Complications After Percutaneous Osteotomies of the Calcaneus.

Background: Open hindfoot surgery is associated with a relatively high rate of complications, including neurovascular injuries and wound healing problems compared with percutaneous techniques. However, there is a scarcity of literature describing the outcomes of these percutaneous techniques given their relatively recent adoption. The present study aims to assess the rate of postoperative complications for 3 commonly performed percutaneous calcaneal osteotomies. Methods: One hundred eighteen patients (unilateral feet) were treated with one of 3 common percutaneous calcaneal osteotomies. Sixty-five patients (55.1%) were treated with a medializing calcaneal osteotomy for hindfoot valgus, 32 patients with a Zadek osteotomy (27.1%) for insertional Achilles tendinopathy, and 21 patients (17.8%) with a modified Dwyer osteotomy for hindfoot varus. Fisher exact test was used to assess for associations between categorical variables. Results: The mean age was 46.2 years and there was a mean follow-up of 16.1 months. The overall rate of postoperative complications was 3.4% (n = 4), and no significant differences were found between the different osteotomy types. Complications included 2 cases (1.7%) of transient neuritis, 1 case of prolonged wound drainage (0.8%), and 1 nonunion (0.8%). None of the complications were associated with any recorded preoperative comorbidity. Discussion: In this series, we found that percutaneous calcaneal osteotomies are a safe alternative method for the treatment of conditions involving the hindfoot. The rate of postoperative complications may be less when compared to the reported rates of open hindfoot correction and should be considered in patients with a traditionally high risk of developing a postoperative complication. Level of Evidence: Level IV, retrospective analysis.

Economic impact of Comorbidities in Total Ankle Arthroplasty and Ankle Arthrodesis.

BACKGROUND: The demand for total ankle arthroplasty (TAA) and ankle arthrodesis surgery is increasing. Findings from other orthopaedic populations suggest an increasing comorbidity burden among those planned for surgery, however, data on TAA and ankle arthrodesis is limited. The goal of this study is to study the comorbidity burden for TAA and ankle arthrodesis. HYPOTHESIS: Comorbidity burden is associated with higher resource utilization for both TAA and ankle arthrodesis. PATIENTS AND METHODS: This retrospective cohort study utilized data from the nationwide Premier Healthcare Database (2006-2016) which contains inpatient claims on n=10,085 ankle arthrodesis and n=4,977 TAA procedures. Patients were categorized into Deyo-Charlson comorbidity index (DCCI) groups. Outcomes were cost of hospitalization, length of stay (LOS), total opioid utilization, discharge to a skilled nursing facility (SNF), and 30-day readmission. Mixed-effects models estimated associations between DCCI and outcomes. We report odds ratios (OR, or % change for continuous outcomes) and 95% confidence intervals (CI). RESULTS: In the TAA group, 67.9% of patients were in DCCI category 0 while 22.4%, 6.6%, and 3.1% were in the 1, 2, and >2 DCCI categories, respectively. This was 61.3%, 18.1%, 9.8% and 10.9% in the ankle arthrodesis group. The most common comorbidities were obesity, diabetes mellitus, and chronic pulmonary disease. Particularly in the ankle arthrodesis group, the proportion of patients with comorbidities has increased over time. After adjustment for relevant covariates, patients in the DCCI group >2 (compared to '0') were associated with stepwise effects of up to 77.1% (CI 70.9%; 83.6%) longer length of stay and up to 48.5% (CI 44.0%; 53.2%) higher cost of hospitalization. DISCUSSIONS: Comorbidity burden is increasing among patients undergoing ankle arthrodesis where it is associated with significantly increased resource utilization. Our data demonstrate the potential impact of patient selection, which may be crucial in optimizing preoperative status. LEVEL OF EVIDENCE: III.

Opioid Consumption and Time to Return to Work After Percutaneous Osteotomy in Foot Surgery.

Surgeries involving the foot and ankle are painful procedures, with many patients unwilling to discontinue prescribed narcotics at 3 months postoperatively. Percutaneous techniques allow for smaller incisions and minimal soft tissue disruption. Fifty consecutive patients underwent outpatient percutaneous foot surgery. Data were collected on pain medication taken and time to return to work. A mean of 3.3 tablets of oxycodone were consumed during the first 2 weeks. No patient was taking narcotics after 2 weeks. Mean time to return to work was 18.9 days. Percutaneous foot and ankle surgery led to a significant reduction in narcotic consumption. [Orthopedics. 2020;43(4):e334-e337.].

