Bone Morphogenic Protein Use in Spinal Surgery.

Bone morphogenic protein (BMP) provides excellent enhancement of fusion in many spinal surgeries. BMP should be a cautionary tale about the use of industry-sponsored research, perceived conflicts of interest, and holding the field of spinal surgery to the highest academic scrutiny and ethical standards. In the case of BMP, not having a transparent base of literature as it was approved led to delays in allowing this superior technology to help patients.

Bone Morphogenetic Protein Use and Cancer Risk Among Patients Undergoing Lumbar Arthrodesis: A Case-Cohort Study Using the SEER-Medicare Database.

BACKGROUND: Recombinant bone morphogenetic proteins (BMPs) are growth factors utilized in lumbar arthrodeses. Limited data from randomized trials suggest that BMP may increase cancer risk. We sought to evaluate cancer risk and mortality following the use of BMP in lumbar arthrodesis. METHODS: Within the linked Surveillance, Epidemiology, and End Results (SEER) Program-Medicare cohort, we conducted a case-cohort study of 7,278 individuals who were ≥65 years of age and had undergone a lumbar arthrodesis from 2004 to 2011. Of these patients, 3,627 were individuals in a 5% random subcohort of Medicare enrollees in SEER areas including 191 who developed cancer, and there were 3,651 individuals outside the subcohort who developed cancer. Weighted Cox proportional-hazards regression was used to estimate hazard ratios (HRs) and 95% confidence intervals (95% CIs) for cancer on the basis of exposure to BMP. RESULTS: In the SEER-Medicare subcohort, 30.7% of individuals who underwent a lumbar arthrodesis received BMP. BMP was not associated with overall cancer risk in univariate analyses (HR, 0.92 [95% CI, 0.82 to 1.02]) or after adjustment for demographic characteristics, comorbidities, hospital size, history of cancer, and calendar year (adjusted HR, 0.94 [95% CI, 0.84 to 1.05]). Individual cancer types were also not significantly elevated (p > 0.05 for all) in BMP users compared with nonusers. In addition, BMP use was not associated with a new cancer in people who had cancer prior to undergoing lumbar arthrodesis (adjusted HR, 1.04 [95% CI, 0.71 to 1.52]) or with mortality after a cancer diagnosis (adjusted HR, 1.05 [95% CI, 0.93 to 1.19]). CONCLUSIONS: In a large population of elderly U.S. adults undergoing lumbar arthrodesis, BMP use was not associated with cancer risk or mortality. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Assessment of outcome following the use of recombinant human bone morphogenetic protein-2 for spinal fusion in the elderly population.

INTRODUCTION: Although the use of recombinant human bone morphogenetic protein-2 (rhBMP-2) for spinal fusion has been fairly studied in the general population, relatively little research has been conducted on its use in the elderly patient demographic despite this population's growth. The authors sought to examine the clinical efficacy, complication rate, and cost-effectiveness of rhBMP-2 use in elderly patients undergoing spinal fusion surgery. EVIDENCE ACQUISITION: We conducted a systematic review of the published literature for elderly patients that underwent spinal fusion surgery with the use of rhBMP-2. A systematic search was performed utilizing the PUBMED and MEDLINE databases in order to identify all papers dealing with recombinant human Bone Morphogenic Protein-2 use in patients over the age of 60 years. EVIDENCE SYNTHESIS: Twenty-five papers were identified that met our inclusion criteria. While successful fusion, improvement in pain, and improved quality of life were encountered in elderly patients who were treated with fusions surgery along with rhBMP-2, there were several complications that were encountered including seroma formation, pleural effusions, and bone non-union. CONCLUSIONS: The literature demonstrated that BMP serves as a potent osteoinductive agent in the elderly with similar efficacy to bone autograft. Although use of BMP showed mixed results and had higher initial costs, when taken into account with complication correction and costs, BMP usage appears to be more economically beneficial overall. Future studies are needed to clarify the clinical significance of the complications encountered in elderly patients treated with rhBMP-2. Future research can assist in developing recommendations which can minimize these risks in the elderly patient demographic.

Effects of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) in grade III open tibia fractures treated with unreamed nails-A clinical and health-economic analysis.

Recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) is licensed in Europe for open tibia fractures treated with unreamed nails. However, there is limited data available on the specific use of rhBMP-2 in combination with unreamed nails for open tibia fractures. The intention of the current study was to evaluate the medical and health-economic effects of rhBMP-2 in Gustilo-Anderson grade III open tibia fractures treated with unreamed nails based on individual patient data from two previously published studies. Linear regression analysis was performed on raw data of 90 patients that were either treated by standard of care with soft tissue management and unreamed nailing (SOC group) (n=50) or with rhBMP-2 in addition to soft tissue management and unreamed nailing (rhBMP-2 group) (n=40). For all types of revision, a significant lower percentage of patients (27.5%) of the rhBMP-2 group had to be revised compared to 48% of the patients of the SOC group (p=0.04). When only invasive secondary interventions such as bone grafting and nail exchange were considered, there was also a statistically significant reduction in the rhBMP-2 group with a revision rate of 10.0% (4 of 40 patients) compared to the SOC group with a revision rate of 28.0% (14 of 50 patients) (p=0.01). Mean fracture healing time of 228 days in the rhBMP-2 compared to 266 days in the SOC group was not statistically significant (p=0.24). Health-economic analysis based on a societal perspective with calculation of overall treatment costs after initial surgery and including productivity losses revealed savings of €6,239 per patient for Germany and €4,752 for the UK in favour of rhBMP-2 which was mainly driven by reduction of productivity losses. In conclusion, rhBMP-2 reduces secondary interventions in patients with grade III open tibia fractures treated with an unreamed nail and its use leads to financial savings for Germany and the UK from a societal perspective.

Use of human recombinant bone morphogenetic protein is associated with increased hospital charges in children with cleft lip and palate having bone graft procedures.

PURPOSE: There is wide variation in the timing of secondary alveolar bone grafting in patients with cleft lip and palate. The objective of the present study was to examine the timing and hospitalization outcomes of bone grafting procedures in a cohort of 5- to 13-year-old patients with a diagnosis of cleft lip and palate. MATERIALS AND METHODS: The Nationwide Inpatient Sample for 2004 to 2010 was used. Outcomes examined included complications, disposition status, hospital charges, and length of stay. Multivariable linear regression analysis was used to examine the association between hospital charges and a group of heterogenous patient-level (age, gender, race, comorbid burden, insurance status, and concomitant procedures) and hospital-level variables. RESULTS: In total, 3,478 patients underwent bone grafting procedures. Excision of bone for grafting was obtained from pelvic bones in 79.4% of cases. Recombinant bone morphogenetic protein (rhBMP) was inserted in 1% of all cases. Nearly 99% were discharged routinely. The overall complication rate was 1.5%. The mean length of hospital stay was 1.3 days and the mean hospitalization charge was $23,852 per case. Those who had insertion of rhBMP had an excess of $14,695 compared with those who did not have rhBMP after adjustment for all other variables (P<.0001). CONCLUSIONS: Bone grafting procedures are safe when performed in patients 5 to 13 years old. Insertion of rhBMP was performed in nearly 1% of patients undergoing bone grafting procedures. Use of rhBMP was associated with a considerable increase in hospital charges.

Cancer risk from bone morphogenetic protein exposure in spinal arthrodesis.

BACKGROUND: The U.S. Food and Drug Administration reported a higher incidence of cancer in patients who had spinal arthrodesis and were exposed to a high dose of recombinant human bone morphogenetic protein-2 (rhBMP-2) compared with the control group in a randomized controlled trial. The purpose of this study was to determine the risk of cancer after spinal arthrodesis with BMP. METHODS: We retrospectively analyzed the incidence of cancer in 467,916 Medicare patients undergoing spinal arthrodesis from 2005 to 2010. Patients with a preexisting diagnosis of cancer were excluded. The average follow-up duration was 2.85 years for the BMP group and 2.94 years for the control group. The main outcome measure was the relative risk of developing new malignant lesions after spinal arthrodesis with or without exposure to BMP. RESULTS: The relative risk of developing cancer after BMP exposure was 0.938 (95% confidence interval [95% CI]: 0.913 to 0.964), which was significant. In the BMP group, 5.9% of the patients developed an invasive cancer compared with 6.5% of the patients in the control group. The relative risk of developing cancer after BMP exposure was 0.98 in males (95% CI: 0.94 to 1.02) and 0.93 (95% CI: 0.90 to 0.97) in females. The control group showed a higher incidence of each type of cancer except pancreatic cancer. CONCLUSIONS: Recent clinical use of BMP was not associated with a detectable increase in the risk of cancer within a mean 2.9-year time window. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Perioperative and long-term clinical outcomes for bone morphogenetic protein versus iliac crest bone graft for lumbar fusion in degenerative disk disease: systematic review with meta-analysis.

