Endplate changes following discectomy: natural history and associations between imaging and clinical data.

PURPOSE: Some patients will experience post-operative back pain following lumbar discectomy, and the potential sources for that pain are poorly understood. One potential source is the vertebral endplates. The goal of this study was to document the changes that occur in lumbar endplates following discectomies, and to assess associations between endplate changes and clinical outcomes. METHODS: Changes in lumbar endplates and discs were assessed from X-rays, CT and MRI exams by comparing preoperative imaging with imaging obtained at yearly intervals up to 5 years. 260 endplates in 137 patients with single-level herniation and discectomy were analyzed. The geometry of osseous defects in the endplates was measured from the CT exams, and marrow and disc changes adjacent to endplates were assessed from the MRI exams. Clinical outcome assessments were collected at each time point. Descriptive statistics were used to describe endplate defect sizes, and logistic regression and analysis of variance were used to identify potential associations between endplate and vertebral body changes and clinical outcomes. RESULTS: Approximately 14 % of the endplates had osseous defects prior to surgery. After surgery, 24 % of inferior and 43 % of superior endplates had defects. Change occurred within the first year and remained relatively constant over the next few years. Disc signal intensity worsened and disc height decreased following surgery. New Modic changes were also observed. None of these changes were associated with having achieved a clinically significant improvement in outcome scores. The follow-up rates were low at the later time points and significant associations cannot be ruled out. CONCLUSIONS: This study documents lesion characteristics in detail and supports that osseous defects in the endplates at the level of a lumbar discectomy may be a relatively common finding following surgery, along with disc height loss, loss of disc signal intensity, and Modic changes. The clinical significance of these imaging findings could not be conclusively determined in this study.

Efficacy of MRI for assessment of spinal trauma: correlation with intraoperative findings.

STUDY DESIGN: Observational diagnostic study on consecutive patients. OBJECTIVE: To assess the efficacy of magnetic resonance imaging (MRI) for detecting spinal soft tissue injury after acute trauma using intraoperative findings as a reference standard. SUMMARY OF BACKGROUND DATA: Recognizing injuries to spinal soft tissue structures is critical for proper decision making and management for blunt trauma victims. Although MRI is considered the gold standard for imaging of soft tissues, its ability to identify specific components of soft tissue damage in acute spine trauma patients is poorly documented and controversial. METHODS: Intraoperative findings were recorded for 21 acute spinal trauma patients (study group) and 14 nontraumatic spinal surgery patients (control group). Preoperative MRI's were evaluated randomly and blindly by 2 neuroradiologists. MRI and intraoperative findings were compared. By using the intraoperative findings as the reference standard, sensitivity, specificity, positive and negative predictive values of MRI in detecting spinal soft tissue injury were determined. RESULTS: MRI was 100% sensitive and specific in detecting injury to the anterior longitudinal ligament. MRI was moderately sensitive (80%) but highly specific (100%) for injury to the posterior longitudinal ligament. In contrast, MRI was highly sensitive but less specific in detecting injury to paraspinal muscles (100%, 77%), intervertebral disk (100%, 71%), and interspinous ligament (100%, 64%). MRI was moderately sensitive and specific in detecting ligamentum flavum injury (80% and 86.7%) but poorly sensitive for facet capsule injury (62.5%). CONCLUSIONS: MRI demonstrated high sensitivity for spinal soft tissue injuries. However, MRI showed a definite trend to overestimate interspinous ligament, intervertebral disk, and paraspinal muscle injuries. On the basis of these results, we would consider MRI to be a useful tool for spine clearance after trauma. Conversely, caution should be applied when using MRI for operative decision making due to its less predictable specificity.

Optimizing success with lumbar disc arthroplasty.

