Impact of surgical risk factors for non-union on lumbar spinal fusion outcomes using cellular bone allograft at 24-months follow-up.

BACKGROUND: The current report investigates fusion rates and patient-reported outcomes following lumbar spinal surgery using cellular bone allograft (CBA) in patients with risk factors for non-union. METHODS: A prospective, open label study was conducted in subjects undergoing lumbar spinal fusion with CBA (NCT02969616) to assess fusion success rates and patient-reported outcomes in subjects with risk factors for non-union. Subjects were categorized into low-risk (≤ 1 risk factors) and high-risk (> 1 risk factors) groups. Radiographic fusion status was evaluated by an independent review of dynamic radiographs and CT scans. Patient-reported outcome measures included quality of life (EQ-5D), Oswestry Disability Index (ODI) and Visual Analog Scales (VAS) for back and leg pain. Adverse event reporting was conducted throughout 24-months of follow-up. RESULTS: A total of 274 subjects were enrolled: 140 subjects (51.1%) were categorized into the high-risk group (> 1 risk factor) and 134 subjects (48.9%) into the low-risk group (≤ 1 risk factors). The overall mean age at screening was 58.8 years (SD 12.5) with a higher distribution of females (63.1%) than males (36.9%). No statistical difference in fusion rates were observed between the low-risk (90.0%) and high-risk (93.9%) groups (p > 0.05). A statistically significant improvement in patient-reported outcomes (EQ-5D, ODI and VAS) was observed at all time points (p < 0.05) in both low and high-risk groups. The low-risk group showed enhanced improvement at multiple timepoints in EQ-5D, ODI, VAS-Back pain and VAS-Leg pain scores compared to the high-risk group (p < 0.05). The number of AEs were similar among risk groups. CONCLUSIONS: This study demonstrates high fusion rates following lumbar spinal surgery using CBA, regardless of associated risk factors. Patient reported outcomes and fusion rates were not adversely affected by risk factor profiles. TRIAL REGISTRATION: NCT02969616 (21/11/2016).

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.

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.

Intravenous ibuprofen versus diclofenac plus orphenadrine in orthognathic surgery: a prospective, randomized, double-blind, controlled clinical study.

OBJECTIVES: The aim of this prospective, randomized, double-blind, controlled clinical study was to evaluate the analgesic effect of ibuprofen versus diclofenac plus orphenadrine on postoperative pain in orthognathic surgery. MATERIAL AND METHODS: Patients who underwent orthognathic surgery were randomized into two groups to receive intravenously either 600 mg of ibuprofen (I-group) or 75 mg diclofenac plus 30 mg orphenadrine (D-group), both of which were given twice daily. Additionally, both groups were given metamizole 500 mg. Rescue pain medication consisted of acetaminophen 1000 mg and piritramide 7.5 mg as needed. To assess the pain intensity, the primary end point was the numeric rating scale (NRS) recorded over the course of the hospital stay three times daily for 3 days. RESULTS: One hundred nine patients were enrolled (age range, 18 to 61 years) between May 2019 and November 2020. Forty-eight bilateral sagittal split osteotomies (BSSO) and 51 bimaxillary osteotomies (BIMAX) were performed. Surgical subgroup analysis found a significant higher mean NRS (2.73 vs.1.23) in the BIMAX D-group vs. I-group (p = 0.015) on the third postoperative day. Additionally, as the patient's body mass index (BMI) increased, the mean NRS (r = 0.517, p = 0.001) also increased. No differences were found between age, gender, length of hospital stay, weight, operating times, number of patients with complete pain relief, acetaminophen or piritramide intake, and NRS values. No adverse events were observed. CONCLUSION: The results of this study demonstrate that ibuprofen administration and lower BMI were associated with less pain for patients who underwent bimaxillary osteotomy on the third postoperative day. Therefore, surgeons may prefer ibuprofen for more effective pain relief after orthognathic surgery. CLINICAL RELEVANCE: Ibuprofen differs from diclofenac plus orphenadrine in class and is a powerful analgetic after orthognathic surgery.

A Retrospective Database Review of the Indications, Complications, and Incidence of Subsequent Spine Surgery in 12,297 Spinal Cord Stimulator Patients.

