Prodisc vs Charite Patient Satisfaction

[soreback]

According to Spine-health.com the Prodisc has a more favorable patient satisfaction rating than the Charite. Do you think these numbers are accurate?
Here�s the info �
�The ProDisc was designed in the late 1980's by Thierry Marnay, a French Orthopaedic Spine Surgeon. From 3/90 to 2/93, Marnay implanted this artificial disc into 64 patients. In 1999, these patients were studied to determine the long-term results of implantation. Three of these patients had died from unrelated causes, but 58 of the surviving 61 patients (95%) were found and studied extensively at 7-11 year follow-ups. All implants were intact and functioning. There had been no implant removals, revisions, or failures.
There was no evidence of subsidence (sinking or settling in bone) on follow-up radiographs compared to the peri-operative films, as reported by the operating surgeon as well as by an independent US Orthopaedic spine surgeon.
A significant (p <0.001) reduction in patient-reported back pain and leg pain was identified. 92.7% of these patients were "satisfied" or "extremely satisfied" with the procedure.
Two-thirds of these patients had single level implants while one-third had two level ProDiscs. There was no outcome difference between the 1 and 2 level ProDisc implantations.
Most importantly, at this long-term follow-up, there were no device-related safety issues, no untoward effects, no complications, and no adverse events.�

�Factors critical for a good result using the Charit� are proper patient selection, selecting the correct prosthesis size, and proper prosthesis positioning with the CentreLine Instruments
Several clinical studies have been published documenting the European experience with this disc since 1987. Worldwide experience with this unconstrained anatomic disc replacement is now greater than 6,000 cases.
� Cinotti reported on 46 Italian patients in 1996, with 2-5 year follow-up. He saw no implant failures, but did report reoperation in 19% for continued pain and one case of implant dislocation due to wrong size selection. Overall patient satisfaction was 63%.
� LeMaire reported his French series in 1997, following 105 patients a mean of 51 months with 79% good outcomes and no device failures.
� Zeegers reported 50 patients in 1999 in a Dutch series. He showed 70% good results with 2 year follow-up, but he did report 24 reoperations in 12 patients, none due to device failure.�

[ans]

Wow, that's pretty mind-blowing re: Pro-Disc. Wonder if this was taken from a refereed article (can't find the link). Paul?

Thanks, Allan

[soreback]

Allan
Here's the link to that info-
http://spine-health.com/research/dis...ificial04.html
Thanks Deb

[ans]

Hi Deb,

Thanks for the link. If these claims are true, then your post is the most important one I've seen in this forum.

Best, Allan

[letteski]

ans and Deb,

This is definitely something that cot my eye a few months ago when It was shared on the forum sorry you missed it ans. It�s hard to come by prodisc information these days. If anyone has anything else to share I would love to get my hands on it.

As for this prodisc information it is quite promising and when the prodisc hits the market look out! Should be very interesting indeed.

[JeffreyD]

Just a reminder to those of you honestly seeking to gather pertinent information and "do your homework" because you or a loved one has a serious spine problem; be very careful what information you glean along the way. For instance, what I got out of these "numbers" years ago when I was researching for my own case, was that ADR surgery is successful more often than not. One certainly can't read into this comparison that one disc is "more satisfactory" than the other.............none of these studies tells you much if anything about the condition of the people involved prior to surgery. All you really know is that they had bad discs!
My heart goes out to those nearing the final stages of making irreversible surgical choices for their spine problems. Be careful and choose the best surgeon for your condition(s).

God bless,
Jeff

[soreback]

Thanks Jeffrey, I absolutely agree that it depends solely on what a person has experienced throughout the years such as other surgeries, etc.

To my surprise, I received a telephone call yesterday from Dr. Zeegers (I sent him an email 2 weeks ago requesting a second opinion) and we had about a 15 minute conversation about Charite vs. ProDisc.

Although he openly admits his favorite is the Charite, he said it's most important to choose a surgeon who is very experienced with this type of procedure.

I am one week away from surgery, still a bit nervous, but ready for some relief.

[Alastair]

It's absolutely true, there isn't any difference between the Prodisc and the Charit� in performance.

If you're going to have your surgeon with Zeegers you have got the world's most experienced ADR surgeon on your side. We all need a bit of luck with this major surgery, but with all that experience it takes you well into a winning side.
Best,
Alastair

[soreback]

Dr. Z told me his only concern with the ProDisc was what to do with it if it needed to be removed? It doesn't come out, ever.

I confirmed this w/ Dr. Delamarter's office and they said it's true, it won't come out, they would just fuse the area if needed.

I am down to the last day (tomorrow) in which I must choose Charite vs. ProDisc. I am still confused. So many believe the Charite has proven itself for so long, and without FDA approval, I am still undecided if I should take the risk on the ProDisc.

[Rein]

You're exactly at the point where each person here has been when they finally had to just hope they'd researched as well and completely as possible and had all the facts available to make a good decision. Now it really comes down to flipping a coin, keeping your fingers crossed and diving into the deep end of the pool.

In all my reading the latest info I've come across seriously questions the Charite's negative affect on the facets, especially for patients in the 2+ years post-op category. I have seen nothing yet that indicates that problem with the ProDisc, but bear in mind that the ProDisc study hasn't been released yet, we only have individual patient input to go on. That said, I haven't heard one ProDisc recipient on this forum state that they had facet issues post-op. Anyone want to corroborate or dispute that, please?

My thinking is that if you put in the best prosthesis, then there won't be a need to remove it. Also, the word "ever" is pretty permanent, but we know that nothing really is, and medicine improves by leaps and bounds every year. Just because they haven't figured out a way to reverse a procedure *now* doesn't mean it won't be possible in the future. I don't recall at what level you need your ADR, but if it is the most typical, the L5-S1, plenty of the members here are having that level fused anyway, so getting ADR at that level and looking at possible fusion revision down the line may not be the worst thing in the world...

Sorry if this complicates things for you yet further! ;-)