Percutaneous Zadek osteotomy for the treatment of insertional Achilles tendinopathy.

BACKGROUND: Insertional Achilles tendinopathy (IAT) is a challenging common lower extremity disorder, despite several treatment options described in literature. Open dorsal closing wedge calcaneal osteotomy or Zadek Osteotomy (ZO), for the treatment of the IAT has good clinical results but a high rate of postoperative complications. The purpose of this study is to describe percutaneous ZO for the treatment of the IAT and to evaluate its impact on the clinical and functional postoperative outcomes. METHODS: Twenty-six consecutive patients presenting with unilateral IAT refractory to nonoperative measures were treated with percutaneous ZO. Visual Analogue Scale (VAS) and Foot Function Index Score (FFI) were recorded preoperatively and at final follow-up visit (12±3) months. Postoperative complications, satisfaction, and relief of the pain were also recorded. RESULTS: The percutaneous ZO showed a significant improvement (p<0.0001) in preoperative to postoperative FFI (from 65±9 to 8±12) and VAS (from 9±1 to 1±2). Two postoperative complications (8%) were observed: a case of symptomatic non-union and hardware pain, both in healthy patients. The overall rate of satisfaction after surgery was (92%). The relief from pain was achieved after an average period of 12 weeks. CONCLUSIONS: ZO is a safe and effective procedure for the treatment of IAT. The use of a minimally invasive surgical approach is associated with excellent pain reduction (VAS score) and improved clinical function (FFI score). When compared to the open surgical approach, the percutaneous ZO may decrease recovery time and postoperative complications. LEVEL OF EVIDENCE: III, retrospective case series.

Failure of Fixation With Nickel-Titanium Staples in First Metatarsophalangeal Arthrodesis With Hallux Valgus Deformity.

First metatarsophalangeal (MTP) joint arthrodesis is a treatment option for patients with arthritic hallux valgus (HV). Nickel-titanium staples allow continuous compression throughout the fusion site and have been shown to achieve successful union in many procedures. However, their efficacy has not been tested in patients with underlying HV deformity. Three cases of severe HV deformity that underwent first MTP arthrodesis with 2 nickel-titanium staples placed 60° from each other and had failure are reported. The authors believe this construct does not provide adequate rotational control for first MTP arthrodesis in patients with severe HV deformity. [Orthopedics. 2019; 42(4):e402-e404.].

Predictive Factors and Rates of Fusion in Minimally Invasive Transforaminal Lumbar Interbody Fusion Utilizing rhBMP-2 or Mesenchymal Stem Cells.

BACKGROUND: Several fusion adjuncts exist to enhance fusion rates during minimally invasive transforaminal lumbar interbody fusion (MI-TLIF). The objective of this study was to compare fusion rates in patients undergoing MI-TLIF with either rhBMP-2 or cellularized bone matrix (CBM). METHODS: We conducted a single surgeon retrospective cohort study of patients who underwent MI-TLIF with either rhBMP-2 or CBM placed in an interbody cage. Single and multilevel procedures were included. Fusion was assessed on computed tomography scans at 12-month follow-up by an independent, blinded, board-certified neuroradiologist. Fusion rates and rate of revision surgery were compared with a Fisher exact test between the 2 groups. A multivariate regression analysis was performed to identify patient factors that were predictive of radiographic nonunion after MI-TLIF. RESULTS: A total of 93 fusion levels in 78 patients were reviewed. Thirty-nine patients received CBM, and 39 patients received rhBMP-2. The patients receiving rhBMP-2 were older on average (61.4 vs 55.6, P = .03). The overall fusion rate was 68% in the CBM group (32/47 levels) and 78% in the rhBMP-2 group (36/46) (P = .35). Only preoperative hypertension was predictive of radiographic nonunion (odds ratio = 3.5, P = .05). There were 3 smokers in the CBM group and 4 smokers in the BMP group, and 1 in each group experienced radiographic pseudarthrosis. A total of 4 patients, 3 in the CBM group and 1 in the BMP group (P = .61), required revision for symptomatic pseudarthrosis. All of these patients had a single-level index procedure. CONCLUSIONS: There were no differences in radiographic fusion and rate of revision surgery in patients who underwent MI-TLIF with either rhBMP-2 or CBM as fusion adjuncts. LEVEL OF EVIDENCE: 3. CLINICAL RELEVANCE: Both rhBMP-2 and CBMs can be used as effective fusion adjuncts without any clear advantage of one over the other.

