MicroRNA-29a: a novel target for non-operative management of symptomatic lumbar spinal stenosis.

PURPOSE: Lumbar spinal stenosis (LSS) is the most common reason for spinal surgery in patients over the age of 65, and there are few effective non-surgical treatments. Therefore, the development of novel treatment or preventative modalities to decrease overall cost and morbidity associated with LSS is an urgent matter. The cause of LSS is multifactorial; however, a significant contributor is ligamentum flavum hypertrophy (LFH) which causes mechanical compression of the cauda equina or nerve roots. We assessed the role of a novel target, microRNA-29a (miR-29a), in LFH and investigated the potential for using miR-29a as a therapeutic means to combat LSS. METHODS: Ligamentum flavum (LF) tissue was collected from patients undergoing decompressive surgery for LSS and assessed for levels of miR-29a and pro-fibrotic protein expression. LF cell cultures were then transfected with either miR-29a over-expressor (agonist) or inhibitor (antagonist). The effects of over-expression and under-expression of miR-29a on expression of pro-fibrotic proteins was assessed. RESULTS: We demonstrated that LF at stenotic levels had a loss of miR-29a expression. This was associated with greater LF tissue thickness and higher mRNA levels of collagen I and III. We also demonstrated that miR29-a plays a direct role in the regulation of collagen gene expression in ligamentum flavum. Specifically, agents that increase miR-29a may attenuate LFH, while those that decrease miR-29a promote fibrosis and LFH. CONCLUSION: This study demonstrates that miR-29a may potentially be used to treat LFH and provides groundwork to initiate the development of a therapeutic product for LSS.

Neck Symptoms and Associated Clinical Outcomes in Patients Following Concussion.

OBJECTIVE: To examine the frequency and association of neck pain symptoms in patients with a concussion. STUDY SETTING AND PARTICIPANTS: Three-hundred and thirty-one consecutively enrolled patients aged 9 to 68 years with a diagnosed concussion 1 to 384 days post-injury were enrolled at a concussion clinic from a single integrated healthcare system in Western Pennsylvania between 2019 and 2021. DESIGN: Retrospective cohort analysis of prospectively collected concussion screening tool intake survey responses and clinical outcomes data. The primary outcome was self-reported neck pain or difficulty with neck movement on the Concussion Clinical Profiles Screening (CP Screen) tool, recovery time, and incidence of treatment referral. Immediate Post-concussion Assessment and Cognitive Testing (ImPACT) composite scores, Vestibular/Ocular Motor Screening (VOMS) item scores, type and severity of neck symptoms, mechanism of injury, time from injury to clinic presentation, medical history, and concussion symptom profile were secondary outcomes. RESULTS: Of the 306 consecutively enrolled eligible patients in the registry, 145 (47%) reported neck pain, 68 (22.2%) reported difficulty moving their neck, and 146 (47.7%) reported either symptom. A total of 47 (15.4%) participants reported more severe neck symptoms, and this group took longer to recover (40 ± 27 days) than those not reporting neck symptoms (30 ± 28 days; U = 8316, P < .001). Stepwise logistic regression predicting more severe neck symptoms was significant (Nagelkerke R2 = 0.174, χ 2 = 9.315, P = .316) with older age ( P = .019) and mechanism of injury including motor vehicle collisions (MVCs) ( P = .047) and falls ( P = .044) as risk factors. MVCs and falls were associated with over 4 times and 2 times greater risk, respectively, for reporting more severe neck symptoms. CONCLUSION: Neck pain and stiffness symptoms are common in patients with a concussion following high-energy mechanisms of injury including MVCs or falls from height. These symptoms are associated with prolonged recovery. Providers should evaluate neck symptoms and consider targeted treatment strategies to limit their effects in patients with a concussion.

Utility of transcranial motor-evoked potential changes in predicting postoperative deficit in lumbar decompression and fusion surgery: a systematic review and meta-analysis.

