ProDisc-C Total Disc Replacement. IDE* Clinical Study. When I made the decision to have neck surgery,
I had two options as to how to fix the problem. One was the ProDisc-C
total disc replacement, or the ACDF (anterior cervical discectomy fusion)
surgery. Although Dr. Albert of the Rothman Institute indicated they
would both be successful, the research I did beforehand led me to believe
that neck flexibility could be slightly compromised with the ACDF.
There are several different ACDF or disc replacement devices on the market. Your choice will be limited by what your
doctor has learned to use and what your medical insurance will cover. If you like the idea of the Prodisc-C and your
doctor is not trained to implant this, you will have to find a different doctor. My medical insurance gave me the option,
so with Dr. Albert's advice I chose the Prodisc-C. To date, I believe this was the right choice.
below will take you to the Clinical Study of the ProDisc-C as written by the manufacturer, Synthes, from West Chester, PA,
comparing it with ACDF surgery. It is quite easy to read. Read the Synthes report.
On December 17, 2007 this device was approved by
the US Food and Drug Administration. You can link to the FDA's brief
overview of this device here.
The full FDA report, titled, Summary
of Safety and Effectveness Data is available here. This document is written in medical mumbo-jumbo - not an easy read
for me. However, it too has comparative studies between the ACDF and
the testing that took place as part of the FDA's approval process.
I found it interesting that this device has been available worldwide since
2002. I had mine implanted in September 2008, although the Rothman
Institute had been using it for some years.
The FDA report describes all the potential risks and adverse events that could happen. Don't be scared away by this; think of the risks and hazards if you do nothing.
was saddened to read of the 54 rabbits who had to give their lives as part
of the FDA's approval process. Many thousands of rabbits give their lives
every year in the name of advancing human medicine. If you find relief like I did from this surgery, I encourage
you to give a donation on behalf of these little guys to the Southeastern PA-DE House Rabbit Society (a rescue organization for house rabbits), to the Main Line Animal Rescue (MLAR), or to the Chester County SPCA.org or your local animal shelter.
* IDE stands for Investigational
Device Exemption - allows the device to be used in a clinical study in order
to collect safety and effectiveness data. This is required to support
a Premarket Approval (PMA) when is submitted to the FDA who use it as
part of their approval process. Read more at the FDA website.
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