of this study was to characterize, through a series of preclinical mechanical bench and biomechanical tests, the effectiveness of this device. Methods A number of samples were created using similar preparation methods in order to characterize the nucleus replacement device in multiple mechanical bench tests, using ASTM-guided protocols, where appropriate. Mechanical bench testing included static testing to characterize the devices compressive, shear properties, and fatigue testing to determine the devices compressive fatigue strength, wear, and durability. Biomechanical testing, using human cadaveric lumbar spines, was also conducted to determine the ability of the device to restore multidirectional segmental flexibility and to determine its resulting endplate contact stress. Results The static compressive and shear moduli of the nucleus replacement device were determined to be between 4.2–5.6 MPa and 1.4–1.9 MPa, respectively. Similarly, the ultimate compressive and shear strength were 12,400 N and 6,993 N, respectively. The maximum axial compressive fatigue strength of the tested device that was able to withstand a runout without failure was determined to be approximately 3 MPa. The wear assessment determined that the device is durable and yielded minimal wear rates of 0.29mg/Mc. Finally, the biomechanical testing demonstrated that the device can restore the multidirectional segmental flexibility to a level seen in the intact condition while concurrently producing a uniform endplate contact stress. Conclusions The results of the present study provided a mechanical justification supporting the clinical use of the nucleus replacement device and also help explain and support the positive clinical results obtained from two European studies and one US pilot study. Clinical Relevance Nucleus replacement devices are rapidly emerging to address specific conditions of degenerative disc disease. Preclinical testing of such devices is paramount in order to potentially ensure successful clinical outcomes post implantation