Medical News and Perspectives |

Open Access to Data Closes the Book on Efficacy of Popular Bone-Graft Device

Mike Mitka, MSJ
JAMA. 2013;310(4):359-360. doi:10.1001/jama.2013.8485.
Text Size: A A A
Published online


New studies suggest a popular spinal bone-graft device has no clinical advantages over traditional bone grafting methods for reducing chronic lower back pain. Perhaps as important, the way these studies came about suggests a better approach to conducting postmarketing surveillance of medical devices and drugs.

The device in question is the Infuse Bone Graft, manufactured by Medtronic. It uses recombinant human bone morphogenetic protein 2 (rhBMP-2), a genetically engineered protein with bone growth–stimulating properties, as a bone graft substitute. The rhBMP-2 device was approved in 2002 by the US Food and Drug Administration (FDA) for anterior lumbar interbody fusion surgery to reduce chronic low back pain. Earlier studies found rhBMP-2 to be superior to other grafting therapies, and the device was soon generating almost $1 billion in annual revenues for Medtronic.

Figures in this Article

Sign In to Access Full Content

Don't have Access?

Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more

Subscribe for full-text access to content from 1998 forward and a host of useful features

Activate your current subscription (AMA members and current subscribers)

Purchase Online Access to this article for 24 hours

First Page Preview

View Large
First page PDF preview


Place holder to copy figure label and caption

Graphic Jump LocationImage not available.

The Infuse Bone Graft, which uses recombinant human bone morphogenetic protein 2, offers no clinical advantages compared with standard bone grafting, new research finds.



Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).


Some tools below are only available to our subscribers or users with an online account.

Sign In to Access Full Content

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Topics
PubMed Articles