The Effect of Parkinson's Disease on Patients Undergoing Lumbar Spine Surgery.

STUDY DESIGN: Retrospective Database Analysis. OBJECTIVE: The purpose of this study was to assess characteristics and outcomes of patients with Parkinson's disease (PD) undergoing lumbar spine surgery for degenerative conditions. METHODS: The Nationwide Inpatient Sample was examined from 2002 to 2011. Patients were included for study based on ICD-9-CM procedural codes for lumbar spine surgery and substratified to degenerative diagnoses. Incidence and baseline patient characteristics were determined. Multivariable analysis was performed to determine independent risk factors increasing incidence of lumbar fusion revision in PD patients. RESULTS: PD patients account for 0.9% of all degenerative lumbar procedures. At baseline, PD patients are older (70.7 versus 58.9, p < 0.0001) and more likely to be male (58.6% male, p < 160.0001). Mean length of stay (LOS) was increased in PD patients undergoing lumbar fusion (5.1 days versus 4.0 days, p < 0.0001) and lumbar fusion revision (6.2 days versus 4.8 days, p < 180.0001). Costs were 7.9% (p < 0.0001) higher for lumbar fusion and 25.2% (p < 0.0001) higher for lumbar fusion revision in PD patients. Multivariable analysis indicates that osteoporosis, fluid/electrolyte disorders, blood loss anemia, and insurance status are significant independent predictors of lumbar fusion revision in patients with PD. CONCLUSION: PD patients undergoing lumbar surgery for degenerative conditions have increased LOS and costs when compared to patients without PD.

Safety and Effectiveness of Talus Subchondroplasty and Bone Marrow Aspirate Concentrate for the Treatment of Osteochondral Defects of the Talus.

Eleven patients with symptomatic talus osteochondral defects who underwent subchondroplasty with bone marrow aspirate concentrate injection were retrospectively reviewed. Foot and Ankle Outcome Score and visual analog scale pain score were recorded preoperatively and at the 1-year postoperative visit. The mean osteochondral defect size was 1.3×1.4 cm. The weight-bearing visual analog scale pain score improved from a mean of 7.8 to 1.8, and the Foot and Ankle Outcome Score improved from a mean of 67.1 to 89.6. At 1-year follow-up, 10 patients reported they would have the procedure again. Subchondroplasty and bone marrow aspirate concentrate injection offered good pain relief for talus osteochondral defects. The procedure allows immediate weight bearing postoperatively and does not compromise future treatments. [Orthopedics. 2018; 41(5):e734-e737.].

Comparing the Incidence of Index Level Fusion Following Minimally Invasive Versus Open Lumbar Microdiscectomy.

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: To determine the incidence of index level fusion following open or minimally invasive lumbar microdiscectomy. METHODS: We conducted a retrospective review of 174 patients with a symptomatic single-level lumbar herniated nucleus pulposus who underwent microdiscectomy via a mini-open approach (MIS; 39) or through a minimally invasive dilator tube (135). Outcomes of interest included revision microdiscectomy and the ultimate need for index level fusion. Continuous variables were analyzed with independent sample t test, and χ2 analysis was used for categorical data. A multivariate regression analysis was performed to identify predictive factors for patients that required index level fusion after lumbar microdiscectomy. RESULTS: There was no difference in patient demographics in the open and MIS groups aside from length of follow-up (60.4 vs 40.03 months, P < .0001) and body mass index (24.72 vs 27.21, P = .03). The rate of revision microdiscectomy was not statistically significant between open and MIS approaches (10.3% vs 10.4%, P = .90). The rate of patients who ultimately required index level fusion approached significance, but was not statistically different between open and MIS approaches (10.3% vs 4.4%, P = .17). Multivariate regression analysis indicated that the need for eventual index level fusion after lumbar microdiscectomy was statistically predicted in smokers and those patients who underwent revision microdiscectomy (P < .05) in both open and MIS groups. CONCLUSIONS: Our results suggest a low likelihood of patients ultimately requiring fusion following microdiscectomy with predictors including smoking status and a history of revision microdiscectomy.