PURPOSE: This study aimed at determining the variables that may prove useful in predicting clinical outcomes following lumbar disc arthroplasty. METHODS: Pre- and post-operative imaging assessments were obtained for 99 single-level lumbar disc arthroplasty patients from a prospective IDE study. The assessments and patient demographics were tested to identify variables that were significantly associated with clinical outcomes. RESULTS: Clinical outcome data were available for 85 % of patients at the 5-year follow-up. Numerous assessments made from the pre-operative imaging were found to have statistically significant associations with clinical outcomes at 2 and 5 years. The most notable factors were related to the amount of degeneration at the index level, with patients achieving better outcome scores at 5 years if they have higher grades of degeneration preoperatively. CONCLUSIONS: Several variables may prove effective at optimizing clinical outcomes including a preoperative disc height <8 mm, Modic type 2 changes adjacent to the target disc, a low amount of lordosis present at the treatment level, low levels of fatty replacement of the paraspinal musculature, a prominent amount of facet joint or disc degeneration, and the presence of flat or convex vertebral endplates. There were also post-operative findings associated with better patient outcomes including a larger percent of the endplate covered with the implant, larger implant heights, greater increases in disc space heights, and a larger increase in index level lumbar lordosis. These variables could be explored in other clinical studies to facilitate meta-analyses that could identify effective strategies to optimize clinical outcomes with lumbar disc arthroplasty.

A cadaver study to compare vertebral augmentation with a high-viscosity cement to augmentation with conventional lower-viscosity cement.

STUDY DESIGN: Comparison of extravasations in fractured cadaver vertebrae augmented with commercial low-viscosity versus high-viscosity cements. OBJECTIVE: Use of high-resolution, 3-dimensional (3D) imaging to test the hypothesis that high-viscosity cements can reduce the type and severity of extravasations after vertebral augmentation procedures. SUMMARY OF BACKGROUND DATA: Cement extravasations are one of the primary complications of vertebral augmentation procedures. There is some evidence that high-viscosity cements might reduce extravasations, but additional data are needed to confirm the early findings. METHODS: A range of vertebral fractures were created in fresh human cadavers. One group was then augmented with a low-viscosity polymethylmethacrylate (PMMA)-based cement and the other group injected with high-viscosity PMMA-based cement. High-resolution computerized tomography exams were obtained, and extravasations were assessed using 3D volume renderings. The type and severity of extravasations were recorded and analyzed. RESULTS: The proportion of vertebrae with any type of extravasation through the posterior wall to the spinal canal, into small vessels laterally or anteriorly, through the endplates, or anywhere around the body was not significantly different between the high-viscosity and low-viscosity groups. There was significantly less severe extravasation through the endplates (P=0.02), and a trend toward less severe extravasation through vessels (P=0.06) with the high versus low-viscosity cements. CONCLUSIONS: In agreement with previous research, high-viscosity PMMA-based cement may help to reduce the more severe forms of extravasations after vertebral augmentation procedures in newly fractured vertebrae.

Definition of Normal Vertebral Morphometry Using NHANES-II Radiographs.

A robust definition of normal vertebral morphometry is required to confidently identify abnormalities such as fractures. The Second National Health and Nutrition Examination Survey (NHANES-II) collected a nationwide probability sample to document the health status of the United States. Over 10,000 lateral cervical spine and 7,000 lateral lumbar spine X-rays were collected. Demographic, anthropometric, health, and medical history data were also collected. The coordinates of the vertebral body corners were obtained for each lumbar and cervical vertebra using previously validated, automated technology consisting of a pipeline of neural networks and coded logic. These landmarks were used to calculate six vertebral body morphometry metrics. Descriptive statistics were generated and used to identify and trim outliers from the data. Descriptive statistics were tabulated using the trimmed data for use in quantifying deviation from average for each metric. The dependency of these metrics on sex, age, race, nation of origin, height, weight, and body mass index (BMI) was also assessed. There was low variation in vertebral morphometry after accounting for vertebrae (eg, L1, L2), and the R 2 was high for ANOVAs. Excluding outliers, age, sex, race, nation of origin, height, weight, and BMI were statistically significant for most of the variables, though the F-statistic was very small compared to that for vertebral level. Excluding all variables except vertebra changed the ANOVA R 2 very little. Reference data were generated that could be used to produce standardized metrics in units of SD from mean. This allows for easy identification of abnormalities resulting from vertebral fractures, atypical vertebral body morphometries, and other congenital or degenerative conditions. Standardized metrics also remove the effect of vertebral level, facilitating easy interpretation and enabling data for all vertebrae to be pooled in research studies. © 2022 The Authors. JBMR Plus published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.

