32. Absence of Bias Between Training Cases and Randomized Cases in Prospective Randomized FDA Studies of Cervical Disc Replacement: 788 Cases

Abstract

BACKGROUND CONTEXT: At the time of this writing the only three prospective FDA studies on cervical arthroplasty (Kineflex-C, PCM, Secure-C) that utilized training cases and finished enrollment participated in this collaborative effort, so there was no selection involved.