Can triggered electromyography monitoring throughout retraction predict postoperative symptomatic neuropraxia after XLIF? Results from a prospective multicenter trial.

PURPOSE: This multicenter study aims to evaluate the utility of triggered electromyography (t-EMG) recorded throughout psoas retraction during lateral transpsoas interbody fusion to predict postoperative changes in motor function. METHODS: Three hundred and twenty-three patients undergoing L4-5 minimally invasive lateral interbody fusion from 21 sites were enrolled. Intraoperative data collection included initial t-EMG thresholds in response to posterior retractor blade stimulation and subsequent t-EMG threshold values collected every 5 min throughout retraction. Additional data collection included dimensions/duration of retraction as well as pre-and postoperative lower extremity neurologic exams. RESULTS: Prior to expanding the retractor, the lowestt-EMG threshold was identified posterior to the retractor in 94 % of cases. Postoperatively, 13 (4.5 %) patients had a new motor weakness that was consistent with symptomatic neuropraxia (SN) of lumbar plexus nerves on the approach side. There were no significant differences between patients with or without a corresponding postoperative SN with respect to initial posterior blade reading (p = 0.600), or retraction dimensions (p > 0.05). Retraction time was significantly longer in those patients with SN vs. those without (p = 0.031). Stepwise logistic regression showed a significant positive relationship between the presence of new postoperative SN and total retraction time (p < 0.001), as well as change in t-EMG thresholds over time (p < 0.001), although false positive rates (increased threshold in patients with no new SN) remained high regardless of the absolute increase in threshold used to define an alarm criteria. CONCLUSIONS: Prolonged retraction time and coincident increases in t-EMG thresholds are predictors of declining nerve integrity. Increasing t-EMG thresholds, while predictive of injury, were also observed in a large number of patients without iatrogenic injury, with a greater predictive value in cases with extended duration. In addition to a careful approach with minimal muscle retraction and consistent lumbar plexus directional retraction, the incidence of postoperative motor neuropraxia may be reduced by limiting retraction time and utilizing t-EMG throughout retraction, while understanding that the specificity of this monitoring technique is low during initial retraction and increases with longer retraction duration.

Lumbarized sacrum as a relative contraindication for lateral transpsoas interbody fusion at L5-6.

STUDY DESIGN: Retrospective review. OBJECTIVE: To determine if lumbarized sacra at the L5-6 level (functional L4-5) are a contraindication to a lateral transpsoas approach. SUMMARY OF BACKGROUND DATA: Transitional vertebrae at the lumbosacral junction present mechanical and morphologic changes, though these changes have not been characterized with respect to the feasibility of a lateral transpsoas approach. METHODS: Three hundred fifty-one patients were scheduled for lumbar interbody fusion using a mini-open lateral transpsoas approach (XLIF) at L4-5 from 2004 to 2008 at a single institution. In patients with 6 lumbar vertebrae, accessibility, based on neuromonitoring, of the L5-6 level (functional L4-5) was reviewed. Qualitative assessments using axial magnetic resonance imaging (MRI) were performed and compared with a sample of patients with normal anatomy treated at L4-5. RESULTS: Of the 351 patients scheduled for treatment at L4-5, 10 (2.8%) were determined to have 6 lumbar vertebrae with the symptomatic level at L5-6. Of those 10, 2 (20%) could be treated using a lateral transpsoas approach, and 8 (80%) were converted to another approach after a corridor through the psoas muscle was not found, based on neuromonitoring feedback. Review of axial MRI showed a teardrop-shaped psoas detached from the lateral border of the disc space in patients with transitional anatomy unapproachable at L5-6, resemblant of L5-S1 in normal anatomy. In the 2 patients who could be safely approached, the psoas anatomy at L5-6 was similar to a normal L4-5 level, with a domed/helmet shape, attached laterally to the disc space. CONCLUSIONS: Treating the L5-6 level using a lateral transpsoas approach in individuals with lumbarized sacra can be challenging due to anatomy more similar to the L5-S1 level in normal patients. Preoperative planning using axial MRI and intraoperative adherence to advanced neuromonitoring can aid in identifying and avoiding injury in these rare patients.

Outcomes of posterior cervical fusion and decompression: a systematic review and meta-analysis.

