Depression State Correlates with Functional Recovery Following Elective Lumbar Spine Fusion.

STUDY DESIGN: Retrospective review of single-institution cohort. OBJECTIVE: To determine how depression state impacts postoperative Patient-Reported Outcomes Measurement Information System (PROMIS) scores and achievement of minimum clinically important difference (MCID) following lumbar fusion. Depression has been shown to negatively impact outcomes following numerous orthopedic surgeries. Situational and major clinical depression can differentially affect postoperative outcomes. METHODS: Adult patients undergoing elective 1-3 level lumbar fusion were reviewed. Patients with a formal diagnosis of major depression were classified as "clinically depressed" whereas patients with at least "mild" PROMIS Depression scores in the absence of formal depression diagnosis were deemed "situationally depressed." ANOVA testing was used to assess differences within and between groups. Multivariate regression was used to identify features associated with the achievement of MCID. RESULTS: 200 patients were included. The average age was 65.9 ± 12.2 years. 75 patients (37.5%) were non-depressed, 66 patients (33.0%) were clinically depressed, and 59 patients (29.5%) were situationally depressed. Situationally depressed patients had worse preoperative PF and PI scores and were more likely to have severe symptoms (P=0.001, P=0.001). All groups improved significantly from preoperative baseline scores. All groups met MCID PF at different rates, with highest proportion of situationally depressed reaching this metric (P = 0.03). Rates of achieving MCID PI were not significantly different between groups (P=0.47). Situational depression was predictive of achieving MCID PF (P=0.002) but not MCID PI. CONCLUSIONS: Our study investigated the relationship between depression and postoperative PROMIS scores and identified situationally depressed patients as having the worst preoperative impairment. Despite this, the situationally depressed cohort had the highest likelihood of achieving MCID PF, suggestive of a bidirectional relationship between lumbar degenerative disease and subclinical, situational depression. These findings may help guide preoperative counseling on expectations, and patient selection.

Impact of congestive heart failure on patients undergoing lumbar spine fusion for adult spine deformity.

Background: With the increasing amount of elective spine fusion patients presenting with cardiac disease and congestive heart failure, it is becoming difficult to assess when it is safe to proceed with surgery. Assessing the severity of heart failure (HF) through ejection fraction may provide insight into patients' short- and long-term risks. Purpose: The purpose of this study was to assess the severity of HF on perioperative outcomes of spine fusion surgery patients. Study Design/Setting: This was a retrospective cohort study of the PearlDiver database. Patient Sample: We enrolled 670,526 patients undergoing spine fusion surgery. Outcome Measures: Thirty-day and 90-day complication rates, discharge destination, length of stay (LOS), physician reimbursement, and hospital costs. Methods: Patients undergoing elective spine fusion surgery were isolated and stratified by preoperative HF with preserved ejection fraction (P-EF) or reduced ejection fraction (R-EF) (International Classification of Diseases-9: 428.32 [chronic diastolic HF] and 428.22 [chronic systolic HF]). Means comparison tests (Chi-squared and independent samples t-tests, as appropriate) compared differences in demographics, diagnoses, comorbidities, procedural characteristics, LOS, 30-day and 90-day complication outcomes, and total hospital charges between those diagnosed with P-EF and those not R-EF. Binary logistic regression assessed the odds of complication associated with HF, controlling for levels fused (odds ratio [OR] [95% confidence interval]). Statistical significance was set at P < 0.05. Results: Totally 670,526 elective spine fusion patients were included. Four thousand and seventy-seven were diagnosed with P-EF and 2758 R-EF. Overall, P-EF patients presented with higher rates of morbid obesity, chronic kidney disease, chronic obstructive pulmonary disease, diabetes mellitus, and hypertension (all P < 0.001). In relation to No-HF, P-EF patients had higher rates of 30-day major complications including pulmonary embolism, pneumonia, cerebrovascular accident (CVA), myocardial infarctions (MI), sepsis, and death (all P < 0.001). Furthermore, P-EF was associated significantly with increased odds of pneumonia (OR: 2.07 [1.64-2.56], P < 0.001) and sepsis (OR: 2.09 [1.62-2.66], P < 0.001). Relative to No-HF, R-EF was associated with significantly higher odds of MI (OR: 3.66 [2.34-5.47]), CVA (OR: 2.70 [1.67-4.15]), and pneumonia (OR: 1.85 [1.40-2.40]) (all P < 0.001) postoperative within 30 days. Adjusting for prior history of MI, CAD, and the presence of a pacemaker R-EF was a significant predictor of an MI 30 days postoperatively (OR: 2.2 [1.14-4.32], P = 0.021). Further adjusting for history of CABG or stent placement, R-EF was associated with higher odds of CVA (OR: 2.11 [1.09-4.19], P = 0.028) and MI (OR: 2.27 [1.20-4.43], P = 0.013). Conclusions: When evaluating the severity of HF before spine surgery, R-EF was associated with a higher risk of major complications, especially the occurrence of a myocardial infarction 30 days postoperatively. During preoperative risk assessment, congestive HF should be considered thoroughly when thinking of postoperative outcomes with emphasis on R-EF.

