De novo methicillin-resistant Staphylococcus aureus vs. methicillin-sensitive Staphylococcus aureus infections of the spine, similar clinical outcome, despite more severe presentation in surgical patients.

Vertebral osteomyelitis (VO) is a severe infection of the vertebral body and the adjacent disc space, where Staphylococcus aureus is most commonly isolated. The objective of this retrospective study was to determine risk factors for and compare outcome differences between de novo methicillin-resistant Staphylococcus aureus (MRSA) VO and methicillin-sensitive Staphylococcus aureus (MSSA) VO. A retrospective cohort study was performed by review of the electronic medical records of 4541 consecutive spine surgery patients. Among these 37 underwent surgical treatment of de novo MRSA and MSSA spinal infections. Patient demographics, pre- and postoperative neurological status (ASIA impairment score), surgical treatment, inflammatory laboratory values, nutritional status, comorbidities, antibiotics, hospital stay, ICU stay, reoperation, readmission, and complications were collected. A minimum follow-up (FU) of 12 months was required. Among the 37 patients with de novo VO, 19 were MRSA and 18 were MSSA. Mean age was 52.4 and 52.9 years in the MRSA and MSSA groups, respectively. Neurological deficits were found in 53% of patients with MRSA infection and in 17% of the patients with MSSA infection, which was statistically significant (p < 0.05). Chronic renal insufficiency and malnutrition were found to be significant risk factors for MRSA VO. Preoperative albumin was significantly lower in the MRSA group (p < 0.05). Patients suffering from spinal infection with chronic renal insufficiency and malnutrition should be watched more carefully for MRSA. The MRSA group did not show a significant difference with regard to final clinical outcome despite more severe presentation.

Artificial intelligence clustering of adult spinal deformity sagittal plane morphology predicts surgical characteristics, alignment, and outcomes.

PURPOSE: AI algorithms have shown promise in medical image analysis. Previous studies of ASD clusters have analyzed alignment metrics-this study sought to complement these efforts by analyzing images of sagittal anatomical spinopelvic landmarks. We hypothesized that an AI algorithm would cluster preoperative lateral radiographs into groups with distinct morphology. METHODS: This was a retrospective review of a multicenter, prospectively collected database of adult spinal deformity. A total of 915 patients with adult spinal deformity and preoperative lateral radiographs were included. A 2 × 3, self-organizing map-a form of artificial neural network frequently employed in unsupervised classification tasks-was developed. The mean spine shape was plotted for each of the six clusters. Alignment, surgical characteristics, and outcomes were compared. RESULTS: Qualitatively, clusters C and D exhibited only mild sagittal plane deformity. Clusters B, E, and F, however, exhibited marked positive sagittal balance and loss of lumbar lordosis. Cluster A had mixed characteristics, likely representing compensated deformity. Patients in clusters B, E, and F disproportionately underwent 3-CO. PJK and PJF were particularly prevalent among clusters A and E. Among clusters B and F, patients who experienced PJK had significantly greater positive sagittal balance than those who did not. CONCLUSIONS: This study clustered preoperative lateral radiographs of ASD patients into groups with highly distinct overall spinal morphology and association with sagittal alignment parameters, baseline HRQOL, and surgical characteristics. The relationship between SVA and PJK differed by cluster. This study represents significant progress toward incorporation of computer vision into clinically relevant classification systems in adult spinal deformity. LEVEL OF EVIDENCE IV: Diagnostic: individual cross-sectional studies with the consistently applied reference standard and blinding.

Rates of early complications and mortality in patients older than 80 years of age after surgical treatment of acute traumatic spinal fractures: ankylosing spondylitis versus osteoporosis.