BACKGROUND CONTEXT: Posterior cervical fusion (PCF) with decompression is a treatment option for patients with conditions such as spondylosis, spinal stenosis, and degenerative disc disorders that result in myelopathy or radiculopathy. The annual rate, number, and cost of PCF in the United States has increased. Far fewer studies have been published on PCF outcomes than on anterior cervical fusion (ACF) outcomes, most likely because far fewer PCFs than ACFs are performed. PURPOSE: To evaluate the patient-reported and clinical outcomes of adult patients who underwent subaxial posterior cervical fusion with decompression. STUDY DESIGN/SETTING: Systematic review and meta-analysis. PATIENT SAMPLE: The total number of patients in the 31 articles reviewed and included in the meta-analysis was 1,238 (range 7-166). OUTCOME MEASURES: Preoperative to postoperative change in patient-reported outcomes (visual analog scales for arm pain and neck pain, Neck Disability Index, Japanese Orthopaedic Association [JOA] score, modified JOA score, and Nurick pain scale) and rates of fusion, revision, and complications or adverse events. METHODS: This study was performed according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and a preapproved protocol. PubMed and Embase databases were searched for articles published from January 2001 through July 2018. Statistical analyses for patient-reported outcomes were performed on the outcomes' raw mean differences, calculated as postoperative value minus preoperative value from each study. Pooled rates of successful fusion, revision surgery, and complications or adverse events, and their 95% confidence intervals, were also calculated. Two subgroup analyses were performed: one for studies in which only myelopathy or radiculopathy (or both) were stated as surgical indications and the other for studies in which only myelopathy or ossification of the posterior longitudinal ligament (or both) were stated as surgical indications. This study was funded by Providence Medical Technology, Inc. ($32,000). RESULTS: Thirty-three articles were included in the systematic review, and 31 articles were included in the meta-analysis. For all surgical indications and for the 2 subgroup analyses, every cumulative change in patient-reported outcome improved. Many of the reported changes in patient-reported outcome also exceeded the minimal clinically important differences. Pooled outcome rates with all surgical indications were 98.25% for successful fusion, 1.09% for revision, and 9.02% for complications or adverse events. Commonly reported complications or adverse events were axial pain, C5 palsy, transient neurological worsening, and wound infection. CONCLUSIONS: Posterior cervical fusion with decompression resulted in significant clinical improvement, as indicated by the changes in patient-reported outcomes. Additionally, high fusion rates and low rates of revision and of complications and adverse events were found.

Complications and Risk Factors Using Structural Allograft Versus Synthetic Cage: Analysis 17 783 Anterior Cervical Discectomy and Fusions Using a National Registry.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To determine the rates of perioperative complications in patients undergoing anterior cervical discectomy and fusion (ACDF) with allograft versus synthetic cage. METHODS: A large national administrative health care database was queried for ACDF procedures performed between 2007 and 2014 using ICD-9 (International Statistical Classification of Diseases, 9th revision) and CPT (Current Procedural Terminology) codes. Cases that utilized structural allograft and synthetic cages were identified via CPT codes. Gender, age, frequency of obesity, cigarette use, diabetes, and number of levels fused were compared between the 2 cohorts using χ2 test. Complications within 90 days were identified via ICD-9 codes and compared between the 2 cohorts. Revision rates within 2 years were noted. RESULTS: A total of 10 648 ACDF cases using synthetic cages and 7135 ACDFs using structural allograft were identified. The demographics between the 2 cohorts were similar. Overall complication rate was 8.71% in the synthetic cage group compared with 7.76% in the structural allograft group (P < .01). Use of synthetic cage was associated with higher rate of respiratory complications, 0.57% compared with 0.31% in the structural allograft cohort (P = .03), while use of structural allograft was associated with a higher rate of dysphagia, 0.64% compared with 0.33% (P < .01). Revision rate at 2 years was 0.50% and 0.56% in the synthetic cage and allograft groups, respectively (P = .03). CONCLUSIONS: This data suggests that synthetic cages are associated with a marginally higher overall rate of complications with similar revision rates.

Allograft Versus Demineralized Bone Matrix in Instrumented and Noninstrumented Lumbar Fusion: A Systematic Review.

STUDY DESIGN: Systematic review. OBJECTIVES: The aim was to determine the fusion efficacy of allograft and demineralized bone matrix (DBM) in lumbar instrumented and noninstrumented fusion procedures for degenerative lumbar disorders. METHODS: A literature search was conducted using the PubMed and Cochrane databases. To be considered, publications had to meet 4 criteria: patients were treated for a degenerative lumbar disorder, a minimum group size of 10 patients, use of allograft or DBM, and at least a 2-year follow-up. Data on the study population, follow-up time, surgery type, grafting material, fusion rates, and its definition were collected. RESULTS: The search yielded 692 citations with 17 studies meeting the criteria including 4 retrospective and 13 prospective studies. Six studies used DBM and 11 employed allograft alone or in the combination with autograft. For the allograft, fusion rates ranged from 58% to 68% for noninstrumented and from 68% to 98% for instrumented procedures. For DBM, fusion rates were 83% for noninstrumented and between 60% and 100% for instrumented lumbar fusion procedures. CONCLUSIONS: Both allograft and DBM appeared to provide similar fusion rates in instrumented fusions. On the other hand, in noninstrumented procedures DBM was superior. However, a large variation in the type of surgery, outcomes collection, lack of control groups, and follow-up time prevented any significant conclusions. Thus, studies comparing the performance of allograft and DBM to adequate controls in large, well-defined patient populations and with a sufficient follow-up time are needed to establish the efficacy of these materials as adjuncts to fusion.

