I've been accepted into the Stanford trials for Collagenase (in this trial 2/3 of the participants receive the study drug, 1/3 placebo; after Stage 1 of trial is over, those who received placebo are eligible for study drug). I have a 45 degree contracture on ring finger of RH.-MP jooint I had successful NA 2.5 years ago but in last 6 mos DD has returned to RH and started in LH (in LH I have it in PIP joint of all four fingers nd it's affecting palm but limited contrtacture so far).

Right now I'm trying to decide between another NA procedure vs. enrolling in the study. My concerns about the study are:-- being assigned to placebo group and having to endure multiple injections, pain of 3 injections per visit and pain (that can last up to 14 days or more) when "breaking" the cord ; allergic reaction resulting in swelling of hand, arm and/or lymph nodes or worse, 5 visits per injection--up to 25 visits in 9 months. As I understand it, Collagenase is not a cure although there is less chance DD will return in the same spot than thee is with NA.

Right now, I guess, most folks would think I'm lucky being accepted into the trial. However, I can't quite figure out why I should take the risks mentioned above rather than just having another NA procedure and waiting for Collagenase to come to market in 2009 and hope it works miracles on my left hand. At this point, cost is not a factor since NA should be mostly covered by Medicare.

I'm really interested in opinions, reasons, ideas as to why I should go for the trial instead of a second NA procedure.

Thanks much!

My personal view is that
- collagenase treatment uses basically the same procedure as NA. Both first weaken the cord and then rupture it by mechanical force. Collagenase can be called an enzyme fasciotomy, NA a needle fasciotomy.
- to me the real benefit of collagenase will be that most MDs will believe they can do it while NA requires some training. Once collagenase becomes generally available the benefit will be that you will probably find someone in your vicinity who can inject collagenase. The downside might be that the procedure might not always be that simple and instead of breaking the cord there the cord might only be extended, potentially painful and quick recurrence. But that's only speculation from my side.
- from a marketing perspective collagenase beats NA by far. You can sell collagenase with good profit margin and your market is basically any MD who can do an injection, i.e. every MD. Sounds great. On the contrary NA, which requires skill and not a product. As a company you could at best sell training (but France offers that for free) or night splints (already available). Not good.

What would I do if I had to choose? If I had NA in my vicinity I would probably go NA. If I had to travel far for NA and had the collagenase trial close by, I would probably cross my fingers (if I can) and go collagenase. And besides that, as Randy pointed out, it might depend on the joint. Badalamente et al. report in their 2002 study (already 5 years ago, time is fleeting ...) very high success rates for PIP release (70 -85 percent) and also quite low recurrence rates after 4 years (MCP: about 15 percent, PIP about 40 percent). It is a little unclear how they measured recurrence and their statistics are still unreliable due to the low number of patients at that time. Phase 3 will provide further insight.

Wolfgang



Edited at 10.11.07 11:29