PURPOSE: The primary aim of this study was to evaluate whether TcMEP alarms can predict the occurrence of postoperative neurological deficit in patients undergoing lumbar spine surgery. The secondary aim was to determine whether the various types of TcMEP alarms including transient and persistent changes portend varying degrees of injury risk. METHODS: This was a systematic review and meta-analysis of the literature from PubMed, Web of Science, and Embase regarding outcomes of transcranial motor-evoked potential (TcMEP) monitoring during lumbar decompression and fusion surgery. The sensitivity, specificity, and diagnostic odds ratio (DOR) of TcMEP alarms for predicting postoperative deficit were calculated and presented with forest plots and a summary receiver operating characteristic curve. RESULTS: Eight studies were included, consisting of 4923 patients. The incidence of postoperative neurological deficit was 0.73% (36/4923). The incidence of deficits in patients with significant TcMEP changes was 11.79% (27/229), while the incidence in those without changes was 0.19% (9/4694). All TcMEP alarms had a pooled sensitivity and specificity of 63 and 95% with a DOR of 34.92 (95% CI 7.95-153.42). Transient and persistent changes had sensitivities of 29% and 47%, specificities of 96% and 98%, and DORs of 8.04 and 66.06, respectively. CONCLUSION: TcMEP monitoring has high specificity but low sensitivity for predicting postoperative neurological deficit in lumbar decompression and fusion surgery. Patients who awoke with new postoperative deficits were 35 times more likely to have experienced TcMEP changes intraoperatively, with persistent changes indicating higher risk of deficit than transient changes. LEVEL OF EVIDENCE II: Diagnostic Systematic Review.

Multilevel tandem spondylolisthesis associated with a reduced "safe zone" for a transpsoas lateral lumbar interbody fusion at L4-5.

OBJECTIVE: The aim of this study was to investigate the effect of degenerative spondylolisthesis (DS) on psoas anatomy and the L4-5 safe zone during lateral lumbar interbody fusion (LLIF). METHODS: In this retrospective, single-institution analysis, patients managed for low-back pain between 2016 and 2021 were identified. Inclusion criteria were adequate lumbar MR images and radiographs. Exclusion criteria were spine trauma, infection, metastases, transitional anatomy, or prior surgery. There were three age and sex propensity-matched cohorts: 1) controls without DS; 2) patients with single-level DS (SLDS); and 3) patients with multilevel, tandem DS (TDS). Axial T2-weighted MRI was used to measure the apical (ventral) and central positions of the psoas relative to the posterior tangent line at the L4-5 disc. Lumbar lordosis (LL), pelvic incidence (PI), pelvic tilt (PT), sacral slope (SS), and PI-LL mismatch were measured on lumbar radiographs. The primary outcomes were apical and central psoas positions at L4-5, which were calculated using stepwise multivariate linear regression including demographics, spinopelvic parameters, and degree of DS. Secondary outcomes were associations between single- and multilevel DS and spinopelvic parameters, which were calculated using one-way ANOVA with Bonferroni correction for between-group comparisons. RESULTS: A total of 230 patients (92 without DS, 92 with SLDS, and 46 with TDS) were included. The mean age was 68.0 ± 8.9 years, and 185 patients (80.4%) were female. The mean BMI was 31.0 ± 7.1, and the mean age-adjusted Charlson Comorbidity Index (aCCI) was 4.2 ± 1.8. Age, BMI, sex, and aCCI were similar between the groups. Each increased grade of DS (no DS to SLDS to TDS) was associated with significantly increased PI (p < 0.05 for all relationships). PT, PI-LL mismatch, center psoas, and apical position were all significantly greater in the TDS group than in the no-DS and SLDS groups (p < 0.05). DS severity was independently associated with 2.4-mm (95% CI 1.1-3.8 mm) center and 2.6-mm (95% CI 1.2-3.9 mm) apical psoas anterior displacement per increased grade (increasing from no DS to SLDS to TDS). CONCLUSIONS: TDS represents more severe sagittal malalignment (PI-LL mismatch), pelvic compensation (PT), and changes in the psoas major muscle compared with no DS, and SLDS and is a risk factor for lumbar plexus injury during L4-5 LLIF due to a smaller safe zone.

Examining the safety profile of a standard dose tranexamic acid regimen in spine surgery.