Cell-based gene therapy for repair of critical size defects in the rat fibula.

More than a decade has passed since the first experiments using adenovirus-transduced cells expressing bone morphogenetic protein 2 were performed for the synthesis of bone. Since this time, the field of bone gene therapy has tackled many issues surrounding safety and efficacy of this type of strategy. We present studies examining the parameters of the timing of bone healing, and remodeling when heterotopic ossification (HO) is used for bone fracture repair using an adenovirus gene therapy approach. We use a rat fibula defect, which surprisingly does not heal even when a simple fracture is introduced. In this model, the bone quickly resorbs most likely due to the non-weight bearing nature of this bone in rodents. Using our gene therapy system robust HO can be introduced at the targeted location of the defect resulting in bone repair. The HO and resultant bone healing appeared to be dose dependent, based on the number of AdBMP2-transduced cells delivered. Interestingly, the HO undergoes substantial remodeling, and assumes the size and shape of the missing segment of bone. However, in some instances we observed some additional bone associated with the repair, signifying that perhaps the forces on the newly forming bone are inadequate to dictate shape. In all cases, the HO appeared to fuse into the adjacent long bone. The data collectively indicates that the use of BMP2 gene therapy strategies may vary depending on the location and nature of the defect. Therefore, additional parameters should be considered when implementing such strategies.

Motion within the unstable cervical spine during patient maneuvering: the neck pivot-shift phenomenon.

BACKGROUND: Cervical extrication collars are applied to millions of blunt trauma victims despite the lack of any evidence that a collar can protect against secondary injuries to the cervical spine. Cadaver studies support that in the presence of a dissociative injury, substantial motion can occur within the occipitocervical spine with collar application or during patient transfers. Little is known about the biomechanics of cervical stabilization; hence, it is difficult to develop and test improved immobilization strategies. MATERIALS: Severe unstable injuries were created in seven fresh whole human cadavers. Rigid collars were applied with the body in a neutral position. Computed tomographic examinations were obtained before and after tilting the body or backboard as would be done during patient transport or to inspect the back. Relative displacements between vertebrae at the site of the injury were measured from the Computed tomographic examinations. The overall relative alignment between body and collar was assessed to understand the mechanisms that may facilitate motion at the injury site. RESULTS: Intervertebral motion averaged 7.7 mm±6.8 mm in the axial plain and 2.9 mm±2.5 mm in the cranial-caudal direction. The rigid collars appeared to create pivot points where the collar contacts the head in the region under the ear and where the collar contacts the shoulders. DISCUSSION: Rigid cervical collars appear to create pivot points that shift the center of rotation lateral to the spine and contribute to the intervertebral motions that were measured. Immobilization strategies that avoid these neck pivot-shift phenomena may help to reduce secondary injuries to the cervical spine. The whole cadaver model with simulation of patient maneuvers may provide an effective test method for cervical immobilization.

Diagnosis of unstable cervical spine injuries: laboratory support for the use of axial traction to diagnose cervical spine instability.

BACKGROUND: The ability to detect damage to the intervertebral structures is critical in the management of patients after blunt trauma. A practical and inexpensive method to identify severe structural damage not clearly seen on computed tomography would be of benefit. The objective of this study was to assess whether ligamentous injury in the subaxial cervical spine can be reliably detected by analysis of lateral radiographs taken with and without axial traction. METHODS: Twelve fresh, whole, postrigor-mortis cadavers were used for this study. Lateral cervical spine radiographs were obtained during the application of 0 N, 89 N, and 178 N of axial traction applied to the head. Progressive incremental sectioning of posterior structures was then performed at C4-C5 with traction imaging repeated after each intervention. Intervertebral distraction was analyzed using computer-assisted software. RESULTS: Almost imperceptible intervertebral separation was found when traction was applied to intact spines. In the subaxial cervical spine, the average posterior disc height consistently increased under traction in severely injured spines. The average disc height increase was 14% of the C4 upper endplate width, compared with an average of 2% in the noninjured spines. A change of more than 5% in posterior disc height under traction was above the 95% confidence interval for intact spines, with sensitivity of 83% and specificity of 80%. Applied force of 89 N (20 lb) was sufficient to demonstrate injury. The combination of assessing alignment and distraction under traction increased both the sensitivity and specificity to nearly 100%. CONCLUSION: This study supports further clinical investigations to determine whether low-level axial traction may be a useful adjunct for detecting unstable subaxial cervical spine injuries in an acute setting.