Adjunctive Use of Bone Growth Stimulation Increases Cervical Spine Fusion Rates in Patients at Risk for Pseudarthrosis.

STUDY DESIGN: A prospective multicenter clinical trial (NCT03177473) was conducted with a retrospective cohort used as a control arm. OBJECTIVE: The purpose of this study was to evaluate cervical spine fusion rates in subjects with risk factors for pseudarthrosis who received pulsed electromagnetic field (PEMF) treatment. SUMMARY OF BACKGROUND DATA: Certain risk factors predispose patients to pseudarthrosis, which is associated with prolonged pain, reduced function, and decreased quality of life. METHODS: Subjects in the PEMF group were treated with PEMF for 6 months postoperatively. The primary outcome measure was fusion status at the 12-month follow-up period. Fusion status was determined using anterior/posterior, lateral, and flexion/extension radiographs and computed tomography (without contrast). RESULTS: A total of 213 patients were evaluated (PEMF, n=160; Control, n=53). At baseline, the PEMF group had a higher percentage of subjects who used nicotine (P=0.01), had osteoporosis (P<0.05), multi-level disease (P<0.0001), and were >65 years of age (P=0.01). The PEMF group showed over two-fold higher percentage of subjects that had ≥3 risk factors (n=92/160, 57.5%) compared with the control group (n=14/53, 26.4%). At the 12-month follow-up, the PEMF group demonstrated significantly higher fusion rates compared with the control (90.0% vs. 60.4%, P<0.05). A statistically significant improvement in fusion rate was observed in PEMF subjects with multi-level surgery (P<0.0001) and high BMI (>30 kg/m2; P=0.0021) when compared with the control group. No significant safety concerns were observed. CONCLUSIONS: Adjunctive use of PEMF stimulation provides significant improvements in cervical spine fusion rates in subjects having risk factors for pseudarthrosis. When compared with control subjects that did not use PEMF stimulation, treated subjects showed improved fusion outcomes despite being older, having more risk factors for pseudarthrosis, and undergoing more complex surgeries.

Development of a Novel Risk Stratification Score to Predict 30-Day Mortality in Cervical Trauma Patients: CLAAD Score.

STUDY DESIGN: Case control. OBJECTIVE: Traumatic cervical spine injuries are associated with a substantial risk of mortality. The aim of this study is to develop a novel mortality prediction model for patients with cervical trauma who require operative treatment. SUMMARY OF BACKGROUND DATA: Patients with cervical spine trauma have a high risk of postoperative complications and mortality. There are few reliable systems that can accurately predict mortality after surgery for cervical spine trauma, and those that do exist are typically not specific to cervical trauma. MATERIALS AND METHODS: The National Surgical Quality Improvement Program (NSQIP) database was used to identify patients undergoing surgery for cervical spine trauma. Univariate analyses were performed to identify variables associated with mortality. Variables that were found to be significant in the univariate models were compiled into a multivariable model. The final model was compared with the American Society of Anesthesiologists (ASA), a modified Charlson comorbidity index (mCCI), and the 5-factor modified frailty index (mFI-5) in respect to predicting 30-day mortality after cervical trauma. The score was then externally validated using the Nationwide Inpatient Sample (NIS) database. RESULTS: Fifty-five (6.7%) of 822 patients did not survive 30 days after surgery. The final multivariable logistic regression model consisted of the following variables: circumferential fusion "C." long "L" fusion (more than 4 levels), anemia "A," age over 60 "A," and dialysis "D." The risk of mortality increased with increasing CLAAD score, with mortality rates of 0.9%, 3.1%, 7.4%, 22.7%, and 14.3% for scores of 0, 1, 2, 3, and 4, respectively. The CLAAD model had an AUC of 0.73 for predicting mortality after cervical trauma. CONCLUSIONS: The CLAAD score is a simple and effective system that can help identify patients at risk of increased mortality within 30 days of cervical trauma. LEVEL OF EVIDENCE: Level III.

Increased Time to Fixation After Traumatic Spinal Cord Injury Influenced by Race and Insurance Status.

