scholarly journals Recombinant Human Bone Morphogenetic Protein–2 Use in Adult Spinal Deformity Surgery: Comparative Analysis and Healthcare Utilization at 24 Months’ Follow-up

2020 ◽  
pp. 219256822094737
Author(s):  
Nicholas Dietz ◽  
Mayur Sharma ◽  
Michael Kelly ◽  
Beatrice Ugiliweneza ◽  
Dengzhi Wang ◽  
...  
Keyword(s):  
Health Care ◽  
Spinal Deformity ◽  
Adult Spinal Deformity ◽  
Bone Morphogenetic Protein 2 ◽  
Index Hospitalization ◽  
Outpatient Services ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone

Study Design: Retrospective cohort study. Objective: Recombinant human bone morphogenetic protein–2 (rhBMP-2) is used to achieve fusion in adult spinal deformity (ASD) surgery. Our aim was to investigate the long-term impact of rhBMP-2 use for clinical outcomes and health care utilization in this patient population. Methods: We conducted an analysis using MarketScan to identify health resource utilization of rhBMP-2 use for ASD after surgical intervention compared to fusion without rhBMP-2 at 24 months’ follow-up. Outcomes assessed included length of stay, complications, pseudoarthrosis, reoperation, outpatient services, and health care payments. Results: Of 7115 patients who underwent surgery for ASD, 854 received rhBMP-2 and 6261 were operated upon without use of rhBMP-2. One month after discharge, the rhBMP-2 cohort had a nonsignificant trend in fewer complications (15.38%) than those who did not receive rhBMP-2 (18.07%), P = .0558. At 12 months, pseudoarthrosis was reported in 2.8% of cases with no BMP and 01.14% of cases with BMP, P = .0048. Average payments at 12 months were $120 138 for the rhBMP-2 group and $118 373 for the no rhBMP-2 group, P = .8228. At 24 months, payments were $141 664 for the rhBMP-2 group and $144 179 for the group that did not receive rhBMP-2, P = .5946. Conclusions: In ASD surgery, use of rhBMP-2 was not associated with increased complications or reoperations at index hospitalization and 1-month follow-up. Overall payments, including index hospitalization, readmissions, reoperations, and outpatient services were not different compared to those without the use of rhBMP-2 at 12 months and 24 months after discharge.

scholarly journals Insights into complication rates, reoperation rates, and healthcare utilization associated with use of recombinant human bone morphogenetic protein–2 in patients with spine infections

2019 ◽  
Vol 46 (1) ◽  
pp. E8 ◽  
Author(s):  
Mayur Sharma ◽  
Nicholas Dietz ◽  
Ahmad Alhourani ◽  
Beatrice Ugiliweneza ◽  
Dengzhi Wang ◽  
...  
Keyword(s):  
Healthcare Utilization ◽  
Bone Morphogenetic Protein 2 ◽  
Complication Rates ◽  
Index Hospitalization ◽  
Outpatient Services ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Lower Complication ◽  
Reoperation Rates ◽  
Recombinant Human Bone

OBJECTIVEUse of recombinant human bone morphogenetic protein–2 (rhBMP-2) in patients with spine infections is controversial. The purpose of this study was to identify long-term complications, reoperations, and healthcare utilization associated with rhBMP-2 use in patients with spine infections.METHODSThis retrospective study extracted data using ICD-9/10 and CPT codes from MarketScan (2000–2016). Patients were dichotomized into 2 groups (rhBMP-2, no rhBMP-2) based on whether rhBMP-2 was used during fusion surgery for spinal infections. Outcomes of interest were reoperation rates (index level, other levels), readmission rates, discharge disposition, length of stay, complications, and healthcare resource utilization at the index hospitalization and 1, 3, 6, 12, and 24 months following discharge. Outcomes were compared using nonparametric 2-group tests and generalized linear regression models.RESULTSThe database search identified 2762 patients with > 24 months’ follow-up; rhBMP-2 was used in 8.4% of their cases. The patients’ median age was 53 years, 52.43% were female, and 15.11% had an Elixhauser Comorbidity Index ≥ 3. Patients in the rhBMP-2 group had higher comorbidity indices, incurred higher costs at index hospitalization, were discharged home in most cases, and had lower complication rates than those in the no–rhBMP-2 group. There was no statistically significant between-groups difference in complication rates 1 month following discharge or in reoperation rates at 3, 6, 12, and 24 months following the procedure. Patients in the no–rhBMP-2 group incurred higher utilization of outpatient services and medication refill costs at 1, 3, 6, 12, and 24 months following surgery.CONCLUSIONSIn patients undergoing surgery for spine infection, rhBMP-2 use was associated with lower complication rates and higher median payments during index hospitalization compared to cases in which rhBMP-2 was not used. There was no significant between-groups difference in reoperation rates (index and other levels) at 3, 6, 12, and 24 months after the index operation. Patients treated with rhBMP-2 incurred lower utilization of outpatient services and overall payments. These results indicate that rhBMP-2 can be used safely in patients with spine infections with cost-effective utilization of healthcare resources and without an increase in complications or reoperation rates.