OBJECTIVE: The purpose of this retrospective cohort study was to analyze the early complications and mortality associated with multilevel spine surgery for unstable fractures in patients older than 80 years of age with ankylosing spondylitis and to compare the results with an age- and sex-matched cohort of patients with unstable osteoporotic fractures. METHODS: A retrospective review of the electronic medical records at a single institution was conducted between January 2014 and December 2019. Patient demographics, surgical characteristics, complications, hospital course, and 90-day mortality were collected. Comorbidities were stratified using the age-adjusted Charlson Comorbidity Index (CCI). RESULTS: Among 11,361 surgically treated patients, 22 patients with ankylosing spondylitis (AS group) and 24 patients with osteoporosis (OS group) were identified. The mean ages were 83.1 ± 3.1 years and 83.2 ± 2.6 years, respectively. A significant difference in the mean CCI score was found (7.6 vs 5.6; p < 0.001). Multilevel posterior fusion procedures were conducted in all patients, with 6.7 ± 1.4 fused levels in the AS group and 7.1 ± 1.1 levels fused in the OS group (p > 0.05). Major complications developed in 10 patients (45%) in the AS group compared with 4 patients (17%) in the OS group (p < 0.05). The 90-day mortality was 36% in the AS group compared with 0% in the OS group (p < 0.001). CONCLUSIONS: Patients older than 80 years of age with AS bear a high risk of adverse events after multilevel spinal fusion procedures. The high morbidity and 90-day mortality should be clearly discussed and carefully weighed against surgical treatment.

A low protein maternal diet during gestation has negative effects on male fertility markers in rats - A Systematic Review and Meta-analysis.

Research indicates that some adult diseases including reproductive pathologies are programmed in utero during foetal development. In particular, maternal low dietary protein, during the most critical developmental periods of male foetal development, may have a detrimental impact on male fertility through direct and epigenetic mechanisms. The aim of our study was to evaluate the impact of a gestational low protein diet on fertility markers in male offspring in rats through a systematic review and meta-analysis. A systematic search using PubMed, and EMBASE databases was performed and two investigators independently screened the 1,703 prospective articles. Eleven articles met the eligibility criteria. Outcome measures were pooled using random-effects models and expressed as mean differences (MDs) at 95% CIs for each study. The results reveal significant reduction in testis weight (MD (mean difference) -0.08 g; -0.12, -0.42; p = .0001), epididymal sperm count (MD -35.34 × 106 cells; -52.15, -18.53; p = .0001), number of Sertoli cells (MD -7.27 × 106 (-13.92, -0.62; p = .03), testosterone (T) concentration (MD -0.29 ng/ml; -0.48, -0.09; p = .004) and luteinising hormone (LH) concentration (MD of -0.24 ng/ml; -0.45, 0.04; p = .02) in comparison with controls. In contrast, follicle-stimulating hormone (FSH) concentration (MD of 0.07 ng/ml; -0.16, 0.29; p = .56) was not significantly different from controls. We conclude that low gestational dietary protein maternal intake potentially negatively impacts fertility in male progeny later in life. The mechanisms of action responsible for these phenomena remain unclear.

GDF15, an update of the physiological and pathological roles it plays: a review.

Growth differentiation factor 15 (GDF15) is a peptide hormone, and a divergent member of the transforming growth factor beta (TGFß) superfamily. In normal physiology, GDF15 is expressed in multiple tissues at a low concentration. GDF15 is overexpressed during and following many pathological conditions such as tissue injury and inflammation in order to play a protective role. However, GDF15 appears to promote tumour growth in the later stages of malignant cancer. The recently identified endogenous receptor for GDF15, GDNF family receptor a-like (GFRAL), has allowed elucidation of a physiological pathway in which GDF15 regulates energy homeostasis and body weight, primarily via appetite suppression. The anorectic effect of GDF15 provides some therapeutic potential in management of cancer-related anorexia/cachexia and obesity. Despite the identification of GFRAL as a GDF15 receptor, there appears to be other signalling mechanisms utilized by GDF15 that further increase the possibility of development of therapeutic treatments, should these pathways be fully characterized. In this review, GDF15 function in both physiological and pathological conditions in various tissues will be discussed.

The effect of dietary protein intake on factors associated with male infertility: A systematic literature review and meta-analysis of animal clinical trials in rats.

