Complications, Costs, and Quality Outcomes of Patients Undergoing Cervical Deformity Surgery With Intraoperative BMP Use.

STUDY DESIGN: An epidemiological study using national administrative data from the MarketScan database. OBJECTIVE: The aim of this study was to identify the impact of bone morphogenetic protein (BMP) on postoperative outcomes in patients undergoing adult cervical deformity (ACD) surgery. SUMMARY OF BACKGROUND DATA: BMP has been shown to stimulate bone growth and improve fusion rates in spine surgery. However, the impact of BMP on reoperation rates and postoperative complication rate is controversial. METHODS: We queried the MarketScan database to identify patients who underwent ACD surgery from 2007 to 2015. Patients were stratified by BMP use in the index operation. Patients <18 years and those with any history of tumor or trauma were excluded. Baseline demographics and comorbidities, postoperative complication rates, and reoperation rates were analyzed. RESULTS: A total of 13,549 patients underwent primary ACD surgery, of which 1155 (8.5%) had intraoperative BMP use. The overall 90-day complication rate was 27.6% in the non-BMP cohort and 31.1% in the BMP cohort (P < 0.05). Patients in the BMP cohort had longer average length of stay (4.0 days vs. 3.7 days, P < 0.05) but lower revision surgery rates at 90 days (14.5% vs. 28.3%, P < 0.05), 6 months (14.9% vs. 28.6%, P < 0.05), 1 year (15.7% vs. 29.2%, P < 0.05), and 2 years (16.5% vs. 29.9%, P < 0.05) postoperatively. BMP use was associated with higher payments throughout the 2-year follow-up period ($107,975 vs. $97,620, P < 0.05). When controlling for baseline group differences, BMP use independently increased the odds of postoperative complication (odds ratio [OR] 1.22, 95% confidence interval [CI] 1.1-1.4) and reduced the odds of reoperation throughout 2 years of follow-up (OR 0.49, 95% CI 0.4-0.6). CONCLUSION: Intraoperative BMP use has benefits for fusion integrity in ACD surgery but is associated with increased postoperative complication rate. Spine surgeons should weigh these benefits and drawbacks to identify optimal candidates for BMP use in ACD surgery. LEVEL OF EVIDENCE: 3.

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.

Cost-effective studies in spine surgeries: a narrative review.

BACKGROUND CONTEXT: Although the pathologic processes that affect the spine remain largely unchanged, our techniques to correct them continue to evolve with the development of novel medical and surgical interventions. Although the primary purpose of new technologies is to improve patients' quality of life, the economic impact of such therapies must be considered. PURPOSE: To review the available peer-reviewed literature on spine surgery that addresses the cost-effectiveness of various treatments and technologies. STUDY DESIGN: A narrative literature review. METHODS: Articles published between January 1, 2000 and December 31, 2012 were selected from two Pubmed searches using keywords cost-effectiveness AND spine (216 articles) and cost analysis AND spine (358 articles). Relevant articles on cost analyses and cost-effectiveness were selected by the authors and reviewed. RESULTS: Cervical and lumbar surgeries (anterior cervical discectomy and fusion, standard open lumbar discectomy, and standard posterior lumbar laminectomy) are reasonably cost effective at 2 years after the procedure (<100,000 US dollars per quality-adjusted life years gained) and become more cost effective with time because of sustained clinical improvements with relatively low additional incurred costs. The usage of transfusion avoidance technology is not cost effective because of the low risk of complications associated with allogenic transfusions. Although intraoperative neuromonitoring and imaging modalities are both cost saving and cost-effective, their cost-effectiveness is largely dependent on the baseline rate of neurologic complications and implant misplacement, respectively. More rigorous studies are needed to evaluate the cost-effectiveness of recombinant bone morphogenetic protein. CONCLUSIONS: An ideal new technology should be able to achieve maximal improvement in patient health at a cost that society is willing to pay. The cost-effectiveness of technologies and treatments in spine care is dependent on their durability and the rate and severity of the baseline clinical problem that the treatment was designed to address.

