Why I decided to brace my daughter with the SpineCor

[concerned dad]

regarding the 62 month patient....

I'd also like to know what the Cobb angle was on that patient at the beginning of brace treatment. Details, details.

the x-rays are identified with patient numbers.
This patient had:
Th40 L40 in 1995 (treatment started)
weaning started (whatever that means) in 1997
Th32 L30 in 1999
Th27 L31 in 2002

[Pooka1]

Ah, I have lost the train of thought but I think my reference was to Patient #1382470. It was unclear because I didn't add the slide number thinking it was in the url I posted.

In re Patient #1382470, as far as I can tell, this is her history...

28 May 1996 - presents with L23 (RELATIVELY SMALL CURVE!!!)
28 May 1996 - can reduce it to L14 by standing oddly

13 June 1996 - gets brace on - shoot an immediate L6

17 July 1996 - L0

(no data presented for over 3.5 years)

10 Feb 2000 - now presents with a TL15 w/out brace therefore curve moved upward
10 Feb 2000 - TL9 w/brace

(no data for 1.5 years)

23 Aug 2001 - TL11 in brace(?)

21 Aug 2002 - TL11 in brace(?)

No data presented for period after 21 Aug 2002 despite the fact that I believe the Powerpoint is quite recent. Why?

[concerned dad]

Ah, I have lost the train of thought but I think my reference was to Patient #1382470. It was unclear because I didn't add the slide number thinking it was in the url I posted.

Yeah, above I was referring to the one weaned 62 months

In re Patient #1382470, as far as I can tell, this is her history...

28 May 1996 - presents with L23 (RELATIVELY SMALL CURVE!!!)
28 May 1996 - can reduce it to L14 by standing oddly

I got a good laugh out of this. I thought you meant that it was odd that her curve changed when she was standing. I'm looking to see evidence in the previous xray that she was sitting. Then I realized what you meant.
Anyway, remember we do not know the context in which these slides were shown. I am guessing that the "standing oddly" was somehow showing the corrective posture or movement.

regarding the small curve, perhaps they were addressing the K20 and L60 (whatever exactly that means) aspect of her curve.

13 June 1996 - gets brace on - shoot an immediate L6

17 July 1996 - L0

(no data presented for over 3.5 years)

10 Feb 2000 - now presents with a TL15 w/out brace therefore curve moved upward
10 Feb 2000 - TL9 w/brace

recall what I posted above concerning the weaning protocol. Take an xray after being out of brace for 72 hours, then another xray in brace. If the difference is less than 5 degrees then stop all bracing.
Here the difference is 6 degrees. And we know, you cant measure that accurately. So, I am GUESSING that this marked the end of brace treatment entirely.

But the math is wrong. 24 months would imply that she failed the 5 degree test. Wore the brace part time for another 6 months. And then finally passed the 5 degree test.

(no data for 1.5 years)

23 Aug 2001 - TL11 in brace(?)

21 Aug 2002 - TL11 in brace(?)

Not sure why you question if it is in brace or not. The brace is clearly visable in the inbrace x-rays.
That's a belly button ring I think. Not a brace grommet.

No data presented for period after 21 Aug 2002 despite the fact that I believe the Powerpoint is quite recent. Why?

Well, who knows how far this patient had to travel back to Montreal. If I am interpreting this right, it demonstrates a stable curve after several years. Maybe she figured - Why bother going back, move on with life.
A curve that presented in a 10 year old girl corrected from 23 to 11? Not bad. Perhaps they were also addressing the K20 and L60 as the side view is also shown in the last slide of the series. K20 and L60 went to 34 and 43 (whatever that means - I think it relates to the 3 dimensional aspect of the curve but my mind is sort of stumped when we get much past even one dimension)

[Pooka1]

(snip)
regarding the small curve, perhaps they were addressing the K20 and L60 (whatever exactly that means) aspect of her curve.

I believe:
K = kyphosis
L = lumbar and lordosis
C = cervical

Well, who knows how far this patient had to travel back to Montreal. If I am interpreting this right, it demonstrates a stable curve after several years. Maybe she figured - Why bother going back, move on with life.
A curve that presented in a 10 year old girl corrected from 23 to 11? Not bad.

I think some very high percentage of L23 curves never progress no matter what you do (or don't do).

I'd like to see them present a T30-something case history.

[concerned dad]

I believe:
K = kyphosis
L = lumbar and lordosis
C = cervical


I think some very high percentage of L23 curves never progress no matter what you do (or don't do).

Well, how many "spontaneously correct" to 11? Heck, if it went to 10 they might be able to claim a cure.

I'd like to see them present a T30-something case history.

Isnt the Th40 I noted above an example? Again, the abbreviation/shorthand is foreign to me.
This patient had:
Th40 L40 in 1995 (treatment started)
weaning started (whatever that means) in 1997
Th32 L30 in 1999
Th27 L31 in 2002

Can we expect many 40 degree curves to correct 33%?
And, the more I look at this the more I am convinced about the weaning thing. If I am interpreting it correctly, it means that not only did the curve correct 33%. But held the correction (and even improved?) 5 years after all bracing ceased.