BACKGROUND: Studies have shown that the amount of protein in the diet affects the hypothalamic-pituitary-testis axis and sub-optimal quantity reduces male fertility potential in both animals and humans. However, individual research reports on the factors associated with male infertility are collectively uncharacterized. AIM: We systematically reviewed, and meta-analysed animal (rats) studies on the effect of low protein diet on factors associated with male infertility. METHODS: PubMed Central, EMBASE and Scopus databases were searched from inception to 30 March 2019 for the study concepts and related keywords in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol. Data on the outcome measures were extracted and pooled across trials using random-effects model and expressed as mean differences (MD) at a 95% confidence interval (CI). RESULTS: Twelve trials identified from 3327 studies, met our inclusion criteria in the comparison of a low protein diet (2-10% protein) vs control protein diet (17-23% protein). The results showed that a low protein diet caused a significant reduction in the body weight (P = 0.0001) testis weight (P = 0.0001), seminal vesicle weight (P = 0.0003), epididymis weight P = 0.02), serum testosterone (P = 0.001) and follicle-stimulating hormone (FSH) concentrations (P = 0.04) compared with the control treatments. No effect on luteinizing hormone (LH) plasma concentration (P = 0.13) was observed. CONCLUSION: This study revealed that low protein diet caused significant reductions in body weight, testis, epididymis and seminal vesicle weights, serum testosterone and FSH concentration in rats. We infer that sub-optimal protein consumption reduces the gonadal and endocrine function, and consequently male infertility.

Prospective multi-centric evaluation of upper cervical and infra-cervical sagittal compensatory alignment in patients with adult cervical deformity.

PURPOSE: Reciprocal mechanisms for standing alignment have been described in thoraco-lumbar deformity but have not been studied in patients with primary cervical deformity (CD). The purpose of this study is to report upper- and infra-cervical sagittal compensatory mechanisms in patients with CD and evaluate their changes post-operatively. METHODS: Global spinal alignment was studied in a prospective database of operative CD patients. Inclusion criteria were any of the following: cervical kyphosis (CK) > 10°, cervical scoliosis > 10°, cSVA (C2-C7 Sagittal vertical axis) > 4 cm or CBVA (Chin Brow Vertical Angle) > 25°. For this study, patients who had previous fusion outside C2 to T4 segments were excluded. Patients were sub-classified by increasing severity of cervical kyphosis [CL (cervical lordosis): < 0°, CK-low 0°-10°, CK-high > 10°] and cSVA (cSVA-low 0-4 cm, cSVA-mid 4-6 cm, cSVA-high > 6 cm) and were compared for pre- and 3-month post-operative regional and global sagittal alignment to determine compensatory recruitment. RESULTS: 75 CD patients (mean age 61.3 years, 56% women) were included. Patients with progressively larger CK had a progressive increase in C0-C2 (CL = 34°, CK-low = 37°, CK-high = 44°, p = 0.004), C2Slope and T1Slope-CL (p < 0.05). As the cSVA increased, there was progressive increase in C2Slope, T1Slope and TS-CL (p < 0.05) and patients compensated through increasing C0-C2 (cSVA-low = 33°, cSVA-mid = 40°, cSVA-high = 43°, p = 0.007) and pelvic tilt (cSVA-low = 14.9°, cSVA-mid = 24.1°, cSVA-high = 24.9°, p = 0.02). At 3 months post-op, with significant improvement in cervical alignment, there was relaxation of C0-C2 (39°-35°, p = 0.01) which positively correlated with magnitude of deformity correction. CONCLUSIONS: Patients with cervical malalignment compensate with upper cervical hyper-lordosis, presumably for the maintenance of horizontal gaze. As cSVA increases, patients also tend to exhibit increased pelvic retroversion. Following surgical treatment, there was relaxation of upper cervical compensation.

Development of a validated computer-based preoperative predictive model for pseudarthrosis with 91% accuracy in 336 adult spinal deformity patients.

OBJECTIVEPseudarthrosis can occur following adult spinal deformity (ASD) surgery and can lead to instrumentation failure, recurrent pain, and ultimately revision surgery. In addition, it is one of the most expensive complications of ASD surgery. Risk factors contributing to pseudarthrosis in ASD have been described; however, a preoperative model predicting the development of pseudarthrosis does not exist. The goal of this study was to create a preoperative predictive model for pseudarthrosis based on demographic, radiographic, and surgical factors.METHODSA retrospective review of a prospectively maintained, multicenter ASD database was conducted. Study inclusion criteria consisted of adult patients (age ≥ 18 years) with spinal deformity and surgery for the ASD. From among 82 variables assessed, 21 were used for model building after applying collinearity testing, redundancy, and univariable predictor importance ≥ 0.90. Variables included demographic data along with comorbidities, modifiable surgical variables, baseline coronal and sagittal radiographic parameters, and baseline scores for health-related quality of life measures. Patients groups were determined according to their Lenke radiographic fusion type at the 2-year follow-up: bilateral or unilateral fusion (union) or pseudarthrosis (nonunion). A decision tree was constructed, and internal validation was accomplished via bootstrapped training and testing data sets. Accuracy and the area under the receiver operating characteristic curve (AUC) were calculated to evaluate the model.RESULTSA total of 336 patients were included in the study (nonunion: 105, union: 231). The model was 91.3% accurate with an AUC of 0.94. From 82 initial variables, the top 21 covered a wide range of areas including preoperative alignment, comorbidities, patient demographics, and surgical use of graft material.CONCLUSIONSA model for predicting the development of pseudarthrosis at the 2-year follow-up was successfully created. This model is the first of its kind for complex predictive analytics in the development of pseudarthrosis for patients with ASD undergoing surgical correction and can aid in clinical decision-making for potential preventative strategies.