Long-Segment Fusion for Adult Spinal Deformity Correction Using Low-Dose Recombinant Human Bone Morphogenetic Protein-2

Neurosurgery ◽  
2016 ◽  
Vol 79 (2) ◽  
pp. 212-221 ◽  
Author(s):  
Paul J. Schmitt ◽  
John P. Kelleher ◽  
Tamir Ailon ◽  
Joshua E. Heller ◽  
Manish K. Kasliwal ◽  
...  
Keyword(s):  
Low Dose ◽  
Adult Spinal Deformity ◽  
Fusion Rate ◽  
Bone Morphogenetic Protein 2 ◽  
Iliac Crest Bone Graft ◽  
High Dose ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone

Abstract BACKGROUND: Although use of very high-dose recombinant human bone morphogenetic protein-2 (rhBMP-2) has been reported to markedly improve fusion rates in adult spinal deformity (ASD) surgery, most centers use much lower doses due to cost constraints. How effective these lower doses are for fusion enhancement remains unclear. OBJECTIVE: To assess fusion rates using relatively low-dose rhBMP-2 for ASD surgery. METHODS: This was a retrospective review of consecutive ASD patients that underwent thoracic to sacral fusion. Patients that achieved 2-year follow-up were analyzed. Impact of patient and surgical factors on fusion rate was assessed, and fusion rates were compared with historical cohorts. RESULTS: Of 219 patients, 172 (78.5%) achieved 2-year follow-up and were analyzed. Using an average rhBMP-2 dose of 3.1 mg/level (average total dose = 35.9 mg/case), the 2-year fusion rate was 73.8%. Cancellous allograft, local autograft, and very limited iliac crest bone graft (<20 mL, obtained during iliac bolt placement) were also used. On multivariate analysis, female sex was associated with a higher fusion rate, whereas age, comorbidity score, deformity type, and 3-column osteotomy were not. There were no complications directly attributable to rhBMP-2. CONCLUSION: Fusion rates for ASD using low-dose rhBMP-2 were comparable to those reported for iliac crest bone graft but lower than for high-dose rhBMP-2. Importantly, there were substantial differences between patients in the present series and those in the historical comparison groups that could not be fully adjusted for based on available data. Prospective evaluation of rhBMP-2 dosing for ASD surgery is warranted to define the most appropriate dose that balances benefits, risks, and costs.

scholarly journals A large database study of hospitalization charges and follow-up re-admissions in US lumbar fusion surgeries using a cellular bone allograft (CBA) versus recombinant human bone morphogenetic protein-2 (rhBMP-2)

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Bradley Wetzell ◽  
Julie B. McLean ◽  
Mark A. Moore ◽  
Venkateswarlu Kondragunta ◽  
Kimberly Dorsch
Keyword(s):  
Lumbar Fusion ◽  
Bone Allograft ◽  
Bone Morphogenetic Protein 2 ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Initial Procedure ◽  
Cellular Bone ◽  
Recombinant Human Bone ◽  
Cellular Bone Allograft

Abstract Background The objective of this study was to retrospectively compare initial procedure and 12-month follow-up hospitalization charges and resource utilization (lengths of stay; LOS) for lumbar fusion surgeries using either recombinant human bone morphogenetic protein-2 (rhBMP-2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V-CBA) via a large US healthcare system database. Potentially relevant re-admissions during the follow-up period were also assessed. Methods A total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2, of whom 3503 (21.66%) patients had follow-up re-admission data. Initial patient, procedure, and hospital characteristics were assessed to determine confounding factors. Multivariate regression modeling compared differences in hospitalization charges (in 2018 US dollars) and LOS (in days) between the groups, as well as incidences of potentially relevant re-admissions during the 12-month follow-up period. Results The adjusted mean initial procedure and 12-month follow-up hospital charges were significantly lower in the V-CBA group versus the rhBMP-2 group ($109,061 and $108,315 versus $160,191 and $130,406, respectively; P < 0.0001 for both comparisons). This disparity remained in an ad hoc comparison of charges for initial single-level treatments only (V-CBA = $103,064, rhBMP-2 = $149,620; P < 0.0001). The adjusted mean initial LOS were significantly lower in the V-CBA group (3.77 days) versus the rhBMP-2 group (3.88 days; P < 0.0001), but significantly higher for the cumulative follow-up hospitalizations in the 12-month follow-up period (7.87 versus 7.46 days, respectively; P < 0.0001). Differences in rates of follow-up re-admissions aligned with comorbidities at the initial procedure. Subsequent lumbar fusion rates were comparable, but significantly lower for V-CBA patients who had undergone single-level treatments only, in spite of V-CBA patients having significantly higher rates of initial comorbidities that could negatively impact clinical outcomes. Conclusions The results of this study indicate that use of V-CBA for lumbar fusion surgeries performed in the US may result in substantially lower overall hospitalization charges versus rhBMP-2, with both exhibiting similar rates of 12-month re-admissions and subsequent lumbar fusion procedures.

