Radiographic Risk Factors for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion (ACDF): A Systematic Review and Meta-Analysis.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVES: To assess the radiographic risk factors for adjacent segment disease (ASD) following anterior cervical discectomy and fusion (ACDF) for degenerative cervical spine pathologies. METHODS: PubMed, Embase and the Cochrane Library databases were searched up to December 2023. The primary inclusion criteria were degenerative spinal conditions treated with ACDF, comparing radiological parameters in patients with and without postoperative ASD. The radiographic parameters included intervertebral disc height, cervical sagittal alignment, sagittal segmental alignment, range of motion, segmental height, T1 slope, sagittal vertical axis (SVA), thoracic inlet angle (TIA), and plate to disc distance (PPD). Risk of bias was assessed for all studies. The Cochrane Review Manager was utilized to perform the meta-analysis. RESULTS: From 7044 articles, 13 retrospective studies were included in the final analysis. Three studies had "not serious" bias and the other 10 studies had serious or very serious bias. The total number of patients in the included studies was 1799 patients. Five studies included single-level ACDF, 2 studies included multi-level ACDF, and 6 studies included single or multi-level ACDF. On meta-analysis, the significant risk factors associated with ASD development were reduced postoperative cervical lordosis (mean difference [MD] = 3.35°, P = .002), reduced last-follow-up cervical lordosis (MD = -3.02°, P = .0003), increased preoperative to postoperative cervical sagittal alignment change (MD = -3.68°, P = .03), and the presence of developmental cervical canal stenosis (Odds ratio [OR] = 4.17, P < .001). CONCLUSIONS: Decreased postoperative cervical lordosis, greater change in cervical sagittal alignment and developmental cervical canal stenosis were associated with an increased risk of ASD following ACDF.

Clinical risk factors associated with the development of adjacent segment disease in patients undergoing ACDF: A systematic review.

BACKGROUND CONTEXT: Cervical fusion for degenerative disorders carries a known risk of adjacent segment disease (ASD), a complication that often requires surgical intervention to relieve symptoms. Proposed risk factors for development of ASD include both clinical and radiographic patient characteristics. However, the true impact of these risk factors is less understood due to limitations in sample sizes and loss to follow-up in individual studies. PURPOSE: To review and critically examine current literature on the clinical risk factors associated with development of ASD in the cervical spine following ACDF. STUDY DESIGN: Systematic Review and Meta-Analysis. METHODS: We systematically reviewed the literature in December 2019 according to the PRISMA guidelines. Methodological quality of included papers and quality of evidence were evaluated according to MINORS and GRADE framework. Meta-analysis was performed to compute the odds ratio(OR)with corresponding 95% confidence interval(CI)for dichotomous data, and mean difference(MD) with 95% CI for continuous variables. RESULTS: 6,850 records were obtained using database query. Title/abstract screening resulted in 19 articles for full review, from which 10 papers met the criteria for analysis. There were no significant differences in gender (OR 0.99, 95% CI 0.75-1.30), BMI (MD -0.09, 95% CI -0.46 to 0.29), smoking (OR 1.13, 95% CI 0.80-1.59), alcohol (OR 1.07, 95% CI 0.70-1.64), diabetes (OR 0.85, 95% CI 0.56-1.31), number of segments fused (OR 0.86, 95% CI 0.64-1.16), and preoperative JOA (MD -0.50, 95% CI -1.04 to 0.04). Age (MD 3.21, 95% CI 2.00-4.42), congenital/developmental stenosis (OR 1.94, 95% CI 1.06-3.56), preoperative NDI (MD 4.18, 95% CI 2.11 to 6.26), preoperative VAS (neck) (MD 0.54 95% CI 0.09-0.99), and preoperative VAS (arm) (MD 0.98, 95% CI 0.43-1.34) were found to be statistically significant risk factors. CONCLUSION: Patients with congenital stenosis, advanced age, and high preoperative NDI are at increased risk of developing ASD.

