A Review and Analysis of the YODA Trials: What Can We Glean Clinically?
1Department of Orthopaedics, 1000 Blythe Boulevard, Charlotte, NC, 28203, USA.
Abstract:
Medtronic's biologic, Infuse (rhBMP-2), was approved by the FDA in 2002. Since its approval, a whirlwind of controversy developed culminating in an investigation by the Senate Finance committee. These events led to a landmark agreement between Medtronic and Yale University to perform a comprehensive and unbiased analysis of all patient related data. The project was named the Yale Open Data Access (YODA). The purpose of this article is to evaluate the results of the YODA project and determine what is clinically meaningful.
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