Complications associated with the use of bone morphogenetic protein in pediatric patients

Matthew E. Oetgen, B. Stephens Richards

Research output: Contribution to journalArticle

28 Citations (Scopus)

Abstract

Background: Recombinant human bone morphogenetic protein (rhBMP) has been found to be a powerful adjunct to healing nonunions and obtaining fusions. Despite the apparent clinical efficacy and good safety profile reported with rhBMP use in adults, there is little data regarding the safety of this product in pediatric patients. We evaluated the use of rhBMP-2 in pediatric patients to determine if any complications were associated with its use. Methods: We performed a retrospective review of 81 patients, all less then 18 years old, in whom rhBMP-2 was used. Theoretical complications associated with rhBMP-2 use were compiled based on a review of the published literature on rhBMP-2. A review of each patient's chart and radiographs was performed to record the occurrences of complications, which may have been associated with the use of rhBMP-2. Results: A total of 16 complications were found, which may have been attributed to the use of rhBMP-2. There were no incidences of systemic toxicity associated with rhBMP-2 use. Nine patients were noted to have some local operative site problem, 3 deep infections were noted, 1 patient was found to have a postoperative compartment syndrome, 2 patients were found to have neurologic complications (1 with progressive myelopathy and 1 with weakness and dural fibrosis), and 1 patient with neurofibromatosis and previously diagnosed intracranial gliomas was found to have subsequent enlargement of these gliomas. In reviewing these complications, only the case of dural fibrosis and subsequent weakness was thought to possibly be directly related to the use of rhBMP-2. Conclusion: We found few complications in pediatric patients, which were felt to be directly attributable to the use of rhBMP-2. As such, rhBMP-2 use seems to be relatively safe in this young patient population. Due to the current use of this product in pediatric patients in an "off-label" fashion, we recommend a thorough discussion of the possible risks and benefits of this product with the family before its use. Level of Evidence: Therapeutic studies-Level IV.

Original languageEnglish (US)
Pages (from-to)192-198
Number of pages7
JournalJournal of Pediatric Orthopaedics
Volume30
Issue number2
DOIs
StatePublished - Mar 2010

Fingerprint

Bone Morphogenetic Proteins
Pediatrics
Glioma
Fibrosis
recombinant human bone morphogenetic protein-2
Safety
Compartment Syndromes
Neurofibromatoses
Spinal Cord Diseases
Nervous System

Keywords

  • Bone morphogenetic protein
  • Complications
  • Pediatrics

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Orthopedics and Sports Medicine

Cite this

Complications associated with the use of bone morphogenetic protein in pediatric patients. / Oetgen, Matthew E.; Richards, B. Stephens.

In: Journal of Pediatric Orthopaedics, Vol. 30, No. 2, 03.2010, p. 192-198.

Research output: Contribution to journalArticle

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abstract = "Background: Recombinant human bone morphogenetic protein (rhBMP) has been found to be a powerful adjunct to healing nonunions and obtaining fusions. Despite the apparent clinical efficacy and good safety profile reported with rhBMP use in adults, there is little data regarding the safety of this product in pediatric patients. We evaluated the use of rhBMP-2 in pediatric patients to determine if any complications were associated with its use. Methods: We performed a retrospective review of 81 patients, all less then 18 years old, in whom rhBMP-2 was used. Theoretical complications associated with rhBMP-2 use were compiled based on a review of the published literature on rhBMP-2. A review of each patient's chart and radiographs was performed to record the occurrences of complications, which may have been associated with the use of rhBMP-2. Results: A total of 16 complications were found, which may have been attributed to the use of rhBMP-2. There were no incidences of systemic toxicity associated with rhBMP-2 use. Nine patients were noted to have some local operative site problem, 3 deep infections were noted, 1 patient was found to have a postoperative compartment syndrome, 2 patients were found to have neurologic complications (1 with progressive myelopathy and 1 with weakness and dural fibrosis), and 1 patient with neurofibromatosis and previously diagnosed intracranial gliomas was found to have subsequent enlargement of these gliomas. In reviewing these complications, only the case of dural fibrosis and subsequent weakness was thought to possibly be directly related to the use of rhBMP-2. Conclusion: We found few complications in pediatric patients, which were felt to be directly attributable to the use of rhBMP-2. As such, rhBMP-2 use seems to be relatively safe in this young patient population. Due to the current use of this product in pediatric patients in an {"}off-label{"} fashion, we recommend a thorough discussion of the possible risks and benefits of this product with the family before its use. Level of Evidence: Therapeutic studies-Level IV.",
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