scholarly journals Outcome of nonunion fractures in dogs treated with fixation, compression resistant matrix, and recombinant human bone morphogenetic protein-2

2017 ◽  
Vol 30 (02) ◽  
pp. 153-159 ◽  
Author(s):  
Anna Massie ◽  
Mark Fuller ◽  
Frank Verstraete ◽  
Boaz Arzi ◽  
Amy Kapatkin
Keyword(s):  
Bone Morphogenetic Protein ◽  
Bone Fractures ◽  
Perioperative Complications ◽  
Human Bone ◽  
Bone Morphogenetic Protein 2 ◽  
Long Bone ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone

SummaryObjectives: To report the use of compression resistant matrix (CRM) infused with recombinant human bone morphogenetic protein (rhBMP-2) prospectively in the healing of non union long-bone fractures in dogs.Methods: A longitudinal cohort of dogs that were presented with nonunion fractures were classified and treated with CRM soaked with rhBMP-2 and fracture fixation. They were followed with serial radiographs and evaluated for healing times and complications according to the time frame and definitions previously established for orthopaedic clinical cases.Results: Eleven nonunion fractures in nine dogs were included. Median healing time was 10 weeks (range: 7–20 weeks). Major perioperative complications due to bandage morbidity were encountered in two of 11 limbs and resolved. All other complications were minor. They occurred perioperatively in eight of 11 limbs. Minor follow-up complications included short-term in one of two limbs, mid-term in one of three, and long-term in four of five limbs. Nine limbs returned to full function and two limbs returned to acceptable function at the last follow-up.Clinical significance: Nonunion fractures given a poor prognosis via standard-of-care treatment were successfully repaired using CRM with rhBMP-2 accompanying fixation. These dogs, previously at high risk of failure, returned to full or acceptable function.

The safety and efficacy of anterior cervical discectomy and fusion with polyetheretherketone spacer and recombinant human bone morphogenetic protein–2: a review of 200 patients

2008 ◽  
Vol 8 (6) ◽  
pp. 529-535 ◽  
Author(s):  
Luis M. Tumialán ◽  
Jeff Pan ◽  
Gerald E. Rodts ◽  
Praveen V. Mummaneni
Keyword(s):  
Bone Morphogenetic Protein ◽  
Clinical Outcomes ◽  
Collagen Sponge ◽  
Bone Morphogenetic Protein 2 ◽  
Ct Scans ◽  
Safety And Efficacy ◽  
Morphogenetic Protein ◽  
Human Bone Morphogenetic Protein ◽  
Recombinant Human Bone

Object The goal in this study was to demonstrate the safety and efficacy of anterior cervical discectomy and fusion ([ACDF]; single- or multilevel procedure) performed using titanium plates and polyetheretherketone (PEEK) spacers filled with recombinant human bone morphogenetic protein–2 (rhBMP-2) impregnated in a type I collagen sponge to achieve fusion. Methods The authors retrospectively reviewed 200 patients who underwent a single- or multilevel ACDF with titanium plate fixation and PEEK spacer filled with a collagen sponge impregnated with low-dose rhBMP-2. Clinical outcomes were assessed using pre- and postoperative Nurick grades and the Odom criteria. Radiographic outcomes were assessed using dynamic radiographs and computed tomography (CT) scans. Results The follow-up period ranged from 8 to 36 months (mean 16.7 months). A single-level ACDF was performed in 96 patients, 2-level ACDF in 62 patients, 3-level ACDF in 36 patients, and 4-level ACDF in 6 patients. Long-term follow-up was available for 193 patients. The Odom outcomes were rated as good to excellent in 165 patients (85%), fair in 24 (12.4%), and poor in 4 (2%). Among patients with myelopathy, Nurick grades improved from a preoperative mean of 1.42 to a postoperative mean of 0.26. All patients (100%) achieved solid radiographic fusion on dynamic radiographs and CT scans. Fourteen patients (7%) in this series experienced clinically significant dysphagia, and 4 (2%) required repeated operation for hematoma or seroma. Conclusions An ACDF performed using a PEEK spacer filled with rhBMP-2 leads to good to excellent clinical outcomes and solid fusion, even in multilevel cases and in patients who are smokers. The incidence of symptomatic dysphagia may be decreased with a lower dose of rhBMP-2 that is placed only within the PEEK spacer.

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