Kineflex Lumbar Aritifical Disc Clinical Trial

Pauletteski,

Here are the exclusions:

1. Any back or leg pain of unknown origin
2. Previous trama to the study treatment level, resulting in compression or bursting
3. Previous retroperitoneal surgery, or sufficient previous surgeries that preclude using an anterior approch
4. Other spinal surgery at affected level
5. Previous thoracic or lumbar fusion
6. Documented abnormal abdominal vessel or muscular/fascial pathology/morphology
7. Degenerative spondylolisthesis with greater 3 mm slippage at study level
8. Isthmic (spondylolytic) spondylolisthesis at study level
9. Spondylitis (i.e., inflamation of the spine) at study level
10. Documented significant spinal, foraminal or lateral stenosis at study level
11. Disk space height less than or equal to 3 mm at study level
12. Documented presence of free nucular fragment at study level
13. Extensive facet arthritis or degeneration of the facets at any level noted on MRI, CT or X-ray
14. Scoliosis of the lumbar spine with greater than 11 degree coronal deformity
15. Metabolic bone disease
16. Active systemic infection
17. Active malignancy or history of metastatic malignancy
18. Any terminal or autoimmune disease
19. Any other disease, condition or surgery which might impair healing
20. Recent history of chemical or alcohol dependence
21. Current or extended use of any drug known to interfere with bone or spine tissue healing
22. Known metal allergy
23. Mobid obesity (BMI > 40 or more than 100 pounds overweight)
24. Transitinol vertebrae at level to be treated that has not clearly fused
25. Current prisoner
26. Currently involved in spinal litigation
27. Currently experiencing an episode of major mental illness or manifesting physical symptoms without diagnosable medical condtion to account the symptoms, which may indicate symtoms of psychological rather than physical origin
28. Pregnancy at time of enrollment, since this would contraindicate abdominal surgery
29. Participation in any other investigational drug, biologic or medical device study within 30 days prior to the study surgery

Margaret,
There seem to be differences in pre-op requirements and out of pocket expenses based on where the Kineflex/Charite study surgery is performed. I did not need an EKG nor do I have to pay for any post-op visits to my surgeon. It seems the surgeon can have his own requirements. The exclusions, however, were the same.
Good luck as you prepare for surgery.

Mars,

Great information. I did not know it was different from doctor to doctor. How is your back doing? What is your opinion of the Kineflex ADR now that you have one?

Hi Margaret,
Sorry I took so long to answer. I've been busy doing things I hadn't been able to do last year and haven't had much time at the computer. In answer to your question, now that I've had my Kineflex disc for almost 6 months (I see my surgeon on Friday) I have no complaints. It has worked extremely well for me, changing my life greatly. Sometimes I find it hard to believe I used to have back pain. I am going to take care of my back from now on.
Best of luck as you await your surgery.

I'm glad you are doing well Mars. I'm hoping I will receive the Kineflex rather than the Charite. Seems like the all metal ADR is better. I'm a little bit worried about the Charite and future facet problems that might develop due to it. I'd rather have a lettle less motion and more protection for my facets. Won't be long now... I'm getting a bit nervous.

Mars, Did you have much in the way of nerve distraction. If so, how long until it was no longer an issue?

Todd B.

Todd,
I had no nerve distraction, which surprised me because my L5-S1 disc space was almost bone on bone. I had twinges now and then but they didn't last long and rarely bother me now.

Hi everyone,

Iam 20 years old and need a disc replacement I have BCBS and I also was denied for the surgery of the Chartie, I recently saw Dr. Guyer in Texas and have been excepted for the New Kineflex Clinical Trial. My surgery date is for March of 2006. If anyone has had this surgery please let me know how it has gone. Maybe what to expect.
Thanks for all responses.
Amanda

Hello Family,

Just a few more weeks before my surgery. I went to my doctor here in New Orleans for the physical, EKG and bloodwork. My sister will be flying down from Wisconsin this Saturday. She will come with me to Plano, TX and stay with me while I have my surgery. I'll email my outcome when I get back.

Ooooooooh, Margaret! Down to single digit days remaining! Are you getting excited?

Wishing you the best, and sending all good thoughts to you on the 19th,
-j