Short-Term Complications of Anterior Fixation of Odontoid Fractures.

STUDY DESIGN: Retrospective study. OBJECTIVE: Anterior fixation of odontoid fracture has been associated with high morbidity and mortality in small, single institution series. Identifying risk factors may improve risk stratification and highlight factors that could be optimized preoperatively. The objective of this study was to determine the 30-day complication rate following anterior fixation of odontoid fractures and to identify associated risk factors among patients in a large national database. METHODS: Patients who underwent anterior fixation were identified in the American College of Surgeons National Quality Improvement Program database (ACS NSQIP) from 2007 to 2012. Patient demographics, medical comorbidities, perioperative complications, and postoperative complications up to 30 days were analyzed by univariate and multivariate analysis. RESULTS: Overall, 103 patients met criteria for the study. The average age was 73.9 years and patients were predominantly white (85.4%). Cardiac comorbidity was common (66.0%), as were dependent functional status (14.6%) and bleeding disorders (13.6%). Complications occurred in 37.9% of patients, and mortality was high (6.8%). Age, white race, and history of bleeding disorders were independently predictive of complications in the multivariate analysis. The postoperative hospital stay was >5 days for 45.6% of patients. CONCLUSION: In a large, multicenter database study, anterior fixation of odontoid fracture was associated with high morbidity and mortality. Although advanced age was associated with increased risk of complications, patients undergoing anterior fixation were older, on average, than in prior studies. Bleeding disorder was a potentially modifiable risk factor for complications that could be optimized prior to surgery.

Incidence and Risk Factors for 30-Day Unplanned Readmissions After Elective Posterior Lumbar Fusion.

STUDY DESIGN: Retrospective study of prospectively collected data. OBJECTIVE: To perform a multiinstitutional assessment on the incidence and risk factors for unplanned readmissions following elective posterior lumbar fusion (PLF) surgery. SUMMARY OF BACKGROUND DATA: Understanding what may drive rehospitalizations is a necessary step toward higher quality care. Identifying risk factors for unplanned readmission is especially important for elective PLF, which is a common procedure that is known to be associated with significant adverse events. METHODS: Adult patients undergoing PLF were identified using current procedure terminology (CPT) from the American College of Surgeons National Surgical Quality Improvement Program. Both descriptive and comparative statistics were performed for patient characteristics, clinical factors, and postoperative complications. Subsequently, a step-wise multivariate logistic regression was employed. RESULTS: Of the 2301 patients who met inclusion criteria for this study, 117 were unplanned readmissions (5.1%). These occurred at a mean of 15.9 days (range: 3-30 days) after surgery. The risk-adjusted analysis revealed that bleeding disorder (odds ratio, OR = 2.8, confidence intervals, CI = 1.0-7.6, P = 0.043), insulin dependent diabetes (OR = 2.5, CI = 1.4-4.4, P = 0.004), and total length of stay > 5 days (OR = 1.8, CI = 1.2-2.8, P = 0.009) were independent predictors for unplanned readmission. Significant postoperative complications included wound complications (OR = 27.6, CI = 13.9-54.8, P < 0.0001), pulmonary embolism and/or deep vein thrombosis/thrombophlebitis (OR = 11.9, CI = 5.0-28.5, P < 0.0001), sepsis (OR = 8.5, CI = 2.3-32.1, P = 0.002), and urinary tract infections (OR = 2.4, CI = 0.9-6.9, P = 0.094). CONCLUSION: The unplanned readmission rate for patients undergoing PLF was low, but this study's findings of potentially modifiable risk factors suggest that substantial improvement with this quality metric is possible. LEVEL OF EVIDENCE: N/A.

The Impact of Resident Involvement in Elective Posterior Cervical Fusion.

