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Immediate Effects of Use of Recombinant Bone Morphogenetic Protein in Children Having Spinal Fusion and Refusion
Veerasathpurush Allareddy1, Veerajalandhar Allareddy, Natalia Martinez-Schlurmann
1*Department of Orthodontics, College of Dentistry, The University of Iowa, Iowa City, IA †Division of Pediatric Critical Care, Rainbow Babies and Children's Hospital, University Hospitals, Case Medical Center, Cleveland, OH ‡Graduate student, University of Nebraska Medical Center, Omaha, NE §Office of Global Health, Harvard School of Dental Medicine, Boston, MA ¶Department of Periodontics, College of Dentistry, The University of Iowa, Iowa City, IA.
Insights
Recombinant human bone morphogenetic protein (rhBMP) use in pediatric spinal fusion surgery was not linked to most complications. However, rhBMP was associated with a higher risk of other infections in children undergoing spinal fusion procedures.
Area of Science:
- Pediatric Orthopedics
- Spinal Surgery
- Biomaterials in Medicine
Background:
- Conflicting safety reports exist regarding recombinant human bone morphogenetic protein (rhBMP) use in adult spinal fusion procedures (SFP).
- The safety and complication rates associated with rhBMP in pediatric SFP are not well-established.
Purpose of the Study:
- To estimate the prevalence of complications in children undergoing SFP with rhBMP insertion.
- To determine if rhBMP use increases the risk of complications in pediatric SFP.
Main Methods:
- Retrospective analysis of the Nationwide Inpatient Sample (NIS) database from 2004-2010.
- Inclusion of patients under 18 years old who underwent SFP, with or without rhBMP.
- Multivariable logistic regression models were used to assess the association between rhBMP and complications.
Main Results:
- Out of 72,898 pediatric SFP cases, 7.1% involved rhBMP.
- Overall complication rates were similar between the rhBMP (15.2%) and no-rhBMP (14.3%) groups.
- A statistically significant increased odds of "other infections" (OR=2.09) were observed in the rhBMP group, but not for other assessed complications.
Conclusions:
- rhBMP is utilized in pediatric SFP despite lacking FDA approval.
- The study found no increased risk for most complications with rhBMP use in pediatric SFP, except for "other infections".
- Further research is needed to understand the long-term effects of rhBMP in pediatric spinal fusion.
Study Design:
Retrospective study of Nationwide Inpatient Sample (NIS).
Objective:
The objective of this study is to estimate the prevalence of complications in children who had insertion of recombinant human bone morphogenetic protein (rhBMP) at the time of spinal fusion procedures (SFP) and to examine if the use of rhBMP is associated with an increased risk of complications.
Summary Of Background Data:
Use of rhBMP for SFP has been associated with conflicting safety profile reports in adults.
Methods:
NIS (years 2004-2010) was used. All patients with age < 18 years who had a SFP during hospitalization with or without insertion of rhBMP were selected. Complications were selected based on a literature review of studies examining outcomes of SFP. Association between insertion of rhBMP and occurrence of complications was examined by multivariable logistic regression models.
Results:
Of the 72,898 children who underwent SFP, 7.1% children had insertion of rhBMP. Overall complication rate was 14.34% (15.2% in rhBMP group and 14.3% in no-rhBMP group). There was no statistically significant difference in the overall complication rate [odds ratio (OR) = 1.08, 95% confidence intervals (CI) = 0.89-1.30] or among 14 different complications between rhBMP and no-rhBMP groups. Children who had rhBMP were associated with higher odds for "other infections" (OR = 2.09, 95% CI = 1.26-3.48, P = 0.004) when compared with their counterparts.
Conclusion:
Despite the lack of Food and Drug Administration approval, rhBMP was not infrequently used in pediatric SFP. In this large retrospective study using administrative data, the use of rhBMP in children during SFP was not associated with higher risks for majority of assessed complications with the exception of "other infections". Future studies must examine the long-term impact of use of rhBMP in children with SFP.
Level Of Evidence:
3.
