Why I decided to brace my daughter with the SpineCor

[Pooka1]

Failure at >5*

If the measurement precision is +/- 5*, the failure point has to be set at some point higher than that.

Setting it at >5* is actually the MOST conservative approach. He would have been blasted had he chosen a number far above the precision of the measurement. That is, this will identify the MOST number of "failures."

Now he can go on and table the extent of failure (how far above 5) and possibly asked why he didn't do it if he doesn't. But he should not be understood to be claiming "6* is a failure" per se. I believe that is an incorrect interpretation of the approach.

Love,
a random yahoo

[RugbyLaura]

Dear Random Yahoo,

Crikey, that's all Greek to me! I'll have another look at it in the morning & hope that it makes sense then. I think my brain is degenerating through all this worry.

CD,

growth spurts in girls comprises only a short period of time while the age of 6-10 years, usually there is no change of curvature even in an untreated patient with a curvature of >20°.

Again, I'm struggling with the language but would like to point out that my daughter's curve progressed from 28 to 38 degrees in 7 months while she was 9. Have I got the point wrong?

[Pooka1]

My point is that he must pick a Cobb angle increase that is not in the noise. Anything less than 5* is in the noise of the measurement error.

That is the reason he uses >5* as an indicator of a "failure." A better, less confusing term instead of "failure" would be using >5* as an indicator of an "increase." He is simply using the term "failure" as the smallest increase he can confidently measure. It's obviously not a failure if you start at 20* and end at 26* so he doesn't mean that.

He can't say a +3* change is a "failure" or even an "increase" because he can't be confident that it is a real increase because it is smaller than 5* and therefore within the measurement error (precision).

So whatever number he picks, we know it must be >5*

Now if he picks a 10* increase then he is not counting the curves that we know definitely increased (between 6* and 9*). So rather than miss any observable increases, he sets it at the top of the error bars, 5*. This will catch all measurable increases in curves.

Is that clearer?

[RugbyLaura]

Yep

(thanks)

[concerned dad]

A better, less confusing term instead of "failure" would be using >5* as an indicator of an "increase."

snip

Is that clearer?

Yes, good explanation. Isnt there a similar thing going on with "false" and "wrong"?
Is there a reason that greek statistics fellow we were discussing earlier didnt title his paper ".... most published research findings are wrong" instead of the term he used ".... most published research findings are false".

[Pooka1]

"False" and "wrong" can both mean erroneous.

Maybe "false" is more commonly used for fact cases whereas "wrong" is more commonly used for moral or ethical situations?

[michele27]

Re: Rebuttal to Weiss study

Hi,

This does not directly address the issue of the age and development of a patient treated with Spinecor vs. curve progression, but may give a little more insight to the overall results of Dr. Weiss' study. That is assuming there was only one 2005 Weiss study concerning Spinecor(otherwise this may be irrelvant). I found this in the forum archives, but I couldn't find an "official" published rebuttal like the one published in response to the Wong study. Sorry, it's a little long!

Michele

Dear Dr Rivard

I hope you do not mind that I write directly to you.

I live in the UK and unfortunately my
daughter (now 11 years 10 months, no Menarche yet) was
earlier last year diagnosed with a T12 25 degree scoliosis,
progressing in some months to 29 degree. With a hard brace
(febr 2005) we achieved a 25 % correction, (down to 21 degree
in brace) and on review this month we seem to be stable, in
that the curve is still 29 degree.

I am concerned that with the current brace we are not
achieving as much correction as we should/ could be getting,
and as we are due a new brace anyway, I am reconsidering my
options.

I think that at least I need to "press" for better correction
from our next hard brace, but having "looked" at the
Spinecor, and reading the studies published on the
Spinecorporation website I do wonder whether this is an
option for us.

Although the results as published seem impressive, i am
worried that the concept doesn't appear to be having the
wholehearted backing of the orthopaedic community and
specifically that, as i understand it, The Nuffield Hospital
Oxford pulled out of the joint study (with your own
hospital), because they were not happy with the results. The
other worry is the study which i saw, by dr Weiss, who
questioned to effectiveness of the brace as well.

Have you got any insight as to why use in Oxford and through
Dr Weiss were not succesful, and are you able to reassure me?

I understand that a further study by yourself will be
published soon. Are you able to advice me when and where they
will be published, and are you already able to give any
outline of the results?

I would be grateful for any advice you might be able to give
to help to settle my anxieties. I am well aware that I cannot
afford at this stage to make a wrong choice with regards to
my daughter's treatment, as she will have to live with the
consequences forever

With regards

Gerbo Huisman
Lichfield, UK


and the reply from Andrew mills of the Spinecorporation



Dear Mr Huisman

Your email has been forwarded on to Dr Rivard however; I can easily answer your questions. More reduction in a rigid brace will not necessarily make any significant difference to the outcome.
Rigid bracing at best will prevent progression from the initial pre-treatment cobb angle, applying more force to give the illusion of more correction on an in brace x-ray may make you feel the treatment is better but that is not necessarily the case at all. There is some debate amongst practioners about the compromise between reduction of major curves, compensatory curves and balance, from my point of view all three should be considered and one not optimumized at the expense of the others.
For 12 - 24 months post rigid brace treatment curves will tend increase until they stabilize out, generally close to where treatment started.

At your daughter’s age the risk of progression is, as you know very high and it is possible you may yet see more progression despite bracing.
SpineCor treatment will not perform miracles but offers the best possibly of achieving a final stable result post treatment with the lowest Cobb angle achievable in any particular case.
In Montreal we now have long-term follow-up, 5 years, post bracing in a large proportion of the original 400 patient study group.
Results of the latest follow-up, not yet, published show exceptional stability post treatment with overall better results than any conventional rigid brace treatment.
With more than 5,000 patients treated worldwide now there is no question in our mind concerning the efficacy of SpineCor Treatment. There have of course been some failures, which basically stem from failures in training. Our training program has changed significantly in recent years to prevent future treatment centre failures.