STUDY DESIGN: Retrospective Cohort Study. OBJECTIVES: Although the optimal timing of surgical intervention for traumatic spinal cord injury (TSCI) is controversial, early intervention has been recognized as being beneficial in several studies. The objective of this study was to evaluate the socioeconomic factors that may delay time to surgical fixation in the management of TSCI. METHODS: The present study utilized the Trauma Quality Improvement Program (TQIP) dataset to identify patients aged greater than 18 undergoing spinal fusion for TSCI from 2007-2016. Patients were divided into subgroups based on race and insurance types. Multivariable linear regression was used to compare time to procedure based on race and payer type while adjusting for demographic and injury-specific factors. Significance was set at P < .05. RESULTS: Using multivariable analysis, Hispanic and Black patients were associated with significantly increased time to fixation of 12.1 h (95% CI 5.5-18.7, P < .001), and 20.1 h (95% CI 12.1-28.1, P < .001), respectively compared to White patients. Other cohorts based on racial status did not have significantly different times to fixation (P > .05). Medicaid was associated with an increased time to fixation compared to private insurance (11.6 h, 95% CI 3.9-19.2, P = .003). CONCLUSIONS: Black and Hispanic race and Medicaid were associated with statistically significant increases in time to fixation following TSCI, potentially compromising quality of patient care and resulting in poorer outcomes. More research is needed to elucidate this relationship and ensure equitable care is being delivered.

An Integrated 3-Dimentional Navigation System Increases the Accuracy, Efficiency, and Safety of Percutaneous Thoracolumbar Pedicle Screw Placement in Minimally Invasive Approaches: A Randomized Cadaveric Study.

STUDY DESIGN: Cadaveric study. OBJECTIVES: The purpose of this study was to compare a novel, integrated 3D navigational system (NAV) and conventional fluoroscopy in the accuracy, efficiency, and radiation exposure of thoracolumbar percutaneous pedicle screw (PPS) placement. METHODS: Twelve skeletally mature cadaveric specimens were obtained for twelve individual surgeons. Each participant placed bilateral PS at 11 segments, from T8 to S1. Prior to insertion, surgeons were randomized to the sequence of techniques and the side (left or right). Following placement, a CT scan of the spine was obtained for each cadaver, and an independent reviewer assessed the accuracy of screw placement using the Gertzbein grading system. Outcome metrics of interest included a comparison of breach incidence/severity, screw placement time, total procedure time, and radiation exposure between the techniques. Bivariate statistics were employed to compare outcomes at each level. RESULTS: A total of 262 screws (131 using each technique) were placed. The incidence of cortical breaches was significantly lower with NAV compared to FG (9% vs 18%; P = .048). Of breaches with NAV, 25% were graded as moderate or severe compared to 39% in the FG subgroup (P = .034). Median time for screw placement was significantly lower with NAV (2.7 vs 4.1 min/screw; P = .012), exclusive of registration time. Cumulative radiation exposure to the surgeon was significantly lower for NAV-guided placement (9.4 vs 134 µGy, P = .02). CONCLUSIONS: The use of NAV significantly decreased the incidence of cortical breaches, the severity of screw breeches, screw placement time, and radiation exposure to the surgeon when compared to traditional FG.

Risk of spinal surgery among individuals who have been re-vascularized for coronary artery disease.

HYPOTHESIS: Revascularization is a more effective intervention to reduce future postop complications. METHODS: Patients undergoing elective spine fusion surgery were isolated in the PearlDiver database. Patients were stratified by having previous history of vascular stenting (Stent), coronary artery bypass graft (CABG), and no previous heart procedure (No-HP). Means comparison tests (chi-squared and independent samples t-tests, as appropriate) compared differences in demographics, diagnoses, and comorbidities. Binary logistic regression assessed the odds of 30-day and 90-day postoperative (postop) complications associated with each heart procedure (Odds Ratio [95 % confidence interval]). Statistical significance was set p < 0.05. RESULTS: 731,173 elective spine fusion patients included. Overall, 8,401 pts underwent a CABG, 24,037 pts Stent, and 698,735 had No-HP prior to spine fusion surgery. Compared to Stent and No-HP patients, CABG patients had higher rates of morbid obesity, chronic kidney disease, and diabetes (p < 0.001 for all). Meanwhile, stent patients had higher rates of PVD, hypertension, and hyperlipidemia (all p < 0.001). 30-days post-op, CABG patients had significantly higher complication rates including pneumonia, CVA, MI, sepsis, and death compared to No-HP (all p < 0.001). Stent patients vs. No-HF had higher 30-day post-op complication rates including pneumonia, CVA, MI, sepsis, and death. Furthermore, adjusting for age, comorbidities, and sex Stent was significantly predictive of a MI 30-days post-op (OR: 1.90 [1.53-2.34], P < 0.001). Additionally, controlling for levels fused, stent patients compared to CABG patients had 1.99x greater odds of a MI within 30-days (OR: 1.99 [1.26-3.31], p = 0.005) and 2.02x odds within 90-days postop (OR: 2.2 [1.53-2.71, p < 0.001). CONCLUSION: With regards to spine surgery, coronary artery bypass graft remains the gold standard for risk reduction. Stenting does not appear to minimize risk of experiencing a post-procedure cardiac event as dramatically as CABG.

