Safety, Effectiveness of rhBMP-2 in Spine Fusion Questioned
Two meta-analyses show no clear difference in effectiveness; more harms with rhBMP-2
MONDAY, June 17 (HealthDay News) -- For spinal fusion, recombinant human bone morphogenetic protein-2 (rhBMP-2) may increase fusion rates, but is associated with increased pain and more adverse effects than iliac crest bone graft (ICBG), according to two meta-analyses published in the June 18 issue of the Annals of Internal Medicine.
Mark C. Simmonds, Ph.D., from the University of York in the United Kingdom, and colleagues examined the effectiveness and safety of rhBMP-2 versus ICBG in spinal fusion surgery. Individual-participant data were included from 11 eligible trials sponsored by Medtronic and one other eligible trial. The researchers found that, compared with ICBG, the Oswestry Disability Index scores were 3.5 percent lower with rhBMP-2 at 24 months and radiographic fusion was 12 percent higher. Pain was significantly more common at or shortly after surgery with rhBMP-2. Although the number of events precluded definitive conclusions, cancer was significantly more common after rhBMP-2.
Rongwei Fu, Ph.D., from the Oregon Health & Science University and Portland Veterans Affairs Medical Center, and colleagues examined the effectiveness and harms of rhBMP-2 in spinal fusion using individual-patient data from 13 randomized controlled trials and 31 cohort studies. The researchers found that overall effectiveness and safety were similar for rhBMP-2 and ICBG in lumbar spine fusion. rhBMP-2 correlated with a non-significantly increased risk of retrograde ejaculation and urogenital problems for anterior lumbar interbody fusion and with increased risk for wound complications and dysphagia in anterior cervical spine fusion. The cancer risk was increased with rhBMP-2 at 24 months, although event rates were low.
"On the basis of the currently available evidence, it is difficult to identify clear indications for rhBMP-2 in spinal fusion," Fu and colleagues write.
The second review was funded in part by Medtronic.
Full Text - Simmonds (http://annals.org/article.aspx?articleid=1696645 )Full Text - Fu (http://annals.org/article.aspx?articleid=1696646 )Editorial 1 (http://annals.org/article.aspx?articleid=1696648 )Editorial 2 (http://annals.org/article.aspx?articleid=1696649 )Editorial 3 (http://annals.org/article.aspx?articleid=1696650 )Editorial 4 (http://annals.org/article.aspx?articleid=1696651 )