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Table 3 Conclusions made by Centers A and B after conducting independent summary reviews and meta-analysis of rhBMP-2 trials

From: Comparison of two independent systematic reviews of trials of recombinant human bone morphogenetic protein-2 (rhBMP-2): the Yale Open Data Access Medtronic Project

Center Conclusions
A “At 24 months, rhBMP-2 increases fusion rates, reduces pain by a clinically insignificant amount, and increases early postsurgical pain compared with ICBG. Evidence of increased cancer incidence is inconclusive.”
“The use of rhBMP-2 in spinal fusion surgery increases the likelihood of successful fusion at up to 24 months, but this does not seem to translate into a clinically significant reduction in pain. The small improvements in fusion and in the level of pain reduction, which manifest after 6 months, also seem to come at the expense of more frequent pain in the immediate postoperative period and, possibly, an increased number of cancer cases. We believe that it is important that clinicians explain these findings to patients so that they can make informed choices about the type of surgery they would prefer.”
B “In spinal fusion, rhBMP-2 has no proven clinical advantage over bone graft and may be associated with important harms, making it difficult to identify clear indications for rhBMP-2.”
In conclusion, we found…no evidence that rhBMP-2 is more effective than ICBG in spinal fusion, with some evidence of an association with important harms. More research is needed to provide more reliable estimates of risk for cancer and other adverse events and to identify patient populations in which use of rhBMP-2 may be beneficial, such as cases where use of bone graft alone is associated with a high risk for pseudarthrosis. On the basis of the currently available evidence, it is difficult to identify clear indications for rhBMP-2 in spinal fusion.”