Evaluation of complications associated with off-label use of recombinant human bone morphogenetic protein-2 (rhBMP-2) in pediatric orthopaedics

详细信息    查看全文

• 作者：Norbert Stiel ; Tim N. Hissnauer…
• 关键词：Bone morphogenetic protein ; rhBMP ; 2 ; Pediatrics ; Complications ; Cancer ; Safety
• 刊名：Journal of Materials Science Materials in Medicine
• 出版年：2016
• 出版时间：December 2016
• 年：2016
• 卷：27
• 期：12
• 全文大小：235 KB
• 刊物类别：Chemistry and Materials Science
• 刊物主题：Chemistry
  Biomaterials
  Characterization and Evaluation Materials
  Polymer Sciences
  Metallic Materials
  Ceramics,Glass,Composites,Natural Materials
  Surfaces and Interfaces and Thin Films
  
• 出版者：Springer Netherlands
• ISSN：1573-4838
• 卷排序：27

文摘

The off-label use of recombinant human bone morphogenetic protein-2 to promote bone healing in adults has significantly increased in recent years, while reports of recombinant human bone morphogenetic protein-2 application in children and adolescents are very rare. The aim of this study was to evaluate the safety of single and repetitive recombinant human bone morphogenetic protein-2 use in pediatric orthoapedics. Therefore we reviewed the medical records of 39 patients who had been treated with recombinant human bone morphogenetic protein-2 at our institution. Their mean age was 10.9 years. Recombinant human bone morphogenetic protein-2 was used in 17 patients for spine fusion, in 11 patients for the treatment of congenital pseudarthrosis of the tibia or tibial nonunion, in 5 patients for the management of femoral nonunion, in 5 patients for nonunions at other locations, and in 1 case for tibial shortening. Special attention was paid to identify all adverse events that may be attributed to recombinant human bone morphogenetic protein-2 use, including local inflammatory reactions, allergic reactions, systemic toxicity, excessive wound swelling, hematoma, compartment syndrome, infection, heterotopic ossification, excessive bone growth, carcinogenicity, and the consequences of repeated applications of recombinant human bone morphogenetic protein-2. Follow-up was a mean of 39 months. Forty-six operations with application of rhBMP-2 were performed. Complications that may be due to application of recombinant human bone morphogenetic protein-2 were seen after 18 operations including swelling, increase in temperature, wound secretion, redness and hyperthermia. We consider the three cases of necessary revisions, one due to hematoma, one due to development of a compartment syndrome, and one due to deep infection, to be the only complications related to the use of recombinant human bone morphogenetic protein-2. In conclusion, we found few complications attributable to application of recombinant human bone morphogenetic protein-2 in pediatric patients.