New and Need Info on 3 level ADR

[Slackwater]

Originally posted by FS:
Hello,
Weighing options in pain is proving to be very difficult and any feedback/personal experience would be greatly appreciated.
Thanks, FS, waiting for relief in Georgia

I posted the msg in another part of the forum.

Yale University maybe within reason for your location in Georgia. UCSF is similar to the travel distance to see Dr. Delamarter(sp). My personal preference is the same time zone, but flexible.
======================================


There is an activ L™ (Aesculap Implant Systems, aka Braun) clinical FDA trial with US-based surgeons.
ClinicalTrials.gov shows two (2) sites in the trial, listed below. Rush Univ. Med School lists Dr. Deutsch with an ongoing activ L™ trial; UCSF ~may be participating.

Listed, Recruiting
James Yue, MD
Yale University
Orthopædics and Rehabilitation
Yale Physicians Building
800 Howard Avenue
P.O. Box 208071
New Haven, CT 06520-8071
Appointments (203) 737-5656
Yale Orthopaedics Clinical Trials

Listed, Not Recruiting
Dr. Rolando Garcia
Aventura Hosptial and Medical Center
21000 N.E. 28 Ave, Ste 104
Aventura FL 33180
Phone: 305-937-1999
Fax: 305-931-6554
Dr. Garcia may have been the first surgeon to implant the activ L™ in the U.S, January 30, 2007.


Not Listed on ClinicalTrials.gov, Ongoing Trial
Harel Deutsch, MD
Co-director, Rush Spine and Back Center
1725 W. Harrison St. Ste. 970
Chicago, IL 60612
Phone: (312) 942-6644
Fax: (312) 942-2176
Dr. Deutsch has ongoing trials listed @ the bottom of this page/link.


Not Listed on ClinicalTrials.gov, possible future involvement
Dr. Christopher Ames
Co-director of the UCSF Spine Center and UCSF Neurospinal Surgery
UCSF Spine Center
400 Parnassus Ave. 3rd Floor
San Francisco, CA 94143
(415) 353-7500
(866) 81-SPINE or (866) 817-7463
A newsletter, on page 6, mentioned Dr. Ames / UCSF will serve as an investigational device site for activ-L™.


Please assume that an artificial disc is not appropriate for everyone. I think the FDA has "approved" its use in adults up to age 60 who have a single degenerative disc in one of the two lowest lumbar discs (?and have never had a fusion operation?) A compassionate use request may, sometimes has, allowed a deviation from the rules.

[FS]

Thanks everyone for your feedback, info and personal experience, it is invaluable. I too have read Volume 7, Spine Journal...appears to be good news for me. I had not really considered going to Yale or being in a clinical trial, just something scary to me being used for experimental purposes by those who may not have the level of experience I feel I need for 3 levels. I also thought clinical trials were still for only 1 level problems at this time in the US.I am however from CN originally and have family pretty close to New Haven so I might need to rethink my options on which doctors to consider when I get an answer from WC on the money issues.
On another note, since my original post, I've gotten confirmation from Dr. Bertagnoli and from Dr. Delamarter that they both recommend 3 level ADR. It felt like good news and not so good news at the same time, but at least now I know for sure that I do have options in lieu of 3 level fusion. I still need to get a 2nd opinion from whomever WC decides to send me to and depending on that diagnosis/treatment plan, my attorney thinks I may even need to get a 3rd opinion from someone else of our choosing. Unfortunately, since this WC is actually the State of Georgia, it is doubtful that I would be allowed another opinion outside the state. I have no idea how long all of this will take as WC seems to be moving very slow, while it seems I am continuing to get worse....not able to work anymore, more pain, more meds, less sleep, ect...Just hope it doesn't drag on for too much longer. I never thought I would be looking forward to major surgery! Still scary stuff, but considering the current quality of my life, don't think I have any other option...
Thanks again for all the feedback.
FS

[Slackwater]

Originally posted by FS:
I had not really considered going to Yale or being in a clinical trial, just something scary to me being used for experimental purposes by those who may not have the level of experience I feel I need for 3 levels. I also thought clinical trials were still for only 1 level problems at this time in the US.

I can not encourage you one way or the other, just share data. However, the gentleman at Yale, Dr. Yue has very likely done 3-level ADR in the US through one of the other trials. He also worked with, published with Dr. Bertagnoli (~6 pubmed article co-authored by both).

Understand/agree US FDA is 1-level. There are "compassionate use" exceptions.

Originally posted by FS:
On another note, since my original post, I've gotten confirmation from Dr. Bertagnoli and from Dr. Delamarter that they both recommend 3 level ADR. It felt like good news and not so good news at the same time, but at least now I know for sure that I do have options in lieu of 3 level fusion.

Agree, a choice of only 3-level fusion is frus<span class="ev_code_RED">frustrating</span>trating. My motivation increased when I realized there was another option. Your motivation may/will get you through hard times and some of the pain. Breathe deeply. I am not Deepak Chopra, but ... de-motivation may lead to more pain. Pain level will affect surgical decisions, unfortunately sometimes that pain-level is measured by lawyers / WC in pills mg/day of Vicodin, Oxycontin, Lyrica, ... Your Oswestry Score (activities of daily living) is mush from your limited description.

Take the attorney's advice, within reason. I took my attorney's advice to a point, but he said get 2-level fusion (?to increase the insurace settlement, his fees?) which I deferred.

[CindyLou]

FS,
You have hard decisions ahead of you. But you are doing your homework. If you do, indeed, need 3 levels, I would weigh heavily who you let do the job. Hands down, Zeegers and Bertagnoli, have done thousands of these. 3 levels is major, major surgery. Bertagnoli did my 3 levels, and I am in your age bracket as well. I have had a slow recovery...I am 10 months post op, but I couldn't be happier with my results. Please feel free to PM me with any questions. Best of luck to you!

[Terry]

FS:

Like CindyLou said, you have tough decisions to make. There are several of us who have had multiple disc replacements and are doing well. I had 4 levels done 1 year 3 months ago. I went back to work in 8 weeks though this varies widely for everyone. Your body will guide you in what you can do and not do. It will definitely be a one-day-at-a-time experience.

Hang in there and welcome to the group. Many good people here.

Terry Newton