Pivotal trials of orthopedic surgical devices in the United States: predominance of two-arm non-inferiority designs

Pivotal trials of orthopedic surgical devices in the United States: predominance of two-arm non-inferiority designs

Abstract Background The United States Food and Drug Administration (FDA) reviews class III orthopedic devices submitted for premarket approval with pivotal clinical trials. The purpose of this study was to determine the types of orthopedic devices reviewed, the design of their pivotal clinical trial...

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Bibliographic Details
Main Author: S. Raymond Golish
Format: Article
Language:English
Published: BMC 2017-07-01
Series:Trials
Subjects:
Orthopedic surgery
Medical devices
Orthopedic surgical devices
Spinal devices
United States Food and Drug Administration
Randomized clinical trials
Online Access:http://link.springer.com/article/10.1186/s13063-017-2032-2

Internet

http://link.springer.com/article/10.1186/s13063-017-2032-2

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