Activ-L Clinical Trial Underway

[mmglobal]

I spoke to Dr. Rolando Garcia yesterday. (Yes, he reviews cases on the weekend... I felt bad because he had his 5 year-old tugging on him... seems that baseball is more important than spine!) I've spent some time with Dr. Garcia at several spine meetings (and at parties.) He's quite an interesting fellow. His hobby is studying the history of spine arthroplasty. He has very interesting information about the early days of motion preservation... Did JFK really have the first lumbar ADR (Fernstrom Balls)? He thinks not. I could write more about Dr. Garcia's interesting take on the history of arthroplasty, but it's Sunday night and I have to get to my family too, although they are much older than 5.

Dr. Garcia was honored to be the first to implant Activ-L in the US under the new clinical trial. This trial is very unique because there is not a single control procedure. It's being compared to both ProDisc and Charite'. Study surgeons are using thier disc of greatest experience as the control procedure. This will be very interesting to see how this pans out. I believe that ProDisc really benefitted by learning from the mistakes of the Charite' surgeons... that the collective knowledge about patient selection and complications was advanced by Charite, so that ProDisc results benefitted by being second. I also have lamented the fact that both studies compared expert fusion surgeons to novice ADR surgeons. The Activ-L clinical trial will give us good data as all procedures will be performed by well seasoned ADR surgeons.

Have patients been waiting for the start of the trial? Dr. Garcia did 10 procedures in the first week!

Unfortunately, they cannot start a 2-level arm of the study until ProDisc is approved. Dr. Garcia and other Activ-L surgeons I know are talking like there will be a 2-level study, but I've learned not to hold my breath where clinical trials are concerned.

We also discussed other emerging technologies... I hope to post more later.

I posted the press release (now old news) about the Activ-L trial here.

Good news for the spine community!

Mark

[Cathy]

What a guy!! Actually I need to make that plural to include both Mark and Dr. Garcia. Mark sent Dr. Garcia my profile and spoke to him this past Friday and Dr. Garcia called me and emailed me the following day. That is amazing. For those of you who do not know, I am in desparate need of an ADR at L4 before I autofuse. I live about four or five hours away from the surgeon's office. Therefore I wanted to send my MRI to the doctor to see if he would take me on as a patient. Without Mark on my side and a very caring doctor (who is willing to look at films and make calls on even on the weekend), I'm sure that this process would have taking several weeks if not more. One day turn around is crazy. Hopefully work comp will get on board so we can "get er done"

Thanks again Mark,
Cathy

[Maria]

Mark,
Interesting stuff/doctor!
Cathy, so glad Mark could make this happen for you as I was wondering where you were with this process. Mark definately made it all happen much quicker for me than the slow slow drag of CA WC~ and of course as a respected member of the spine community things just came together much better between consulting surgeons and Mark.
** Actually I had to come back and add that Dr.Delamarter would not have even seen me as I was already being followed by another doctor in that practice and it was difficult enough w/office staff to get past that. So actually Mark made that happen completely as did he the visit with Dr.Regan~

I'm hopeful you'll get what you need post haste! Please keep us posted on your progress. Also it's interesting to hear how other state WC will react with the aid of someone like Mark ~ my Nurse Case Manager was definately impressed w/Mark~