OBJECTIVE: Perioperative blood loss during spinal surgery is associated with complications and in-hospital mortality. Weight-based administration of tranexamic acid (TXA) has the potential to reduce blood loss and related complications in spinal surgery; however, evidence for standardized dosing is lacking. The purpose of this study was to evaluate the impact of a standardized preoperative 2 g bolus TXA dosing regimen on perioperative transfusion, blood loss, thromboembolic events, and postoperative outcomes in spine surgery patients. METHODS: An institutional review board approved this retrospective review of prospectively enrolled adult spine patients (> 18 years of age). Patients were included who underwent elective and emergency spine surgery between September 2018 and July 2021. Patients who received a standardized 2 g dose of TXA were compared to patients who did not receive TXA. The primary outcome measure was perioperative transfusion. Secondary outcomes included estimated blood loss and thromboembolic or other perioperative complications. Descriptive statistics were calculated, and continuous variables were analyzed with the two-tailed independent t-test, while categorical variables were analyzed with the Fisher's exact test or chi-square test. Stepwise multivariate regression analysis was performed to examine independent risk factors for perioperative outcomes. RESULTS: TXA was administered to 353 of 453 (78%) patients, and there were no demographic differences between groups. Although the TXA group had more operative levels and a longer operative time, the transfusion rate was not different between the TXA and no-TXA groups (7.4% vs 8%, p = 0.83). Stepwise multivariate regression found that the number of operative levels was an independent predictor of perioperative transfusion and that both operative levels and operative time were correlated with estimated blood loss. TXA was not identified as an independent predictor of any postoperative complication. CONCLUSIONS: A standardized preoperative 2 g bolus TXA dosing regimen was associated with an excellent safety profile, and despite increased case complexity in terms of number of operative levels and operative time, patients treated with TXA did not require more blood transfusions than patients not treated with TXA.

Ionizing Radiation Induces Disc Annulus Fibrosus Senescence and Matrix Catabolism via MMP-Mediated Pathways.

Previous research has identified an association between external radiation and disc degeneration, but the mechanism was poorly understood. This study explores the effects of ionizing radiation (IR) on inducing cellular senescence of annulus fibrosus (AF) in cell culture and in an in vivo mouse model. Exposure of AF cell culture to 10-15 Gy IR for 5 min followed by 5 days of culture incubation resulted in almost complete senescence induction as evidenced by SA-ßgal positive staining of cells and elevated mRNA expression of the p16 and p21 senescent markers. IR-induced senescent AF cells exhibited increased matrix catabolism, including elevated matrix metalloproteinase (MMP)-1 and -3 protein expression and aggrecanolysis. Analogous results were seen with whole body IR-exposed mice, demonstrating that genotoxic stress also drives disc cellular senescence and matrix catabolism in vivo. These results have important clinical implications in the potential adverse effects of ionizing radiation on spinal health.

ISSLS prize in basic science 2021: a novel inducible system to regulate transgene expression of TIMP1.

PURPOSE: Inflammatory and oxidative stress upregulates matrix metalloproteinase (MMP) activity, leading to intervertebral disc degeneration (IDD). Gene therapy using human tissue inhibitor of metalloproteinase 1 (hTIMP1) has effectively treated IDD in animal models. However, persistent unregulated transgene expression may have negative side effects. We developed a recombinant adeno-associated viral (AAV) gene vector, AAV-NFκB-hTIMP1, that only expresses the hTIMP1 transgene under conditions of stress. METHODS: Rabbit disc cells were transfected or transduced with AAV-CMV-hTIMP1, which constitutively expresses hTIMP1, or AAV-NFκB-hTIMP1. Disc cells were selectively treated with IL-1ß. NFκB activation was verified by nuclear translocation. hTIMP1 mRNA and protein expression were measured by RT-PCR and ELISA, respectively. MMP activity was measured by following cleavage of a fluorogenic substrate. RESULTS: IL-1ß stimulation activated NFκB demonstrating that IL-1ß was a surrogate for inflammatory stress. Stimulating AAV-NFκB-hTIMP1 cells with IL-1ß increased hTIMP1 expression compared to unstimulated cells. AAV-CMV-hTIMP1 cells demonstrated high levels of hTIMP1 expression regardless of IL-1ß stimulation. hTIMP1 expression was comparable between IL-1ß stimulated AAV-NFκB-hTIMP1 cells and AAV-CMV-hTIMP1 cells. MMP activity was decreased in AAV-NFκB-hTIMP1 cells compared to baseline levels or cells exposed to IL-1ß. CONCLUSION: AAV-NFκB-hTIMP1 is a novel inducible transgene delivery system. NFκB regulatory elements ensure that hTIMP1 expression occurs only with inflammation, which is central to IDD development. Unlike previous inducible systems, the AAV-NFκB-hTIMP1 construct is dependent on endogenous factors, which minimizes potential side effects caused by constitutive transgene overexpression. It also prevents the unnecessary production of transgene products in cells that do not require therapy.