STUDY DESIGN: Retrospective study of prospectively collected data OBJECTIVE.: The aim of this study was to assess the impact of resident surgeon involvement on patient outcomes following posterior cervical fusion (PCF) surgery. SUMMARY OF BACKGROUND DATA: Recently, there has been a significant uptrend in the number of PCF performed in the United States. Prior studies have investigated patient outcomes after cervical arthrodesis. Despite the heightened concern for patient safety and quality improvement, the data on the safety of resident participation in PCF is sparse. METHODS: The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) was examined from 2005 to 2012. Current Procedural Terminology codes were used to query the database for adults (≥18 years) who underwent PCF. Multivariate logistic regression models were employed on data adjusted by propensity scores to determine whether resident involvement was an independent predictor for the outcomes of interest. RESULTS: A total of 448 cases were assessed in NSQIP. Less than half of these cases involved residents (224, 43.1%). Resident involvement was found to be a significant predictor for blood transfusions [odds ratio (OR) = 1.7, confidence interval (CI) = 1.1-2.6, P = 0.010], length of stay of more than 5 days (OR = 1.6, CI = 1.0-2.6, P = 0.040), and operative time more than 4 hours (OR = 3.6, CI = 1.7-7.4, P = 0.0007). Other independent risk factors for prolonged length of stay included age 81 years or older versus 50 years or younger (OR = 4.7, CI = 1.7-12.6, P = 0.016) and diabetes (OR = 2.3, CI = 1.3-4.1, P = 0.006). In addition, multifusion was identified as a significant risk factor for extended operative time (OR = 1.8, CI = 1.1-2.9, P = 0.023). CONCLUSION: The present study used a large, nationwide sample to assess the impact of resident involvement in PCF. Resident participation was not associated with mortality, but had a minimal association with morbidity. LEVEL OF EVIDENCE: 3.

Impact of Operation Time on 30-Day Complications After Adult Spinal Deformity Surgery.

STUDY DESIGN: Retrospective analysis of prospectively collected data. OBJECTIVE: There is a paucity of data on the effect of operative duration on postoperative complications during adult spinal deformity surgery (ASDS). The study attempts to explore and quantify the association between increased operation times and postoperative complications. METHODS: A retrospective cohort analysis was performed on the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database from 2010 to 2014. Patients (≥18 years of age) from the NSQIP database undergoing ASDS were separated into cohorts based on quartiles of operation duration. Chi-square and multivariate logistic regression models were used to identify risk factors. RESULTS: A total of 5338 patients met the inclusion criteria and were divided per quartiles based on operative duration in minutes (154, 235, 346, and 1156 minutes). Multivariate logistic regressions revealed that in comparison to the lowest quartile of operative duration, the highest quartile group was associated significantly with length of stay ≥5 days (odds ratio [OR] = 5.85), any complication (OR = 9.88), wound complication (OR = 5.95), pulmonary complication (OR = 2.85, P = .001), venous thromboembolism (OR = 12.37), intra-/postoperative transfusion (OR = 12.77), sepsis (OR = 5.27), reoperations (OR = 1.48), and unplanned readmissions (OR = 1.29). The odds ratio was higher when comparing a higher quartile group with the reference group across all associations. P < .001 unless otherwise noted. CONCLUSION: ASDS operation time is associated with multiple postoperative complications, including, but not limited to, wound and pulmonary complications, venous thromboembolism, postoperative transfusion, length of stay ≥5 days, sepsis, reoperation, and unplanned readmission.

Incidence, Impact, and Risk Factors for 30-Day Wound Complications Following Elective Adult Spinal Deformity Surgery.

STUDY DESIGN: Case-control study. OBJECTIVE: To determine the incidence, impact, and risk factors for wound complications within 30 days following elective adult spinal deformity surgery. METHODS: Current Procedural Terminology and International Classification of Diseases, Ninth Edition, diagnosis codes were used to query the database for adults who underwent spinal deformity surgery from 2010 to 2014. Patients were separated into groups of those with and without wound complications. Univariate analysis and multivariate logistic regression were used to analyze the influence of patient factors, operative variables, and clinical characteristics on the incidence of postoperative wound complication. This study was qualified as exempt by the Mount Sinai Hospital Institutional Review Board. RESULTS: A total of 5803 patients met the criteria for this study. Wound complications occurred in 140 patients (2.4%) and were significantly associated with other adverse outcomes, including higher rates of unplanned reoperation (P < .0001) and prolonged length of stay (P < .0001). Regardless of fusion length, wound complication rates were higher with a posterior approach (short = 2.7%; long = 3.7%) than an anterior one (short = 2.2%; long = 2.7). According to the multivariate analysis, posterior fusion (odds ratio [OR] = 1.8; P = .010), obese class II (OR = 1.7; P = .046), obese class III (OR = 2.8; P < .0001), preoperative blood transfusion (OR = 6.1; P = .021), American Society of Anesthesiologists class ≥3 (OR = 1.7; P = .009), and operative time >4 hours (OR = 1.8; P = .006) were statistically significant risk factors for wound complications. CONCLUSION: The 30-day incidence of wound complication in adult spinal deformity surgery is 2.4%. The risk factors for wound complication are multifactorial. This data should provide a step toward developing quality improvement measures aimed at reducing complications in high-risk adults.

