Five-Year Follow-Up of a Prospective, Randomized Trial Comparing Two Lumbar Total Disc Replacements.

Study Design: This was a prospective, randomized, controlled, multicenter study.

Objective: The purpose of this study was to compare outcomes of two lumbar total disc replacements (TDRs) at 5-year follow-up and report results of serum ion level analysis in a subgroup of patients receiving a metal-on-metal implant.

Summary Of Background Data: Lumbar TDR has been compared with fusion in several randomized studies, finding TDR noninferior to fusion and superior on some measures.

Comparison of 2 lumbar total disc replacements: results of a prospective, randomized, controlled, multicenter Food and Drug Administration trial with 24-month follow-up.

Study Design: This was a prospective, randomized, controlled multicenter study with 24-month follow-up.

Objective: The purpose of this study was to evaluate the safety and efficacy in a Food and Drug Administration Investigation Device Exemption of a new lumbar total disc replacement (TDR) by comparing it to an earlier TDR approved for sale.

Summary Of Background Data: Randomized trials have reported TDR to produce results similar or superior to lumbar fusion.