ISSLS PRIZE IN BIOENGINEERING SCIENCE 2018: dynamic imaging of degenerative spondylolisthesis reveals mid-range dynamic lumbar instability not evident on static clinical radiographs.

PURPOSE: Degenerative spondylolisthesis (DS) in the setting of symptomatic lumbar spinal stenosis is commonly treated with spinal fusion in addition to decompression with laminectomy. However, recent studies have shown similar clinical outcomes after decompression alone, suggesting that a subset of DS patients may not require spinal fusion. Identification of dynamic instability could prove useful for predicting which patients are at higher risk of post-laminectomy destabilization necessitating fusion. The goal of this study was to determine if static clinical radiographs adequately characterize dynamic instability in patients with lumbar degenerative spondylolisthesis (DS) and to compare the rotational and translational kinematics in vivo during continuous dynamic flexion activity in DS versus asymptomatic age-matched controls. METHODS: Seven patients with symptomatic single level lumbar DS (6 M, 1 F; 66 ± 5.0 years) and seven age-matched asymptomatic controls (5 M, 2 F age 63.9 ± 6.4 years) underwent biplane radiographic imaging during continuous torso flexion. A volumetric model-based tracking system was used to track each vertebra in the radiographic images using subject-specific 3D bone models from high-resolution computed tomography (CT). In vivo continuous dynamic sagittal rotation (flexion/extension) and AP translation (slip) were calculated and compared to clinical measures of intervertebral flexion/extension and AP translation obtained from standard lateral flexion/extension radiographs. RESULTS: Static clinical radiographs underestimate the degree of AP translation seen on dynamic in vivo imaging (1.0 vs 3.1 mm; p = 0.03). DS patients demonstrated three primary motion patterns compared to a single kinematic pattern in asymptomatic controls when analyzing continuous dynamic in vivo imaging. 3/7 (42%) of patients with DS demonstrated aberrant mid-range motion. CONCLUSION: Continuous in vivo dynamic imaging in DS reveals a spectrum of aberrant motion with significantly greater kinematic heterogeneity than previously realized that is not readily seen on current clinical imaging. LEVEL OF EVIDENCE: Level V data These slides can be retrieved under Electronic Supplementary Material.

Cervical spine bone density in young healthy adults as a function of sex, vertebral level and anatomic location.

PURPOSE: Bone mineral density (BMD) measured using quantitative computed tomography (QCT) has been shown to correlate with bone mechanical properties. Knowledge of BMD within specific anatomic regions of the spine is valuable to surgeons who must secure instrumentation to the vertebrae, to medical device developers who design screws and disc replacements, and to researchers who assign mechanical properties to computational models. The objective of this study was to comprehensively characterize BMD in the cervical spine of young healthy adults. METHODS: QCT was used to determine BMD in the cervical spines of 31 healthy adults (age 20-35). Subject-specific 3D models of each vertebra were created from CT scans, and anatomic regions of interest were identified in each bone (C1: 3 regions; C2: 9 regions, C3-C7: 13 regions). Statistical tests were performed to identify differences in BMD according to vertebral level, anatomic regions within vertebrae, and sex. RESULTS: BMD varied significantly among vertebral levels and among anatomic regions within each vertebra. Females had higher BMD than males (p = .041) primarily due to higher BMD in the posterior regions of each vertebra. CONCLUSIONS: These data can serve as a baseline to identify BMD changes in older and symptomatic patients. This data set is also the first report of volumetric bone density within different anatomic regions of the atlas and axis of the cervical spine. The finding of higher BMD in females is in agreement with the previous QCT results but contradicts DEXA results that are known to be dependent upon bone size.

A novel MRI classification system for congenital functional lumbar spinal stenosis predicts the risk for tandem cervical spinal stenosis.