STUDY DESIGN: Systematic review with meta-analysis. OBJECTIVES: To compare the perioperative and long-term postoperative effectiveness of bone morphogenetic protein (BMP) for lumbar arthrodesis in skeletally mature adults with degenerative disk disease (DDD) to that of the current golden standard treatment, iliac crest autologous bone graft (ICBG). SUMMARY OF BACKGROUND DATA: The treatment efficacy of lumbar arthrodesis in DDD is a complex clinical and economic issue for patients and health care providers. METHODS: Comprehensive electronic literature search was performed using following databases: Ovid MEDLINE; Embase; Cochrane Library; Central Register of Controlled Trials (CENTRAL); Database of Abstracts of Reviews of Effects; Methodology Register; Technology Assessment Database; and Economic Evaluation Database. The full year ranges of each database until May of 2012 were included. RESULTS: Eight randomized controlled clinical trials of 383 citations were selected. The included studies involved 1138 participants. The pooled 2-year postoperative clinical outcomes were equivalent in BMP and ICBG groups, and exceeded minimum clinically important differences for Oswestry Disability Index, SF-36 (physical scale), and numeric rating scale (back pain). ICBG was associated with increased pain and complications at the donor site (P<0.01). The pooled average operative time was 21 minutes less in BMP versus ICBG (P<0.001). The pooled rate of additional surgical treatment was 2 times less in the BMP than in the ICBG groups (P=0.006). The pooled risk of nonunion at 24-month follow-up was 2 times less in the BMP than in the ICBG groups (P=0.037), however, this effect was likely biased. CONCLUSIONS: BMP, in particular rhBMP-2, is a good alternative to autogenous bone graft, especially in cases when harvesting of autologous bone is contraindicated or undesirable, operation time is limited, and there are no contraindications for BMP use.However, the current study did not reveal evidence robust enough to develop strong medical recommendations concerning BMP use for lumbar arthrodesis in degenerative disk disease.

Cost estimates of biologic implants among orthopedic surgeons.

The use and development of biologic implants such as autogenous bone grafts and bone morphogenetic proteins (BMPs) remain on the rise in orthopedic surgery. Apart from the differences in efficacies seen between the different methods, there is also a difference in the cost associated with each. We generated a questionnaire inquiring about current use of osteobiologics and cost perceptions, and distributed it to 30 orthopedic surgeons. When answers were compared to operating room pricing data from each institution, surgeons grossly over and underestimated the costs associated with each of the osteobiologics in the questionnaire. More than 25% of those questioned did not know the cost of the osteobiologics they had used in the last 3 months. Furthermore, none of the participating institutions had a committee with physician participation concerning the use of these techniques. As the use and cost of osteobiologics by orthopedic surgeons continues to increase, so should the importance of educating those surgeons on the financial outcomes so as to assuage extraneous and unnecessary economic ramifications.

Impact of bone morphogenetic proteins on frequency of revision surgery, use of autograft bone, and total hospital charges in surgery for lumbar degenerative disease: review of the Nationwide Inpatient Sample from 2002 to 2008.