Extrication collars can result in abnormal separation between vertebrae in the presence of a dissociative injury.

BACKGROUND: Cervical collars are applied to millions of trauma victims with the intent of protecting against secondary spine injuries. Adverse clinical outcomes during the management of trauma patients led to the hypothesis that extrication collars may be harmful in some cases. The literature provides indirect support for this observation. The purpose of this study was to directly evaluate cervical biomechanics after application of a cervical collar in the presence of severe neck injury. METHODS: Cranial-caudal displacements in the upper cervical spine were measured in cadavers from images taken before and after application of collars following creation of an unstable upper cervical spine injury. RESULTS: In the presence of severe injury, collar application resulted in 7.3 mm +/- 4.0 mm of separation between C1 and C2 in a cadaver model. In general, collars had the effect of pushing the head away from the shoulders. CONCLUSIONS: This study was consistent with previous evidence that extrication collars can result in abnormal distraction within the upper cervical spine in the presence of a severe injury. These observations support the need to prioritize additional research to better understand the risks and benefits of cervical stabilization methods and to determine whether improved stabilization methods can help to avoid potentially harmful displacements between vertebrae.

Quality of spinal motion with cervical disk arthroplasty: computer-aided radiographic analysis.

STUDY DESIGN: Kinematic study of a single site in an investigational device exemption trial. OBJECTIVE: Evaluate the center of rotation (COR) after Bryan cervical arthroplasty and compare adjacent segment motion after cervical disk arthroplasty and fusion using validated radiographic analysis. SUMMARY OF BACKGROUND DATA: The goal of cervical arthroplasty is to reestablish spinal kinematics after anterior decompression. Excellent maintenance of range of motion has been reported for a variety of the prostheses; however, the manner the prostheses perform this task is different. A parameter that may be as important as range of motion is restoring the quality of motion. One of the important components is the COR that is easily studied biomechanically but has not been reported from in vivo studies. Furthermore, the effects on the quality of motion at adjacent levels have not been studied. The purpose of this study is to determine the quality of motion after Bryan cervical disk arthroplasty at the target level and the adjacent segments. METHODS: The first 48 patients diagnosed with single level cervical disk degenerative disease and associated myelopathy or radiculopathy from a single institution enrolled in the Bryan disk investigational device exemption trial were selected for inclusion. Twenty-two investigational patients and 26 anterior cervical discectomy and fusion controls were evaluated radiographically preoperatively and 3, 6, 12, and 24 months postoperatively. These results were analyzed using Quantitative Motion Analysis software manufactured by Medical Metrics Inc. Kinematic parameters included translation, sagittal rotation, anterior/posterior disk height, and the calculation of the COR both in the sagittal and coronal planes. RESULTS: At the arthroplasty level, the COR shifted more posterior (0.3 mm, 1% end plate width) and cephalad (4.9 mm, 20% end plate width) compared with the preoperative position, however, this change was not statistically significant (P=0.06). The variability of the COR, however, was less after arthroplasty compared with preoperative values. There was no significant difference in the short term between the adjacent levels after fusion compared with the prosthesis. At later time points (12 and 24 mo), however, the COR was significantly posterior at the level above arthroplasty compared with fusion (P<0.01). COR X was not significantly (P>0.3) different below fusions compared with arthroplasty. Sagittal rotation significantly increased at the level above for both the fusion and prosthesis groups. A trend was noted for increased translation (2.5% end plate width) at the level above a fusion compared with the Bryan disk at 24 months postoperatively, but this did not reach statistical significance. CONCLUSIONS: Sagittal rotation increases above the level of the arthroplasty and fusion. In the long term, the arthroplasty group had a more posterior COR at the level above, compared with the level above a fusion. Translation at the level above a fusion was slightly increased but not statistically compared with the level above the arthroplasty with similar amounts of sagittal rotation (flexion/extension). Although not reaching statistical significance, the COR seemed to shift more posterior and cephalad at the arthroplasty level with less variability compared with the preoperative position.