Trends and Costs of Anterior Cervical Discectomy and Fusion: a Comparison of Inpatient And Outpatient Procedures.

Study Design: Epidemiologic Study. Objectives: To identify the trends in utilization of outpatient discharge for single level anterior cervical discectomy and fusion (ACDF), between 2007 and 2014, and to compare the costs and incidence of complications against a cohort of inpatients. Methods: We retrospectively reviewed 18,386 patients from the PearlDiver database from between 2007 and 2014. Discharge status was determined from billing codes. The total cost of all procedures and diagnostic tests, was determined for the global period from the time of diagnosis up until 90-days post-operatively, and the incidence of complications was recorded for 30-days. Results: The proportion of outpatient discharges was stable around 20% from 2007 to 2014 (range17-23%). The mean 90-day cost was lower for outpatients ($39,528 v. $47,330) but reimbursement fell nearly 1/3 from 2007-2014 for both groups, and the difference between the two narrowed over time ($13,745 difference in 2008, to $3,834 in 2014). Outpatients had a lower incidence of overall 30-day complications (9.5% v. 18.6%, p<0.0001), but were also significantly less comorbid (mean Charlson comorbidity index 2.32 v. 3.85, p<0.001). Older patient age, obesity, cardiac, renal, and pulmonary comorbidity were each more common in the inpatients (p<0.05 for each). Conclusions: Outpatient discharge after ACDF is a viable treatment option with a reasonable safety profile and decreased costs relative to inpatient admission. Appropriate patient selection is key, and the standard of care nationally for the comorbid patient remains inpatient admission. The economic trends and epidemiologic data presented here should be useful for health policy decisions.

A Multicenter Radiographic Evaluation of the Rates of Preoperative and Postoperative Malalignment in Degenerative Spinal Fusions.

STUDY DESIGN: Multicenter, retrospective, institutional-review-board -approved study at 18 institutions in the United States with 24 treating investigators. OBJECTIVE: This study was designed to retrospectively assess the prevalence of spinopelvic malalignment in patients who underwent one- or two-level lumbar fusions for degenerative (nondeformity) indications and to assess the incidence of malalignment after fusion surgery as well as the rate of alignment preservation and/or correction in this population. SUMMARY OF BACKGROUND DATA: Spinopelvic malalignment after lumbar fusion has been associated with lower postoperative health-related quality of life and elevated risk of adjacent segment failure. The prevalence of spinopelvic malalignment in short-segment degenerative lumbar fusion procedures from a large sample of patients is heretofore unreported and may lead to an under-appreciation of these factors in surgical planning and ultimate preservation or correction of alignment. METHODS: Lateral preoperative and postoperative lumbar radiographs were retrospectively acquired from 578 one- or two-level lumbar fusion patients and newly measured for lumbar lordosis (LL), pelvic incidence (PI), and pelvic tilt. Patients were categorized at preop and postop time points as aligned if PI-LL < 10° or malaligned if PI-LL≥10°. Patients were grouped into categories based on their alignment progression from pre- to postoperative, with preserved (aligned to aligned), restored (malaligned to aligned), not corrected (malaligned to malaligned), and worsened (aligned to malaligned) designations. RESULTS: Preoperatively, 173 (30%) patients exhibited malalignment. Postoperatively, 161 (28%) of patients were malaligned. Alignment was preserved in 63%, restored in 9%, not corrected in 21%, and worsened in 7% of patients. CONCLUSION: This is the first multicenter study to evaluate the preoperative prevalence and postoperative incidence of spinopelvic malalignment in a large series of short-segment degenerative lumbar fusions, finding over 25% of patients out of alignment at both time points, suggesting that alignment preservation/restoration considerations should be incorporated into the decision-making of even degenerative lumbar spinal fusions. LEVEL OF EVIDENCE: 3.

Trends Analysis of rhBMP2 Utilization in Single-Level Anterior Lumbar Interbody Fusion in the United States.