BACKGROUND CONTEXT: Bone morphogenetic proteins (BMPs) were developed with the goal of improving clinical outcomes through the promotion of bony healing and reducing morbidity from iliac crest bone graft harvest. PURPOSE: To complete a population-based assessment of the impact of BMP on use of autograft, rates of operative treatment for lumbar pseudoarthrosis, and hospital charges. STUDY DESIGN: Nationwide Inpatient Sample (NIS) retrospective cohort assessment of 46,452 patients from 2002 to 2008. PATIENT SAMPLE: All patients who underwent lumbar arthrodesis procedures for degenerative spinal disease. OUTCOME MEASURES: Use of BMP, revision surgery status as a percentage of total procedures, and autograft harvest in lumbar fusion procedures completed for degenerative diagnoses. METHODS: Demographic and geographic/practice data, hospital charges, and length of stay of all NIS patients with thoracolumbar and lumbosacral procedure codes for degenerative spinal diagnoses were recorded. Codes for autograft harvest, use of BMP, and revision surgery were included in multivariable regression analysis. RESULTS: The assessment found 46,452 patients from 2002 to 2008 undergoing thoracolumbar or lumbar arthrodesis procedures for degenerative disease. Assuming a representative sample, this cohort models more than 200,000 US patients. There was steady growth in lumbar spine fusion and in the use of BMP. The use of BMP increased from 2002 to 2008 (odds ratio [OR], 1.50; 95% confidence interval [CI], 1.48-1.52). Revision procedures decreased over the study period (OR, 0.94; 95% CI, 0.91-0.96). The use of autograft decreased substantially after introduction of BMP but then returned to baseline levels; there was no net change in autograft use from 2002 to 2008. The use of BMP correlated with significant increases in hospital charges ($13,362.39; standard deviation ± 596.28, p<.00001). The use of BMP in degenerative thoracolumbar procedures potentially added more than $900 million to hospital charges from 2002 to 2008. CONCLUSIONS: There was an overall decrease in rates of revision fusion procedures from 2002 to 2008. Introduction of BMP did not correlate with decrease in use of autograft bone harvest. Use of BMP correlated with substantial increase in hospital charges. The small decrease in revision surgeries recorded, combined with lack of significant change in autograft harvest rates, may question the financial justification for the use of BMP.

Epidemiological trends in the utilization of bone morphogenetic protein in spinal fusions from 2002 to 2011.

STUDY DESIGN: Retrospective database analysis. OBJECTIVE: A nationwide population-based database was analyzed to assess the utilization trends of bone morphogenetic protein (BMP) in spine fusion surgery from 2002-2011. SUMMARY OF BACKGROUND DATA: The utilization of off-label BMP in spine procedures is not well characterized. The purpose of this study was to analyze a population-based database to characterize the national trends of BMP utilization in terms of incidence, demographics, costs, and mortality. METHODS: Data from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project was queried for each year from 2002-2011. Patients undergoing an anterior cervical fusion or posterior cervical fusion, anterior lumbar fusion or posterior lumbar fusion, or a posterior thoracic fusion were identified and separated into cohorts. The frequency of BMP utilization was assessed in each surgical cohort by year. Patient demographics, hospital parameters, costs, and mortality rates were assessed. RESULTS: The adjusted annual number of procedures with BMP increased from 1116 in 2002 to 79,294 in 2011 (P < 0.001), representing 26.9% of all spinal fusion procedures. The rate of BMP utilization within each surgical cohort also significantly increased during the 10-year period (P < 0.001). The posterior lumbar fusion cohort accounted for the majority of spinal fusions that used BMP, representing 76.8% of all spinal fusions between 2002 and 2011. The anterior lumbar fusion cohort was associated with the highest proportion of BMP utilization, peaking at 56.9% of all anterior lumbar interbody fusions in 2006. The trend of BMP utilization in the anterior cervical fusion cohort peaked in 2007 with 10.6% of cases and then declined to 6.4% in 2011. There was a statistically significant trend of older patients with increasing comorbidities receiving BMP during this period. Hospital costs (adjusted for inflation) significantly increased an average of $9560 from 2002-2010. There were no significant trends with regard to the length of hospitalization stay and mortality rates during this period. CONCLUSION: This nonconflicted study demonstrates that the utilization of BMP has dramatically increased from 2002-2011. Interestingly, off-label application of BMP accounts for the vast majority of BMP utilization. The increase in the total hospital costs is likely multifactorial; older patients with more comorbidities undergoing surgery as well as the increasing utilization of BMP are all likely contributory factors. The length of hospitalization stay and mortality rates did not increase during the 10-year period.