Selecting caudal fusion levels: 2 year functional and stiffness outcomes with matched pairs analysis in multilevel fusion to L5 versus S1.

PURPOSE: Controversy persists as to whether to end multilevel thoracolumbar fusions caudally at L5 or S1. Some argue that stopping at L5 may preserve greater function, but there are few data comparing functional limitations due to lumbar stiffness in patients with fusion to L5 versus S1. The aim of this study was to evaluate whether patients undergoing multilevel thoracolumbar fusions with an L5 caudal endpoint have a better lumbosacral function than patients with an S1 caudal endpoint. METHODS: Patients undergoing successful thoracolumbar fusion of 5 or more levels to L5 or S1, with solid fusion at 2 year follow-up, were examined from a single European center in addition to a multi-center North American database of 237 patients. In total, 40 patients with a distal stopping point of L5 were matched with a subset of 40 patients with a distal endpoint of S1 ± pelvic fixation. The L5 and S1 groups were matched for the final Oswestry Disability Index (ODI), Sagittal Vertical Axis (SVA C7-S1), number of fusion levels, and age. Impacts of lumbar stiffness on function as measured by the Lumbar Stiffness Disability Index (LSDI) were compared using the conditional logistic regression. RESULTS: After matching, there was no significant difference between the S1 and L5 groups for the final ODI (29.22 ± 21.6 for S1 versus 29.21 ± 21.7 for L5; p = 0.98), SVA (29.5 ± 40.3 mm for S1 versus 33.7 ± 37.1 mm for L5; p = 0.97), mean age (61.6 ± 11.0 years for S1 versus 58.3 ± 12.6 years for L5; p = 0.23), and number of fusion levels (9.7 ± 3.3 levels for S1 versus 9.0 ± 3 levels for L5; p = 0.34). The final 2-year postoperative LSDI scores were not significantly different between the S1 group (28.08 ± 21.47) and L5 group (29.21 ± 21.66) (hazard ratio 0.99, 95 % CI 0.97-1.03, p = 0.81). CONCLUSION: The analysis of patients with multilevel thoracolumbar fusions demonstrated that after minimum 2 year follow-up, self-reported functional impacts of lumbar stiffness were not significantly different between the patients with distal endpoints of L5 versus S1. The choice of distal fusion level of L5 does not appear to retain sufficient spinal flexibility to substantially affect postoperative function. LEVEL OF EVIDENCE: Level III.

Potential of predictive computer models for preoperative patient selection to enhance overall quality-adjusted life years gained at 2-year follow-up: a simulation in 234 patients with adult spinal deformity.

