New comer: clinical trial VS. solid lmbar fusion

Thanks to all you share thier knowledge and insights. I could use your wisdom.

Shortly after a solid fusion at L5-S1, L4-L5 went out. After 2 1/2 yrs of pain, various pain meds, epidurals and various non-traditional treatments, I saw Dr. Carl Lauryssen in LA this June. He suggested trying a new device that will be offered as a Trial (date TBA). It is a newer but different version of exisiting lumbar stabilization systems (dynesys) Dr. L viewed current MRI and CT and agreed with Dx of grade 1 sondylolithesis at L5-L4 with neural foraminal stenosis adn diffuse disc protrusions.

My question: Would it be worth waiting to particiapte in this Trial and be one of the first to have the device implanted or would be wiser to have the solid fusion another Doc recommends? Plus it is unclear what my costs will be out of pocket since I dont think my BC will pay for any of it. Thanks Walt

[Harrison]

Aloha, Tango Man.

For me, the thought of waiting any longer was risky. Then (2003-04), I was suffering from worsening nerve pain, while not knowing the extent of my L5-S1 degradation. My pain was tolerable, but quality of life was very poor.

When I had surgery in June of 2004, I was starting to autofuse. If I had waited even just a few more months, the autofusion would have been too far along -- the doc would have sewn me back up!

So, one of many points of consideration is the rate of disease progression, autofusion, worsening pain....as well as the risks of waiting for ANY specific solution.

There is of course, much more to sort out. Maybe others can chime in. But do keep us posted!

[Harrison]

By the way, I'd like to revisit the clinical trial qualifications and disqualification criteria. Also see: http://www.zimmerspine.eu/z/ctl/op/global/action/1/id/9...mplate/MP/navid/4188

As you mentioned, our friends at BCBS, who brag about insuring 1/3 of America, do NOT insure you for this procedure...as you hinted. See their policy here:
http://www2.bluecrosswisconsin.com/provider/medpolicy/p...s_spinal_system.html

In the meantime, see this related article -- and you can register for free for the full-text article.
______________________________________________

NOTE: To view the article with Web enhancements, go here.
Clinical Outcomes of the Dynesys Dynamic Neutralization System: 1-year Preliminary Results

William C. Welch, M.D.; Boyle C. Cheng, PH.D.; Tariq E. Awad, M.D.; Reginald Davis, M.D.; James H. Maxwell, M.D.; Rick Delamarter, M.D.; Jeffrey K. Wingate, M.D.; John Sherman, M.D.; M. Mason Macenski, PH.D.

Neurosurg Focus. 2007; ©2007 American Association of Neurological Surgeons
Posted 05/11/2007

Object: In this study the authors present the preliminary clinical outcomes of dynamic stabilization with the Dynesys spinal system as part of a multicenter randomized prospective Food and Drug Administration (FDA) investigational device exemption (IDE) clinical trial.

Methods: This study included 101 patients from six IDE sites (no participants were omitted from the analysis) who underwent dynamic stabilization of the lumbar spine with the Dynesys construct. Patient participation was based on the presence of degenerative spondylolisthesis or retrolisthesis (Grade I), lateral or central spinal stenosis, and their physician's determination that the patient required decompression and instrumented fusion for one or two contiguous spinal levels between L-1 and S-1. Participants were evaluated preoperatively, postoperatively at 3 weeks, and then at 3-, 6-, and 12-month intervals. The 100-mm visual analog scale was used to score both lower-limb and back pain. Patient functioning was evaluated using the Oswestry Disability Index (ODI), and the participants' general health was assessed using the Short Form-12 questionnaire. Overall patient satisfaction was also reported.

One hundred one patients (53 women and 48 men) with a mean age of 56.3 years (range 27-79 years) were included. The mean pain and function scores improved significantly from the baseline to 12-month follow-up evaluation, as follows: leg pain improved from 80.3 to 25.5, back pain from 54 to 29.4, and ODI score from 55.6 to 26.3%.

Conclusions: The early clinical outcomes of treatment with Dynesys are promising, with lessening of pain and disability found at follow-up review. Dynesys may be preferable to fusion for surgical treatment of degenerative spondylolisthesis and stenosis because it decreases back and leg pain while avoiding the relatively greater tissue destruction and the morbidity of donor site problems encountered in fusion. However, long-term follow-up care is still recommended.

[ans]

Sorry that you're in a hard position but I respect Dr. Lauryssen and w/get another opinion from him - not that this helps you. My inclination is to wait as long as I can tolerate it before having surgery but others say that this is deleterious. So we start at the beginning: confused!

Am in LA, know of most of the "rated" LA surgeons.

Good luck to you. Best, ans

[Toebin]

Tango Man,

Very tough choices involved with your case.

Harrison brings up some of the issues to consider that are vital to your individual case. And I would just bring up one other issue related to the clinical trial itself.

I am a "control" patient in a randomized ADR clinical trial (2 level). I went in knowing I may not get the devices and was also told up front that I would not know what I had been randomized FOR until I actually got into the OR... Lots to consider there knowing you might not be given the devices you entered the trial to get, and you have to really be sure your ok with whatever course of treatment is decided "for" you.

In my case I figured I either get the new devices OR I get the "gold standard" fusion and I felt I had nothing to loose.. HOWEVER, in my ignorant bliss I was not aware that the "standard" fusion contained some limitations on the type of fusion materials my surgeon was allowed to use. Which with 20/20 hindsight may have affected my outcomes post operatively.

I got wonderful care and have no issues with not getting the ADR's I had hoped for. As a matter of fact it was probably the best scenario for me. However there were some materials available that could have made me heal faster/better that my surgeon was not allowed to consider because of the clinical trials rigid definition of how the fusion would be performed (also very understandably).

Had I not gone for the trial my surgeon would have been free to use any material he felt "best" for my individual case. And in my ignorance I didn't know there were options related to that area of the process.

Insurance coverage was not an issue for me as the ADR's would have been provided as part of the trial , and my insurance would cover the underlying costs of the basic exposure of my spine to what ever type of repair was finally done.

So when considering becoming involved with a trial just make sure you address the "devil in the detail" aspects... on top of everything else.