Twenty-four-month interim results from a prospective, single-arm clinical trial evaluating the performance and safety of cellular bone allograft in patients undergoing lumbar spinal fusion.

BACKGROUND: Autologous bone grafts are the gold standard for spinal fusion; however, harvesting autologous bone can result in donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allografts (CBAs) are a viable alternative that avoids the need for bone harvesting and may increase fusion success alone or when used as an adjunct material. The present study examined the efficacy and safety of CBA when used as an adjunct graft material to lumbar arthrodesis. METHODS: A prospective, single-arm, multicenter clinical trial (NCT02969616) was conducted in adult subjects (> 18 years of age) undergoing lumbar spinal fusion with CBA graft (CBA used as primary (≥ 50% by volume), with augmentation up to 50%). Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcomes were assessed with the Oswestry Disability Index (ODI), and Visual Analog Scales (VAS) score for back and leg pain. Adverse events were assessed through the 24-month follow-up period. The presented data represents an analysis of available subjects (n = 86) who completed 24 months of postoperative follow-up at the time the data was locked for analysis. RESULTS: Postoperative 24-month fusion success was achieved in 95.3% of subjects (n = 82/86) undergoing lumbar spinal surgery. Clinical outcomes showed statistically significant improvements in ODI (46.3% improvement), VAS-Back pain (75.5% improvement), and VAS-Leg pain (85.5% improvement) (p < 0.01) scores at Month 24. No subject characteristics or surgical factors were associated with pseudoarthrosis. A favorable safety profile with a limited number of adverse events was observed. CONCLUSIONS: The use of CBA as an adjunct graft material showed high rates of successful lumbar arthrodesis and significant improvements in pain and disability scores. CBA provides an alternative to autograft with comparable fusion success rates and clinical benefits. TRIAL REGISTRATION: NCT02969616.

Pulsed Electromagnetic Field Stimulation in Lumbar Spine Fusion for Patients With Risk Factors for Pseudarthrosis.

BACKGROUND: Lumbar spinal fusion surgeries are increasing steadily due to an aging and ever-growing population. Patients undergoing lumbar spinal fusion surgery may present with risk factors that contribute to complications, pseudarthrosis, prolonged pain, and reduced quality of life. Pulsed electromagnetic field (PEMF) stimulation represents an adjunct noninvasive treatment intervention that has been shown to improve successful fusion and patient outcomes following spinal surgery. METHODS: A prospective, multicenter study investigated PEMF as an adjunct therapy to lumbar spinal fusion procedures in patients at risk for pseudarthrosis. Patients with at least 1 of the following risk factors were enrolled: prior failed fusion, multilevel fusion, nicotine use, osteoporosis, or diabetes. Fusion status was determined by radiographic imaging, and patient-reported outcomes were also evaluated. RESULTS: A total of 142 patients were included in the analysis. Fusion status was assessed at 12 months follow-up where 88.0% (n = 125/142) of patients demonstrated successful fusion. Fusion success for patients with 1, 2+, or 3+ risk factors was 88.5%, 87.5%, and 82.3%, respectively. Significant improvements in patient-reported outcomes using the Short Form 36, EuroQol 5 Dimension (EQ-5D) survey, Oswestry Disability Index, and visual analog scale for back and leg pain were also observed compared with baseline scores (P < 0.001). A favorable safety profile was observed. PEMF treatment showed a positive benefit-risk profile throughout the 6-month required use period. CONCLUSIONS: The addition of PEMF as an adjunct treatment in patients undergoing lumbar spinal surgery provided a high rate of successful fusion with significant improvements in pain, function, and quality of life, despite having risk factors for pseudarthrosis. CLINICAL RELEVANCE: PEMF represents a useful tool for adjunct treatment in patients who have undergone lumbar spinal surgery. Treatment with PEMF may result in improved fusion and patient-reported outcomes, regardless of risk factors. TRIAL REGISTRATION: NCT03176303.

Prevention of Proximal Junctional Kyphosis Using Proximal Fixation Techniques.