Novel Methods to Measure Height and Volume in Healthy and Degenerated Lumbar Discs in MRIs: A Reliability Assessment Study.

BACKGROUND: In the regeneration and therapy of degenerated intervertebral discs, the height, volume or categorizing assessments, such as Pfirrmann classification, are used to quantify the discs themselves and the effects of therapy. Here, the question of transferability, in the sense of reliability, of the results arises in the common exchange. METHODS: We have investigated two established and a newly developed (9-point measurement), easy to use methods for height measurement and volume measurement on degenerated and healthy lumbar intervertebral discs of 66 patients regarding inter- and intra-observer reliability. RESULTS: In overview, we found very different reliabilities. While the intra-observer reliability showed good to excellent agreement for both healthy and degenerated lumbar discs for the height and volume measurements, the inter-observer reliability was low or moderate in some cases. The 9-point method for height determination consistently showed better reliability for both healthy and degenerated discs, for both intra- and inter-observer reliability, compared to the two established methods. CONCLUSIONS: We recommend using the 9-point measurement as the method to communicate lumbar disc height, both for healthy and degenerated discs. Due to the partly low or moderate reliability, significant differences in the measured heights can already occur, which can lead to a worsened comparability.

Demographic, clinical, and operative risk factors associated with postoperative adjacent segment disease in patients undergoing lumbar spine fusions: a systematic review and meta-analysis.

BACKGROUND CONTEXT: Adjacent segment disease (ASD) is a potential complication following lumbar spinal fusion. PURPOSE: This study aimed to demonstrate the demographic, clinical, and operative risk factors associated with ASD development following lumbar fusion. STUDY DESIGN/SETTING: Systematic review and meta-analysis. PATIENT SAMPLE: We identified 35 studies that reported risk factors for ASD, with a total number of 7,374 patients who had lumbar spine fusion. OUTCOME MEASURES: We investigated the demographic, clinical, and operative risk factors for ASD after lumbar fusion. METHODS: A literature search was done using PubMed, Embase, Medline, Scopus, and the Cochrane library databases from inception to December 2019. The methodological index for non-randomized studies (MINORS) criteria was used to assess the methodological quality of the included studies. A meta-analysis was done to calculate the odds ratio (OR) with the 95% confidence interval (CI) for dichotomous data and mean difference (MD) with 95% CI for continuous data. RESULTS: Thirty-five studies were included in the qualitative analysis, and 22 studies were included in the meta-analyses. The mean quality score based on the MINORS criteria was 12.4±1.9 (range, 8-16) points. Significant risk factors included higher preoperative body mass index (BMI) (mean difference [MD]=1.97 kg/m2; 95% confidence interval [CI]=1.49-2.45; p<.001), floating fusion (Odds ratio [OR]=1.78; 95% CI=1.32-2.41; p<.001), superior facet joint violation (OR=10.43; 95% CI=6.4-17.01; p<.001), and decompression outside fusion construct (OR=1.72; 95% CI=1.25-2.37; p<.001). CONCLUSIONS: The overall level of evidence was low to very low. Higher preoperative BMI, floating fusion, superior facet joint violation, and decompression outside fusion construct are significant risk factors of development of ASD following lumbar fusion surgeries.

Intervertebral Disc Regeneration Injection of a Cell-Loaded Collagen Hydrogel in a Sheep Model.

Degenerated intervertebral discs (IVDs) were treated with autologous adipose-derived stem cells (ASC) loaded into an injectable collagen scaffold in a sheep model to investigate the implant's therapeutic potential regarding the progression of degeneration of previously damaged discs. In this study, 18 merino sheep were subjected to a 3-step minimally invasive injury and treatment model, which consisted of surgically induced disc degeneration, treatment of IVDs with an ASC-loaded collagen hydrogel 6 weeks post-operatively, and assessment of the implant's influence on degenerative tissue changes after 6 and 12 months of grazing. Autologous ASCs were extracted from subcutaneous adipose tissue and cultivated in vitro. At the end of the experiment, disc heights were determined by µ-CT measurements and morphological tissue changes were histologically examined.Histological investigations show that, after treatment with the ASC-loaded collagen hydrogel implant, degeneration-specific features were observed less frequently. Quantitative studies of the degree of degeneration did not demonstrate a significant influence on potential tissue regeneration with treatment. Regarding disc height analysis, at both 6 and 12 months after treatment with the ASC-loaded collagen hydrogel implant a stabilization of the disc height can be seen. A complete restoration of the intervertebral disc heights however could not be achieved.The reported injection procedure describes in a preclinical model a translational therapeutic approach for degenerative disc diseases based on adipose-derived stem cells in a collagen hydrogel scaffold. Further investigations are planned with the use of a different injectable scaffold material using the same test model.