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.

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.

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.

Bone morphogenetic proteins in orthopaedic trauma surgery.

Fracture healing describes the normal post-traumatic physiologic process of bone regeneration. Commonly, this complicated process occurs without interruption, however, certain clinical situations exist that may benefit from the usage of bone healing enhancement agents. Bone morphogenetic proteins (BMPs) assist in the process of bone healing by recruiting bone-forming cells to the area of trauma. The usage of BMP currently has two FDA-approved indications: (1) treatment of acute tibial fractures treated with intramedullary fixation and (2) treatment of long bone non-union. Despite this limited scope, off-label BMP usage continues to push the envelope for new applications. Although proven to be clinically successful, BMP use must be balanced with the large costs associated with their application. Regardless, more prospective randomised clinical trials must be conducted to validate and expand the role of BMP in the setting of trauma.

Prevalence, complications, and hospital charges associated with use of bone-morphogenetic proteins in spinal fusion procedures.

CONTEXT: No national data exist to examine use of bone-morphogenetic proteins (BMPs) in spinal fusion surgery. OBJECTIVE: To determine the patterns of use and rates of complications and financial charges associated with BMP use in spinal fusion nationally. DESIGN, SETTING, AND PATIENTS: Retrospective cohort study of 328,468 patients undergoing spinal fusion procedures from 2002-2006 identified from the Nationwide Inpatient Sample database, a 20% sample of US community hospitals. MAIN OUTCOME MEASURES: The rates of use of BMP among patients undergoing spinal fusion procedures are examined along with complications, length of stay, and hospital charges associated with use of this fusion adjunct. RESULTS: The nationwide usage of BMP has increased from 0.69% of all fusions in 2002 to 24.89% of all fusions in 2006. Use of BMP varied by patient sex, race, and primary payer with increased use seen in women (56.26% with BMP vs 53.35% without BMP; odds ratio [OR], 1.12; 95% confidence interval, [CI], 1.09-1.16) and Medicare patients (29.62% with BMP vs 27.16% without BMP; OR, 1.43; 95% CI, 1.31-1.56) and decreased use in nonwhite patients (8.69% with BMP vs 10.23% without BMP; OR, 0.80; 95% CI, 0.75-0.85). When comparing immediate postoperative, in-hospital rates of complications for the year 2006 among patients undergoing spinal fusion by BMP use status, no differences were seen for lumbar, thoracic, or posterior cervical procedures. On univariate analysis and after multivariable adjustment, the use of BMP in anterior cervical fusion procedures was associated with a higher rate of complication occurrence (7.09% with BMP vs 4.68% without BMP; adjusted OR, 1.43; 95% CI, 1.12-1.70) with the primary increases seen in wound-related complications (1.22% with BMP vs 0.65% without BMP; adjusted OR, 1.67; 95% CI, 1.10- 2.53) and dysphagia or hoarseness (4.35% with BMP vs 2.45% without BMP; adjusted OR, 1.63; 95% CI, 1.30-2.05). Bone-morphogenetic protein use was associated with greater inpatient hospital charges across all categories of fusion. Increases between 11% and 41% of total hospital charges were reported, with the greatest percentage increase seen for anterior cervical fusion. CONCLUSION: Bone-morphogenetic protein was used in approximately 25% of all spinal fusions nationally in 2006, with use associated with more frequent complications for anterior cervical fusions and with greater hospital charges for all categories of fusions.

A health economic analysis of the use of rhBMP-2 in Gustilo-Anderson grade III open tibial fractures for the UK, Germany, and France.