Analysis of translation and angular motion in loaded and unloaded positions in the lumbar spine.

BACKGROUND CONTEXT: Abnormalities in intervertebral rotation and translation are important to diagnosis and treatment planning for common spinal disorders. Tests that do not sufficiently load the spine can result in mis-diagnosed motion abnormalities. Upright flexion and extension x-rays are commonly used despite known limitations. Additional evidence is needed in support of preliminary studies suggesting that the change from standing to supine may sufficiently stress the spine to diagnose motion abnormalities. PURPOSE: Compare intervertebral translation between flexion and extension to translation between upright and supine positions in a representative clinical population. STUDY DESIGN/SETTING: Prospective analysis of images retrospectively collected from routine clinical practices. METHODS: After obtaining IRB approval for analysis of previously obtained images, patients were identified via chart reviews where a neutral-lateral x-ray and an MRI or CT exam were obtained for diagnosis of a spinal disorder and where flexion-extension x-rays had been obtained to help diagnose abnormal intervertebral motion. The mid-sagittal slice from the MRI or CT exam was paired with the neutral-lateral radiograph. Intervertebral translation at the L4-L5 and L5-S1 levels between supine and standing and between flexion and extension were measured from the images using previously validated methods. The translations were classified as normal or abnormal with reference to a previously obtained database of intervertebral motion in radiographically normal and asymptomatic volunteers. RESULTS: At the L5-S1 level in particular, there tended to be greater translation between the supine and standing than between upright flexion and extension. On average, translations were below that found in asymptomatic volunteers. No abnormal translations were detected from flexion-extension radiographs whereas approximately 7% of levels had abnormal translations between supine and upright positions. CONCLUSIONS: Intervertebral translations between supine and standing, measured using the mid-sagittal slice from a MRI or CT exam and a lateral x-ray with the patient standing can help to identify abnormal motion. This would be particularly valuable for patients with limited flexion and extension. This study thereby adds to the evidence in support of measuring intervertebral motion between the supine and upright positions to detect abnormal intervertebral motion.

Biomechanical effect of triquetral and scaphoid excision on simulated midcarpal arthrodesis in cadavers.

PURPOSE: To examine the biomechanical effects of triquetral and scaphoid excision on wrist motion and radiolunate contact characteristics in a cadaveric model after simulated 4-corner arthrodesis with rigid internal fixation. METHODS: Ten fresh-frozen cadaveric upper extremities were studied. For all surgical manipulations, the motion was measured and contact characteristics were assessed using ultralow prescale pressure-sensitive film. RESULTS: Compared with the intact specimen, simple 4-corner arthrodesis with scaphoid retention led to a significant decrease in flexion (-23%), extension (-69%), radial deviation (-129%), and ulnar deviation (-25%), but no significant change in radiolunate contact characteristics. After 4-corner arthrodesis with scaphoid excision, there was a significant increase in radial deviation (+213%) without significant change in radiolunate contact characteristics, but average radial deviation was still less than in the intact specimen. After further excision of the triquetrum, radial deviation increased significantly (+238%), to a mean value 5% greater than that of the intact state, but at the cost of a significant increase in mean radiolunate contact pressure (+44% compared to the intact state). CONCLUSIONS: When performing 4-corner arthrodesis, scaphoid and triquetrum excision may improve motion at the cost of increased mean radiolunate contact pressure.

Comparison of fusion assessment techniques: computer-assisted versus manual measurements.

