Expanding indications for lumbar and cervical total disc replacements

INTRODUCTION: 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. AREAS COVERED: 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. EXPERT OPINION: 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.

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Publication Details

Journal
Expert Review of Medical Devices
Published
2026-08-03
DOI
https://doi.org/10.1080/17434440.2026.2713110
Primary Topic
Spine and Intervertebral Disc Pathology
Type
article
Field-Weighted Citation Impact
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article

Expanding indications for lumbar and cervical total disc replacements

Jessica Shellock, Jack E. Zigler, Scott L. Blumenthal, Donna D. Ohnmeiss et al.
Expert Review of Medical Devices
Spine and Intervertebral Disc Pathology
article

Expanding indications for lumbar and cervical total disc replacements

Jessica Shellock, Jack E. Zigler, Scott L. Blumenthal, Donna D. Ohnmeiss, Richard D. Guyer
article en

Abstract

INTRODUCTION: 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. AREAS COVERED: 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. EXPERT OPINION: 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.

Expert Review of Medical Devices
Texas Back Institute (US)
Openalex Percentile: Top 10%
Spine and Intervertebral Disc Pathology
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