Expanding indications for lumbar and cervical total disc replacements

Lumbar and cervical total disc replacements (TDR) have been used for decades. As with most devices, in Food and Drug Administration (FDA) trials, patient selection criteria are narrow, potentially not maximizing applicability of the device. The literature provides strong support for TDR, reporting outcomes similar or superior to fusion and often with a lower re-operation rate. Expanding indications is a natural extension as surgeons gain experience with a technology. With responsible expanding indications, benefits of TDR can be available to more patients.

For lumbar and cervical TDR, there is an overview of clinical outcomes, on-label indications, then expanded indications. TDR use has expanded to hybrid (TDR at one level and fusion at another), treatment of adjacent segment degeneration after prior fusion, and treatment of more than 2 levels. The literature included in this review was derived from searches involving PubMed, OVID, and an extensive internal electronic library to identify articles related to lumbar and cervical TDR, with focus on indications.

The authors support responsible expansion of indications for TDR, based on literature-based evidence. While expanding indications is appropriate, this should be undertaken in small steps with patient safety at the forefront.