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Pooka1
12-05-2009, 07:38 AM
I found one set of extended comments... it was on Fix's site in a thread mamamax was on...

http://www.fixscoliosis.com/forum/threads/102-SpineCor-vs-rigid-Brace

Wong wrote:


Thanks for your email. This discussion has been brought up again and again.

Our study team got more than 5 years of experience for using SpineCor from intensive training in St Justine Hospital (3 team members were granted with the training certificates) to real practice and then quitted the prescription. Our names not being listed in the relevant website recently is with an apparent reason.

In our randomized controlled trial study, we followed the treatment protocol suggested by the inventor of SpineCor. Honestly speaking, our team did hope SpineCor works.... We published and shared our experience of using SpineCor with others but some "practitioners" might think our team did something wrong without further considering the actual mechanism of SpineCor and the patients' compliance and acceptance - it is not a fair, objective and unbiased comment. Definitely, we shared our own experience through publications and it does not mean every researcher / practitioner will have the same experience as ours. Anyway, I am looking forward to seeing new developments of SpineCor including more randomized controlled trial studies in particular from the independent bodies / institutions like our team.

It seems someone is mistaken (or lying).

I think there are more comments out there from Wong that I read but I can't prove it. I'll keep looking.

mamamax
12-05-2009, 08:01 AM
Please read the rest of the tread - regarding the Spinecor manufacturer's rebuttal to the controversy. If you read the six page rebuttal - Spinecor states that the 3 team members, while they had "certificates", these certificates were introductory level training certificates only - not certificates of full training which would deem them fully certified.


Reading the six page rebuttal:

The Wong study authors and facility where the patients were treated - were not qualified to a proficient standard in the Sinecor treatment system. Proficient standard means: qualified to treat patients unsupervised. That those involved were not qualified (to a proficient standard) begs many questions regarding quality care and ethics.

The treatment center did not order enough brace components to effectively brace 22 patients nor did they order enough replacement components necessary to effectively maintain that amount of braces.

The rebuttal breaks these two points down in great detail. Bottom line - There is no way this study could have been successful with unqualified providers and less than adequate brace components.

I will never look at any study the same way again. Both Wong (and Weiss) are not certified at a level proficient enough as to provide this treatment unsupervised. If they were - they would be listed as such on the Spinecor manufacturer's web page, where one can find certified providers world wide. In fact, of those listed on the manufacturer's web page as being proficient, two are independent of the surgeon inventors and manufacturer and have published studies showing far more success.

I think journal and SOSORT acceptance criteria for such studies should be a bit tighter in the future. If a provider of a given treatment is not qualified to administer that treatment unsupervised they should not be granted funding to do a study or submit their findings. Furthermore, perhaps any manufacturer should not be selling braces to anyone not qualified at a proficient level as defined above. A very valuable learning experience this - and relative to any future study we may read regarding any treatment.

Pooka1
12-05-2009, 08:06 AM
Nothing in the rest of the thread negates the FACT that someone, either Wong (with no dog in the fight) or Spinecor (with the only dog in the fight) is mistaken or lying in this.

Spinecor is on thin ice claiming Wong et al. were not qualified. There is almost no chance Wong et al. would have done that study without getting the qualification certificates because it wouldn't make it out of peer review otherwise.

We'll wait and see if this goes any further within professional circles.

Pooka1
12-05-2009, 08:08 AM
Furthermore, perhaps any manufacturer should not be selling braces to anyone not qualified at a proficient level as defined above.

:rolleyes::rolleyes::rolleyes:

Don't hold your breath. They exist to turn a profit.

mamamax
12-05-2009, 08:28 AM
:rolleyes::rolleyes::rolleyes:

Don't hold your breath. They exist to turn a profit.

Don't think I didn't think of that Sharon - which lead me to ponder how many other times something like this may have happened with other bracing types - rather irritating isn't it?

mamamax
12-05-2009, 08:33 AM
Nothing in the rest of the thread negates the FACT that someone, either Wong (with no dog in the fight) or Spinecor (with the only dog in the fight) is mistaken or lying in this.

Spinecor is on thin ice claiming Wong et al. were not qualified. There is almost no chance Wong et al. would have done that study without getting the qualification certificates because it wouldn't make it out of peer review otherwise.

We'll wait and see if this goes any further within professional circles.

I think an official word from a manufacturer is an important document (one they certainly know can be used in a court of law).