STUDY DESIGN: Retrospective case study. OBJECTIVE: To evaluate the trends and demographics of recombinant human bone morphogenetic protein 2 (rhBMP2) utilization in single-level anterior lumbar interbody fusion (ALIF) in the United States. METHODS: Patients who underwent single-level ALIF from 2005 to 2011 were identified by searching ICD-9 diagnosis and procedure codes in the PearlDiver Patient Records Database (PearlDiver Technologies, Fort Wayne, IN), a national database of orthopedic insurance records. The year of procedure, age, gender, and region of the United States were analyzed for each patient. RESULTS: A total of 921 patients were identified who underwent a single-level ALIF in this study. The average rate of single-level ALIF with rhBMP2 utilization increased (35%-48%) from 2005 to 2009, but sharply decreased to 16.7% in 2010 and 15.0% in 2011. The overall incidence of single-level ALIF without rhBMP2 (0.20 cases per 100 000 patients) was more than twice of the incidence of single-level ALIF with rhBMP2 (0.09 cases per 100 000 patients). The average rate of single-level ALIF with rhBMP2 utilization is highest in West (41.4%), followed by Midwest (33.3%), South (26.5%) and Northeast (22.2%). The highest incidence of single-level ALIF with rhBMP2 was observed in the group aged less than 65 years (compared with any other age groups, P < .001), with an incidence of 0.21 per 100 000 patients. CONCLUSIONS: The incidence of rhBMP2 utilization in single-level ALIF increased from 2006 to 2009, but decreased in 2010 and 2011. The Northeast region had the lowest incidence of rhBMP2 utilization. The group aged less than 65 years trended to have the higher incidence of single-level ALIF with rhBMP2 utilization.

Postoperative Complications Associated With rhBMP2 Use in Posterior/Posterolateral Lumbar Fusion.

STUDY DESIGN: Retrospective database review. OBJECTIVE: Posterior/posterolateral lumbar fusion (PLF) is an effective treatment for a variety of spinal disorders; however, variations in surgical technique have different complication profiles. The aim of our study was to quantify the frequency of various complications in patients undergoing PLF with and without human recombinant bone morphogenetic protein 2 (rhBMP2). METHODS: We queried the orthopedic subset of the Medicare database (PearlDiver) between 2005 and 2011 for patients undergoing PLF procedures with and without rhBMP2. Complication and reoperation rates were analyzed within 1 year of the index procedure. Complications assessed include: acute renal failure, deep vein thrombosis, dural tear, hematoma, heterotopic ossification, incision and drainage, cardiac complications, nervous system complications, osteolysis, pneumonia, pseudarthrosis, pulmonary embolism, radiculopathy, respiratory complications, sepsis, urinary retention, urinary tract infection, mechanical, and wound complications. Chi-square analysis was used to calculate the complication differences between the groups. RESULTS: Our data revealed higher overall complication rates in patients undergoing PLF with rhBMP2 versus no_rhBMP2 (76.9% vs 68.8%, P < .05). Stratified by gender, rhBMP2 males had higher rates of mechanical complications, pseudarthrosis, and reoperations compared with no_rhBMP2 males (P < .05), whereas rhBMP2 females had higher rates of pseudarthrosis, urinary tract infection, and urinary retention compared with no_rhBMP2 females (P < .05). CONCLUSION: Our data revealed higher overall complication rates in PLF patients given rhBMP2 compared with no_rhBMP2. Furthermore, our data suggests that rhBMP2-associated complications may be gender specific.

Intrawound Vancomycin Decreases the Risk of Surgical Site Infection After Posterior Spine Surgery: A Multicenter Analysis.

STUDY DESIGN: Secondary analysis of data from a prospective multicenter observational study. OBJECTIVE: The aim of this study was to evaluate the occurrence of surgical site infection (SSI) in patients with and without intrawound vancomycin application controlling for confounding factors associated with higher SSI after elective spine surgery. SUMMARY OF BACKGROUND DATA: SSI is a morbid and expensive complication associated with spine surgery. The application of intrawound vancomycin is rapidly emerging as a solution to reduce SSI following spine surgery. The impact of intrawound vancomycin has not been systematically studied in a well-designed multicenter study. METHODS: Patients undergoing elective spine surgery over a period of 4 years at seven spine surgery centers across the United States were included in the study. Patients were dichotomized on the basis of whether intrawound vancomycin was applied. Outcomes were occurrence of SSI within postoperative 30 days and SSI that required return to the operating room (OR). Multivariable random-effect log-binomial regression analyses were conducted to determine the relative risk of having an SSI and an SSI with return to OR. RESULTS: .: A total of 2056 patients were included in the analysis. Intrawound vancomycin was utilized in 47% (n = 966) of patients. The prevalence of SSI was higher in patients with no vancomycin use (5.1%) than those with use of intrawound vancomycin (2.2%). The risk of SSI was higher in patients in whom intrawound vancomycin was not used (relative risk (RR) -2.5, P < 0.001), increased number of levels exposed (RR -1.1, P = 0.01), and those admitted postoperatively to intensive care unit (ICU) (RR -2.1, P = 0.005). Patients in whom intrawound vancomycin was not used (RR -5.9, P < 0.001), increased number of levels were exposed (RR-1.1, P = 0.001), and postoperative ICU admission (RR -3.3, P < 0.001) were significant risk factors for SSI requiring a return to the OR. CONCLUSION: The intrawound application of vancomycin after posterior approach spine surgery was associated with a reduced risk of SSI and return to OR associated with SSI. LEVEL OF EVIDENCE: 2.

