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The Big File All issues not easily categorized in the above forums are here. Comments on general health, diet, "getting comfortable," and more are here.


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  #1  
Old 04-28-2005, 01:28 AM
Nichole Nichole is offline
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Thakn you Harrison for posting the article on the Kineflex study. It is very exciting to hear some information abou this disc. I have a 50% chance of having this disc implanted in my back thru this study.

I have been a little nervous not hearing anything about it. So thank you again Harrison for being the saving grace.
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Nichole
Seattle,WA

ADR June 15, 2005 WOOOO HOOOOO
Herrniated L5-S1, Tear in Annulus
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  #2  
Old 04-28-2005, 10:26 PM
Patrick Patrick is offline
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Yes, I will hop on this wagon too...Thanks alot Harrison. Nichole, have you gotten any info from Spinal Motion at all?
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*10 plus years of back pain
*'99 first MRI shows L4-5 bulge
*'04 MRI shows L4-5 grade 3 annular tear & rupture with moderate DDD
*'05 Discogram shows concordant pain at L4-5
*8/18/05 scheduled ADR surgery participant in Kineflex/Charite study
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  #3  
Old 04-29-2005, 11:07 AM
Nichole Nichole is offline
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Patrick,

I actually received a flyer from Tammy at Dr. Schwaeglers office. I will email it to you.
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Nichole
Seattle,WA

ADR June 15, 2005 WOOOO HOOOOO
Herrniated L5-S1, Tear in Annulus
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  #4  
Old 04-29-2005, 11:54 AM
Eddie_G's Avatar
Eddie_G Eddie_G is offline
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Can you post the flyer here? I'm so interested in this new disc I'm gonna pop one!!!!!! AGAIN!!!!!!!

Please please pretty please????
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12/16/03 Work Accident
Herniation and DDD at L4-L5
4/1/05 Discectomy
Epidurals and facet injections
5/15/06 Discogram confirmed L4-L5 DDD also an asymptomatic L5-S1 tear
10/24/06 L4-L5 Prodisc surgery with Dr. Goldstein
CAT scans & X-Rays show ossification
Trigger Point Injections, Medial Branch Blocks, Acupuncture, Weekly Deep Tissue Massage
10/27/08 Discogram (positive L5-S1 tear)
11/25/08 L5-S1 fusion with Dr. Goldstein
FAILED BACK SYNDROME
Liberty Mutual WC
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  #5  
Old 04-29-2005, 03:27 PM
Ksrowd Ksrowd is offline
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Everyone,
Has anyone been able to find a description of the clinical study and the participating doctors and site?
Kevin
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Ruptured Disk 04/98
Discectomy 07/07/98
DDD L5/S1
Prodisc Surgery 07/07/05
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  #6  
Old 04-29-2005, 03:33 PM
ans ans is offline
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Recieved an email from them. They can't release the location of the 20 trial areas until contracts are finalized. Contact was a nice guy so I expect to hear from him.
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Severe, extensive DDD, considered inoperable by Dr. Regan, Lauressen, & some guy at UCLA. Severe foraminal stenosis (guess they can't operate!) and some spinal cord compression that Lauryssen would fix if gets outta hand.
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  #7  
Old 04-29-2005, 07:52 PM
Kim Kim is offline
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I got an email from the rep too. I specifically asked if TBI would participate in the trials. He said they are in negotiations with them and are very optomisitic that they will take part. He stated he would let me know when the paperwork was finalized as to whether they would be involved.
He stated contracts should be finalized at least with TBI within the month.
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Kim
Herniated disc L5/S1 2000 Discectomy 10/2003 Rhizotomy 8/2004 and 3/2005Discogram 11/04 grade 7 tear L5/S1
L4/L5 Grade 5 tear with herniation and stenosis
Evaluated by Dr Blumenthal at TBI
2/2005 ADR 2 level recommended
2 level lumbar fusion
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  #8  
Old 04-29-2005, 09:17 PM
Nichole Nichole is offline
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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.
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Nichole
Seattle,WA

ADR June 15, 2005 WOOOO HOOOOO
Herrniated L5-S1, Tear in Annulus
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  #9  
Old 04-30-2005, 01:30 AM
Patrick Patrick is offline
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Congratulations Nichole, I am glad to see you are all set up now. Thanks for posting all this information too.

I just had another MRI done and it looks like my L2-3 disk problem has regressed since my last pictures were done in July of 04'. I hope this is now stable enough so I can just worry about getting approved for the one level at L4-5 which is still a mess and causing a bunch of pain. If my insurance refuses to cover the Charite then I will be jumping into the study also if I qualify.
__________________
*10 plus years of back pain
*'99 first MRI shows L4-5 bulge
*'04 MRI shows L4-5 grade 3 annular tear & rupture with moderate DDD
*'05 Discogram shows concordant pain at L4-5
*8/18/05 scheduled ADR surgery participant in Kineflex/Charite study
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  #10  
Old 04-30-2005, 11:33 PM
Nichole Nichole is offline
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Posts: 106
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Best of luck to you Patrick with your insurance. My fingers are crossed for you. Keep in touch and let me know how your progress is.

Nichole
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Nichole
Seattle,WA

ADR June 15, 2005 WOOOO HOOOOO
Herrniated L5-S1, Tear in Annulus
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