Maybe something can be gained from the failed bracing study. If we, for the sake of argument, assume for a moment that the bracing in the SRS/Nachemson study had no affect, cant we use that group as a "worst case" control? Recall, the bracing study did NOT include the SpineCor.

[Pooka1]

Isnt the Th40 I noted above an example? Again, the abbreviation/shorthand is foreign to me.
This patient had:
Th40 L40 in 1995 (treatment started)
weaning started (whatever that means) in 1997
Th32 L30 in 1999
Th27 L31 in 2002

Can we expect many 40 degree curves to correct 33%?

When did weaning end prior to the 1999 measurement?

Based on the stated criteria IIRC, I don't think this patient wore any brace between 1999 and 2002 but I'm not sure. There could have been data in-between where she failed the weaning criteria and wore the brace in this period. Had the Spincor literature been clearer (N.B., I'm not gigging the PP slides here) there wouldn't be any rooom for wonder.

Also, we can expect a +/- 10* on the same radiograph if two different readers are involved as I understand it.

And, the more I look at this the more I am convinced about the weaning thing. If I am interpreting it correctly, it means that not only did the curve correct 33%. But held the correction (and even improved?) 5 years after all bracing ceased.

That could be right if we knew clearly when all bracing ceased.

Maybe something can be gained from the failed bracing study. If we, for the sake of argument, assume for a moment that the bracing in the SRS/Nachemson study had no affect, cant we use that group as a "worst case" control? Recall, the bracing study did NOT include the SpineCor.

All that data can be used with IBMs I think.

[Pooka1]

No data presented for period after 21 Aug 2002 despite the fact that I believe the Powerpoint is quite recent. Why?

I don't know which idiot wrote this but I now think that talk was given in 2003, maybe not even a year after the last data point for the patient in question.

[concerned dad]

slow down there...
You have me googling IIRC and IBM.

IIRC - if I recall correctly, OK
but IBM?
do you mean this thing I'm typing on? or is it some scolio term dealing with bracing models or something?

[Pooka1]

slow down there...
You have me googling IIRC and IBM.

IIRC - if I recall correctly, OK
but IBM?
do you mean this thing I'm typing on? or is it some scolio term dealing with bracing models or something?

IBM = individual based modeling. I got tired of writing it out.

[Pooka1]

Forgot to respond to this...

In re the patient with a putative stable TL11...

Not sure why you question if it is in brace or not. The brace is clearly visible in the inbrace x-rays. That's a belly button ring I think. Not a brace grommet.

The problem is we don't know when this patient last took off the brace. Maybe it was five minutes before that radiograph. If so, that is essentially close to the in-brace angle despite the fact the brace is not worn for the radiograph.

That was my point.

Given Linda's anecdotal observation that many patients go against advice and simply continue to wear the brace more hours and beyond the end of the weaning protocol, I think we have to be skeptical of these long-term Spinecor results per se. That is unfortunate because that really is no fault of the researchers. Essentially, they may in fact not have enough control over the study to ever publish.

I don't know that but I'm saying we need to rule that out at this point in a very convincing fashion.

Last, this weaning business is inherently squirrelly. Do other braces have a weaning period? Isn't the fact that a weaning period is specified for all patients even those past skeletal maturity problematic?

It is now incumbent on the Spinecor types to publish CLEAR data on when the brace was last removed prior to a radiograph and to somehow vouch that the patient isn't secretly wearing it. I suspect most patients who fail the first weaning are wearing that brace full time and longer than 6 months against protocol.

[jillw]

In re the patient with a putative stable TL11...

Do other braces have a weaning period? ....

Others would have a more definite answer to that question, but of the two people with scoliosis bracing that I personally knew, they both were weaned of their braces. One wore a Milwaukee and one wore a Boston brace. Caveat - not only is this anecdotal, but these people are adults now and I don't know if protocol has changed.

[Pooka1]

(snip)
But what about the data for the SpineCor? A paper published in 2007 (Colliard, Journal of Pediatric Orthopedics) complied with the new SRS guidelines for bracing studies. (And, correct me if I am wrong, I think this is the first Brace paper that came out presenting data in accordance with the new SRS guidelines).

The following article uses the new SRS criteria is in the same journal volume and number but was printed on pp. 369-374 whereas the the Spinecor article immediately follows on pp. 375-379.

Janicki, et al., 2007

So technically, it was published "first."

[concerned dad]

The following article uses the new SRS criteria is in the same journal volume and number but was printed on pp. 369-374 whereas the the Spinecor article immediately follows on pp. 375-379.

Janicki, et al., 2007

So technically, it was published "first."

Absolutely correct, it was first. I totally missed that paper and I was even looking at the table of contents of the journal.
But the results are very discouraging for the two braces studied. Particularly for larger curves. They say:
The results of both orthoses were unfavorable when
compared with previous studies and the natural history of the
condition. Neither orthosis was effective, when compared
with the natural history of AIS, at preventing progression to
surgery in subset of patients with curves of 35 degrees or
more. Although not included in this analysis, our patients
with initial curves of 41 to 45 degrees also had poor results
using either orthosis. The use of a TLSO did not prevent curve
progression or the need for surgery in only 20% to 25% of our
patients. This was true even when the initial curves of 25 to
35 degrees were evaluated separately. The Providence
orthosis did not prevent curve progression or surgery in
40% to 55% of patients. The best results were obtained in
curves of 25 to 35 degrees. On the basis of these results, we
are reconsidering our guidelines and are considering orthotic
management in skeletally immature patients with progressive
curves of 20 to 24 degrees.