Internet-based reference case managers for clinical practice and research collaboration.

Historically in medicine, the internet has been used for unidirectional information extraction via search engines that provide database and literature output. Current Web-based case managers allow submission and reception of digital media and have been used to link specialists and provide forums for rapid, bidirectional information sharing.

Trends and Cost of Posterior Cervical Fusions With and Without Recombinant Human Bone Morphogenetic Protein-2 in the US Medicare Population.

STUDY DESIGN: Retrospective database review. OBJECTIVE: To analyze and report the trends and cost of posterior cervical fusions (PCFs) with and without off-label recombinant human bone morphogenetic protein-2 (rhBMP-2) in the Medicare population. METHODS: Patient records from the PearlDiver database were retrospectively reviewed from January 1, 2005, to December 31, 2012, to distinguish individuals who underwent a PCF with or without rhBMP-2. Total numbers, incidence, age, gender, geographic region, reimbursement, and length of stay were analyzed and summarized. RESULTS: The combined total of non-rhBMP-2 (n = 39 479; 85.51%) and rhBMP-2 PCF (n = 6692; 14.49%) procedures performed between 2005 and 2012 was 46 171. In general, the number of PCFs without rhBMP-2 consistently increased over time, while the number of PCFs with rhBMP-2 had only a slight increase from 2005 to 2012. On average, PCFs without rhBMP-2 were associated with $1197 higher cost than those with rhBMP-2, but the average length of stay was similar (6 days). From 2005 to 2012, the average cost for procedures with and without rhBMP-2 increased by $12 605 and $7291, respectively. The percentage of rhBMP-2 use peaked in 2007 and dwindled until 2010, and declined an additional 2.84% from 2011 to 2012. Multiple age, region, and gender tendencies were observed. CONCLUSIONS: To our knowledge, this was the first study to use the PearlDiver database to report incidence and cost trends of PCF procedures. This article provides meaningful trend data on PCFs to surgeons and clinicians, researchers, and patients, as well as functions as a beacon for future research questions.

Autograft versus Allograft for Cervical Spinal Fusion: A Systematic Review.

STUDY DESIGN: Systematic review. OBJECTIVE: To compare the effectiveness and safety between iliac crest bone graft (ICBG), non-ICBG autologous bone, and allograft in cervical spine fusion. To avoid problems at the donor site, various allograft materials have been used as a substitute for autograft. However, there are still questions as to the comparative effectiveness and safety of cadaver allograft compared with autologous ICBG. METHODS: A systematic search of multiple major medical reference databases was conducted to identify studies evaluating spinal fusion in patients with cervical degenerative disk disease using ICBG compared with non-ICBG autograft or allograft or non-ICBG autograft compared with allograft in the cervical spine. Radiographic fusion, patient-reported outcomes, and functional outcomes were the primary outcomes of interest. Adverse events were evaluated for safety. RESULTS: The search identified 13 comparative studies that met our inclusion criteria: 2 prospective cohort studies and 11 retrospective cohort studies. Twelve cohort studies compared allograft with ICBG autograft during anterior cervical fusion and demonstrated with a low evidence level of support that there are no differences in fusion percentages, pain scores, or functional results. There was insufficient evidence comparing patients receiving allograft with non-ICBG autograft for fusion, pain, revision, and functional and safety outcomes. No publications directly comparing non-ICBG autograft with ICBG were found. CONCLUSION: Although the available literature suggests ICBG and allograft may have similar effectiveness in terms of fusion rates, pain scores, and functional outcomes following anterior cervical fusion, there are too many limitations in the available literature to draw any significant conclusions. No individual study provided greater than class III evidence, and when evaluating the overall body of literature, no conclusion had better than low evidence support. A prospective randomized trial with adequate sample size to compare fusion rates, efficacy measures, costs, and safety is warranted.