OBJECTIVE Patients with adult spinal deformity (ASD) experience significant quality of life improvements after surgery. Treatment, however, is expensive and complication rates are high. Predictive analytics has the potential to use many variables to make accurate predictions in large data sets. A validated minimum clinically important difference (MCID) model has the potential to assist in patient selection, thereby improving outcomes and, potentially, cost-effectiveness. METHODS The present study was a retrospective analysis of a multiinstitutional database of patients with ASD. Inclusion criteria were as follows: age ≥ 18 years, radiographic evidence of ASD, 2-year follow-up, and preoperative Oswestry Disability Index (ODI) > 15. Forty-six variables were used for model training: demographic data, radiographic parameters, surgical variables, and results on the health-related quality of life questionnaire. Patients were grouped as reaching a 2-year ODI MCID (+MCID) or not (-MCID). An ensemble of 5 different bootstrapped decision trees was constructed using the C5.0 algorithm. Internal validation was performed via 70:30 data split for training/testing. Model accuracy and area under the curve (AUC) were calculated. The mean quality-adjusted life years (QALYs) and QALYs gained at 2 years were calculated and discounted at 3.5% per year. The QALYs were compared between patients in the +MCID and -MCID groups. RESULTS A total of 234 patients met inclusion criteria (+MCID 129, -MCID 105). Sixty-nine patients (29.5%) were included for model testing. Predicted versus actual results were 50 versus 40 for +MCID and 19 versus 29 for -MCID (i.e., 10 patients were misclassified). Model accuracy was 85.5%, with 0.96 AUC. Predicted results showed that patients in the +MCID group had significantly greater 2-year mean QALYs (p = 0.0057) and QALYs gained (p = 0.0002). CONCLUSIONS A successful model with 85.5% accuracy and 0.96 AUC was constructed to predict which patients would reach ODI MCID. The patients in the +MCID group had significantly higher mean 2-year QALYs and QALYs gained. This study provides proof of concept for using predictive modeling techniques to optimize patient selection in complex spine surgery.

Recovery following adult spinal deformity surgery: the effect of complications and reoperation in 149 patients with 2-year follow-up.

PURPOSE: To identify the effect of complications and reoperation on the recovery process following adult spinal deformity (ASD) surgery by examining health-related quality of life (HRQOL) measures over time via an integrated health state analysis (IHS). METHODS: A retrospective review of a multicenter, prospective ASD database was conducted. Complication number, type, and need for reoperation (REOP) or not (NOREOP) were recorded. Patients were stratified as having no complication (NOCOMP), any complication (COMP), only minor complications (MINOR) and any major complications (MAJOR). HRQOL measures included Oswestry Disability Index (ODI), Short Form-36 (SF-36), and Scoliosis Research Society-22 (SRS22) at baseline, 6 weeks, 1 and 2 years postoperatively. All HRQOL scores were normalized to each patient's baseline scores and an IHS was then calculated. RESULTS: 149 patients were included. COMP, MINOR, and MAJOR had significantly lower normalized SRS mental scores at 1 and 2 years than NOCOMP (p < 0.05). REOP had significantly worse normalized 1 and 2 year mental component score (MCS), SRS mental, and total score than NOCOMP (p < 0.05). COMP, MINOR, and MAJOR all had significantly lower SRS mental IHSs than NOCOMP (p < 0.05). REOP had significantly lower IHSs for MCS and SRS satisfaction than NOREOP (p < 0.05). REOP had a significantly lower MCS and SRS mental IHS than NOCOMP (p < 0.05). CONCLUSION: An IHS analysis suggests there was a significantly protracted mental recovery phase associated with patients that had at least one complication, as well as either a minor and major complication. The addition of a reoperation also adversely affected the mental recovery as well as overall satisfaction.

Patients with spinal deformity over the age of 75: a retrospective analysis of operative versus non-operative management.

PURPOSE: The goal of the present study was to compare the outcomes of operative and non-operative patients with adult spinal deformity (ASD) over 75 years of age. METHODS: A retrospective review of a multicenter prospective adult spinal deformity database was conducted examining patients with ASD over the age of 75 years. Demographics, comorbidities, operation-related variables, complications, radiographs, and Health-related quality of life (HRQOL) measures collected included Oswestry Disability Index, Short Form-36, and Scoliosis Research Society-22 preoperatively, and at 1 and 2 years later. Minimum clinically important difference (MCID) was calculated and also compared. RESULTS: 27 patients (12 operative, 15 non-operative) were studied. There were no significant differences (p > 0.05) between operative and non-operative patients for age, body mass-index, and comorbidities, but operative patients had worse baseline HRQOL than non-operative patients. Operative patients had a significant improvement in radiographic parameters in 2-year HRQOL, whereas non-operative patients did not (p > 0.05). Operative patients were significantly more likely to reach MCID (range 41.7-81.8 vs. 0-33.3 %, p < 0.05). In the surgical group, 9 (75 %) patients had at least 1 complication (24 total complications). CONCLUSIONS: In the largest series to date comparing operative and non-operative management of adult spinal deformity in elderly patients greater than 75 years of age, reconstructive surgery provides significant improvements in pain and disability over a 2-year period. Furthermore, operative patients were more likely to reach MCID than non-operative patients. When counseling elderly patients with ASD, such data may be helpful in the decision-making process regarding treatment.