OBJECT: Fusion assessment after cervical arthrodesis can be subjective. Measures such as bridging bone quantification or extent of (limited) motion on dynamic studies are common but difficult to interpret and fraught with biases. We compared manual measurement and computer-assisted techniques in assessing fusion after anterior cervical discectomy and fusion (ACDF). METHODS: One hundred patients who underwent ACDF (512 intervertebral levels) were randomly selected for this radiographic review (follow-up 3-36 months). Two assessment techniques were performed by different observers, with each blinded to the results of the other. The manual spinous process displacement measurement technique was used to calculate motion between the spinous processes under magnification on a digital imaging workstation. Computer-assisted measurements of intervertebral angular motion were made using Quantitative Motion Analysis (QMA) software. Fusion criteria were arbitrarily set at 1 mm of motion for the manual technique and 1.5 degrees of angular motion for the QMA technique. RESULTS: The manual measurement technique revealed fusion in 61.7% (316 of 512) of the interspaces assessed, and QMA revealed fusion in 64.3% (329 of 512). These two assessment techniques agreed in 87.5% of cases, with a correlation coefficient of 0.68 between the two data sets. In cases in which the two techniques did not agree, QMA revealed fusion and the manual measurement revealed nonfusion in 64% of the disagreements; 98% of the disagreements occurred when motion was < 2 mm or 2 degrees. CONCLUSIONS: Although osseous fusion after arthrodesis remains difficult to assess, new computer-assisted techniques may remove the subjectivity generally associated with assessing fusion.

Efficient and rapid osteoinduction in an immune-competent host.

Osteoinductive systems to induce targeted rapid bone formation hold clinical promise, but development of technologies for clinical use that must be tested in animal models is often a difficult challenge. We previously demonstrated that implantation of human cells transduced with Ad5F35BMP2 to express high levels of bone morphogenetic protein-2 (BMP2) resulted in rapid bone formation at targeted sites. Inclusion of human cells in this model precluded us from testing this system in an immune-competent animal model, thus limiting information about the efficacy of this approach. Here, for the first time we demonstrate the similarity between BMP2-induced endochondral bone formation in a system using human cells in an immune-incompetent mouse and a murine cell-based BMP2 gene therapy system in immune-competent animals. In both cases the delivery cells are rapidly cleared, within 5 days, and in neither case do they appear to contribute to any of the structures forming in the tissues. Endochondral bone formation progressed through a highly ordered series of stages that were both morphologically and temporally indistinguishable between the two models. Even longterm analysis of the heterotopic bone demonstrated similar bone volumes and the eventual remodeling to form similar structures. The results suggest that the ability of BMP2 to rapidly induce bone formation overrides contributions from either immune status or the nature of delivery cells.

Observer agreement in assessing flexion-extension X-rays of the cervical spine, with and without the use of quantitative measurements of intervertebral motion.

BACKGROUND CONTEXT: Flexion-extension X-rays are commonly used to identify abnormalities in intervertebral motion, despite little evidence for the reliability of the information that clinicians derive from these test. PURPOSE: Quantify observer agreement on intervertebral motion abnormalities assessed with and without the use of computer-assisted technology. STUDY DESIGN: Assess interobserver agreement among clinicians when they evaluate cervical flexion-extension X-rays using the methods they now use in clinical practice, and compare this to observer agreement when the same clinicians reassess the X-rays using computer-assisted technology. METHODS: Seventy-five flexion-extension X-rays of the cervical spine, obtained from several clinical practices, were assessed by seven practicing physicians who routinely assess these X-rays. Observers assessed the studies using the methods they routinely use, and then reassessed the studies, at least a month later, using validated computer-assisted methods. Agreement among clinicians with and without computer-assisted technology was assessed using kappa statistics. RESULTS: Agreement was poor (kappa=0.17) with methods routinely used in clinical practice. Computer-assisted analysis improved interobserver agreement (kappa=0.77). With computer-assisted methods, disagreements involved cases with severe degeneration or static misalignment where motion was within normal limits, or in fusion cases where there was between 1 and 1.5 degrees of motion at the fusion site. CONCLUSIONS: This study suggests that commonly used methods to assess flexion-extension X-rays of the cervical spine may not provide reliable clinical information about intervertebral motion abnormalities, and that validated, computer-assisted methods can dramatically improve agreement among clinicians. The lack of definitions of instability and fusion acceptable to all the clinicians was likely a primary source of disagreement with both manual and computer-assisted assessments.

