Few complications reported amidst greater rhBMP-2 use in pediatric fusion cases

The protein is commonly used in spinal fusions, but the evidence that it is safe for use in children is not conclusive, according to investigators.

SAN FRANCISCO — The use of recombinant human bone morphogenetic protein-2 in pediatric spine fusion procedures is increasing, but more evidence is needed to determine if its use is completely safe in these cases, according to a presenter.

Brandon G. Rocque, MD, MS, and colleagues recently studied the effect of recombinant human bone morphogenetic protein-2 (rhBMP-2) in children and compared complication rates associated with the use of the protein to the complication rates in similar cases in which rhBMP-2 was not used.

“There is no apparent difference in the complication rates. We must be very, very careful that we do not take this as evidence that BMP is safe for use in children. That is absolutely not what I am saying. In fact, I would argue that this agent is being used in children a lot and it is incumbent upon us to assure that this is being studied,” Rocque said when he presented these results.

Pediatric BMP use on the rise

The FDA has not approved rhBMP-2 for pediatric spine surgery, according to Rocque.

Brandon G. Rocque

The study Rocque and colleagues performed involved an analysis of the literature to determine the possible complications related to rhBMP-2 use in pediatric spine fusion. They also used the PearlDiver Technologies private payer database, which contains United Healthcare records, to identify pediatric spine fusions, including ones for scoliosis, performed from 2005 to 2011. They analyzed the results of the procedures based on the procedure codes to determine the complication rates for spinal fusions performed with and without rhBMP-2.

Rocque and colleagues found 4,658 patients underwent spine fusion; the protein was used in 1,752 cases or 37.61% of the fusions. Most of the patients were female. The ages for about 95% of the patients ranged from 10 years to 19 years.

“The vast majority had thoracolumbar fusion,” Rocque said.

Similar complication rates

Rocque noted there were similar complication rates for the two groups; 9.82% in the group with rhBMP-2 and 9.88% in the group without rhBMP-2.

“None of the factors that we could analyze, such as age, gender, location of fusion, had any impact in the complication rate, nor was a difference between those with BMP and without BMP present in any of these subgroups,” he said, noting BMP is being used more frequently in pediatric spinal fusion procedures despite the need for more evidence to determine if it is safe for these patients.

Rocque discussed his study’s limitations.

“This is a very homogenous population — mostly affluent participants, private health care, young, mostly women, no information about where they live or any information of why they had surgery, what levels were fused, or how they did it. It only noted if they had spine fusion with or without BMP,” he said.

Furthermore, conditions that might qualify as complications in this study, such as ectopic bone formation and risk of malignancy, were difficult to determine from the database used, Rocque said. – by Robert Linnehan

Reference:

Rocque BG. Paper #829. Presented at: American Association of Neurological Surgeons Annual Meeting; April 5-9, 2014; San Francisco.

For more information:

Brandon G. Rocque, MD, MS, can be reached at the Department of Neurological Surgery, 1600 7th Ave. S, Lowder 400, Birmingham, AL 35233; email: brandon.rocque@childrensal.org.

Disclosure: Rocque has no relevant financial disclosures.