STUDY DESIGN: Retrospective review. OBJECTIVE: To analyze the indications, incidence of minor and major complications, and rate of subsequent spinal surgery or revision after spinal cord stimulator (SCS) placement for degenerative spine disease. SUMMARY OF BACKGROUND DATA: Despite the application of SCS in various chronic pain conditions, there remains a growing debate on the efficacy and necessity of SCS in degenerative spine disease. METHODS: A nationally representative sample of Medicare patients who had an open (via laminectomy) SCS placement for degenerative spine disease between 2005 and 2014 were studied. Indications, complications, and the rate of subsequent spinal surgery within 90 days, one year, two years, and three years postoperatively were studied using Current Procedural Terminology (CPT) and International Classification of Diseases (ICD) codes. RESULTS: We included 12,297 SCS patients in our study cohort. The most common indications for SCS placement were postlaminectomy syndrome (25.2%) and chronic pain syndrome (20.2%). There was a 4.2 and 17.2% incidence of postoperative back or spine emergency department (ED) visits, and a 0.3 and 3.4% incidence of SCS electrode removal or reimplantation within 90 days and 1 year, respectively. Other reported surgical complications were wound infection (4.3%), hematoma (0.5%), and seroma (0.4%) at one year postoperatively. Within 90 days after SCS implantation, the rate of subsequent spine surgery or revision was 0.9%. This incidence was 7.1, 11.7, and 15.5% at one, two, and three years, respectively. CONCLUSIONS: In our retrospective analysis of Medicare patients, the most common indication for SCS implantation was postlaminectomy syndrome. Common postoperative complications included wound infection, and removal of SCS electrodes at one year postoperatively. About 17% patients had an ED visit for spine-related symptoms within one year of device implantation, and 15.5% underwent subsequent spinal decompression and/or fusion within 3 years after primary SCS placement.

Correction to: Prior bariatric surgery lowers complication rates following spine surgery in obese patients.

The AHRQ (Agency for Healthcare Research and Quality) has requested the correction of the result Tables 1-3 of this study: All stated numbers below 10 shall be modified to read "<10" instead.

Prior bariatric surgery lowers complication rates following spine surgery in obese patients.

BACKGROUND: Bariatric surgery (BS) is an increasingly common treatment for morbid obesity that has the potential to effect bone and mineral metabolism. The effect of prior BS on spine surgery outcomes has not been well established. The aim of this study was to assess differences in complication rates following spinal surgery for patients with and without a history of BS. METHODS: Retrospective analysis of the prospectively collected New York State Inpatient Database (NYSID) years 2004-2013. BS patients and morbidly obese patients (non-BS) were divided into cervical and thoracolumbar surgical groups and propensity score matched for age, gender, and invasiveness and complications compared. RESULTS: One thousand nine hundred thirty-nine spine surgery patients with a history of BS were compared to 1625 non-BS spine surgery patients. The average time from bariatric surgery to spine surgery is 2.95 years. After propensity score matching, 740 BS patients were compared to 740 non-BS patients undergoing thoracolumbar surgery, with similar comorbidity rates. The overall complication rate for BS thoracolumbar patients was lower than non-BS (45.8% vs 58.1%, P < 0.001), with lower rates of device-related (6.1% vs 23.2%, P < 0.001), DVT (1.2% vs 2.7%, P = 0.039), and hematomas (1.5% vs 4.5%, P < 0.001). Neurologic complications were similar between BS patients and non-BS patients (2.3% vs 2.7%, P = 0.62). For patients undergoing cervical spine surgery, BS patients experienced lower rates of bowel issues, device-related, and overall complication than non-BS patients (P < 0.05). CONCLUSIONS: Bariatric surgery patients undergoing spine surgery experience lower overall complication rates than morbidly obese patients. This study warrants further investigation into these populations to mitigate risks associated with spine surgery for bariatric patients.

Outcomes following surgical management of femoral neck fractures in elderly dialysis-dependent patients.

INTRODUCTION: Proximal femur fractures are one of the most common fractures observed in dialysis-dependent patients. Given the large comorbidity burden present in this patient population, more information is needed regarding post-operative outcomes. The goal of this study was to assess morbidity and mortality following operative fixation of femoral neck fractures in the dialysis-dependent elderly. METHODS: The full set of medicare data from 2005 to 2014 was retrospectively analyzed. Elderly patients with femoral neck fractures were selected. Patients were stratified based on dialysis dependence. Post-operative morbidity and mortality outcomes were compared between the two populations. Adjusted odds were calculated to determine the effect of dialysis dependence on outcomes. RESULTS: A total of 320,629 patients met the inclusion criteria. Of dialysis-dependent patients, 1504 patients underwent internal fixation and 2662 underwent arthroplasty. For both surgical cohorts, dialysis dependence was found to be associated with at least 1.9 times greater odds of mortality within 1 and 2 years post-operatively. Blood transfusions within 90 days and infections within 2 years were significantly increased in the dialysis-dependent study cohort. Dialysis dependence alone did not contribute to increased mechanical failure or major medical complications. CONCLUSION: Regardless of the surgery performed, dialysis dependence is a significant risk factor for major post-surgical morbidity and mortality after operative treatment of femoral neck fractures in this population. Increased mechanical failure in the internal fixation group was not observed. The increased risk associated with caring for this population should be understood when considering surgical intervention and counseling patients.

Cannulated Lag Screw Fixation of Displaced Lateral Humeral Condyle Fractures Is Associated With Lower Rates of Open Reduction and Infection Than Pin Fixation.