Initial intervertebral stability after anterior cervical discectomy and fusion with plating.

BACKGROUND CONTEXT: Anterior cervical locking plates are currently used to provide secure fixation, which appears to help promote fusion, although the details of the in vivo biomechanical effects of plating on the spine are unknown. PURPOSE: To determine if any motion was present initially in the plated anterior cervical discectomy and fusion (ACDF) and, if so, where the motion occurred. STUDY DESIGN: A cohort of patients that were part of a prospective study on postoperative changes after cervical fusion were evaluated for motion at the fusion site about 2 weeks after ACDF. METHODS: Forty-eight segments in 27 patients undergoing ACDF with a cervical plate were evaluated. The patients underwent flexion and extension radiography approximately 2 weeks after surgery. Intervertebral motion at the fusion site was evaluated with validated quantitative motion analysis. RESULTS: Motion was perceived at 29 levels in 18 patients. The sources of motion were either actual bending of the plate itself, motion at the screw-bone interface, or screw-plate interface. CONCLUSIONS: In many patients, anterior cervical plating after ACDF does not eliminate motion at the fusion site. Depending on the quality of bone, type of bone graft, and nature of the injury, this information may influence decisions regarding implants and postoperative bracing.

Threshold Limit Graphical Approach to Understanding Outcome Predictive Metrics: Data from the Osteoarthritis Initiative.

Scatter plots, bar charts, linear regressions, analysis of variance, and other graphics and tests are frequently used to document associations between an independent variable and an outcome. However, these methods are also frequently limited when understanding how to use an independent variable in subsequent research or patient management. A novel graphical approach to visualizing data-the threshold limit graph-was therefore developed. Publically available data from the Osteoarthritis Initiative was used to illustrate the graphical approach to understanding the association between the change in joint space width (ΔJSW, independent variable) over four years, and knee symptoms at four years (using the Knee Injury and Osteoarthritis Outcome Score [KOOS], dependent variable). Using data for 4,202 knees, the traditional scatter plot and linear regression approach showed a significant but weak linear relationship between the symptom subscore of the KOOS and ΔJSW. However, the threshold level of ΔJSW that affects symptoms was not clear from the data. The same dataset was then plotted using the threshold limit graphical approach, which revealed a non-linear relationship between the variables. In contrast to the scatter plot, plotting the average KOOS symptom subscore for subgroups of the data, with each subgroup defined using sequentially increasing or decreasing ΔJSW thresholds revealed that symptoms got worse with joint space loss, but only when there was a significant amount of ΔJSW. A threshold limit analysis was repeated using small, randomly selected subsets of the data (N = ~100) to demonstrate the utility of the technique for identifying trends in smaller datasets. The threshold limit graph is a simple, graphical approach that may prove helpful in understanding how an independent variable might be used to predict outcomes. This approach provides an additional option for visualizing and quantifying associations between variables.

The Assessment of Fusion Following Sacroiliac Joint Fusion Surgery.

Sacroiliac joint fusions (SIJF) have been the subject of many research studies. The technical success of an SIJF is in part determined by whether osseous bridging occurs across the sacroiliac joint (SIJ). However, no validated SIJF assessment method has been described. Our objective was to document previously described SIJF assessment methods and define and validate a detailed assessment system for SIJF. Our results are only intended to establish computed tomography (CT)-based guidelines for SIJF to be used in a subsequent large clinical study to correlate them with clinical outcomes. The SIJF literature was reviewed to document previous descriptions of SIJF assessments. A detailed system was then developed for assessing SIJF from CT exams. To provide data that can be used to address a range of research questions, the system included assessing bridging bone relative to the SIJ anatomy, bridging bone immediately adjacent to the threaded implants crossing the joint, as well as bridging bone close to but not immediately adjacent to the implants. The system was applied to assessing SIJF from thin-slice CT exams in 19 patients 12 months following surgery. Two experienced radiologists implemented the assessment system, and in the event of a disagreement, an adjudicator was used. Most prior studies provide very little detail about how SIJF was assessed. Using the new assessment system, the agreement between the primary readers was substantial (0.67 using Gwet's AC1 statistic). Bridging bone representing a fusion of the SIJ was identified in most patients both immediately adjacent to the threaded implants crossing the joint, as well as distant to the implants. A detailed radiographic assessment system proved to be applicable to SIJF. The assessment system includes explicit language describing the location and extent of bridging bone across the SIJ. Standardization of the assessment of the SIJFs may allow for a more meaningful comparison of data between studies.