PURPOSE: The purpose of this study was to develop a simple and clinically useful morphological classification system for congenital lumbar spinal stenosis using sagittal MRI, allowing clinicians to recognize patterns of lumbar congenital stenosis quickly and be able to screen these patients for tandem cervical stenosis. METHODS: Forty-four subjects with an MRI of both the cervical and lumbar spine were included. On the lumbar spine MRI, the sagittal canal morphology was classified as one of three types: Type I normal, Type II partially narrow, Type III globally narrow. For the cervical spine, the Torg-Pavlov ratio on X-ray and the cervical spinal canal width on MRI were measured. Kruskal-Wallis analysis was done to determine if there was a relationship between the sagittal morphology of the lumbar spinal canal and the presence of cervical spinal stenosis. RESULTS: Subjects with a type III globally narrow lumbar spinal canal had a significantly lower cervical Torg-Pavlov ratio and smaller cervical spinal canal width than those with a type I normal lumbar spinal canal. CONCLUSION: A type III lumbar spinal canal is a globally narrow canal characterized by a lack of spinal fluid around the conus. This was defined as "functional lumbar spinal stenosis" and is associated with an increased incidence of tandem cervical spinal stenosis.

Mechanical role of the posterior column components in the cervical spine.

PURPOSE: To quantify the mechanical role of posterior column components in human cervical spine segments. METHODS: Twelve C6-7 segments were subjected to resection of (1) suprasinous/interspinous ligaments (SSL/ISL), (2) ligamenta flavum (LF), (3) facet capsules, and (4) facets. A robot-based testing system performed repeated flexibility testing of flexion-extension (FE), axial rotation (AR), and lateral bending (LB) to 2.5Nm and replayed kinematics from intact flexibility tests for each state. Range-of-motion, stiffness, moment resistance and resultant forces were calculated. RESULTS: The LF contributes largely to moment resistance, particularly in flexion. Facet joints were primary contributors to AR and LB mechanics. Moment/force responses were more sensitive and precise than kinematic outcomes. CONCLUSIONS: The LF is mechanically important in the cervical spine; its injury could negatively impact load distribution. Damage to facets in a flexion injury could lead to AR or LB hypermobility. Quantifying the contribution of spinal structures to moment resistance is a sensitive, precise process for characterizing structural mechanics.

Avoiding and Managing Intraoperative Complications During Cervical Spine Surgery.

The incidence of intraoperative complications during cervical spine surgery is low; however, if they do occur, intraoperative complications have the potential to cause considerable morbidity and mortality. Spine surgeons should be familiar with methods to minimize intraoperative complications. If they do occur, surgeons must be prepared to immediately treat each potential complication to reduce any associated morbidity.

Prevalence of venous thromboembolic events after elective major thoracolumbar degenerative spine surgery.

STUDY DESIGN: A case-control study. OBJECTIVE: The purposes of this study were to establish the prevalence of venous thromboembolic disease in patients undergoing elective major thoracolumbar degenerative spine surgery and identify risk factors. SUMMARY OF BACKGROUND DATA: Venous thromboembolic events (VTE) are a serious complication of orthopedic surgery, but the prevalence of VTE after elective thoracolumbar degenerative spine surgery is not well known. METHODS: This was a case-control study of 5766 consecutive elective thoracolumbar degenerative spine surgeries. Symptomatic pulmonary emboli (PE) were diagnosed by spiral chest CT scans, nuclear scintigraphic ventilation-perfusion, and angiography. Deep vein thromboses (DVT) were diagnosed by venous duplex scans. The prevalence of VTE was analyzed according to patient demographic variables and type of surgery performed. RESULTS: The prevalence of developing a VTE was 1.5% (89/5766), with a prevalence of symptomatic PE of 0.88% (51/5766) and DVT of 0.66% (38/5766). There were 47% males and 53% females with a mean age of 60.3 years. In patients undergoing 5-segment fusions the prevalence of PE was 3.1% (P=0.022). Patients who had ≥4 segments fused had a prevalence of PE of 1.7% (P=0.014). The odds of having a PE in those above 65 years at the time of surgery were 2.196 times as large as for those below 65 years. Noncontributory factors included sex, instrumentation, and revision surgery. CONCLUSIONS: This case-control study of 5766 patients who underwent elective thoracolumbar degenerative spine surgery revealed a prevalence of VTE of 1.5%, with a prevalence of PE of 0.88% and DVT of 0.66%. Patients with increasingly extensive surgery had a higher risk of PE, specifically those undergoing fusion of ≥5 segments.