Trends, Costs, and Complications of Anterior Cervical Discectomy and Fusion With and Without Bone Morphogenetic Protein in the United States Medicare Population.

STUDY DESIGN: Retrospective database review. OBJECTIVES: After the Food and Drug Administration approved bone morphogenetic protein-2 (BMP) in 2002, BMP was used off-label in the cervical spine to increase bone growth and bony fusion. Since then, concerns have been raised regarding complication rates and safety. This study was conducted to examine the use of BMP in anterior cervical discectomy and fusion (ACDF) in the Medicare population and to determine risk of complications and associated costs within 90 days of surgery. METHODS: Patients who underwent ACDF were identified using Current Procedural Terminology (CPT) and International Classification of Diseases, Ninth Revision Procedure codes (ICD9-P). Complications were identified using ICD9 diagnostic codes. Charges were calculated as amount billed, and reimbursements were calculated as amounts paid by Medicare. Data for these analyses came from a nationwide claims database. RESULTS: A total of 215 047 patients were identified who had ACDF from 2005 to 2011. For the majority of the procedures (89.0%), BMP was not used. BMP use rose from 11.84% in 2005 to a peak of 16.73% in 2007 before decreasing to 12.01% in 2011. BMP was used 16% more in women than men. BMP use was the highest in the West (13.6%) followed by Midwest (11.8%), South (10.6%), and Northeast (7.5%). There was a higher overall complication rate in the BMP group (2.1%) compared with the non-BMP group (1.9%) (odds ratio [OR] = 1.11, 95% CI = 1.01-1.22). The BMP group also had a higher rate of wound complications (0.98% vs 0.76%, OR = 1.29, 95% CI = 1.12-1.48). In this study population, there was no difference in dysphagia/hoarseness, neurologic, medical, or other complications. During the 90-day perioperative period, BMP surgeries were charged at 17.6% higher than non-BMP surgeries. CONCLUSIONS: The use of BMP in ACDF in the Medicare population has decreased since a peak in 2007. The rate of wound and overall complications for BMP use with ACDF was higher than without. Our results regarding dysphagia/hoarseness did not show a statistically meaningful difference, which is in contrast with many other studies. Charges associated with BMP use were higher during the 90-day perioperative period.

Trends Analysis of rhBMP Utilization in Single-Level Posterior Lumbar Interbody Fusion in the United States.

STUDY DESIGN: Retrospective study. OBJECTIVES: Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been widely used in spinal fusion surgery, but there is little information on rhBMP-2 utilization in single-level posterior lumbar interbody fusion (PLIF). The purpose of our study was to evaluate the trends and demographics of rhBMP-2 utilization in single-level PLIF. METHODS: Patients who underwent single-level PLIF from 2005 to 2011 were identified by searching ICD-9 diagnosis and procedure codes in the PearlDiver Patient Records Database, a national database of orthopedic insurance records. The year of procedure, age, gender, and region of the United States were recorded for each patient. Results were reported for each variable as the incidence of procedures identified per 100 000 patients searched in the database. RESULTS: A total of 2735 patients had single-level PLIF. The average rate of single-level PLIF with rhBMP-2 maintained at a relatively stable level (28% to 31%) from 2005 to 2009, but decreased in 2010 (9.9%) and 2011 (11.8%). The overall incidence of single-level PLIF without rhBMP-2 (0.68 cases per 100 000 patients) was statistically higher (P < .01) compared to single-level PLIF with rhBMP-2 (0.21 cases per 100 000 patients). The average rate of single-level PLIF with rhBMP-2 utilization was the highest in West (30.1%), followed by Midwest (26.9%), South (20.5%), and Northeast (17.8%). The highest incidence of single-level PLIF with rhBMP-2 was observed in the age group <65 years (0.3 per 100 000 patients). CONCLUSIONS: To our knowledge, this is the first study to report on the demographics associated with rhBMP-2 use in single-level PLIF. There was a 3-fold increase in the rate of PLIF without rhBMP-2 compared to PLIF with rhBMP-2, with both procedures being mainly done in patients less than 65 years of age.

A Retrospective Analysis of Complications Associated With Bone Morphogenetic Protein 2 in Anterior Lumbar Interbody Fusion.