Autologous Stem Cells in Cervical Spine Fusion.

STUDY DESIGN: Systematic review. OBJECTIVES: To systematically review, critically appraise and synthesize evidence on use of stem cells from autologous stem cells from bone marrow aspirate, adipose, or any other autologous sources for fusion in the cervical spine compared with other graft materials. METHODS: A systematic search of PubMed/MEDLINE was conducted for literature published through October 31, 2018 and through February 20, 2020 for EMBASE and ClinicalTrials.gov comparing autologous cell sources for cervical spine fusion to other graft options. RESULTS: From 36 potentially relevant citations identified, 10 studies on cervical fusion met the inclusion criteria set a priori. Two retrospective cohort studies, one comparing cancellous bone marrow (CBM) versus hydroxyapatite (HA) and the other bone marrow aspirate (BMA) combined with autograft and HA versus autograft and HA alone, were identified. No statistical differences were seen between groups in either study for improvement in function, symptoms, or fusion; however, in the study evaluating BMA, the authors reported a statistically greater fusion rate and probability of fusion over time in the BMA versus the non-BMA group. Across case series evaluating BMA, authors reported improved function and pain and fusion ranged from 84% to 100% across the studies. In general, complications were poorly reported. CONCLUSIONS: The overall quality (strength) of evidence of effectiveness and safety of autologous BMA for cervical arthrodesis in the current available literature was very low. Based on currently available data, firm conclusions regarding the effectiveness or safety of BMA in cervical fusions cannot be made.

Use of Autologous Stem Cells in Lumbar Spinal Fusion: A Systematic Review of Current Clinical Evidence.

STUDY DESIGN: Systematic review. OBJECTIVES: To systematically review, critically appraise and synthesize evidence on use of autologous stem cells sources for fusion in the lumbar spine. METHODS: A systematic search of PubMed/MEDLINE, EMBASE and ClinicalTrials.gov through February 20, 2020 was conducted comparing autologous cell grafts to other biologics for lumbar spine fusion. The focus was on studies comparing distinct patient groups. RESULTS: From 343 potentially relevant citations, 15 studies met the inclusion criteria set a priori. Seven studies compared distinct patient groups, with BMA being used in combination with allograft or autograft not as a standalone material. No economic evaluations were identified. Most observational studies were at moderately high risk of bias. When used for primary lumbar fusion, no statistical differences in outcomes or complications were seen between BMA+autograft/or +allograft compared to autograft/allograft alone. Compared with allograft, data from a RCT suggested statistically better fusion and lower complication rates with concentrated BMA+allograft. When used in revisions, no differences in outcomes were seen between BMA+allograft and either autograft or rh-BMP-2 but fusion rates were lower with BMA+allograft, leading to additional revision surgery. CONCLUSIONS: There was substantial heterogeneity across studies in patient populations, sample size, biologic combinations, and surgical characteristics making direct comparisons difficult. The overall quality of evidence for fusion rates and the safety of BMA in lumbar fusion procedures was considered very low, with studies being at moderately high or high risk of bias.

Development of AOSpine BOnE (Bone Osteobiologics and Evidence) Classification.