Collateral Adverse Outcomes After Lumbar Spine Surgery.

Collateral adverse outcomes are the expected or unavoidable results of a procedure that is performed in a standard manner and typically experienced by the patient. Collateral adverse outcomes do not result from errors, nor are they rare. Collateral adverse outcomes occur as the direct result of a surgical procedure and must be accepted as a trade-off to attain the intended benefits of the surgical procedure. As such, collateral adverse outcomes do not fit into the traditional definition of a complication or adverse event. Examples of collateral adverse outcomes after lumbar spine arthrodesis include lumbar stiffness, postoperative psychological stress, postoperative pain, peri-incisional numbness, paraspinal muscle denervation, and adjacent-level degeneration. Ideally, a comparison of interventions for the treatment of a clinical condition should include information on both the negative consequences (expected and unexpected) and potential benefits of the treatment options. The objective evaluation and reporting of collateral adverse outcomes will provide surgeons with a more complete picture of invasive interventions and, thus, the improved ability to assess alternative treatment options.

The need for structural allograft biomechanical guidelines.

Because of their osteoconductive properties, structural bone allografts retain a theoretic advantage in biologic performance compared with artificial interbody fusion devices and endoprostheses. Present regulations have addressed the risks of disease transmission and tissue contamination, but comparatively few guidelines exist regarding donor eligibility and bone processing issues with a potential effect on the mechanical integrity of structural allograft bone. The lack of guidelines appears to have led to variation among allograft providers in terms of processing and donor screening regarding issues with recognized mechanical effects. Given the relative lack of data on which to base reasonable screening standards, we undertook basic biomechanical evaluation of one source of structural bone allograft, the femoral ring. Of our tested parameters, the minimum and maximum cortical wall thicknesses of femoral ring allograft were most strongly correlated with the axial compressive load to failure of the graft, suggesting that cortical wall thickness may be a useful screening tool for compressive resistance expected from fresh cortical bone allograft. Development of further biomechanical and clinical data to direct standard development appears warranted.

The need for structural allograft biomechanical guidelines.

Because of their osteoconductive properties, structural bone allografts retain a theoretic advantage in biologic performance compared with artificial interbody fusion devices and endoprostheses. Current regulations have addressed the risks of disease transmission and tissue contamination, but comparatively few guidelines exist regarding donor eligibility and bone processing issues with a potential effect on the mechanical integrity of structural allograft bone. The lack of guidelines appears to have led to variation among allograft providers in terms of processing and donor screening regarding issues with recognized mechanical effects. Given the relative lack of data on which to base reasonable screening standards, a basic biomechanical evaluation was performed on one source of structural bone allograft, the femoral ring. Of the tested parameters, the minimum and maximum cortical wall thicknesses of femoral ring allograft were most strongly correlated with the axial compressive load to failure of the graft, suggesting that cortical wall thickness may be a useful screening tool for compressive resistance expected from fresh cortical bone allograft. Development of further biomechanical and clinical data to direct standard development appears warranted.

Adverse events recording and reporting in clinical trials of cervical total disk replacement.

Adverse events reporting in pivotal trials of new technologies, such as cervical total disk replacement, are essential to determine safety. Important questions concerning the adequacy of reporting about such new technologies in peer-reviewed publications have prompted this analysis to assess the safety of cervical disk replacement compared with fusion as presented in peer-reviewed publications and FDA summary reports. Identifying differences among these reports highlight the poor quality of adverse event reporting in the peer-reviewed literature. Nine peer-reviewed studies and five FDA summary reports documented excellent safety for both cervical fusion and disk arthroplasty. No differences in rates of adverse events were found to exist between the two treatments. The methods of recording and the actual reporting of adverse events were poor in peer-reviewed manuscripts, whereas they were comprehensive but difficult to clinically apply in the FDA summaries. Recommendations to improve documentation and reporting of adverse events are presented.

Developing a toolkit for comparing safety in spine surgery.

