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-   -   Kineflex Lumbar Aritifical Disc Clinical Trial (https://www.adrsupport.org/forums/showthread.php?t=7947)

11-19-2005 10:55 AM

Hello everone out there who is having a hard time getting their insurance companies to approve their ADRs. I have Humana HMO insurance here in New Orleans. I am trying to have the Charite ADR but was denied (1st time). I am appealing but wanted to let everyone know more details about the Kineflex clinical trial in case you want to look into it. You can go to www.Spine-Health.com
to get all the details. The spinal sponsor is SpinalMotion, Inc. their website is http://www.spinalmotion.com. The clinical trial is going on in the following cities:

California
Colorado
Florida
Nevada
North Carolina
Pennsylvania
Texas
Washington

All of the medical centers which are having the clinical studies are listed at Spinal-Motion. There are phone numbers, contact people and the names of the doctors who will be doing the primary investigation.

If anyone esle knows of any other clinical trials (Prodisc vs. ActivL) etc., would you please post information? Thanks!

Margaret

11-19-2005 11:47 AM

Also found information on Activ-L clinical trials...

Dr. James J. Yue, MD will be havinging clinical trials of the Activ-L starting in 2006. Not sure when in 2006, though.

James J. Yue, MD
Dept of Orthopaedic Surgery
800 Howard Ave.
New Haven, CT 06520
Ph: 203-737-5656
Ph: 203-785-2579

Ann F 11-20-2005 11:37 AM

Just saw Dr Yue and Activ-L clinical trials start in March 2006. Yay, I'm a "guinea Pig"!

11-21-2005 09:56 PM

Does anyone know anything about Dr. Carl Lauryssen who is conducting the Charite v. Kinflex trials in Los Angeles? The surgeries will be performed at the Olympia Medical Center in Los Angeles.

I have not seen anyone post on this site who has had a surgery with him. Anyone??

12-02-2005 07:14 PM

Hello Family,

I made an appointment with Dr. Guier at the Texas Back Institute in Plano, TX. My appointment is on Monday, December 5th. If you live more than 300 miles from one of the trial clinics they can write up a waver to accept you as a candidate. I live almost 500 miles from Plano, TX. If you make an appointment be sure to bring your MRI, discography, x-rays, bone density and any other films you have. This is VERY important. The more you bring, the faster the process will go. I was told that they are wanting an MRI that is no more than 6 months old. If your insurance does not cover the surgery then the companies that are sponsoring the clinic trails will pay for it. The only thing you will have to pay for is the doctor's visits and trips to and from the clinic.
Please keep me in your prayrs. I hope I will be accepted as a candidate.

12-08-2005 12:57 AM

I'm back from my visit with Dr. Guyer at the T.B.I. in Plano, TX. I am a candidate for the Kineflex Clinical Trials. My surgery is scheduled for Jan 19th.

Dr. Guyer said that 2/3 of his patients will be receiving the Kineflex ADR and the other 1/3 will receive the Charite ADR.

Make sure you bring in a discogram that is no more than 8 months old otherwise they will ask you to get another one done. Also, bring in an MRI that is no more than 8 months old along with x-rays, and bone density dexa-scan if you are a female. I have to have another dexa-scan done because mine was 11 months old.

After you see the doctor and they qualify you the office will schedule you to come back two weeks before your surgery to have a brace fitted for you and to give you pre-op information. You will then be scheduled to come back a week before the surgery to have blood work done (you can also have you primary physician do this). Follow-up visits will be scheduled 2 weeks pre-op, one month pre-op, 6 months pre-op, 1 year and 2 years (if my memory serves me correctly).

Hope this helps!

12-13-2005 11:03 AM

Hello, I am new to these pages and just replied to the forum for Kineflex vs. Charite trial. I received the Kineflex in the trials at L5-S1 on 12/5/05 by Dr. Andrew Cappuccino in Buffalo, NY. He has over 450 ADR's to his resume. Just curious how this forum works as it seems there are multiple forums for relatively similar topics. Any suggestions on where I would be best off posting? Thanks for any help.

Todd B.
tbzen2@aol.com

Harrison 12-13-2005 07:03 PM

Todd, thanks for asking and welcome! Yes, all these forums are ADR-focused (thus, the web site). What did you want to post --- your ADR recovery? If so, the post-op forum is perfect! Please review the forum descriptions, thx for asking...

12-15-2005 06:40 AM

Hello Family,

More information on the Kineflex trials...

You will be asked to have a EKG and blood work 10 days to 2 weeks before your surgery. Blood work will consist of: CBC, Sed rate, PT, PTT, & CMP (Na, K, CI, CO@, BUN, Cr, Gluc, TP, Alb, Ca, Alk Phos, AST, ALT, TBili).

You will also be required to hve you primary physician write a statement that you are medically clear for surgery.

Tests needed before you visit doctor (tests cannot be more than 6 months old at time of surgery):

Back X-rays needed are:
1. Standing Lateral
2. Standing Lateral Bend - Left
3. Standing Lateral Bend - Right
4. Standing AP
5. Standing Flexion
6. Standing Extension

MRI
Discogram
Bone density

Bring any other films you might have.
__________________________________________________
OUT OF POCKET EXPENSES:

You are required to pay for all doctor's visits. Cost of first visit can be $120.00 to $500.00 max (depending if they take X-rays). All other visits will be $75.00 to $100.00. You will have inital visit, doctor visit before surgery, two weeks after surgery, one month, six months, one year and two years.

You will be required to pay for back brace if needed.

You will be required to have a special x-ray taken of your back with a ring around your waist for measurement purposes. This X-ray will have to be taken at the clinical trail doctor's office.

If anyone needs more information please email me me.

letteski 12-15-2005 11:02 AM

Margaret,

I live in Northern Nevada and this study is taking place in Reno. A friend looked into the study and was told that if he had previous surgeries, he has had a disectomy with this doctor, he would not be allowed into the study.

Is this true, has anyone in the Kineflex study had previous surgeries? Is this a excluding factor?

(He is in his 3 level of appeal for the Charite)


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