BACKGROUND: Adult spinal deformity (ASD) is a disorder characterized by abnormal curvature of the spine resulting from progressive degeneration of spinal elements. Although operative intervention for ASD is commonplace, it is associated with several complications, including proximal junctional kyphosis (PJK) and proximal junctional failure (PJF). The objective of this review is to outline the role of proximal fixation in preventing PJK and PJF. METHODS: We conducted a literature search using the Embase, Scopus, Web of Science, CINHAL, Cochrane Library, and PubMed MEDLINE databases. We considered only studies focusing on adult patients and selected clinical studies investigating proximal fixation techniques. RESULTS: There was mixed evidence of the efficacy of hooks and other instrumentation methods in preventing PJK, although most studies supported the use of hooks. Selection of lower thoracic vertebrae was associated with higher rates of PJK and PJF in several studies, although the relationship was inconsistent, and many studies reported no significant difference in rates of PJK or PJF between different upper instrumented vertebra (UIV) levels. Other techniques that are not related to specific instrumentation or vertebral selection, such as adjusting UIV screw trajectory, were also referenced. However, the evidence supporting these techniques was limited. DISCUSSION: Despite the presence of numerous studies in the literature discussing proximal fixation strategies to reduce the incidence of PJK/PJF, the lack of prospective studies and high variability in study methods make direct comparison challenging. We could not draw strong conclusions regarding the superiority of any one technique, despite promising clinical results with a strong biomechanical basis in several studies. CLINICAL RELEVANCE: This systematic literature review showed that a variety of proximal fixation techniques have been used to prevent PJK/PJF without clear evidence in favor of any particular technique.

Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized Clinical Trial.

BACKGROUND: Staphylococcus aureus is a global pathogen that is frequently responsible for healthcare-associated infections, including surgical site infections (SSIs). Current infection prevention and control approaches may be limited, with S. aureus antibiotic resistance remaining problematic. Thus, a vaccine to prevent or reduce S. aureus infection is critically needed. We evaluated the efficacy and safety of an investigational 4-antigen S. aureus vaccine (SA4Ag) in adults undergoing elective open posterior spinal fusion procedures with multilevel instrumentation. METHODS: In this multicenter, site-level, randomized, double-blind trial, patients aged 18-85 years received a single dose of SA4Ag or placebo 10-60 days before surgery. SA4Ag efficacy in preventing postoperative S. aureus bloodstream infection and/or deep incisional or organ/space SSIs was the primary end point. Safety evaluations included local reactions, systemic events, and adverse events (AEs). Immunogenicity and colonization were assessed. RESULTS: Study enrollment was halted when a prespecified interim efficacy analysis met predefined futility criteria. SA4Ag showed no efficacy (0.0%) in preventing postoperative S. aureus infection (14 cases in each group through postoperative day 90), despite inducing robust functional immune responses to each antigen compared with placebo. Colonization rates across groups were similar through postoperative day 180. Local reactions and systemic events were mostly mild or moderate in severity, with AEs reported at similar frequencies across groups. CONCLUSIONS: In patients undergoing elective spinal fusion surgical procedures, SA4Ag was safe and well tolerated but, despite eliciting substantial antibody responses that blocked key S. aureus virulence mechanisms, was not efficacious in preventing S. aureus infection. Clinical Trials Registration. NCT02388165.

Facial scars resulting from a transbuccal approach during osteosynthesis of a sagittal split osteotomy: A retrospective study.

The purpose of the current study was to assess the quality of facial linear scars. The Stony Brook Scar Evaluation Scale (SBSES) was developed and validated as a tool to assess postoperative scars. Postoperative facial scars were rated using high-quality macrophotographs and SBSES by three independent raters at baseline and three months thereafter. Percentage agreement (PA) and intraclass correlation coefficient (ICC) were used to measure interrater and intrarater reliability. Scar outcomes ranging from 0 (worst) to 5 (best) were evaluated against age and gender. One-hundred-sixty-six patients with a mean age of 30.6 years (range of 17-59) were included in this study. Forty-four were male (26.5%), and 122 were female (73.5%). Mean total SBSES scores were 4.63 (range of 4.56-4.76) at baseline and 4.60 (range of 4.54-4.72) at three months. As patient's age increased, mean total SBSES scores also decreased significantly (r = -0.216, p = 0.005). Gender did not significantly affect raters' perception of scar cosmesis (p = 0.847). Interrater reliability showed an ICC of 0.675 (95% CI, 0.609-0.731) and a PA of 65.4% at baseline, and an ICC of 0.655 (95% CI, 0.585-0.715) and a PA of 64.2% at three months. Intrarater reliability found ICCs ranging from 0.988 to 0.990 and a PA of 96.8% with 3 separate raters. Within the limitations of the study it seems that the transbuccal approach during osteosynthesis of a sagittal split osteotomy seems still to be acceptable when the patient gives his or her informed consent and advanced instruments like an angled screwdriver are not available.

