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Approved Requests to Use Medtronic Data

The following investigators received rhBMP-2 data while the data were being made available between June 2013 and June 2015. Links to their protocols and publications are included.

Date Data Request Approved Principal Investigator Institution Name of Project Protocol Publications
October 10, 2013 Amber Laurie, MS and Rochelle Fu, PhD Oregon Health and Science University Meta-analysis of the influence of patient characteristics on the effectiveness and harms of recombinant human bone morphogenetic protein-2 (rhBMP-2) in lumbar spinal fusion

PDF available here

Published in Spine September 15, 2016. Article available here.
October 21, 2013 Alex Hodkinson, MSc University of Liverpool Differences in the reporting of harms data in internal sponsored reports versus the corresponding published trial reports: Evaluating the safety reporting of rhBMP-2 in 17 Medtronic sponsored trials

PDF available here

Data Transferred, Project Not Pursued, Certificate of Data Destruction Received
November 14, 2013 Andrew Indresano, MD University of Wisconsin-Madison A Re-evaluation of Carcinogenicity and rhBMP-2: A Meta-Analysis of the Individual Participant-Level Data from the Yale University Open Data Access (YODA) Project

PDF available here

Data Transferred, Project Not Pursued, Certificate of Data Destruction Received
January 16, 2014 Vikas Patel, MD University of Colorado Meta-analysis of the Outcomes and Complications in the Spinal Surgery Population Receiving Recombinant Human Bone Morphogenetic Protein-2 vs. Those Receiving Iliac Crest Bone Graft

PDF available here

Published in Spine August 13, 2015. Article available here.

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