STUDY DESIGN: Classification development. OBJECTIVES: The aim of our study was to develop a 3-tier classification for the levels of evidence for osteobiologics and provide a description of the principles by which osteobiologics can be evaluated. BOnE (Bone Osteobiologics and Evidence) classification evaluates each osteobiologic based on the available evidence, and if the published evidence is based on clinical, in vivo or in vitro studies. METHODS: The process of establishing the BOnE classification included 5 face-to-face meetings and 2 web calls among members of the AOSpine Knowledge Forum Degenerative. RESULTS: The 3 levels of evidence were determined based on the type of data on osteobiologics: level A for human studies, level B for animal studies, and level C for in vitro studies, with level A being the highest level of evidence. Each level was organized into 4 subgroups (eg, A1, A2, A3, and A4). CONCLUSIONS: The use and the variety of osteobiologics for spine fusion has dramatically increased over the past few decades; however, literature on their effectiveness is inconclusive. Several prior systematic reviews developed by AOSpine Knowledge Forum Degenerative reported low level of evidence primarily due to the high risk of bias, small sample size, lack of control groups, and limited patient-reported outcomes. BOnE classification will provide a universal platform for research studies and journal publications to classify a new or an existing product and will allow for creating decision-making algorithms for surgical planning.

Allogenic Stem Cells in Spinal Fusion: A Systematic Review.

STUDY DESIGN: Systematic review. OBJECTIVES: To review, critically appraise, and synthesize evidence on the use of allogenic stem cell products for spine fusion compared with other bone graft materials. METHODS: Systematic searches of PubMed/MEDLINE, through October 31, 2018 and of EMBASE and ClinicalTrials.gov through April 13, 2018 were conducted for literature comparing allogenic stem cell sources for fusion in the lumbar or cervical spine with other fusion methods. In the absence of comparative studies, case series of ≥10 patients were considered. RESULTS: From 382 potentially relevant citations identified, 6 publications on lumbar fusion and 5 on cervical fusion met the inclusion criteria. For lumbar arthrodesis, mean Oswestry Disability Index (ODI), visual analogue scale (VAS) pain score, and fusion rates were similar for anterior lumbar interbody fusion (ALIF) using allogenic multipotent adult progenitor cells (Map3) versus recombinant human bone morphogenetic protein-2 (rhBMP-2) in the one comparative lumbar study (90% vs 92%). Across case series of allogenic stem cell products, function and pain were improved relative to baseline and fusion occurred in ≥90% of patients at ≥12 months. For cervical arthrodesis across case series, stem cell products improved function and pain compared with baseline at various time frames. In a retrospective cohort study fusion rates were not statistically different for Osteocel compared with Vertigraft allograft (88% vs 95%). Fusion rates varied across time frames and intervention products in case series. CONCLUSIONS: The overall quality (strength) of evidence of effectiveness and safety of allogenic stem cells products for lumbar and cervical arthrodesis was very low, meaning that we have very little confidence that the effects seen are reflective of the true effects.

Cell Therapy for Treatment of Intervertebral Disc Degeneration: A Systematic Review.

STUDY DESIGN: Systematic review. OBJECTIVE: To review, critically appraise, and synthesize evidence on use of cell therapy for intervertebral disc repair. METHODS: A systematic search of PubMed/MEDLINE was conducted for literature published through October 31, 2018 and EMBASE and ClinicalTrials.gov databases through April 13, 2018 comparing allogenic or autologous cell therapy for intervertebral disc (IVD) repair in the lumbar or cervical spine. In the absence of comparative studies, case series of ≥10 patients were considered. RESULTS: From 1039 potentially relevant citations, 8 studies across 10 publications on IVD cell therapies in the lumbar spine met the inclusion criteria. All studies were small and primarily case series. For allogenic cell sources, no difference in function or pain between mesenchymal cell treatment and sham were reported in 1 small randomized controlled trial; 1 small case series reported improved function and pain relative to baseline but it was unclear if the change was clinically significant. Similarly for autologous cell sources, limited data across case series suggest pain and function may be improved relative to baseline; whether the changes were clinically significant was not clear. Safety data was sparse and poorly reported. The need for subsequent surgery was reported in 3 case-series studies ranging from 6% to 80%. CONCLUSIONS: The overall strength of evidence for efficacy and safety of cell therapy for lumbar IVD repair was very low primarily due to substantial risk of bias, small sample sizes and lack of a comparator intervention. Methodologically sound studies comparing cell therapies to other treatments are needed.