Current trends in demographics, practice, and in-hospital outcomes in cervical spine surgery: a national database analysis between 2002 and 2011.

STUDY DESIGN: Retrospective database analysis. OBJECTIVE: To investigate national trends of cervical spine surgical procedures from 2002 to 2011. SUMMARY OF BACKGROUND DATA: There is a paucity of literature assessing the current practice trends and outcomes of cervical spine surgery following the 2008 Food and Drug Administration public health notifications regarding bone morphogenetic protein (BMP) utilization in cervical spine surgical procedures. METHODS: The National Inpatient Sample database was accessed for each year across 2002 to 2011. Patients undergoing anterior cervical fusion, posterior cervical fusion, and posterior cervical decompression were identified. Patient and hospitalization parameters including demographics, BMP utilization, costs, early postoperative outcomes, and mortality were assessed for each surgical cohort. A Pearson correlation coefficient with a 95% confidence interval (P < 0.05) was used to analyze trends in patient and hospital outcome parameters during this 10-year period. RESULTS: A total of 307,188 cervical spine procedures were performed from 2002 to 2011. Both the anterior cervical fusion and posterior cervical fusion cohort demonstrated a statistically significant increase in the number of procedures performed over time (r = +0.9, P < 0.001). A significant uptrend in patient age (r = +1.0, P < 0.001) and comorbidity burden (r = +0.9, P < 0.001) was demonstrated during the studied decade. Overall, BMP utilization (r = +0.7, P = 0.02) also demonstrated a significant increase during this time period, but demonstrated a decline after peaking in 2007. The posterior cervical fusion cohort demonstrated the greatest comorbidity, length of stay, costs, and mortality. CONCLUSION: This study demonstrates that the number of cervical spine procedures has increased between 2002 and 2011, irrespective of the change in BMP utilization after the 2008 Food and Drug Administration warning. Despite an older patient population with greater comorbidities undergoing cervical spine surgeries, hospital length of stay and mortality has not significantly changed. However, we did note a significant increase in costs during this time period. These findings may be related to advances in surgical technology and instrumentation that may be associated with rising hospital costs.

Allogeneic morphogenetic protein vs. recombinant human bone morphogenetic protein-2 in lumbar interbody fusion procedures: a radiographic and economic analysis.

BACKGROUND: Since the introduction of rhBMP-2 (Infuse) in 2002, surgeons have had an alternative substitute to autograft and its related donor site morbidity. Recently, the prevalence of reported adverse events and complications related to the use of rhBMP-2 has raised many ethical and legal concerns for surgeons. Additionally, the cost and decreasing reimbursement landscape of rhBMP-2 use have required identification of a viable alternative. Osteo allogeneic morphogenetic protein (OsteoAMP) is a commercially available allograft-derived growth factor rich in osteoinductive, angiogenic, and mitogenic proteins. This study compares the radiographic fusion outcomes between rhBMP-2 and OsteoAMP allogeneic morphogenetic protein in lumbar interbody fusion spine procedures. METHODS: Three hundred twenty-one (321) patients from three centers underwent a transforaminal lumbar interbody fusion (TLIF) or lateral lumbar interbody fusion (LLIF) procedure and were assessed by an independent radiologist for fusion and radiographically evident complications. The independent radiologist was blinded to the intervention, product, and surgeon information. Two hundred and twenty-six (226) patients received OsteoAMP with autologous local bone, while ninety-five (95) patients received Infuse with autologous local bone. Patients underwent radiographs (x-ray and/or CT) at standard postoperative follow-up intervals of approximately 1, 3, 6, 12, and 18 months. Fusion was defined as radiographic evidence of bridging across endplates, or bridging from endplates to interspace disc plugs. Osteobiologic surgical supply costs were also analyzed to ascertain cost differences between OsteoAMP and rhBMP-2. RESULTS: OsteoAMP produced higher rates of fusion at 6, 12, and 18 months (p ≤ 0.01). The time required for OsteoAMP to achieve fusion was approximately 40% less than rhBMP-2 with approximately 70% fewer complications. Osteobiologic supply costs were 80.5% lower for OsteoAMP patients (73.7% lower per level) than for rhBMP-2. CONCLUSIONS: Results of this study indicate that OsteoAMP is a viable alternative to rhBMP-2 both clinically and economically when used in TLIF and LLIF spine procedures.