Early Complications and Outcomes in Adult Spinal Deformity Surgery: An NSQIP Study Based on 5803 Patients.

STUDY DESIGN: Retrospective analysis. OBJECTIVE: The purpose of this study is to determine the incidence, impact, and risk factors for short-term postoperative complications following elective adult spinal deformity (ASD) surgery. METHODS: Current Procedural Terminology codes were used to query the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) for adults who underwent spinal deformity surgery from 2010 to 2014. Patients were separated into groups of those with and without complications. Univariate analysis and multivariate logistic regression were used to assess the impact of patient characteristics and operative features on postoperative outcomes. RESULTS: In total, 5803 patients were identified as having undergone ASD surgery in the NSQIP database. The average patient age was 59.5 (±13.5) years, 59.0% were female, and 81.1% were of Caucasian race. The mean body mass index was 29.5(±6.6), with 41.9% of patients having a body mass index of 30 or higher. The most common comorbidities were hypertension requiring medication (54.5%), chronic obstructive pulmonary disease (4.9%), and bleeding disorders (1.2%). Nearly a half of the ASD patients had an operative time >4 hours. The posterior fusion approach was more common (56.9%) than an anterior one (39.6%). The mean total relative value unit was 73.4 (±28.8). Based on multivariate analyses, several patient and operative characteristics were found to be predictive of morbidity. CONCLUSION: Surgical correction of ASD is associated with substantial risk of intraoperative and postoperative complications. Preoperative and intraoperative variables were associated with increased morbidity and mortality. This data may assist in developing future quality improvement activities and saving costs through measurable improvement in patient safety.

Accuracy of Percutaneous Pedicle Screw Placement: Does Training Level Matter?

STUDY DESIGN: In vitro human cadaveric surgical technique study. OBJECTIVE: To assess the accuracy of percutaneous pedicle screw placement in a human cadaveric model using standard fluoroscopic guidance technique, compared across varying levels of experience. SUMMARY OF BACKGROUND DATA: The current literature varies widely in the reported frequency of facet violation during placement of percutaneous pedicle screws. However, as of yet there are no studies examining the effect that training level has on accuracy of placement. MATERIALS AND METHODS: Four surgeons with differing levels of training (PGY-2, PGY-4, fellow, attending) were evaluated on their accuracy of percutaneous placement of screws in a uniform manner. Each of the 10 cadavers was instrumented from L1 to S1 bilaterally, for a total of 120 screws. Specimens were dissected to evaluate for facet and pedicle wall violations. These were then recorded and analyzed to evaluate for correlation among participating surgeons, laterality, spinal level, and cadaver body mass index. RESULTS: Of 120 screws placed, there were 35 total violations [26 superior articular facet violations (21.7%), 5 intra-articular facet joint violations (4.2%), and 4 pedicle breaches (3.3%)]. Among the trainees there was no difference in the likelihood of causing a violation (P=0.8863) but there was a difference when compared with the attending surgeon (P=0.0175). Laterality (P=0.1598), spinal level (P=0.3536), and body mass index (P=0.8547) did not correlate with the likelihood of a violation. CONCLUSIONS: Surgeons of differing training levels are able to safely and accurately place lumbar pedicle screws in a percutaneous manner, with a low likelihood of facet and pedicle wall violations.

Bone morphogenetic protein use in spine surgery in the United States: how have we responded to the warnings?