STUDY DESIGN: Retrospective review. OBJECTIVE: The aim of our study was to quantify the frequency of complications associated with recombinant human bone morphogenetic protein 2 (rhBMP-2) use in anterior lumbar interbody fusion (ALIF). METHODS: The orthopedic subset of the Medicare database (PearlDiver) was queried for this retrospective cohort study using International Statistical Classification of Diseases 9 (ICD-9) and Current Procedure Terminology (CPT) codes for ALIF procedures with and without rhBMP-2 between 2005 and 2010. Frequencies of complications and reoperations were then identified within 1 year from the index procedure. Complications included reoperations, pulmonary embolus, deep vein thrombosis, myocardial infarction, nerve-related complications, incision and drainage procedures, wound, sepsis, pneumonia, urinary tract infections, respiratory, heterotopic ossification, retrograde ejaculation, radiculopathy, and other medical complications. Odds ratios (ORs) and 95% confidence intervals (CIs) were used to assess the statistical significance. RESULTS: We identified a total of 41 865 patients who had an ALIF procedure. A total of 14 384 patients received rhBMP-2 while 27 481 did not. Overall, 6016 (41.8%) complications within 1 year from surgery were noted within the group who received rhBMP-2 and 12 950 (47.1%) complications within 1 year from surgery were recorded in those who did not receive rhBMP-2 (OR = 0.81, CI = 0.77-0.84). Overall, exposure to rhBMP-2 was associated with significantly decreased odds of complications with exception to reoperation rates (0.9% rhBMP-2 vs 1.0% no rhBMP-2; OR = 0.88, CI = 0.71-1.09) and radiculopathy (4.4% rhBMP-2 vs 4.3% no rhBMP-2; OR = 1.02, CI = 0.93-1.13). CONCLUSIONS: The use of rhBMP-2 in patients undergoing ALIF procedure was associated with a significantly decreased rate of complications. Further studies are needed to elucidate a true incidence of complication.

Complication Rates in Posterior Lumbar Interbody Fusion (PLIF) Surgery With Human Bone Morphogenetic Protein 2: Medicare Population.

STUDY DESIGN: Retrospective cohort study among Medicare beneficiaries who underwent posterior lumbar interbody fusion (PLIF) surgery. OBJECTIVE: To identify the complication rates associated with the use of bone morphogenetic protein 2 (BMP2) in PLIF. Human BMP2 is commonly used in the "off-label" manner for various types of spine fusion procedures, including PLIF. However, recent studies have reported potential complications associated with the recombinant human BMP2 (rhBMP2) use in the posterior approach. METHODS: Medicare records within the PearlDiver database were queried for patients undergoing PLIF procedure with and without rhBMP2 between 2005 and 2010. We evaluated complications within 1 year postoperatively. Chi-square was used to compare the complication rates between the 2 groups. RESULTS: A total of 8609 patients underwent PLIF procedure with or without rhBMP2. Individual complication rates in the rhBMP2 group ranged from 0.45% to 7.68% compared with 0.65% to 10.99 in the non-rhBMP2 group. Complication rates for cardiac, pulmonary, lumbosacral neuritis, infection, wound, and urinary tract (include acute kidney failure and post-operative complications) were significantly lower in the rhBMP2 group (P < .05). There was no difference in the rates of central nervous system complications or radiculitis between the 2 groups. CONCLUSION: Our data showed that the patients who received rhBMP2 had lower complication rates compared to the non-rhBMP2 group. However, use of rhBMP2 was associated with a higher rate of pseudarthrosis. We did not observe any difference in radiculitis and central nervous system complications between the groups.

ACDF Graft Selection by Surgeons: Survey of AOSpine Members.

STUDY DESIGN: Cross-sectional survey study. OBJECTIVE: To determine what are the most commonly used graft materials in anterior cervical discectomy and fusion and whether the choice of graft is affected by surgeon's training, years in practice, geographic location, practice setting, or surgeon's perceived difficulty in achieving fusion. METHODS: A 23-question survey was sent out to 5334 surgeons using the Global AO Spine database. Response data was then stratified into surgeon training, years of practice, practice type, and global region. RESULTS: Overall, surgeons believe that graft selection affects fusion rates (89.3% of surgeons) and affects time to fusion (86.0% of surgeons). The use of a cage is currently the most common structural graft component used worldwide at 64.1%. Of surgeons that use cages, the PEEK Cage makes up 84%. North American surgeons differ from this global trend and use composite allograft more commonly. The choice to add a nonstructural graft component was reported at 74%. This result was similar for performing multilevel fusions at 72.8%. The selection of nonstructural graft material depends on whether the type of surgery is considered simple or complex. Most surgeons are not satisfied with available literature comparing effectiveness of grafts but believed that there was sufficient evidence to support the use of their chosen graft. CONCLUSION: Almost all surgeons believe that fusion is important to anterior cervical discectomy and fusion surgery outcomes and that most surgeons believe graft choice affects fusion. However, this survey indicates that there is great variability in the type of graft material used by spine surgeons across the world.

