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