New data reported at the SAS10 Annual Global Symposium on Motion Preservation Technology in New Orleans, USA, shows that significant clinical improvement was achieved and maintained in patients receiving ProDisc-L to five years.
Jack E Zigler, Texas Back Institute, Plano, USA, presented the results of a five-year prospective, randomised, multicentre Food and Drug Administration investigational device exemption (IDE) study of the ProDisc-L total disc replacement vs. circumferential fusion for the treatment of two-level degenerative disc disease. He said that in properly chosen patients, ProDisc-L has been shown to be superior to circumferential fusion at two levels by multiple clinical outcomes. These results support earlier reports that ProDisc-L total disc replacement is a safe and effective surgical treatment of discogenic pain at two vertebral levels in patients who meet the study criteria.
Previously, the results from the IDE clinical trial of the ProDisc-L (Synthes) lumbar total disc replacement were only available to the two-year time point, with longer term outcomes not known. Zigler said that the purpose of this study was to evaluate the safety and effectiveness of the ProDisc-L TDR compared to circumferential spinal fusion for the treatment of discogenic pain at two vertebral levels between L3-S1 at five years.
