Literature DB >> 24903374

A Review and Analysis of the YODA Trials: What Can We Glean Clinically?

Michael E Le1, Mark F Kurd.   

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.

Entities:  

Year:  2014        PMID： 24903374      PMCID： PMC4596165          DOI： 10.1007/s12178-014-9220-4

Source DB:  PubMed          Journal:  Curr Rev Musculoskelet Med        ISSN： 1935-9748


  8 in total

Review 1.  A critical review of recombinant human bone morphogenetic protein-2 trials in spinal surgery: emerging safety concerns and lessons learned.

Authors:  Eugene J Carragee; Eric L Hurwitz; Bradley K Weiner
Journal:  Spine J       Date:  2011-06       Impact factor: 4.166

2.  Adverse effects associated with high-dose recombinant human bone morphogenetic protein-2 use in anterior cervical spine fusion.

Authors:  Lisa B E Shields; George H Raque; Steven D Glassman; Mitchell Campbell; Todd Vitaz; John Harpring; Christopher B Shields
Journal:  Spine (Phila Pa 1976)       Date:  2006-03-01       Impact factor: 3.468

3.  Single-level instrumented posterolateral fusion of the lumbar spine with a local bone graft versus an iliac crest bone graft: a prospective, randomized study with a 2-year follow-up.

Authors:  Seiji Ohtori; Miyako Suzuki; Takana Koshi; Masashi Takaso; Masaomi Yamashita; Kazuyo Yamauchi; Gen Inoue; Munetaka Suzuki; Sumihisa Orita; Yawara Eguchi; Nobuyasu Ochiai; Shunji Kishida; Kazuki Kuniyoshi; Junichi Nakamura; Yasuchika Aoki; Tetsuhiro Ishikawa; Gen Arai; Masayuki Miyagi; Hiroto Kamoda; Tomoaki Toyone; Kazuhisa Takahashi
Journal:  Eur Spine J       Date:  2010-12-17       Impact factor: 3.134

4.  Off-label use of bone morphogenetic proteins in the United States using administrative data.

Authors:  Kevin L Ong; Marta L Villarraga; Edmund Lau; Leah Y Carreon; Steven M Kurtz; Steven D Glassman
Journal:  Spine (Phila Pa 1976)       Date:  2010-09-01       Impact factor: 3.468

5.  Safety and effectiveness of recombinant human bone morphogenetic protein-2 for spinal fusion: a meta-analysis of individual-participant data.

Authors:  Mark C Simmonds; Jennifer V E Brown; Morag K Heirs; Julian P T Higgins; Richard J Mannion; Mark A Rodgers; Lesley A Stewart
Journal:  Ann Intern Med       Date:  2013-06-18       Impact factor: 25.391

Review 6.  Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and meta-analysis.

Authors:  Rongwei Fu; Shelley Selph; Marian McDonagh; Kimberly Peterson; Arpita Tiwari; Roger Chou; Mark Helfand
Journal:  Ann Intern Med       Date:  2013-06-18       Impact factor: 25.391

7.  Ratings of global outcome at the first post-operative assessment after spinal surgery: how often do the surgeon and patient agree?

Authors:  Friederike Lattig; Dieter Grob; Frank S Kleinstueck; François Porchet; Dezsö Jeszenszky; Viktor Bartanusz; David O'Riordan; Anne F Mannion
Journal:  Eur Spine J       Date:  2009-05-22       Impact factor: 3.134

8.  Lumbar posterolateral fusion with local bone graft plus bone extender compared with iliac crest bone graft: a systematic review.

Authors:  Robert A McGuire; Leslie E Pilcher; Joseph R Dettori
Journal:  Evid Based Spine Care J       Date:  2011-05
  8 in total
  1 in total

1.  Building an Open Health Data Analytics Platform: a Case Study Examining Relationships and Trends in Seniority and Performance in Healthcare Providers.

Authors:  A Ravishankar Rao; Daniel Clarke; Maryelena Vargas
Journal:  J Healthc Inform Res       Date:  2018-04-16
  1 in total

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