Dr Weiss, incidentally, treated a group of 20 patients with SpineCor braces on which he based his opinions. These treatments were carried without any training or following the SpineCor treatment protocols, not surprisingly the treatments failed.

Nuffield had issues with funding the SpineCor trial as well as great difficulty in recruiting patients with a randomised protocol for treatment vs. non-treatment. Only 5 patients were treated in 18 months against a recruitment protocol of 20 patients in 12 months. The lack of funding, some training issues and any enthusiasm from the team involved resulted in them just giving up.

In general there are huge problems to introduce SpineCor into the UK since orthotists who traditionally provide bracing treatments find SpineCor very challenging, added to this they are often under great pressure to see patients very quickly and simply do not have the time for SpineCor. Furthermore it needs to be understood that is a big learning curve with SpineCor and the skills required are very different to those for rigid bracing. For these reasons it is essential that trainees treat significant numbers of patients to develop their skills. The current SpineCor accreditation program demands a minimum of twenty patient treatments and 6 months experience before individuals are eligible for accreditation. In the UK there are few treatment centres that offer the opportunity to meet the training criteria in a reasonable period of time. A change in the method of treatment delivery is required for SpineCor to ever become mainstream in the UK.
Personally I am working on ways of changing the way SpineCor is made available to the NHS but this is likely to be slow.
The latest SpineCor treatment results have been submitted and accepted by the European Spine Journal but as yet we do not know when publication might be.

I hope this information is useful to you.

Kind regards

Andrew J Mills MBAPO
Managing Director/Orthotist

The SpineCorporation Limited

It is all a mrf10-26-2006, 10:01 AM
I actually asked Dr Rivard about the Weiss study and he told me several things:

1 - the study was only with 12 patients
2 - When he and Dr Coillard went to Germany to meet with Drs Weiss and instruct them on the proper fiting of the SPinecor they did not agree with Dr Rivard's directions as to how to fit the brace. He said that they insisted on fitting the brace as a three point brace which, according to Dr Rivard, is not the correct way to do it. Dr Rivard said that he trained their orthotists to do it the correct way but that when they went back to Germany, they were not fitting the Spinecor correctly.
3 - He did have follow-up consultations with Drs Weiss and that when he (Dr Rivard) showed his additional study results, Drs Weiss agreed with Dr Rivard but that was after their study was already out there.

It seems if #3 is true, then a rebuttal would have been published. Of course, there may be one and I just haven't been able to find it.
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[Pooka1]

I would just like to say that a study on AIS (or any highly variable condition) with 12 patients is inherently not credible.

Just my opinion.

[RugbyLaura]

Thank you, Michele, for hunting that down. That post was the catalyst for us (me) hunting down the Spinecor brace - via Gerbo.

Seeing it again takes me back...

[concerned dad]

Yes, Thank you Michele for hunting that down and posting it.
Very interesting. And somewhat troubling. I recognized the name Gerbo as the person who started the Spinecor thread. Looking through his posts I saw one of the more recent ones say (from the Spinecor thread)

"Considering I started this thread, I might as well put you in the picture about our current situation. In line with what happened with melisaa's and cheryyl's daughter, we haven't been doing well at all recently, we had our latest check last wednesday and as feared; not good at all, primary curve; about 31, sec curve at T4 39 degrees, no difference in or out of brace, so she has been taken out of it"

So, apparently his daughter started with Spinecor after the email exchange above and before menarche. Things went well until she went through her growth spurt. Gerbo mentions 2 other names/forum participants. Melissa and Cheryl who appear to have had similar results to what Weiss predicted.

Dont get me wrong, we are staying with the Spinecor. I just want to understand as much as possible. This is a small sampling of 3 folks who had poor success. Anyone familiar enough with this forum to know if we (forum participants) have had success through peak height growth with the SPinecor?

[Pooka1]

CD, it's a good thought but I suggest there are not enough testimonials on that to decide the matter AT ALL.

It's anecdotal, stem to stern.

[concerned dad]

Yeah, but it would be reassuring to hear one testamonial. You know, something like .......
"my daughter had a 30 degree progressing curve, we put her in Spinecor at age 11 and now she is age 16 with a 25 degree stable curve".

Not scientific, just reassuring.

[Pooka1]

I would wager it is almost certain, if you polled enough people, you would find folks with that exact testimonial, if only because not all curves will progress even if you do nothing and some may even improve if you do nothing.

Just because your daughter is wearing a Spinecor brace and even if it is known it usually doesn't holds curves like that, it may still be the case that her curve will stop/improve either with or without the help of Spinecor.

It is impossible to overestimate how little is known about Spinecor at this point. There certainly might be a group of patients for which is does usually work. Who knows. Nobody proved it can't work.

(ps. It is my secret goal to make this thread longer than the Spinecor thread. So I hope folks pitch in. Oh and don't tell anyone! )

[RugbyLaura]

(ps. It is my secret goal to make this thread longer than the Spinecor thread. So I hope folks pitch in. Oh and don't tell anyone!)

Perhaps I should have posted Immi's xrays here and you might have commented on them Did I commit a forum faux pas?

[emarismom]

Concerned Dad,

I have not seen the type of testimonial that you are looking for. I agree, it would be "reassuring" to have that type of testimonial!

Laura,

I did see Immi's xrays, they are quite impressive!! Congratulations.