Formal Radiologist Interpretations of Intraoperative Spine Radiographs Have Low Clinical Value.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: To evaluate the clinical relevance, usefulness, and financial implications of intraoperative radiograph interpretation by radiologists in spine surgery. SUMMARY OF BACKGROUND DATA: Due to rising health care costs, spine surgery is under scrutiny to maximize value-based care. Formal radiographic analysis remains a potential source of unnecessary health care costs, especially for intraoperative radiographs. MATERIALS AND METHODS: A retrospective cohort analysis was performed on all adult elective spine surgeries at a single institution between July 2020 and July 2021. Demographic and radiographic data were collected, including intraoperative localization and post-instrumentation radiographs. Financial data were obtained through the institution's price estimator. Radiographic characteristics included time from radiographic imaging to completion of radiologist interpretation report, completion of radiologist interpretation report before the conclusion of surgical procedure, clinical relevance, and clinical usefulness. Reports were considered clinically relevant if the spinal level of the procedure was described and clinically useful if completed before the conclusion of the procedure and deemed clinically relevant. RESULTS: Four hundred eighty-one intraoperative localization and post-instrumentation radiographs from 360 patients revealed a median delay of 128 minutes between imaging and completion of the interpretive report. Only 38.9% of reports were completed before the conclusion of surgery. There were 79.4% deemed clinically relevant and only 33.5% were clinically useful. Localization reports were completed more frequently before the conclusion of surgery (67.2% vs. 34.4%) but with lower clinical relevance (90.1% vs. 98.5%) and clinical usefulness (60.3% vs. 33.6%) than post-instrumentation reports. Each patient was charged $32 to $34 for the interpretation fee, cumulating a minimum total cost of $15,392. CONCLUSIONS: Formal radiographic interpretation of intraoperative spine radiographs was of low clinical utility for spine surgeons. Institutions should consider optimizing radiology workflows to improve timeliness and clinical relevance or evaluate the necessity of reflexive consultation to radiology for intraoperative imaging interpretation to ensure that value-based care is maximized during spine surgeries. LEVEL OF EVIDENCE: 3.

Characterizing Negative Online Reviews of Spine Surgeons.

DESIGN: Retrospective review. OBJECTIVE: Characterize negative reviews of spine surgeons in the United States. SUMMARY: Physician rating websites significantly influence the selection of doctors by other patients. Negative experiences are impacted by various factors, both clinical and nonclinical, geography, and practice structure. The purpose of this study was to evaluate and categorize negative reviews of spine surgeons in the United States, with a focus on surgical versus nonsurgical reviewers. METHODS: Spine surgeons were selected from available online professional society membership directories. A search for reviews was performed on Healthgrades.com, Vitals.com, and RateMDs.com for the past 10 years. Free response reviews were coded by complaint, and qualitative analysis was performed. χ 2 and Fisher exact tests were used to compare categorical variables, and multiple comparisons were adjusted with Benjamini-Hochberg correction. A binary logistic regression model was performed for the top three most mentioned nonclinical and clinical complaint labels. A P -value <0.05 was considered statistically significant. RESULTS: A total of 16,695 online reviews were evaluated, including 1690 one-star reviews (10.1%). Among one-star reviews, 64.7% were written by nonsurgical patients and 35.3% by surgical patients. Nonclinical and clinical comments constituted 54.9% and 45.1% of reviews, respectively. Surgeons in the South had more "bedside manner" comments (43.3%, P <0.0001), while Northeast surgeons had more "poor surgical outcome" remarks compared with all other geographic regions (14.4%, P <0.001). Practicing in the South and Northeast were independent predictors of having complaints about "bedside manner" and "poor surgical outcome," respectively. CONCLUSION: Most one-star reviews of spine surgeons were attributed to nonsurgical patients, who tended to be unsatisfied with nonclinical factors, especially "bedside manner." However, there was substantial geographic variation. These results suggest that spine surgeons could benefit from focusing on nonclinical factors (bedside manner), especially among nonoperative patients, and that regional nuances should be considered in delivering spine care. LEVEL OF EVIDENCE: Level- 5.

Modified Clavien-Dindo-Sink Classification System for operative complications in adult spine surgery.