BACKGROUND: Open reduction/internal fixation remains the most common way to surgically stabilize displaced pediatric lateral humeral condyle fractures, but closed reduction and internal fixation is being increasingly used. Our goal was to compare the clinical and functional results of treating displaced pediatric lateral humeral condylar fractures with traditional smooth or threaded pin fixation versus single cannulated screw fixation. METHODS: From 1998 through 2012, the lateral humeral condyle fractures of 48 patients were treated with pin fixation (22 patients, until 2006) or cannulated, partially threaded screw fixation (26 patients, from 2006 onward). In each, closed reduction with percutaneous fixation was attempted first, followed by open reduction if anatomic reduction was not achieved. For the pin and screw groups, preoperative maximum radiographic displacement averaged 8.4 mm (range, 3.8 to 18.4 mm) and 6.3 mm (range, 2.2 to 15.5 mm), respectively; follow-up averaged 4.3 months (range, 1.5 to 20 mo) and 10.3 months (range, 2 to 30 mo), respectively. We reviewed preoperative and postoperative images and all follow-up clinical examination findings; serially assessed initial displacement, Baumann and carrying angles, range of motion limitations, and clinical alignment; evaluated functional results via the system of Hardacre and colleagues; and investigated all complications. RESULTS: Open reduction was required in 73% (16/22) and 15% (4/26) of the pin and screw groups, respectively (P<0.001). All fractures were reduced to <1 mm postoperative displacement. Postoperative immobilization averaged 5.9 weeks (range, 4 to 11 wk) and 4.5 weeks (range, 3 to 8 wk) for the pin and screw groups, respectively. The only significant difference in complications was the infection rate: 5 (1 deep) in the pin group and none in the screw group (P<0.05). CONCLUSIONS: Closed reduction and percutaneous 4.5-mm lag screw fixation of displaced pediatric lateral humeral condyle fractures is safe and reliable, enabling a higher rate of closed reduction, significantly lower infection rate, and earlier mobilization than traditional pin fixation. LEVEL OF EVIDENCE: Level III-Therapeutic.

Serial Mehta Cast Utilization in Infantile Idiopathic Scoliosis: Evaluation of Radiographic Predictors.

BACKGROUND: Mehta cast utilization has gained a considerable momentum as a nonoperative treatment modality for the initial management of infantile idiopathic scoliosis (IIS). Despite its acceptance, there is paucity of data that characterize the radiographic parameters associated with Mehta casting and the factors correlated with a sustained curve correction. METHODS: A retrospective review of IIS patients who underwent Mehta casting was performed with a mean 2-year follow-up. X-rays were evaluated at each visit for the Cobb angle, focal deformity, rib-vertebral angle difference, and height of concavity and convexity of the apical 3 vertebrae. Concave-to-convex height ratios were calculated and tracked for each patient. Radiographic parameters were compared from precasting to after final casting, and from final casting to most recent follow-up. RESULTS: A total of 45 patients were identified, of whom 18 (40%) were male and 27 (60%) were female, with a mean age of 18.8±9.5 months at first casting and a mean follow-up of 37.7±19.7 months. Following final casting, the mean Cobb angle (25.6 vs. 52.7 degrees), focal deformity (17.4 vs. 30.5 degrees), rib-vertebral angle difference (18 vs. 32.3 degrees), and the concave-to-convex height ratios improved relative to precast parameters, respectively (P<0.001). At final follow-up, mean Cobb angle (16.2 vs. 25.6 degrees) and concave-to-convex height ratios progressively improved when compared with final cast measurements, respectively (P<0.001). Five (11%) patients did not demonstrate sustained curve correction at final follow-up, whereas 4 (9%) required growing-rod placement. Lastly, the regression analysis demonstrated improvements in the focal deformity (17.4 vs. 30.5) and the concave-to-convex height ratios of the +1 and -1 apical vertebrae from the precast to last cast periods (P<0.001). These findings were correlated with sustained Cobb angle correction from cast removal to the most recent follow-up. CONCLUSIONS: Radiographic parameters associated with control of progressive deformity for IIS include improvements in focal deformity and concave-to-convex height ratios for +1 and -1 apical vertebrae after final casting. Mehta casting is an effective treatment for symptomatic IIS and continues to provide IIS patients with significant curve correction. LEVEL OF EVIDENCE: Level IV.

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.

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

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." analysis of variance testing was used to assess differences within and between groups. Multivariate regression was used to identify features associated with the achievement of MCID. RESULTS: Two hundred patients were included. The average age was 65.9 ± 12.2 years. 75 patients (37.5%) were nondepressed, 66 patients (33.0%) were clinically depressed, and 59 patients (29.5%) were situationally depressed. Situationally depressed patients had worse preoperative physical function (PF) and pain interference (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.

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/m 2 ; 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.

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.

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.

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.

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.