The purpose of this study was to determine the cost savings from a societal perspective for recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) in grade III A and B open tibial fractures treated with a locked intramedullary nail and soft-tissue management in the UK, Germany, and France. Health care system costs (direct health care costs) and costs for productivity losses (indirect health care costs) were calculated using the raw data from the Bone Morphogenetic Protein Evaluation Group in Surgery for Tibial Trauma "BESTT study". Return-to-work time for estimation of productivity losses was assumed to correspond with the time of fracture healing. For calculation of secondary interventions costs and productivity losses the respective 2007/2008 national tariffs for surgical procedures and average national wages for the UK, Germany, and France were used. For a 1 year perspective, overall treatment costs per patient after the initial surgery of the control vs. the rhBMP-2 group were 44,757 euros vs. 36,847 euros for the UK, 50,197 euros vs. 40,927 euros for Germany and 48,766 euros vs. 39,474 euros for France in favour of rhBMP-2 with overall savings overall savings per case of rhBMP-2 treatment of 7911 euros for the UK, 9270 euros for Germany, and 9291 euros for France which was mainly due to reduced productivity losses by significant faster fracture healing in the rhBMP-2 group (p=0.01). These savings largely offset the upfront price of rhBMP-2 of 2266 euros (1790 pounds) in the UK, euros 2970 in Germany, and 2950 euros in France. Total net savings can be estimated to be 9.6 million euros for the UK, 14.5 million euros for Germany, and 11.4 million euros for France. The results depend on the methodology used particularly for calculation of productivity losses and return-to-work time which was assumed to correspond with fracture healing time. In summary, despite the apparent high direct cost of rhBMP-2 in grade III A and B open tibial fractures, at a national level there are net cost savings from a societal perspective for all three countries.

Bone morphogenetic proteins in open fractures: past, present, and future.

The management of open fractures continues to be complicated by high rates of treatment failure and significant patient disability and dissatisfaction. The use of bone morphogenetic proteins (BMPs) in the treatment of open fractures has been assessed by a number of different clinical trials, both in the acute management of open fractures and in the delayed reconstruction of bone defects secondary to open fracture. This review describes the scientific basis for the use of BMPs in open fractures, reviews the current evidence for their use in open fractures, provides grades of recommendation for the different uses of BMPs in open fractures, and identifies important areas for additional research.

Spinal reconstruction and bone morphogenetic proteins: open questions.

Spinal fusion is a proven surgical tool for the treatment of degenerative, traumatic, neoplastic, and infectious conditions of the spine. Traditional grafting techniques using autogenous bone graft or allograft have inherent drawbacks including varying pseudoarthrosis rates and well recognized bone graft harvest site complications. Bone morphogenetic proteins (BMPs) offer the exciting prospect of enhanced union rates equal to or greater than autograft and potentially eliminate graft harvest site complications. Many studies have clearly demonstrated the efficacy of BMP products for various applications in spine surgery. BMP has proven effective in achieving union in anterior and posterior lumbar surgery and recently in anterior cervical surgery. Despite the reported success, the universal adoption of BMP is tempered by high costs and lingering safety concerns with reported complications specific to BMP use including vertebral osteolysis, ectopic bone formation, radiculitis and cervical soft tissue swelling. Ongoing clinical and basic-science research is focused on clearly defining guidelines for BMP use in spine surgery and on developing more affordable BMP formulations with dosing that predictably results in spine fusion yet minimizes the possible side effect profile.

The perioperative cost of Infuse bone graft in posterolateral lumbar spine fusion.