OBJECTIVE: Currently there is no standardized mechanism to describe or compare complications in adult spine surgery. Thus, the purpose of the present study was to modify and validate the Clavien-Dindo-Sink complication classification system for applications in spine surgery. METHODS: The Clavien-Dindo-Sink complication classification system was evaluated and modified for spine surgery by four fellowship-trained spine surgeons using a consensus process. A distinct group of three fellowship-trained spine surgeons completed a randomized electronic survey grading 71 real-life clinical case scenarios. The survey was repeated 2 weeks after its initial completion. Fleiss' and Cohen's kappa (κ) statistics were used to evaluate interrater and intrarater reliabilities, respectively. RESULTS: Overall, interobserver reliability during the first and second rounds of grading was excellent with a κ of 0.847 (95% CI 0.785-0.908) and 0.852 (95% CI 0.791-0.913), respectively. In the first round, interrater reliability ranged from good to excellent with a κ of 0.778 for grade I (95% CI 0.644-0.912), 0.698 for grade II (95% CI 0.564-0.832), 0.861 for grade III (95% CI 0.727-0.996), 0.845 for grade IV-A (95% CI 0.711-0.979), 0.962 for grade IV-B (95% CI 0.828-1.097), and 0.960 for grade V (95% CI 0.826-1.094). Intraobserver reliability testing for all three independent observers was excellent with a κ of 0.971 (95% CI 0.944-0.999) for rater 1, 0.963 (95% CI 0.926-1.001) for rater 2, and 0.926 (95% CI 0.869-0.982) for rater 3. CONCLUSIONS: The Modified Clavien-Dindo-Sink Classification System demonstrates excellent interrater and intrarater reliability in adult spine surgery cases. This system provides a useful framework to better communicate the severity of spine-related complications.

Subject-specific inverse dynamics of the head and cervical spine during in vivo dynamic flexion-extension.

The effects of degeneration and surgery on cervical spine mechanics are commonly evaluated through in vitro testing and finite element models derived from these tests. The objectives of the current study were to estimate the load applied to the C2 vertebra during in vivo functional flexion-extension and to evaluate the effects of anterior cervical arthrodesis on spine kinetics. Spine and head kinematics from 16 subjects (six arthrodesis patients and ten asymptomatic controls) were determined during functional flexion-extension using dynamic stereo X-ray and conventional reflective markers. Subject-specific inverse dynamics models, including three flexor muscles and four extensor muscles attached to the skull, estimated the force applied to C2. Total force applied to C2 was not significantly different between arthrodesis and control groups at any 10 deg increment of head flexion-extension (all p values ≥ 0.937). Forces applied to C2 were smallest in the neutral position, increased slowly with flexion, and increased rapidly with extension. Muscle moment arms changed significantly during flexion-extension, and were dependent upon the direction of head motion. The results suggest that in vitro protocols and finite element models that apply constant loads to C2 do not accurately represent in vivo cervical spine kinetics.

Lumbar spinal stenosis.

Lumbar spinal stenosis affects many patients and is one of the most common reasons for spinal surgery in the elderly population. New research and surgical innovations have resulted in a better understanding of the disease and its diagnosis and treatment. To select the optimal treatment approach for each patient, it is helpful to review patient presentations, diagnostic workups, surgical and nonsurgical treatment options, evidence-based outcomes, and the pathophysiology of lumbar spinal stenosis.

Association Between Industry Sponsorship of Spine-Related Clinical Trials, Publication Status, and Research Outcomes.

STUDY DESIGN: Observational Database Study. OBJECTIVES: Prospective clinical trials in spinal surgery are expensive to conduct, especially when randomized, appropriately powered, and/or multicentered. Industry collaborations generate symbiotic relationships promoting technological advancement; however, they also allow for bias. To the authors' knowledge, there is no known analysis of correlations between industry sponsorship and publication rates of spine-related clinical trials. This observational work evaluates such potential associations. METHODS: The ClinicalTrials.gov database was queried with terms spine, spinal, spondylosis, spondylolysis, cervical, lumbar, and compression fracture over an 11-year period. Design characteristics and outcomes were recorded from 822 spine surgery-related trials. Trials were stratified based on funding source and intervention class. Groups were compared via two-tailed chi-square test of independence or Fisher's exact test (α = .05), based on completion status and publication rates of positive vs negative results. RESULTS: Industry-sponsored spine-related clinical trials were more likely to be terminated than their non-industry-sponsored counterparts (P < .001). Of the trials achieving publication, industry-sponsored trials reported positive results at a higher rate than did trials without industry funding (P = .037). Clinical trials examining devices were more likely to be terminated than those studying other intervention classes (P = .001). CONCLUSIONS: High termination rates and positive result publication rates among industry-sponsored clinical trials in spinal surgery likely reflect industry's influence on the research community. Such partnership alleviates financial burden and provides accessibility to cutting-edge innovation. It is essential that all parties remain mindful of the significant bias that funding source may impart on study outcome.