Complications Related to the Recombinant Human Bone Morphogenetic Protein 2 Use in Posterior Cervical Fusion.

STUDY DESIGN: A retrospective cohort study. OBJECTIVE: To compare the complications between posterior cervical fusions with and without recombinant human bone morphogenetic protein 2 (rhBMP2). SUMMARY OF BACKGROUND DATA: Use of rhBMP2 in anterior cervical spinal fusion procedures can lead to potential complications such as neck edema, resulting in airway complications or neurological compression. However, there are no data on the complications associated with the "off-label" use of rhBMP2 in upper and lower posterior cervical fusion approaches. MATERIALS AND METHODS: Patients from the PearlDiver database who had a posterior cervical fusion between 2005 and 2011 were identified. We evaluated complications within 90 days after fusion and data was divided in 2 groups: (1) posterior cervical fusion including upper cervical spine O-C2 (upper group) and (2) posterior cervical fusion including lower cervical spine C3-C7 (lower group). Complications were divided into: any complication, neck-related complications, wound-related complications, and other complications. RESULTS: Of the 352 patients in the upper group, 73 patients (20.7%) received rhBMP2, and 279 patients (79.3%) did not. Likewise, in the lower group of 2372 patients, 378 patients (15.9%) had surgery with rhBMP2 and 1994 patients (84.1%) without. In the upper group, complications were observed in 7 patients (9.6%) with and 34 patients (12%) without rhBMP2. In the lower group, complications were observed in 42 patients (11%) with and 276 patients (14%) without rhBMP2. Furthermore, in the lower group the wound-related complications were significantly higher in the rhBMP2 group (23 patients, 6.1%) compared with the non-rhBMP2 group (75 patients, 3.8%). CONCLUSIONS: Our data showed that the use of rhBMP2 does not increase the risk of complications in upper cervical spine fusion procedures. However, in the lower cervical spine, rhBMP2 may elevate the risk of wound-related complications. Overall, there were no major complications associated with the use of rhBMP2 for posterior cervical fusion approaches. LEVEL OF EVIDENCE: Level III.

Preservation or Restoration of Segmental and Regional Spinal Lordosis Using Minimally Invasive Interbody Fusion Techniques in Degenerative Lumbar Conditions: A Literature Review.

STUDY DESIGN: A literature review. OBJECTIVE: The purpose of this study was to review lumbar segmental and regional alignment changes following treatment with a variety of minimally invasive surgery (MIS) interbody fusion procedures for short-segment, degenerative conditions. SUMMARY OF BACKGROUND DATA: An increasing number of lumbar fusions are being performed with minimally invasive exposures, despite a perception that minimally invasive lumbar interbody fusion procedures are unable to affect segmental and regional lordosis. METHODS: Through a MEDLINE and Google Scholar search, a total of 23 articles were identified that reported alignment following minimally invasive lumbar fusion for degenerative (nondeformity) lumbar spinal conditions to examine aggregate changes in postoperative alignment. RESULTS: Of the 23 studies identified, 28 study cohorts were included in the analysis. Procedural cohorts included MIS ALIF (two), extreme lateral interbody fusion (XLIF) (16), and MIS posterior/transforaminal lumbar interbody fusion (P/TLIF) (11). Across 19 study cohorts and 720 patients, weighted average of lumbar lordosis preoperatively for all procedures was 43.5° (range 28.4°-52.5°) and increased 3.4° (9%) (range -2° to 7.4°) postoperatively (P < 0.001). Segmental lordosis increased, on average, by 4° from a weighted average of 8.3° preoperatively (range -0.8° to 15.8°) to 11.2° at postoperative time points (range -0.2° to 22.8°) (P < 0.001) in 1182 patient from 24 study cohorts. Simple linear regression revealed a significant relationship between preoperative lumbar lordosis and change in lumbar lordosis (r = 0.413; P = 0.003), wherein lower preoperative lumbar lordosis predicted a greater increase in postoperative lumbar lordosis. CONCLUSION: Significant gains in both weighted average lumbar lordosis and segmental lordosis were seen following MIS interbody fusion. None of the segmental lordosis cohorts and only two of the 19 lumbar lordosis cohorts showed decreases in lordosis postoperatively. These results suggest that MIS approaches are able to impact regional and local segmental alignment and that preoperative patient factors can impact the extent of correction gained (preserving vs. restoring alignment). LEVEL OF EVIDENCE: 4.