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Posted by johnw on 11/23/99 at 00:00 (013065)

good question. This type analysis is not part of our current submittal however I beiieve the data will exist in our database and could be evealuated after our initial submittal. The info probably exist in the lifestyle questionaires and pre exam info. I need to ask some questions before answering with certainty.

With respect to your hopes on 100% improvement - internationally our experience has shown success in the 70 -85% range depending on the criteria.Currently we are investing a lot of time evaluating our failures. One strong school of thought is that the failures fall into 2 categories, atypical pf i.e nerve related problems or an underlying condition such as avascular or necrotic bone. The drs. who are proponents of this theory have encouraged us to do another study using higher energies such as we use on nonunion fractures and expanding the treatment area. We hope to start this study soon. It will involve pretreatment MRI's to quantify the condition/vascularity of the underlying bone.

Understanding our failures is critical if we are to ever improve upon our device or the technique.