The panel included physicians Michael Janssen, DO, Rolando Garcia, MD, Lynn Miller, DO, William Reed, MD, and Jack Zigler, MD.
When considering the five-year randomized controlled trials, meta-analyses and observational studies comparing lumbar total disc replacement with fusion, the panel reported lumbar total disc replacement devices are associated with long-term success, few late-onset complications and a lower risk of adjacent segment disease and reoperation when compared with fusion.
The panelists developed two consensus statements:
1. “Five-year investigational device exemption study data, which is long-term data, is readily available to support the utilization of lumbar total disc replacement in the appropriately selected patient.”
2. “The published data on commercially available lumbar TDR technology used in treatment of degenerative disc disease demonstrate: 2a: Significant reductions in adjacent segment degeneration and reoperations compared with lumbar fusion. 2b: Minimal concerns with late onset complications.”
There are six randomized controlled trials examining lumbar total disc replacement for DDD with five-year follow-up data, all of which showed low-level particulate wear debris complications and reoperations. The panel did address challenges, including:
• Patient selection
• Gaining full disc space access
• Adequate release
• Precise implant placement
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