Dr. Novak: I will post some articles describing thier success rate. I was at the FDA panel hearing and was quite impressed, as were the panel and many doctors and researchers in the audience. My neurosurgeon, and his colleagues there, are real optimistic.
As noted above, I will post the results in near future (to nice today to play on the computer), but the high success rate was based on:
€ positive discogram (an extremely painful procedure I went through)
€ positve MRI
€ decrease in disc height
€ lack of fluid in disc (ie, dark disc)
€ disc area L5/L6
€ lower back pain
€ one level of fusion
€ waiting 9 to 12 months after trying more conservative treatments (PT, injections, anti-inflamatories, etc)
€ non-smoker (I never understood this one, maybe you could she some light on this. Interestingly, the neurosurgeon and orthopedic surgeon I have seen both would not do the surgery on a smoker. Huh....)
Success rates are extremely high compared with traditional spinal fusion approaches, but only about 10% higher than pedicle screws. However, none of the surgeons I have seen would be willing to use the screws (even though many still do) due to recent problems and lawsuits.
The fusion rate, for first time fusions, is well over 95% while a bit lower for 2nd or 3rd attempts at same disc level. For a first time traditional spinal fusion there is a 65-70% success rate for a positive fusion. Plus there is a long recovery for traditional fusions with the need to wear a brace for several months. With Spine-Tech's device the recovery time is minimal (especially if inserted orthoscopically), no brace to wear, and back to work within 2 weeks.
Obviously, the success rate for pain relief is based in part on a correct diagnosis.
In the trials, the typical patient had been experiencing back pain for over 5 years.
It is also important to note that the findings from the trials were so positive that this is the first orthopedic device to be granted an "expedited" review by the FDA, which I am sure you know is a status reserved only for drugs, treatments or devices which potentially will save or improve a significant number of lives.
I understand your concern and skeptism. There have been many treatments and surgeries for backpain in the past which have had only moderate success. This device is not to treat all back problems or pain; just degenerative discs as identified with the techniques noted above.
Hope this helps. More later. |