BACKGROUND CONTEXT: There is mounting evidence supporting the efficacy of bone morphogenetic protein (BMP) for both anterior interbody and posterolateral lumbar fusion. However, the relative cost of BMP remains an important concern for physicians, hospitals, and payers. PURPOSE: The purpose of this study is to report on the perioperative costs for patients treated with rhBMP-2 as compared with an iliac crest bone graft (ICBG) supplemented with graft extenders. STUDY DESIGN/SETTING: A prospective randomized controlled trial of rhBMP-2/ACS (Infuse Bone Graft; Medtronic Sofamor Danek, Memphis, TN) versus ICBG+/-graft extender for lumbar spine fusion in patients over 60 years old. PATIENT SAMPLE: One hundred two patients over 60 years old who required a posterolateral lumbar spine fusion randomized between receiving rhBMP-2/ACS or ICBG. OUTCOME MEASURES: All health-care costs over the first 3 months after surgery. METHODS: As part of a prospective randomized trial of rhBMP-2/ACS versus ICBG+/-graft extender for lumbar spine fusion, all costs over the first 3 months after surgery were directly recorded by a dedicated coder funded by Norton Healthcare, Louisville, KY. A dedicated research nurse also followed all patients throughout their hospital stay and posthospitalization recovery to identify any adverse events or additional outpatient medical care. RESULTS: Fifty patients received rhBMP-2/ACS and 52 underwent ICBG harvest. The mean hospital cost for the index admission was $24,736 for the rhBMP-2/ACS group and $21,138 for the ICBG group. Mean inpatient physician costs were $5,082 in the rhBMP-2/ACS group and $5,316 in the ICBG group. Costs associated with posthospital rehabilitation averaged $4,906 in the rhBMP-2/ACS group versus $6,820 in the ICBG group. Total payer expenditure for the 3-month perioperative period averaged $33,860 in the rhBMP-2/ACS group and $37,227 in the ICBG group. CONCLUSIONS: The hospital carries the cost burden associated with the utilization of rhBMP-2/ACS. In contrast, the payer in a Diagnosis-Related Group (DRG) model achieves a net savings, based primarily on the decreased payment for inpatient rehabilitation, but also on decreased hospital reimbursement, physician costs, and other outpatient services.

Prospective nonrandomized comparison of an allograft with bone morphogenic protein versus an iliac-crest autograft in anterior cervical discectomy and fusion.

BACKGROUND CONTEXT: Anterior cervical discectomy and fusion (ACDF) using autogenous iliac bone graft may lead to donor-site morbidity. This has led some surgeons to use alternatives to iliac bone graft, but often the alternatives have greater rates of nonunion and delayed union. Bone morphogenic protein (BMP) studies have found high arthrodesis rates in lumbar fusions. PURPOSE: The objective of this pilot study was to compare the success of BMP combined with bone allograft with iliac bone autograft in ACDF patients. STUDY DESIGN/SETTING: The institutional review board approved a prospective but nonrandomized study of 66 consecutive patients who had primary one- to three-level ACDF with either iliac-crest bone autograft or BMP allograft (0.9 mg BMP per level) followed prospectively over a 2- to 3-year period. PATIENT SAMPLE: Consecutive patients who had primary one- to three-level ACDF with either iliac-crest bone autograft (n=36) or BMP-allograft (n=30). Patients in both iliac bone graft and BMP-allograft groups had comparable preoperative pain and disability. OUTCOME MEASURES: Visual analog scale pain, pain drawing, Oswestry index, pain medication use, opinion of treatment success, and neurological recovery. RESULTS: Given the nonrandomized nature of the study, the study groups were not matched. Within this limitation, both groups of patients had similar improvement in all outcome scales (visual analog scale pain, pain drawing, Oswestry index, pain medication use, and opinion of treatment success) and neurological recovery over the 2- to 3-year follow-up period. Patients in the iliac bone graft group had two pseudarthroses and two complications of the iliac-crest donor site. In the BMP-allograft group, one patient had a pseudarthrosis, but 50% had neck swelling presenting as dysphagia, which was substantially more common than the 14% present in the iliac bone graft group. Patients in the BMP-allograft group had slightly shorter surgery time, but implant and hospitalization costs were higher. CONCLUSIONS: ACDF performed with BMP (0.9 mg BMP per level) allograft is as effective as iliac bone graft in terms of patient outcomes and fusion rates. Safety concerns related to neck swelling and higher initial costs were associated with patients in the bone morphogenic protein group.

Health economics: a cost analysis of treatment of persistent fracture non-unions using bone morphogenetic protein-7.

