The report examined clinical trial data on the Medtronic Prestige ST and the Synthes ProDisc-C. The Bryan Anterior Cervical Disc was excluded from this evaluation. The criteria for the data included; pain, functional disability, neurological status, implant and surgical adverse events and secondary reconstruction.
After two years, both studies showed that CDA's were non-inferior to ACDF's based on the neck disability index score and overall outcomes. Interestingly enough, the Prestige ST trial was found to be of "poor quality" because of systemic differences between patient groups and unclear blinding of neurological assessments. The quality of the ProDisc-C was fair.
The report concludes that both trials were similar with the notable exceptions being secondary reconstructions. The Prestige SF had 9 patients in the ACDF and 3 in the CDA category, while Synthes had 1 in the ACDF group and 0 in the CDA category.
In closing, the report points out that no study has established whether adjacent disc disease (ADD) observed after fusion is a result of altered or abnormal spinal motion patterns, rather than due to normal disease progression. The authors concluded that it cannot be determined whether CDA will reduce ADD.
no surprise there. could you direct me to this report?
ReplyDeleteBrian: You can find the report on "The Gray Sheet" website
ReplyDeleteI had a chance to read the article; they only looked at the published 2 year data, even though ProDisc-C and Prestige have been implanted greater than four years now. If 5-7 year follow-up data is published and is positive this 'may' change things.
ReplyDeleteBCBS and other payors seem to be taking an extremely conservative approach to TDR. The truth of the matter is that some people are willing to get "the best thing available" even if the costs come out of their own pocket. For the time being payors seem to be taking advantage of this fact. Lasik eye surgery, anyone?
Worker's Comp is one payor group that seems relatively convinced that TDR is the better treatment option, notably because patients return back to work relatively quicker.
Here's the link to the BCBS TEC report - http://www.bcbs.com/blueresources/tec/vols/24/artificial-intervertebral.html