BACKGROUND CONTEXT: Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been widely adopted as a fusion adjunct in spine surgery since its approval in 2002. A number of concerns regarding adverse effects and potentially devastating complications of rhBMP-2 use led to a Food and Drug Administration (FDA) advisory issued in 2008 cautioning its use, and a separate warning about its potential complications was published by The Spine Journal in 2011. PURPOSE: To compare trends of rhBMP-2 use in spine surgery after the FDA advisory in 2008 and The Spine Journal warning in 2011. STUDY DESIGN: Retrospective cross-sectional study using a national database. PATIENT SAMPLE: All patients from 2002 to 2013 who underwent spinal fusion surgery at an institution participating in the Nationwide Inpatient Sample (NIS). OUTCOME MEASURES: Proportion of spinal fusion surgeries using rhBMP-2. METHODS: We queried the NIS from 2002 to 2013 and used International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure codes to identify spinal fusion procedures and those that used rhBMP-2. Procedures were subdivided into primary and revision fusions, and by region of the spine. Cervical and lumbosacral fusions were further stratified into anterior and posterior approaches. The percentage of cases using BMP was plotted across time. A linear regression was fit to the data from quarter 3 of 2008 (FDA advisory) through quarter 1 of 2011, and a separate regression was fit to the data from quarter 2 of 2011 (The Spine Journal warning) onward. The slopes of these regression lines were statistically compared to determine differences in trends. No funding was received to conduct this study, and no authors had any relevant conflicts of interest. RESULTS: A total of 4,167,079 patients in the NIS underwent spinal fusion between 2002 and 2013. We found a greater decrease in rhBMP-2 use after The Spine Journal warning compared with the FDA advisory for all fusion procedures (p=.006), primary fusions (p=.006), and revision fusions (p=.004). Lumbosacral procedures also experienced a larger decline in rhBMP-2 use after The Spine Journal article as compared with the FDA warning (p=.0008). This pattern was observed for both anterior and posterior lumbosacral fusions (p≤.0001 for both). Anterior cervical fusion was the only procedure that demonstrated a decline in rhBMP-2 use after the FDA advisory that was statistically greater than after The Spine Journal article (p=.02). CONCLUSIONS: Warnings sanctioned through the spine literature may have a greater influence on practice of the spine surgery community as compared with advisories issued by the FDA.Comprehensive guidelines regarding safe and effective use of rhBMP-2 must be established.

Thirty-Day Morbidity Associated with Pelvic Fixation in Adult Patients Undergoing Fusion for Spinal Deformity: A Propensity-Matched Analysis.

STUDY DESIGN: Retrospective study of prospectively collected data. OBJECTIVE: To determine if patients undergoing spinal deformity surgery with pelvic fixation are at an increased risk of morbidity. METHODS: The American College of Surgeons National Surgical Quality Improvement Program is a large multicenter clinical registry that prospectively collects preoperative risk factors, intraoperative variables, and 30-day postoperative morbidity and mortality outcomes from ~400 hospitals nationwide. Current Procedural Terminology codes were used to query the database between 2010 and 2014 for adults who underwent fusion for spinal deformity. Patients were separated into groups of those with and without pelvic fixation. Univariate analysis and multivariate logistic regression were used to analyze the effect of pelvic fixation on the incidence of postoperative morbidity and other surgical outcomes. RESULTS: Multivariate analysis showed that pelvic fixation was a significant predictor of overall morbidity (odds ratio [OR] = 2.3, 95% confidence interval [CI]: 1.7 to 3.1, p = 0.0002), intra- or postoperative blood transfusion (OR = 2.3, 95% CI: 1.7 to 3.1 p < 0.0001), extended operative time (OR = 4.7, 95% CI: 3.1 to 7.0 p < 0.0001), and length of stay > 5 days (OR = 2.1, 95% CI 1.5 to 2.8, p < 0.0001) in patients undergoing fusion for spinal deformity. However, fusion to the pelvis did not lead to additional risk for other complications, including wound complications (p = 0.3191). CONCLUSION: Adult patients undergoing spinal deformity surgery with pelvic fixation were not susceptible to increased morbidity beyond increased blood loss, greater operative time, and extended length of stay.

Impact of Glycemic Control on Morbidity and Mortality in Adult Idiopathic Scoliosis Patients Undergoing Spinal Fusion.