Safety information in spine surgery is important for informed patient choice and performance-based payment incentives, but measurement methods for surgical safety assessment are not standardized. Published reports of complication rates for common spinal procedures show wide variation. Factors influencing variation may include differences in safety ascertainment methods and procedure types. In a prospective cohort study, adverse events were observed in all patients undergoing spine surgery at two hospitals during a 2-year period. Multiple processes for adverse occurrence surveillance were implemented, and the associations between surveillance methods, surgery invasiveness, and observed frequencies of adverse events were examined. The study enrolled 1,723 patients. Adverse events were noted in 48.3% of the patients. Reviewers classified 25% as minor events and 23% as major events. Of the major events, the daily rounding team reported 38.4% of the events using a voluntary reporting system, surgeons reported 13.4%, and 9.1% were identified during clinical conferences. A review of medical records identified 86.7% of the major adverse events. The adverse events occurred during the inpatient hospitalization for 78.1% of the events, within 30 days for an additional 12.5%, and within the first year for the remaining 9.4%. A unit increase in the invasiveness index was associated with an 8.2% increased risk of a major adverse event. A Current Procedural Terminology-based algorithm for quantifying invasiveness correlated well with medical records-based assessment. Increased procedure invasiveness is associated with an increased risk of adverse events. The observed frequency of adverse events is influenced by the ascertainment modality. Voluntary reports by surgeons and other team members missed more than 50% of the events identified through a medical records review. Increased surgery invasiveness, measured from medical records or billing codes, is quantitatively associated with an increased risk of adverse events.

Patient-specific Cervical Deformity Corrections With Consideration of Associated Risk: Establishment of Risk Benefit Thresholds for Invasiveness Based on Deformity and Frailty Severity.

STUDY DESIGN/SETTING: This was a retrospective cohort study. BACKGROUND: Little is known of the intersection between surgical invasiveness, cervical deformity (CD) severity, and frailty. OBJECTIVE: The aim of this study was to investigate the outcomes of CD surgery by invasiveness, frailty status, and baseline magnitude of deformity. METHODS: This study included CD patients with 1-year follow-up. Patients stratified in high deformity if severe in the following criteria: T1 slope minus cervical lordosis, McGregor's slope, C2-C7, C2-T3, and C2 slope. Frailty scores categorized patients into not frail and frail. Patients are categorized by frailty and deformity (not frail/low deformity; not frail/high deformity; frail/low deformity; frail/high deformity). Logistic regression assessed increasing invasiveness and outcomes [distal junctional failure (DJF), reoperation]. Within frailty/deformity groups, decision tree analysis assessed thresholds for an invasiveness cutoff above which experiencing a reoperation, DJF or not achieving Good Clinical Outcome was more likely. RESULTS: A total of 115 patients were included. Frailty/deformity groups: 27% not frail/low deformity, 27% not frail/high deformity, 23.5% frail/low deformity, and 22.5% frail/high deformity. Logistic regression analysis found increasing invasiveness and occurrence of DJF [odds ratio (OR): 1.03, 95% CI: 1.01-1.05, P =0.002], and invasiveness increased with deformity severity ( P <0.05). Not frail/low deformity patients more often met Optimal Outcome with an invasiveness index <63 (OR: 27.2, 95% CI: 2.7-272.8, P =0.005). An invasiveness index <54 for the frail/low deformity group led to a higher likelihood of meeting the Optimal Outcome (OR: 9.6, 95% CI: 1.5-62.2, P =0.018). For the frail/high deformity group, patients with a score <63 had a higher likelihood of achieving Optimal Outcome (OR: 4.8, 95% CI: 1.1-25.8, P =0.033). There was no significant cutoff of invasiveness for the not frail/high deformity group. CONCLUSIONS: Our study correlated increased invasiveness in CD surgery to the risk of DJF, reoperation, and poor clinical success. The thresholds derived for deformity severity and frailty may enable surgeons to individualize the invasiveness of their procedures during surgical planning to account for the heightened risk of adverse events and minimize unfavorable outcomes.

Are insufficient corrections a major factor in distal junctional kyphosis? A simulated analysis of cervical deformity correction using in-construct measurements.

