Prospective Multicenter Clinical Trials in Orthopedics

Special Concerns and Challenges
  • John D. Van Vleet


The clinical evaluation of orthopedic devices is, in the overall scheme of clinical research, a relatively recent phenomenon. Although innovations in orthopedics date back over 30 yr and the 1976 Medical Device Amendments of the Food, Drug, and Cosmetic Act are commemorating 20 yr, it has been scarcely more than a decade that orthopedic clinical studies have been conducted with any degree of consistency. Pharmaceutical clinical research has a more lengthy history and, as such, has been frequently—and at times inappropriately—used as a template for establishing standards for the conduct of orthopedic research. Both, however, share certain basic elements that are central to realizing good clinical research.


Multicenter Clinical Trial Prospective Multicenter Clinical Trial Early IDEs Anniversary Date Premarket Notification 
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Additional Reading

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© Springer Science+Business Media New York 1998

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  • John D. Van Vleet

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