Revisability of the CHARITE artificial disc replacement: analysis of 688 patients enrolled in the U.S. IDE study of the CHARITE Artificial Disc.

Study Design: A prospective, randomized, multicenter, FDA-regulated Investigational Device Exemption clinical trial.

Objectives: To analyze the incidence of, and reasons for, reoperation in all patients (treatment and control) enrolled in the IDE study.

Summary Of Background Data: This is the first report of the incidence and nature of reoperations following lumbar TDR as part of a controlled, prospective, multicenter trial.