OBJECTIVE: The present study utilized recently developed in-construct measurements in simulations of cervical deformity surgery in order to assess undercorrection and predict distal junctional kyphosis (DJK). METHODS: A retrospective review of a database of operative cervical deformity patients was analyzed for severe DJK and mild DJK. C2-lower instrumented vertebra (LIV) sagittal angle (SA) was measured postoperatively, and the correction was simulated in the preoperative radiograph in order to match the C2-LIV by using the planning software. Linear regression analysis that used C2 pelvic angle (CPA) and pelvic tilt (PT) determined the simulated PT that matched the virtual CPA. Linear regression analysis was used to determine the C2-T1 SA, C2-T4 SA, and C2-T10 SA that corresponded to DJK of 20° and cervical sagittal vertical axis (cSVA) of 40 mm. RESULTS: Sixty-nine cervical deformity patients were included. Severe and mild DJK occurred in 11 (16%) and 22 (32%) patients, respectively; 3 (4%) required DJK revision. Simulated corrections demonstrated that severe and mild DJK patients had worse alignment compared to non-DJK patients in terms of cSVA (42.5 mm vs 33.0 mm vs 23.4 mm, p < 0.001) and C2-LIV SVA (68.9 mm vs 57.3 mm vs 36.8 mm, p < 0.001). Linear regression revealed the relationships between in-construct measures (C2-T1 SA, C2-T4 SA, and C2-T10 SA), cSVA, and change in DJK (all R > 0.57, p < 0.001). A cSVA of 40 mm corresponded to C2-T4 SA of 10.4° and C2-T10 SA of 28.0°. A DJK angle change of 10° corresponded to C2-T4 SA of 5.8° and C2-T10 SA of 20.1°. CONCLUSIONS: Simulated cervical deformity corrections demonstrated that severe DJK patients have insufficient corrections compared to patients without DJK. In-construct measures assess sagittal alignment within the fusion separate from DJK and subjacent compensation. They can be useful as intraoperative tools to gauge the adequacy of cervical deformity correction.

Efficacy of Varying Surgical Approaches on Achieving Optimal Alignment in Adult Spinal Deformity Surgery.

BACKGROUND: The Roussouly, SRS-Schwab, and Global Alignment and Proportion (GAP) classifications define alignment by spinal shape and deformity severity. The efficacy of different surgical approaches and techniques to successfully achieve these goals is not well understood. PURPOSE: Identify the impact of surgical approach and/or technique on meeting complex realignment goals in adult spinal deformity (ASD) corrective surgery. STUDY DESIGN/SETTING: Retrospective study. MATERIALS AND METHODS: Included patients with ASD fused to pelvis with 2-year data. Patients were categorized by: (1) Roussouly: matching current and theoretical spinal shapes, (2) improving in SRS-Schwab modifiers (0, +, ++), and (3) improving GAP proportionality by 2 years. Analysis of covariance and multivariable logistic regression analyses controlling for age, levels fused, baseline deformity, and 3-column osteotomy usage compared the effect of different surgical approaches, interbody, and osteotomy use on meeting realignment goals. RESULTS: A total of 693 patients with ASD were included. By surgical approach, 65.7% were posterior-only and 34.3% underwent anterior-posterior approach with 76% receiving an osteotomy (21.8% 3-column osteotomy). By 2 years, 34% matched Roussouly, 58% improved in GAP, 45% in SRS-Schwab pelvic tilt (PT), 62% sagittal vertical axis, and 70% pelvic incidence-lumbar lordosis. Combined approaches were most effective for improvement in PT [odds ratio (OR): 1.7 (1.1-2.5)] and GAP [OR: 2.2 (1.5-3.2)]. Specifically, anterior lumbar interbody fusion (ALIF) below L3 demonstrated higher rates of improvement versus TLIFs in Roussouly [OR: 1.7 (1.1-2.5)] and GAP [OR: 1.9 (1.3-2.7)]. Patients undergoing pedicle subtraction osteotomy at L3 or L4 were more likely to improve in PT [OR: 2.0 (1.0-5.2)] and pelvic incidence-lumbar lordosis [OR: 3.8 (1.4-9.8)]. Clinically, patients undergoing the combined approach demonstrated higher rates of meeting SCB in Oswestry Disability Index by 2 years while minimizing rates of proximal junctional failure, most often with an ALIF at L5-S1 [Oswestry Disability Index-SCB: OR: 1.4 (1.1-2.0); proximal junctional failure: OR: 0.4 (0.2-0.8)]. CONCLUSIONS: Among patients undergoing ASD realignment, optimal lumbar shape and proportion can be achieved more often with a combined approach. Although TLIFs, incorporating a 3-column osteotomy, at L3 and L4 can restore lordosis and normalize pelvic compensation, ALIFs at L5-S1 were most likely to achieve complex realignment goals with an added clinical benefit and mitigation of junctional failure.