Incidence and risk factors for dysphagia after anterior cervical fusion.

STUDY DESIGN: Retrospective database analysis. OBJECTIVE: To determine the national incidence, mortality, and risk factors for dysphagia associated with anterior cervical spinal fusion surgery in the United States. SUMMARY OF BACKGROUND DATA: Dysphagia is a known complication associated with anterior cervical fusion (ACF). A population-based database was analyzed to characterize the incidence of dysphagia in terms of demographics, mortality, and risk factors associated with ACF. METHODS: Data from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project were obtained from 2002 to 2009. Patients undergoing ACF for cervical myelopathy and/or radiculopathy were identified and separated into cohorts (1- to 2-level and 3+-level fusions), and incidences of dysphagia were identified. Demographics, length of stay, costs, mortality, and use of bone morphogenetic proteins (BMPs) were assessed. Statistical data were analyzed in SPSS (version 20), using the Student t test for discrete variables and the χ test for categorical data. Binomial logistic regression was used to identify independent predictors of dysphagia. A P value of less than 0.001 was used to denote significance. RESULTS: A total of 159,590 ACF cases were identified of which 139,434 were 1- to 2-level ACF and 20,156 were 3+-level ACF. The incidence of dysphagia in the 3+-level ACF group was double that of the 1- to 2-level ACF group (44.8 vs. 22.4 per 1000; P < 0.001). Patients with dysphagia were significantly older than patients without dysphagia (P < 0.001). Dysphagia was more common in males undergoing 1- to 2-level ACF (P < 0.001). BMP was used more frequently for patients with dysphagia in the 1- to 2-level ACF group (9.4% vs. 7.2% of cases; P < 0.001). Logistic regression analysis demonstrated that independent predictors for dysphagia included age (≥65 yr), male sex, 3+-level fusion, BMP use, and preoperative patient comorbidities. CONCLUSION: Dysphagia occurs twice as often after 3+-level ACF compared with 1- to 2-level ACF. Utilization of BMP was also linked to an increased incidence of dysphagia in the 1- to 2-level ACF group. Regardless of the number of levels fused, patients experiencing dysphagia had increased age, comorbid risk factors, hospitalizations, and costs. LEVEL OF EVIDENCE: 3.

Use of bone morphogenetic proteins in spinal fusion surgery for older adults with lumbar stenosis: trends, complications, repeat surgery, and charges.

STUDY DESIGN: Retrospective cohort study of Medicare claims. OBJECTIVE: Examine trends and patterns in the use of bone morphogenetic proteins (BMP) in surgery for lumbar stenosis; compare complications, reoperation rates, and charges for patients undergoing lumbar fusion with and without BMP. SUMMARY OF BACKGROUND DATA: Small, randomized trials have demonstrated higher rates of solid fusion with BMP than with allograft bone alone, with few complications and, in some studies, reduced rates of revision surgery. However, complication and reoperation rates from large population-based cohorts in routine care are unavailable. METHODS: We identified patients with a primary diagnosis of lumbar stenosis who had fusion surgery in 2003 or 2004 (n = 16,822). We identified factors associated with BMP use: major medical complications during the index hospitalization, rates of rehospitalization within 30 days, and rates of reoperation within 4 years of follow-up (through 2008). RESULTS: Use of BMP increased rapidly, from 5.5% of fusion cases in 2003 to 28.1% of fusion cases in 2008. BMP use was greater among patients with previous surgery and among those having complex fusion procedures (combined anterior and posterior approach, or greater than 2 disc levels). Major medical complications, wound complications, and 30-day rehospitalization rates were nearly identical with or without BMP. Reoperation rates were also very similar, even after stratifying by previous surgery or surgical complexity, and after adjusting for demographic and clinical features. On average, adjusted hospital charges for operations involving BMP were about $15,000 more than hospital charges for fusions without BMP, though reimbursement under Medicare's Diagnosis-Related Group system averaged only about $850 more. Significantly fewer patients receiving BMP were discharged to a skilled nursing facility (15.9% vs. 19.0%, P < 0.001). CONCLUSION: In this older population having fusion surgery for lumbar stenosis, uptake of BMP was rapid, and greatest among patients with prior surgery or having complex fusion procedures. BMP appeared safe in the perioperative period, with no increase in major medical complications. Use of BMP was associated with greater hospital charges but fewer nursing home discharges, and was not associated with reduced likelihood of reoperation.