Failure to Normalize Risk Profile of Spine Fusion Patients With Coronary Artery Disease Previously Treated With Percutaneous Stent Revascularization.

BACKGROUND: The impact of an initially less invasive cardiac intervention on outcomes of future surgical spine procedures has been understudied; therefore, we sought to investigate the effect of coronary stents on postoperative outcomes in an elective spine fusion cohort. METHODS: Elective spine fusion patients were isolated with International Classification of Diseases-Ninth Edition and current procedural terminology procedure codes in the PearlDiver database. Patients were stratified by number of coronary stents: (1) 1 to 2 stents (ST12); (2) 3 to 4 stents (ST34); (3) no stents. Mean comparison tests compared differences in demographics, diagnoses, comorbidities, and 30-day and 90-day complication outcomes. Logistic regression assessed the odds of complications associated with coronary stents, controlling for levels fused, age, sex, and comorbidities (odds ratio [95% confidence interval]). Statistical significance was P < 0.05. RESULTS: A total of 726,061 elective spine fusion patients were isolated. Of those patients, 707,396 patients had no stent, 17,087 ST12, and 1578 ST34. At baseline (BL), ST12 patients had higher rates of morbid obesity, chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, and diabetes mellitus compared with no stent and ST34 patients (all P < 0.001). Relative to no stent patients, ST12 patients had a longer length of stay and, at 30 days, significantly higher complication rates, including pneumonia, myocardial infarction (MI), sepsis, acute kidney injury, urinary tract infection (UTI), wound complications, transfusions, and 30-day readmissions (P < 0.05). Controlling for age, sex, comorbidities, and levels fused, ST12 was a significant predictor of MI within 30 days (OR 2.15 [95% CI 1.7-2.7], P < 0.001) and 90 days postoperatively (OR 1.87 [95% CI 1.6-2.2], P < 0.001). ST34 patients compared with no stent patients at 30 days presented with increased rates of complication, including pneumonia, MI, sepsis, UTI, wound complications, and 30-day readmissions. Regression analysis showed no significant differences in complications between ST12 vs ST34 at 30 days, but at 90 days, ST34 was associated with significantly increased rate and odds of death (1.1% vs 0.3%, P = 0.021; OR 1.94 [95% CI 1.13-3.13], P = 0.01). CONCLUSION: Cardiac stents failed to normalize risk profile of patients with coronary artery disease. Postoperatively at 90 days, elective spine fusion patients with 3 or more stents were significantly at risk of mortality compared with patients with fewer or no stents.

Predictors of Complication Severity Following Adult Spinal Deformity Surgery: Smoking Rate, Diabetes, and Osteotomy Increase Risk of Severe Adverse Events.

BACKGROUND: Given the physical and economic burden of complications in spine surgery, reducing the prevalence of perioperative adverse events is a primary concern of both patients and health care professionals. This study aims to identify specific perioperative factors predictive of developing varying grades of postoperative complications in adult spinal deformity (ASD) patients, as assessed by the Clavien-Dindo complication classification (Cc) system. METHODS: Surgical ASD patients ≥18 years were identified in the American College of Surgeons' National Surgical Quality Improvement Program from 2005 to 2015. Postoperative complications were stratified by Cc grade severity: minor (I, II, and III) and severe (IV and V). Stepwise regression models generated dataset-specific predictive models for Cc groups. Model internal validation was achieved by bootstrapping and calculating the area under the curve (AUC) of the model. Significance was set at P < 0.05. RESULTS: Included were 3936 patients (59 ± 16 years, 63% women, 29 ± 7 kg/m2) undergoing surgery for ASD (4.4 ± 4.7 levels, 71% posterior approach, 11% anterior, and 18% combined). Overall, 1% of cases were revisions, 39% of procedures involved decompression, 27% osteotomy, and 15% iliac fixation. Additionally, 66% of patients experienced at least 1 complication, 0% of which were Cc grade I, 51% II, 5% III, 43% IV, and 1% V. The final model predicting severe Cc (IV-V) complications yielded an AUC of 75.6% and included male sex, diabetes, increased operative time, central nervous system tumor, osteotomy, cigarette pack-years, anterior decompression, and anterior lumbar interbody fusion. Final models predicting specific Cc grades were created. CONCLUSIONS: Specific predictors of adverse events following ASD-corrective surgery varied for complications of different severities. Multivariate modeling showed smoking rate, osteotomy, diabetes, anterior lumbar interbody fusion, and higher operative time, among other factors, as predictive of severe complications, as classified by the Clavien-Dindo Cc system. These factors can help in the identification of high-risk patients and, consequently, improve preoperative patient counseling. CLINICAL RELEVANCE: The findings of this study provide a foundation for identifying ASD patients at high risk of postoperative complications .

