A study recently published in the Journal of Spinal Disorders and Techniques examines eight randomized, controlled clinical trials comparing spinal fusion with bone morphogenetic progestin and iliac crest autologous bone graft.
The studies included 1,138 participants and pooled two-year postoperative clinical outcomes. Several articles over the past decade sought to study the impact of rhBMP-2 and whether the substance is associated with increased risk. Since controversy about potential conflict of interest and misrepresentation in the initial FDA studies for Medtronic's BMP product, Infuse, 58 percent of spine surgeons reported being mildly concerned about cancer risks posed by BMP and 40 percent mildly concerned about retrograde ejaculation risks, according to a North American Spine Society poll.
This review included articles from several databases until May of 2012. Here are five things to know about the study's findings:
1. The clinical outcomes were equivalent between the two groups at two years. The minimum clinically important differences for Oswestry Disability Index, SF-36 and numeric rating scale were exceeded.
2. Harvesting bone from the iliac crest was associated with increased pain and complications at the donor site when compared with BMP use.
3. Average operative time was 21 minutes less in the BMP group compared with the iliac crest group. The researchers also found the pooled rate of additional surgical treatment was two times less in the BMP group than the iliac crest bone graft group.
4. Risk of nonunion after 24 months was two times less in the BMP group than the iliac crest bone graft group, but the study authors noted this effect was likely biased.
5. The study authors concluded rhBMP-2 could be a good alternative to autogenous bone graft, especially among cases when autologous bone harvesting is undesirable, they also stated, "The current study did not reveal evidence robust enough to develop strong medical recommendations concerning BMP use for lumbar arthrodesis in degenerative disc disease."
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