KineFlex vs. Charite

Last week blogged that I went to 2 different doctors, Orthopedists, concerning my back troubles. The first was a sports medicine specialist and the second a spine specialist.

As you might recall, the first Doc recommended surgery, spinal Fusion, to relieve my symptoms. I went to the Texas Back Institute (TBI) for a second opinion. Dr. Barten Sachs concurred with the first Doc but suggested we TRY and get insurance to pay for a disc replacement as opposed to the fusion. He indicated I was a good candidate for a clinical trial but that there were no active trials at the moment. And typlical clinical trials are randomized such that 1/2 or 2/3 of the patience receive the trial device and the other portion of patience in the trial receive a spinal fusion. So even if I did get into a study there would still be a chance I would receive a spinal fusion.

The problem I have with Fusion is that the adjacent disc/vertebrae end up taking on the function and stresses of the jointed vertebrae. This can lead to premature degeneration of those adjacent discs after a few years. In effect starting it all over again.

I left Dr. Sachs's office agreeing to have them submit the request to the insurance company for the disc replacement but would proceed with a fusion if the request was denied. I really did not expect an answer for at least a week if not longer.

Tuesday morning I received a call from TBI. Expecting to hear that my insurance declined coverage on th disk replacement, I was surprised to hear them say that a couple of positions opened up in a currently running cclinical trial. The best news however was that this study is to compares 2 different disc replacement devices instead of a disc vs, fusion. I was told I am a good candidate for this study if I were interested. Karen and I went in for an appointment that afternoon for screening. They did some tests, took some more x-rays and after all said and done I have been accepted into trial.

The trial is intended to compare the outcome of disc replacement surgery done using the Kineflex to the Charite artificial disc implants. The Charite implant was the first device to be FDA approved and has 10 years of clinical history. The Kineflex is applying for FDA approval but has been in use in Europe for a couple of years now with very positive results. I have a 50/50 chance of getting one device over the other. Personally I would prefer the KineFlex, just based on what I have read. But I am thrilled either way.

I was quite a pleasantly surprise when they called. I had pretty much accepted that I would have to settle for fusion surgery since the insurance companies are rarely if ever covering disc replacements.

They wanted to schedule surgery for Wednesday November 22nd but that is the day the boys come home for Thanksgiving. I have not seen Bob since July or Tyler since August. I could not be in the hospital during their short stay. So, my surgery is scheduled for Monday November 27th. I will be in the hospital 1-2 days. after that time, I will be able to move about the house and take short walks but will have to take it easy for a week or two. Within a month or two I should be able to resume a normal active lifestyle, including Soccer and Cycling. This is in contrast to the spinal fusion which typically has a much longer recovery time; 3-6 months before normal daily activity can be resumed. It took a year or more to recover for I friend of mine in the officewho had this done.

I am very excited and very nervous. It is bad timing with the holidays coming up and us still working on the house. But it promises a pain free future as opposed to what I envisioned as me in a wheelchair by age 55.

For more information on the study you can visit http://www.spine-health.com/research/trials/kineflex/kineflex01.html

For information on the Charite device see: http://www.spine-health.com/topics/surg/charite/charite01.html

For information on the Kineflex device see:
http://spinalmotion.com/kineflex_lumbar_disc.htm


Wish me luck. I will keep you posted.