February 24, 2018 |
Previous Studies Overstated Evidence on Spinal Fusion Product
June 18, 2013  | 

PORTLAND, OR — An analysis by the Evidence-based Practice Center at Oregon Health & Science University has found that previously published clinical trial studies about a controversial bone growth product used in spinal surgeries overstated the product's effectiveness.

The OHSU analysis found the product offered no real benefit over bone grafts traditionally used in such surgeries and also found that previous studies had underreported harms that occurred in the studies. All but one of those studies were funded by the product's manufacturer, Medtronic.

The OHSU review is one of two independent reviews of the Medtronic product that was published today in the Annals of Internal Medicine. The other independent review, performed by a university in Great Britain, also found that the product offered little benefit over bone grafts and came with potential harms.

The bone growth product — called recombinant human bone morphogenetic protein-2, or rhBMP-2 — is used in spinal fusion surgeries, where vertebrae in the back are permanently joined together to eliminate pain or correct a deformity.

But rhBMP-2 has been at the center of controversy in recent years. Questions have been raised in major newspapers and a major medical journal about the product's safety and efficacy. A panel of experts writing in the summer 2011 edition of The Spine Journal found that study authors with financial ties to Medtronic reported many times fewer complications with the product than were found in Food and Drug Administration reports. Continue>

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