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Published on: March 29, 2018
Complications associated with the use of bone morphogenetic protein in pediatric patients
Matthew E Oetgen1, B Stephens Richards
1Children's National Medical Center, Washington, DC 20010, USA. moetgen@cnmc.org
Insights
Recombinant human bone morphogenetic protein-2 (rhBMP-2) appears safe for pediatric use, with few complications directly linked to the treatment. Further discussion of risks and benefits with families is recommended due to its off-label application.
Area of Science:
- Orthopedics
- Regenerative Medicine
- Pediatric Surgery
Background:
- Recombinant human bone morphogenetic protein (rhBMP) is effective for bone healing and fusions in adults.
- Limited data exists on the safety of rhBMP in pediatric patients.
- This study evaluates rhBMP-2 complications in a pediatric cohort.
Purpose of the Study:
- To assess the safety and complication profile of rhBMP-2 in pediatric patients.
- To identify any adverse events associated with rhBMP-2 use in individuals under 18.
- To provide data supporting the clinical use of rhBMP-2 in children.
Main Methods:
- Retrospective review of 81 pediatric patients (<18 years) who received rhBMP-2.
- Compilation of theoretical rhBMP-2 complications from published literature.
- Chart and radiograph review to document occurrences of potential complications.
Main Results:
- 16 potential complications were identified.
- No systemic toxicity was observed.
- One case of dural fibrosis and weakness was possibly directly related to rhBMP-2; other complications included local issues, infections, compartment syndrome, and neurologic events.
Conclusions:
- rhBMP-2 demonstrates a low rate of directly attributable complications in pediatric patients.
- The use of rhBMP-2 appears relatively safe in this young population.
- Informed consent is crucial, discussing risks and benefits due to off-label use.
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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