STUDY DESIGN: This is a retrospective analysis of administrative database. OBJECTIVE: To elucidate the effect of glycemic control on surgical outcomes of middle-aged and elderly idiopathic scoliosis patients undergoing spinal fusion surgery. SUMMARY OF BACKGROUND DATA: Diabetes mellitus (DM) is a condition thought to adversely affect outcomes of spine surgery. However, no study has stratified glycemic control levels and their impact on outcome for idiopathic scoliosis patients receiving a spinal fusion surgery. Previous studies may have reported higher than true rates of complications for controlled diabetic patients, who are the majority of diabetic patients. MATERIALS AND METHODS: The Nationwide Inpatient Sample was queried from years 2002 to 2011. We extracted idiopathic scoliosis patients older than 45 years of age that received spinal fusion and analyzed complications and outcomes variables among 3 cohorts: nondiabetic patients, controlled diabetics, and uncontrolled diabetics. Multivariate analyses were used to assess whether glycemic control was a risk factor for adverse postoperative outcomes. RESULTS: Controlled diabetics had significantly increased rates of acute renal failure (ARF), while uncontrolled diabetics had significantly increased rates of acute postoperative hemorrhage. In multivariate analyses controlling for patient factors and comorbidities, controlled DM was found to be an independent predictor of ARF [odds ratio (OR), 1.863; 95% confidence interval (CI), 1.346-2.579; P=0.0002), and uncontrolled DM was found to be a significant risk factor for acute postoperative hemorrhage (OR, 2.182; 95% CI, 1.192-3.997; P=0.0115), ARF (OR, 4.839; 95% CI, 1.748-13.392; P=0.0024), deep vein thrombosis (OR, 5.825; 95% CI, 1.329-25.522, P=0.0194) and in-patient mortality (OR, 8.889; 95% CI, 1.001-78.945; P=0.0499). CONCLUSIONS: Controlled DM was found to be a risk factor for ARF in adult idiopathic scoliosis patients undergoing spinal fusion surgery, while uncontrolled DM was shown to be a risk factor for postoperative hemorrhage, ARF, deep vein thrombosis, and mortality. The present study provides valuable data for better informed consent for patients with diabetes considering surgery for idiopathic scoliosis. LEVEL OF EVIDENCE: Level III.

A Comparative Analysis Among the SRS M&M, NIS, and KID Databases for the Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Retrospective cohort analysis. OBJECTIVES: A growing number of publications have utilized the Scoliosis Research Society (SRS) Morbidity and Mortality (M&M) database, but none have compared it to other large databases. The objective of this study was to compare SRS complications with those in administrative databases. SUMMARY OF BACKGROUND DATA: The Nationwide Inpatient Sample (NIS) and Kid's Inpatient Database (KID) captured a greater number of overall complications while the SRS M&M data provided a greater incidence of spine-related complications following adolescent idiopathic scoliosis (AIS) surgery. Chi-square was used to obtain statistical significance, with p < .05 considered significant. METHODS: The SRS 2004-2007 (9,904 patients), NIS 2004-2007 (20,441 patients) and KID 2003-2006 (10,184 patients) databases were analyzed for AIS patients who underwent fusion. Comparable variables were queried in all three databases, including patient demographics, surgical variables, and complications. RESULTS: Patients undergoing AIS in the SRS database were slightly older (SRS 14.4 years vs. NIS 13.8 years, p < .0001; KID 13.9 years, p < .0001) and less likely to be male (SRS 18.5% vs. NIS 26.3%, p < .0001; KID 24.8%, p < .0001). Revision surgery (SRS 3.3% vs. NIS 2.4%, p < .0001; KID 0.9%, p < .0001) and osteotomy (SRS 8% vs. NIS 2.3%, p < .0001; KID 2.4%, p < .0001) were more commonly reported in the SRS database. The SRS database reported fewer overall complications (SRS 3.9% vs. NIS 7.3%, p < .0001; KID 6.6%, p < .0001). However, when respiratory complications (SRS 0.5% vs. NIS 3.7%, p < .0001; KID 4.4%, p < .0001) were excluded, medical complication rates were similar across databases. In contrast, SRS reported higher spine-specific complication rates. Mortality rates were similar between SRS versus NIS (p = .280) and SRS versus KID (p = .08) databases. CONCLUSIONS: There are similarities and differences between the three databases. These discrepancies are likely due to the varying data-gathering methods each organization uses to collect their morbidity data. LEVEL OF EVIDENCE: Level IV.