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Immediate Effects of Use of Recombinant Bone Morphogenetic Protein in Children Having Spinal Fusion and Refusion Procedures in United States.

Publication ,  Journal Article
Allareddy, V; Allareddy, V; Martinez-Schlurmann, N; Rampa, S; Nalliah, RP; Lidsky, KB; Rotta, AT; Elangovan, S
Published in: Spine (Phila Pa 1976)
November 2015

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.

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Published In

Spine (Phila Pa 1976)

DOI

EISSN

1528-1159

Publication Date

November 2015

Volume

40

Issue

21

Start / End Page

1719 / 1726

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Spinal Fusion
  • Retrospective Studies
  • Reoperation
  • Recombinant Proteins
  • Postoperative Complications
  • Orthopedics
  • Male
  • Infant, Newborn
 

Citation

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Allareddy, V., Martinez-Schlurmann, N., Rampa, S., Nalliah, R. P., Lidsky, K. B., Rotta, A. T., & Elangovan, S. (2015). Immediate Effects of Use of Recombinant Bone Morphogenetic Protein in Children Having Spinal Fusion and Refusion Procedures in United States. Spine (Phila Pa 1976), 40(21), 1719–1726. https://doi.org/10.1097/BRS.0000000000001110
Allareddy, Veerasathpurush, Veerajalandhar Allareddy, Natalia Martinez-Schlurmann, Sankeerth Rampa, R. P. Nalliah, K. B. Lidsky, A. T. Rotta, and Satheesh Elangovan. “Immediate Effects of Use of Recombinant Bone Morphogenetic Protein in Children Having Spinal Fusion and Refusion Procedures in United States.Spine (Phila Pa 1976) 40, no. 21 (November 2015): 1719–26. https://doi.org/10.1097/BRS.0000000000001110.
Allareddy V, Martinez-Schlurmann N, Rampa S, Nalliah RP, Lidsky KB, Rotta AT, et al. Immediate Effects of Use of Recombinant Bone Morphogenetic Protein in Children Having Spinal Fusion and Refusion Procedures in United States. Spine (Phila Pa 1976). 2015 Nov;40(21):1719–26.
Allareddy, Veerasathpurush, et al. “Immediate Effects of Use of Recombinant Bone Morphogenetic Protein in Children Having Spinal Fusion and Refusion Procedures in United States.Spine (Phila Pa 1976), vol. 40, no. 21, Nov. 2015, pp. 1719–26. Pubmed, doi:10.1097/BRS.0000000000001110.
Allareddy V, Martinez-Schlurmann N, Rampa S, Nalliah RP, Lidsky KB, Rotta AT, Elangovan S. Immediate Effects of Use of Recombinant Bone Morphogenetic Protein in Children Having Spinal Fusion and Refusion Procedures in United States. Spine (Phila Pa 1976). 2015 Nov;40(21):1719–1726.

Published In

Spine (Phila Pa 1976)

DOI

EISSN

1528-1159

Publication Date

November 2015

Volume

40

Issue

21

Start / End Page

1719 / 1726

Location

United States

Related Subject Headings

  • United States
  • Treatment Outcome
  • Spinal Fusion
  • Retrospective Studies
  • Reoperation
  • Recombinant Proteins
  • Postoperative Complications
  • Orthopedics
  • Male
  • Infant, Newborn