My daughters curve is high (38 degrees two months ago) and they had no success with curves like this. ZERO, NADA. I'll be interested to see if (and by how much) it progressed since late November.
I'm in Syracuse now on my way to Montreal. I wish I had a printer so I could print this paper out and compare it with the Coillard one.

Another issue I thought I would throw out there regards the Boston Brace. I was figuring that if anyone would be financially concerned about the current BrAIST study it would be them as they sort of have the market cornered. I went on their website thinking that if they were a publicly traded company they may have a statement or comment in a note to shareholders or something. This is the kind of stuff that, if you were a shareholder, you would want to see disclosed (and I think Sarbanes Oxley would require it).
Anyway, I didnt find what I was looking for. Apparently it is privately held and there are no links to shareholder documents. But I did see two things that interested me.
The first was a reference to a paper on their website
Brace Treatment of Idiopathic Scoliosis: What Makes Sense in the New Millennium
John B. Emans, MD; SPINE: State of the Art Reviews, Volume 14, No. 1, January 2000. That looked like an interesting one to read, but I couldnt find it anywhere. I was able to access that issue of SPINE electronically but did not find it. Perhaps it is a special volume or something. If anyone has a pointer for that paper I would be interested.

The other thing I noticed on the boston brace website is a "new" brace that is based on "dynamic" treatment principals. They say
Finally, a truly dynamic approach to the treatment of idiopathic scoliosis
Now, imitation is a form of flatery, and I dont know just how similar this is to the SpineCor, but I thought it interesting that they would be exploring new options like this.

[FixScoliosis]

SPINE state of the are reviews

Hi concerned dad

you are not looking for a journal but a book.

publisher
http://www.hanleyandbelfus.com/

hope it helps

[concerned dad]

Well, we’re back from our trip to Montreal. My daughter was fitted with the SpineCor and her in brace curve reduced from 38 to 27. Of course we hope to see a continued decrease in the curve as therapy progresses but only time will tell.

I was very impressed with Drs Rivard and Coillard. They struck me as people who love what they do and who have a sincere desire to help children. Dr Rivard met us in the lobby of the hospital and helped us through the registration and paperwork issues – we would have been lost without him as everything is in French. The brace really is quite the contraption with a seemingly infinite number of configurations of straps and grommets to treat specific types of curves. I can see why significant training would be required to effectively fit the brace to individual curves.

I’d like to get back to looking at the papers if anyone is interested.
Thanks for the reference Fixscoliosis. Unfortunately I cant get online access to books however I did request a copy of the article from the bostonbrace website. They had a link where presumably patients could request a copy of some pertinent literature. It’s been a week today so I better not hold my breath.

And Sharon, thanks for the reference to the “first” study performed in accordance with the SRS criteria. It’s funny, they (Janicki) do indeed note that theirs is the “first” in the text of the paper and I suppose it is true having beaten Coillard out by a few pages.

But that is the paper I thought we could talk about. Finally we have something to compare.

I guess the best way to look at it is to use the SRS reporting Criteria. Both abstracts are pretty clear on the details.

1A. percent of patients who have 5 degrees or less of curve progression
SpineCor 60%
TSLO 15%
Providence 31%

1B. Percent of patients who progressed by 6 degrees or more
SpineCor 10%
TSLO 85%
Providence 69%

2. Progression to surgery
SpineCor 23%
TSLO 79%
Providence 69%

3. Progression beyond 45 degrees
SpineCor 23%
TSLO 56%
Providence 45%

4. 2 year follow up
Janicki didn’t provide 2 year data

The average initial curve was 33.6 for Janicki and 32 for Coillard.

So, it looks like Janicki had some pretty horrendous results. It’s no wonder his conclusion was that a random controlled study should be performed. But, is it just me, or is the comparison between the results from the different braces dramatic. 79% of the TSLO group required surgery? Did I read that right? How can that be?

Anyway, I’ve been wrestling with the controlled random study issue. Rivard and Coillard clearly believe their brace is effective and superior. A comparison using the SRS Criteria above demonstrates this. Early on in their work they (Rivard et al) started a RCT but abandoned it. The current BrAIST trial will mean nothing about the efficacy of the SpineCor. Do we need a RCT (random controlled trial) to prove its efficacy?

Consider this:
If we have two diets A and B. If the folks on Diet A loose 10 pounds and the folks on Diet B loose 30 pounds, can we say that Diet B is better than Diet A? Perhaps yes if the studies are well done. But the relevant question is, Does the fact the Diet B is better than Diet A mean that dieting in general helps you loose weight? In the world of evidence based medicine, is that a valid conclusion? I don’t know but I bet Sharon is going to point me in the right direction.