Factors associated with hospitalization charges for cleft palate repairs and revisions.

PURPOSE: The objective of this study is to provide nationally representative estimates of cleft palate correction and revision procedures performed in hospitalized patients, as well as to examine patient- and hospital-level factors associated with hospitalization charges. MATERIALS AND METHODS: The Nationwide Inpatient Sample for the year 2007 was used. All hospitalizations that had a cleft palate correction or revision of cleft palate repair were selected. Estimates of concomitant procedures performed during the index hospitalization were obtained. The roles of different patient- and hospital-level variables on hospitalization charges were examined by use of multivariable linear regression analysis. RESULTS: A total of 5,969 repairs and/or revisions of cleft palate procedures were performed in hospitals in the entire United States. The mean age per hospitalization was 3.2 years. Whites accounted for 51.3% of procedures, whereas blacks, Hispanics, Asian/Pacific Islanders, Native Americans, and other races accounted for 4.9%, 26.4%, 9.2%, 3.2%, and 5%, respectively. The mean charge per each hospitalization was $19,227, and the total hospitalization charge for the entire United States was $112.96 million. Patients aged less than 1 year (P = .02) and those aged between 8 and 12 years (P = .03) had significantly lower charges compared with those aged 18 years or older. Use of bone morphogenetic protein was associated with higher hospital charges (P = .0006). Compared with the uninsured, those covered by Medicaid (P = .04), private insurance plans (P = .02), and other insurance plans (P = .0005) were associated with higher charges. CONCLUSION: This study identified an association between hospital charges and insurance payer, race, treatments performed, and age. Our results provide insights into nationally representative estimates on management of cleft palate corrections and revisions.

Trends in the use of bone morphogenetic protein as a substitute to autologous iliac crest bone grafting for spinal fusion procedures in the United States.

STUDY DESIGN: Analysis of Nationwide Inpatient Sample (NIS) database for data related to spinal fusion procedures. OBJECTIVE: To identify trends in the use of bone morphogenetic protein (BMP) versus iliac crest bone grafts in various spinal fusion procedures performed in the United States, explore stratification by patient demographics, and analyze the impact on treatment cost. SUMMARY OF BACKGROUND DATA: BMP has been shown to achieve better clinical outcomes in anterior lumbar interbody fusions procedures, which led to its Food and Drug Administration approval for this indication in 2002. Since then, significant off-label use has occurred, without a full description of the results. METHODS: We searched the NIS for data relating to BMP administration or iliac crest bone grafting in a variety of spinal fusion procedures performed from 1993 to 2006, based on International Classification of Diseases, Ninth Revision classification. The NIS is the largest all-payer inpatient care database, with demographic, outcome, and cost data from approximately eight million annual patient discharges throughout the United States. Demographics among patients treated with BMP versus iliac crest bone graft were compared to reduce the likelihood of bias in the analysis. RESULTS: BMP became applied more frequently in each type of spinal fusion procedure examined over our study period, with the exception of anterior lumbar interbody fusions. Patients receiving iliac crest bone grafts versus BMP exhibited very similar demographic characteristics, including age, socioeconomic status, and type of health care setting. Although BMP typically increased the cost of the procedure itself, it improved outcomes and shorter hospital stays often provided a net benefit. CONCLUSION: BMP is increasingly being used in spinal fusion procedures, including ones for which it is not officially approved, because of the surgical and postsurgical benefits it provides. Given the morbidity that this may entail, monitoring outcomes trends will help to inform guidelines for BMP use and ensure that its benefits continue to outweigh its costs.