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.

TachoSil Dural Reconstruction in Extracranial-Intracranial Bypass Surgeries.

BACKGROUND: Superficial temporal artery to middle cerebral artery (STA-MCA) bypass is a treatment option for hemodynamic insufficiency in the anterior cerebral circulation. Complications associated with extracranial-intracranial bypass surgeries are ischemic strokes caused by bypass failure, wound-healing disorders, and further issues from cerebrospinal fluid (CSF) leakage. CSF leakage can provide pathways for infection. It is well known in general neurosurgery that watertight closure of the dura mater is necessary to prevent such complications. OBJECTIVE: To provide a technical description of TachoSil dural reconstruction in standard STA-MCA bypasses and their follow-up analyses. METHODS: In this technical report with observational follow-up, the dura mater was closed partially by adaptive sutures, and the perforation site of the donor vessel was sealed with TachoSil. TachoSil is a collagen sponge covered with clotting factors that provides hemostatic and sealing effects. RESULTS: Our study included eight cases of standard STA-MCA bypasses that had been operated between July 2015 and September 2016. Follow-up examinations were completed for all patients at 1 month and 6 months after surgery. Duplex and Doppler ultrasound demonstrated regular bypass patency in all patients without increased flow velocity at the perforation sites, which is a possible sign of stenosis. No wound-healing disorders or CSF leakage occurred. No cerebrovascular stroke events were observed. CONCLUSION: Duraplasty with TachoSil enables the elastic reconstruction of the dura perforation gap in standard extracranial-intracranial bypass surgeries.

Trends and Costs of External Electrical Bone Stimulators and Grafting Materials in Anterior Lumbar Interbody Fusion.

STUDY DESIGN: Retrospective review. PURPOSE: To identify the trends in stimulator use, pair those trends with various grafting materials, and determine the influence of stimulators on the risk of revision surgery. OVERVIEW OF LITERATURE: A large number of studies has reported beneficial effects of electromagnetic energy in healing long bone fractures. However, there are few clinical studies regarding the use of electrical stimulators in spinal fusion. METHODS: We used insurance billing codes to identify patients with lumbar disc degeneration who underwent anterior lumbar interbody fusion (ALIF). Comparisons between patients who did and did not receive electrical stimulators following surgery were performed using logistic regression analysis, chi-square test, and odds ratio (OR) analysis. RESULTS: Approximately 19% of the patients (495/2,613) received external stimulators following ALIF surgery. There was a slight increase in stimulator use from 2008 to 2014 (multi-level R2=0.08, single-level R2=0.05). Patients who underwent multi-level procedures were more likely to receive stimulators than patients who underwent single-level procedures (p<0.05; OR, 3.72; 95% confidence interval, 3.02-4.57). Grafting options associated with most frequent stimulator use were bone marrow aspirates (BMA) plus autograft or allograft for single-level and allograft alone for multi-level procedures. In both cohorts, patients treated with bone morphogenetic proteins were least likely to receive electrical stimulators (p<0.05). Patients who received stimulation generally had higher reimbursements. Concurrent posterior lumbar fusion (PLF) (ALIF+PLF) increased the likelihood of receiving stimulators (p<0.05). Patients who received electrical stimulators had similar revision rates as those who did not receive stimulation (p>0.05), except those in the multilevel ALIF+PLF cohort, wherein the patients who underwent stimulation had higher rates of revision surgery. CONCLUSIONS: Concurrent PLF or multi-level procedures increased patients' likelihood of receiving stimulators, however, the presence of comorbidities did not. Patients who received BMA plus autograft or allograft were more likely to receive stimulation. Patients with and without bone stimulators had similar rates of revision surgery.

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.

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 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.

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.