A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of Lumbar Total Disc Replacement With the CHARITÉ ™ Artificial Disc Versus Lumbar Fusion

Abstract

Preoperative ROM in flexion/extension was restored and maintained in patients receiving a TDR. TDR with the CHARITE artificial disc resulted in significantly better restoration of disc space height, and significantly less subsidence than anterior interbody fusion with BAK cages. Clinical outcomes and flexion/extension ROM correlated with surgical technical accuracy of CHARITE artificial disc placement. In the majority of cases, placement of the CHARITE artificial disc was ideal.