Orthopedic Surgery Fellowship Directors: Trends in Demographics, Education, Employment, and Institutional Familiarity.

Background: Fellowship directors are assumed to be distinguished in orthopedics, but the traits and training that have enabled them to achieve their leadership positions have not been assessed. Purpose: We sought to identify common demographics, research output, and educational trends of fellowship directors in orthopedics, with an emphasis on racial, ethnic, and gender diversity. Methods: We conducted a literature review to identify published studies on fellowship directors in orthopedic surgery and found 4 cross-sectional studies of fellowship directors in spine, arthroplasty, pediatrics, and sports medicine subspecialties. Another 4 accredited orthopedic subspecialties and their fellowship directors were identified using the American College of Graduate Medical Education Public Accreditation Data System for 2020-2021 and national fellowship directories. Data endpoints included race/ethnicity, age, sex, residency and fellowship training institutions, year of fellowship completion, year of hire at current institution, year of fellowship directors appointment, and h-index. The demographics and educational backgrounds for listed fellowship directors were collected from curricula vitae (CVs). Results: Of the 537 fellowship directors identified among 8 orthopedic subspecialties, the average age was 52.9 ± 2.2 years, 5.6% (N = 30) were women, 79.1% (N = 406) were white, 12.5% (N = 64) were Asian American, 3.7% (N = 19) were African American, 2.9% (N = 15) were Middle Eastern, and 1.7% (N = 9) were Hispanic/Latino. Oncology 20% (N = 4) had the highest percentage of female fellowship directors; 37.6% (N = 202) of fellowship directors were at the same institution they trained at for residency or fellowship. Their average h-index was 18.6 ± 3.7. Conclusion: This study of fellowship directors in orthopedics found that they have a high research output and a high level of institutional familiarity. We identified a need for greater diversity in these leadership positions in both gender and race/ethnicity.

Improvement of postural stability and gait velocity after cervical decompression surgery in patients with cervical spondylotic myelopathy.

OBJECTIVE: Cervical spondylotic myelopathy (CSM) is a progressive degenerative condition that can lead to significant neurological deficits, including gait instability. Biomechanical alterations of gait and its various components are poorly understood. The goal of the current study was to determine how spatiotemporal gait parameters, as well as postural and dynamic stability, change after surgery in CSM patients. METHODS: A total of 47 subjects were included, with 23 test subjects and 24 controls. Baseline measurements were made for both cohorts. In the CSM cohort, repeat measurements were made at 3 and 6 months postoperatively. To record spatiotemporal and dynamic stability parameters, subjects performed walking trials over force plates on a 15-m runway. To assess postural stability, standing balance trials were conducted on a floor-mounted force plate. Three-dimensional motion analysis cameras and gait modeling software were used to quantify and visually represent results. Statistical analysis was completed using repeated-measures ANOVA and paired t-tests. Significance was set at p < 0.05. RESULTS: CSM patients had significantly increased gait velocity at the 6-month follow-up (mean 0.948 ± 0.248 m/sec/leg length) versus baseline (mean 0.852 ± 0.257 m/sec/leg length) (p = 0.039). The tilted ellipse area was significantly decreased at the 6-month follow-up compared with baseline (mean 979.8 ± 856.7 mm2 vs 598.0 ± 391.1 mm2, p = 0.018). Angular momentum excursion was not significantly different between baseline and the 3- and 6-month follow-ups. CONCLUSIONS: CSM patients displayed significant improvement in gait velocity and postural stability parameters after decompressive surgery. Dynamic stability parameters did not change significantly during the study period.

Presence and Severity of Mental Illness Is Associated With Increased Risk of Postoperative Emergency Visits, Readmission, and Reoperation Following Outpatient ACDF: A National Database Analysis.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: The purpose was to compare rates of postoperative ED visits, readmission, and reoperation between patients with and without preexisting mental illness undergoing outpatient anterior cervical discectomy and fusion (ACDF). METHODS: A retrospective review of the Mariner Database was conducted on patients who underwent ACDF between 2010 and 2017. Exclusion criteria included same day revision surgery and patients with a history of spine infection, trauma, or neoplasm. Patients were grouped into 3 categories: those with existing history of anxiety and/or depression, those with severe mental illness, and those without any history of mental illness. Severe mental illness was defined as a combination of diagnosis including schizophrenia, bipolar disorder, and/or psychotic disorder. Outcome measures were analyzed by comparing groups using multivariate logistic regression. Significance was set at P < 0.05. RESULTS: Patients with anxiety/depression and patients with severe mental illness both had significantly increased risk of ED visits and readmission at 30-day and 90-day intervals. Compared to patients without mental illness, patients with severe mental illness (OR 1.93, P < 0.001) had significantly increased rates of reoperation at 90-days and 1-years postoperatively. Patients with anxiety/depression did not have increased rates of reoperation relative to patients without anxiety/depression at any time interval (P > 0.05). CONCLUSION: Anxiety/depression as well as more severe psychiatric disease such as Schizophrenia and Bipolar disorder were significantly associated with increased healthcare utilization following outpatient ACDF. Patients with preexisting mental illness undergoing outpatient ACDF should be carefully evaluated preoperatively and closely followed postoperatively to reduce risk of adverse events.