OBJECTIVE: To compare the cost implications of treatment of persistent fracture non-unions before and after application of recombinant human bone morphogenetic protein-7 (BMP-7). METHOD: Of 25 fracture non-unions, 9 were treated using BMP-7 alone and 16 using BMP-7 and bone grafting. These patients were prospectively followed up, and the costs incurred were analysed. RESULTS: The mean number of procedures per fracture performed before application of BMP-7 was 4.16, versus 1.2 thereafter. Mean hospital stay and cost of treatment per fracture before receiving BMP-7 were 26.84 days and pound 13,844.68, versus 7.8 days and pound 7338.4 thereafter. The overall cost of treatment of persistent fracture non-unions with BMP-7 was 47.0% less than that of the numerous previous unsuccessful treatments (p=0.001). CONCLUSIONS: Treating fracture non-unions is costly, but this could be reduced by early BMP-7 administration when a complex or persistent fracture non-union is present or anticipated.

[Health-economic considerations for the use of BMP-2 for spinal surgery in Germany]. / Gesundheitsökonomische Uberlegungen für den Einsatz des Knochenwachstumsfaktors BMP-2 in der Wirbelsäulenchirurgie für das deutsche Gesundheitssystem.

INTRODUCTION: BMP-2 can replace autogenous bone grafting in lumbar one-level anterior lumbar interbody fusions (ALIF). The current G-DRG system does not reimburse the upfront price of 2,970 euro per BMP-2 application for hospitals in Germany. The purpose of the current study was to create a health economic model to evaluate the financial savings for health care providers (hospitals) and health care payers (health care insurance) that can be achieved by the use of BMP-2 in spine surgery. METHODS: A previously published pooled data analysis was used in which BMP-2 showed significant improvements in the treatment after ALIF surgery compared to autogenous bone grafting, including earlier return to work time and reduced revision rates. These medical findings were transformed into economic data based on the regulations of the German health system of 2005. RESULTS: The significantly shorter return to work time under BMP-2 treatment generates important financial savings for health care insurances offsetting the upfront prize of 2,970 euro for BMP-2. Savings for hospitals are mainly related to shorter surgery time due to the absence of the bone grafting procedure and faster discharge of the patient. CONCLUSIONS: The combination of improved medical outcome by BMP-2 treatment for the patient and net savings for the entire health care system in Germany represents a "dominant" strategy from a health economic perspective. This implicates that BMP-2 in ALIF procedures is to be recommended from a health economic point of view for the German health care system.

Economic considerations for the use of recombinant human bone morphogenetic protein-2 in open tibial fractures in Europe: the German model.

The addition of recombinant human bone morphogenetic protein (rhBMP-2) to the standard of care, consisting of soft tissue management and intramedullary nailing, in the BMP-2 Evaluation in Surgery for Tibial Trauma (BESTT) study led to a significantly better outcome for the patient. Reductions in fracture healing time, secondary interventions for delayed fracture healing and infection rates were observed with 1.50 mg/mL rhBMP-2 compared with the standard of care alone. In Germany the approximate cost of applying one dose of recombinant human bone morphogenetic protein-2 (rhBMP-2) to an open tibial fracture is euro2970. The current German-Diagnosis-Related Group reimbursement system provides one flat rate per hospital stay or treatment case, and does not take into account the costs of rhBMP-2 application. Therefore there is no reimbursement for the price of rhBMP-2 for hospitals by health insurance companies. However, the above mentioned improvements in medical outcome could lead to important savings for health care systems, particularly for health insurance companies. A sound economic model to assess the cost-effectiveness and budget impact of rhBMP-2 is required. Using medical data from the BESTT study the differences in fracture healing time, in reduction of secondary interventions for fracture healing and infection treatment can be transferred into economic savings. It is anticipated that the overall savings that can be achieved by rhBMP-2 treatment in open tibia fractures, offset the upfront price of rhBMP-2 and lead to net savings for health insurance companies.