Predicting fracture through benign skeletal lesions with quantitative computed tomography.

BACKGROUND: There are no proven radiographic guidelines for predicting fracture risk in children and young adults with a benign skeletal lesion. An in vivo diagnostic study was conducted to determine whether a reduction in the load-carrying capacity of a bone measured with quantitative computed tomography was more accurate than current radiographic guidelines for predicting pathologic fracture in patients with a benign skeletal lesion. METHODS: Eighteen patients who presented with a fracture through a benign skeletal lesion were compared with eighteen patients who had a benign skeletal lesion that had been thought to be at increased risk for fracture on the basis of currently used radiographic criteria but had not fractured over a two-year period. Structural analysis was performed to calculate the resistance of the affected bones to compressive, bending, and torsional loads with use of serial transaxial quantitative computed tomography data obtained along the length of the bone containing the lesion and from homologous cross sections through the contralateral, normal bone. At each cross section, the ratio of the structural rigidity of the affected bone divided by that of the normal, contralateral bone was determined. The cross section with the greatest reduction in compressive, bending, and torsional rigidity was identified as that most likely to fracture. RESULTS: The mean age (and standard deviation) of the thirty-six patients was 12.5 +/- 3.6 years. Twenty lesions were located in the femur; eleven, in the tibia; three, in the humerus; one, in the ulna; and one, in the pelvis. A combination of the minimum bending and torsional rigidities calculated from the tomographic data provided optimal performance in differentiating between the fracture and non-fracture groups (100% sensitivity and 94% specificity). In contrast, plain radiographic criteria demonstrated 28% to 83% sensitivity and 6% to 78% specificity. CONCLUSIONS: The combination of bending and torsional rigidity measured noninvasively with quantitative computed tomography was more accurate (97%) for predicting pathologic fracture through benign bone lesions in children than were standard radiographic criteria (42% to 61% accuracy). We believe that this method can provide accurate objective criteria for planning treatment of benign bone lesions and monitoring treatment response.

Development of a novel radiographic measure of lumbar instability and validation using the facet fluid sign.

BACKGROUND: Lumbar spinal instability is frequently referenced in clinical practice and the scientific literature despite the lack of a standard definition or validated radiographic test. The Quantitative Stability Index (QSI) is being developed as a novel objective test for sagittal plane lumbar instability. The QSI is calculated using lumbar flexion-extension radiographs. The goal of the current study was to use the facet fluid sign on MRI as the "gold standard" and determine if the QSI is significantly different in the presence of the fluid sign. METHODS: Sixty-two paired preoperative MRI and flexion-extension exams were obtained from a large FDA IDE study. The MRI exams were assessed for the presence of a facet fluid sign, and the QSI was calculated from sagittal plane intervertebral rotation and translation measurements. The QSI is based on the translation per degree of rotation (TPDR) and is calculated as a Z-score. A QSI > 2 indicates that the TPDR is > 2 std dev above the mean for an asymptomatic and radiographically normal population. The reproducibility of the QSI was also tested. RESULTS: The mean difference between trained observers in the measured QSI was between -0.28 and 0.36. The average QSI was significantly (P = 0.047, one-way analysis of variance) higher at levels with a definite fluid sign (2.3±3.2 versus 0.60±2.4). CONCLUSIONS: Although imperfect, the facet fluid sign observed may be the best currently available test for lumbar spine instability. Using the facet fluid sign as the "gold standard" the current study documents that the QSI can be expected to be significantly higher in the presence of the facet fluid sign. This supports that QSI might be used to test for sagittal plane lumbar instability. CLINICAL RELEVANCE: A validated, objective and practical test for spinal instability would facilitate research to understand the importance of instability in diagnosis and treatment of low-back related disorders.