Ok guys...below is the info about the study. I spoke with my doctors assistant today about this. My doctor just got sworn in. They are behind a little as far as starting the study. She should be receiving the paperwork as far as the release paperwork and etc within about 2 to 2 1/2 weeks. She stated that Seattle is going to have the most amount of patients in the study. She also said that she is going to start to get a list of patients together. So if you are interested please email me at
nikki.slusser@gmail.com and I will pass your information along to her. I am getting really excited now. Surgery will be in June. I am going to be #1. My persistance, my initiative to do my own research and etc has paid off. They are also in the process of signing the paperwork to send back to the FDA to in order for the FDA to give the green light to go ahead and start surgery.
As I get more information I will post it to this thread.
Here's the flyer................................
What is Degenerative Disc Disease? Degenerative Disc Disease (DDD) is a disorder of the spine characterized by a narrowing of the disc space between two vertebrae where the disc resides.
What happens when degenerative disc disease occurs? As the disc ages it becomes brittle, dehydrated, less flexible and it looses height as well as the ability to act as a cushion or shock absorber for the spine.
Mechanical dysfunction may also cause disc degeneration and pain. A disc may be damaged as the result of trauma that overloads the capacity of the disc to withstand the forces passing through it, annular fibers may tear. These torn fibers may be the focus for an inflammatory response and may cause pain.
How common is degenerative disc disease? More than 65 million Americans suffer from low back pain annually. It is one of the most common reasons people see their physicians. By age 50 about 85% of the population have evidence of disc degeneration.
What is a clinical trial? It is a research study designed to answer definite questions about new drugs, treatments, or medical therapies. Clinical trials are carried out to determine if a new treatment is safe and effective. In clinical trials the drug or treatment is offered to volunteers before the U.S. Food and Drug Administration (FDA) determines if it will become available to the general public.
What is the purpose of this study? The researchers are evaluating the Kineflex� artificial disc for the treatment for DDD. The physicians will be comparing the Kineflex artificial disc to one recently approved, in a randomized clinical trial. The goal of the artificial disc is to preserve motion, while minimizing or eliminating pain.
How are patients randomized? Patients who qualify for the study will be placed into one of two groups, treatment with the new device or the approved artificial disc. This is a random selection, like the toss of a coin.
Has this type of surgery ever been done prior to this clinical trial?
Although this is a fairly new procedure in the United States artificial discs� have been used in Europe and South Africa for many years. The Kineflex disc has been implanted is more than 100 patients in South Africa.
What happens after the procedure is completed? Following surgery you will experience some pain related to the surgical site. Pain medication will be available to take as directed by the physician. Initially there may be some limits placed on physical activities, although physical therapy will be prescribed.
All patients will need to be evaluated at regular follow-up visits. There will be one visit post operatively, 6 weeks after surgery and then other visits at 3, 6, 12, and 24 months. During these visits one or more medical professionals will evaluate your physical condition.
How important are the follow-up visits? It is important to know and understand that enrollment in this study requires that you complete all follow-up visits in a timely manner. This is an agreement that you make with the physician and the sponsor of the study. Without the follow-up you potentially could invalidate the study and prevent or lengthen the approval process.
Are there any risks associated with this clinical trial or the surgical procedure? The risks are the same as those associated with other surgery and general anesthesia. Some of the risks include, bleeding, infection, or sensitivity to the prosthetic material. This is not a complete list of all potential side effects. The physician conducting this clinical trail will have a detailed discussion with the patient and family prior to enrollment in the study. At this time patients and family members are encouraged to ask questions to gain a better understanding of all of the risks and potential benefits.
Who is eligible to participate in this clinical trial? To enroll in this study, patients must be diagnosed with DDD, be between 18 and 60 years of age, and have tried conservative therapy for at least 6 months without significant pain relief.
Is it safe to participate in a clinical trial? This medical device trial is being conducted under the FDA regulations and guidance. Additionally the Institutional Review Board of the hospital has approved this clinical trial.
Why should patients participate in a clinical trial? Patients who participate in a clinical trial have the opportunity to play an active role in their health care, and gain access to new treatment options that are not yet available to the general public. Although there are no guarantees of the results, participation in trials does help to advance the science of medicine and potentially help future patients with the same disease.
Sponsored by
Spinal Motion, Inc.
201 San Antonio Circle
Bldg B, Suite 115
Mountain View, CA 94040
Clinical Trial
Information
Kineflex�
Spinal Motion
Artificial Disc
Evergreen Hospital
Medical Center
Physician Investigator(s)
Reginald Knight, MD
David Hanscom, M.D.
Paul Schwaegler, M.D.