Treatment of Hepatitis C Virus Prior to Posterior Lumbar Fusion: No Difference in Medical Outcomes or Reoperation.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: To analyze and confirm the rates of postoperative complications of patients with hepatitis C virus (HCV) undergoing primary posterior lumbar fusion (PLF) and assess whether treatment of HCV before surgery reduces complications. BACKGROUND CONTEXT: HCV causes chronic disease, leading to increased risk of cirrhosis and chronic illness. Currently, there is a lack of research regarding whether the patient's HCV is a modifiable risk factor for postoperative complications after spinal procedures. METHODS: The Mariner database was utilized to find patients from 2010 to 2018 undergoing PLF with active follow-up for a year. Cases involving same-day revision procedures and patients with a history of spine, infection, trauma, human immunodeficiency virus, hepatitis B, or neoplasm were excluded. Patients with a history of HCV diagnosis were identified and further stratified whether they had prior treatment using the national drug codes for antiviral, interferons, or ribavirin. Patients with HCV were matched with those without respect to age, sex, and comorbidity of burden. Outcome measured included 90-day medical complications, infection, readmission, and 1-year reoperation. RESULTS: There were 2,129 patients with HCV and 10,544 patients in the matched control group who underwent primary PLF. Out of the 2,129 patients, 469 (22.0.%) were treated with HCV medications before surgery. Patients with prior history of HCV had a significantly increased risk of wound complications (4.4% vs. 3.2%, odds ratio 1.56, 95% confidence interval 1.24-1.96, P =0.009), and infection (7.7% vs. 5.7%, odds ratio 1.26, 95% confidence interval 1.07-1.53, P =0.009) within 90 days of surgery. Patients treated before surgery did not have a difference in major ( P =0.205) or minor medical complications ( P =0.681) after surgery. CONCLUSIONS: Patients with prior history of HCV are at increased risk for many complications after surgery; however, this risk factor does not seem to be modifiable as the treatment group did not experience any improvement in postoperative outcomes. LEVEL OF EVIDENCE: Level III.

Twelve-Month Results from a Prospective Clinical Study Evaluating the Efficacy and Safety of Cellular Bone Allograft in Subjects Undergoing Lumbar Spinal Fusion.

BACKGROUND: While autologous bone grafts remain the gold standard for spinal fusion procedures, harvesting autologous bone is associated with significant complications, including donor site infection, hematomas, increased operative time, and prolonged pain. Cellular bone allograft (CBA) presents an alternative to autologous bone harvesting, with a favorable efficacy and safety profile. The current study further investigates CBA as an adjunct to lumbar spinal fusion procedures. METHODS: A prospective, multicenter, open-label clinical study was conducted in subjects undergoing lumbar spinal fusion with CBA (NCT02969616). Radiographic fusion status was assessed by an independent review of dynamic radiographs and CT scans. Clinical outcome measures included the Oswestry Disability Index (ODI) and visual analogue scale (VAS) for back and leg pain. Adverse-event reporting was conducted throughout 12 months of follow-up. Available subject data at 12 months were analyzed. RESULTS: A total of 274 subjects were enrolled into the study, with available data from 201 subjects (73.3%) who completed 12 months of postoperative radiographic and clinical evaluation at the time of analysis. Subjects had a mean age of 60.2 ± 11.5 years. A higher number of women (n = 124, 61.7%) than men (n = 77, 38.3%) were enrolled, with a collective mean BMI of 30.6 + 6.5 kg/m2 (range 18.0-51.4). At month 12, successful fusion was achieved in 90.5% of subjects. A significant (p < 0.001) improvement in ODI, VAS-back, and VAS-leg clinical outcomes was also observed compared to baseline scores. One adverse event related to CBA (postoperative radiculopathy) was reported, with surgical exploration demonstrating interbody extrusion of graft material. This subject reported successful fusion at month 12. CONCLUSIONS: CBA represents a viable substitute for harvesting of autograft alone with a high rate of successful fusion and significant improvements in subject-reported outcomes, such as pain and disability. Positive benefit was observed in subjects reporting single and multiple risk factors for pseudoarthrosis.