Intermediate Dosing of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2) Improves Fusion Rates with No Increase in Major Complications but Does Not Improve Health Related Quality of Life for Adult Spinal Deformity (ASD) at Minimum Two Years: A Prospective, Multicenter Analysis

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.

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

Neurosurgery ◽

10.1227/neu.0000000000001194 ◽

2016 ◽

Vol 79 (2) ◽

pp. 212-221 ◽

Cited By ~ 8

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.

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