ProDisc-L safe at five years


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.