This study really shows the problem trying to mine the data. I have spoken to several of the most experienced cervical ADR surgeons in the world and int he US about the study. None of them are experiencing rampant HO numbers as this study would suggest. None of them is experiencing HO numbers at a level that would even give them pause.
HO with the Bryan disc is a completely different topic. The Bryan procedure involves milling a negative into the endplate to accomodate the implant. It's a difficult procedure that is error prone. Excessive milling of the bone and potential positioning issues greatly increases the risk of HO. I believe that is why we have not seen Bryan approval and I never hear any buzz about it. Medtronic believes so strongly in the Bryan that they purchased the Bristol disc (now the prestige). IMHO, they knew that the Bryan was a non-starter.
I believe that what we see in this study is a prime example of why we must do everything we can to make sure that we are dealing with surgeons that are highly experienced with the technology they are using. I don't care if I'm dealing with the most experienced ADR guy in the world... I don't want to be his first, fifth, or tenth procedure with new devices or new instrumentation. This study lists nine surgeons and 54 patients? What was their training like? What other cervical ADR experience do they have? Is there an axe to grind?
There is one tidbit of incredibly valuable information that I take from that study. If you need ProDisc-C, don't go to those guys!
Mark
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