The six page rebuttal from Spinecor is very detailed and truly explains a LOT ... cannot upload it here as the forum features do not allow a document over 100kb to be uploaded - the rebuttal is something like 142 - but you can access the entire document in post #10 here:
http://www.fixscoliosis.com/forum/threads/102-SpineCor-vs-rigid-Brace

Pooka1
12-05-2009, 08:38 AM
Yes it is irritating and not helpful whether it is done consciously or inadvertently.

Reason #4,940,113 why the literature is a mess.

Science works best by disproving false things. It doesn't work so well when you START with a preconceived notion that something is correct and then design experiments or cherry pick data to support it.

It is FAR more impressive when an idea withstands a grueling test to falsify it than if yet another creampuff softball study done by the inventor comes out.

The best evidence is when the inventor designs that grueling falsifying test themself and the thing comes out looking good.

This also works for literature reviews.

If you cherry pick aberrant papers in the literature just because they appeal to a pet hypothesis and tout them as the only correct results in a sea of opposite findings, or if you quote-mine individual paragraphs, sentences, and even phrases that "stand out" to you, that is NOT likely going to advance the understanding of a subject.

What is likely to advance the subject is carefully dissecting aberrant papers for flaws. Not all aberrant papers are wrong but until you look for the flaws, they shouldn't be paraded around as correct. And many of course can be shown to be fatally flawed which explains their aberrant position. The poster child for this is the Danish Twins study which is likely an annoyance at this point to researchers having to constantly mention it and shoot it down. It never should have been published.

Pooka1
12-05-2009, 08:38 AM
I think an official word from a manufacturer is an important document

I think it is a piece of self-serving nonsense.

mamamax
12-05-2009, 08:54 AM
Yes it is irritating and not helpful whether it is done consciously or inadvertently.

Reason #4,940,113 why the literature is a mess.

Science works best by disproving false things. It doesn't work so well when you START with a preconceived notion that something is correct and then design experiments or cherry pick data to support it.

It is FAR more impressive when an idea withstands a grueling test to falsify it than if yet another creampuff softball study done by the inventor comes out.

The best evidence is when the inventor designs that grueling falsifying test themself and the thing comes out looking good.

This also works for literature reviews.

If you cherry pick aberrant papers in the literature just because they appeal to a pet hypothesis and tout them as the only correct results in a sea of opposite findings, or if you quote-mine individual paragraphs, sentences, and even phrases that "stand out" to you, that is NOT likely going to advance the understanding of a subject.

What is likely to advance the subject is carefully dissecting aberrant papers for flaws. Not all aberrant papers are wrong but until you look for the flaws, they shouldn't be paraded around as correct. And many of course can be shown to be fatally flawed which explains their aberrant position. The poster child for this is the Danish Twins study which is likely an annoyance at this point to researchers having to constantly mention it and shoot it down. It never should have been published.

Someone might say that pigs are flying (and breaking the sound barrier) but - I actually agree with you on this (generally speaking)!

mamamax
12-05-2009, 08:59 AM
I think it is a piece of self-serving nonsense.

This we do not agree on (in this case), which involves a large controversy. In times of controversy, a detailed published rebuttal from a manufacturer serves to set the record straight, point-by-point ... and also, serves as a legal stand in a court of law.

txmarinemom
12-05-2009, 09:12 AM
Don't think I didn't think of that Sharon - which lead me to ponder how many other times something like this may have happened with other bracing types - rather irritating isn't it?


Unfortunately, it's well known patients don't always receive the treatment best suited for them. While we'd all like to believe every doctor (MD, DO or DC) and/or surgeon has our best interests at heart, it simply isn't true across the board. I'd venture to guess for every patient who receives the most appropriate brace, the most appropriate hardware/instrumentation, another does not. Not only that, plenty of people push products in which they have a vested interest - whether that's owning stock in the manufacturer, receiving money for promotional spots, or reaping the monetary benefit of research funding.

It IS a business, and it's big business.

A good example of "is it best, or is it profitable?" is demonstrated by the continued use of growth rods vs. VEPTR.

While VEPTR has documented great success (importantly, in treating scoliosis absent Thoracic Insufficiency Syndrome), there are still doctor/facilties who persist in using growth rods - despite guaranteed spontaneous fusion . Look deeper, and you'll find most of those surgeons receive some sort of funding for growth rod studies from growth rods manufacturers.

It's an incredible disservice to patients, and it brings a large responsibility on us to self-advocate.

There's a great blog (http://spineblogger.blogspot.com/) I've been following since inception that demonstrates just how much money drives the spine industry: While not specifically geared toward patients, some of you who like to stay current on technology should enjoy it. Posts in the last few days include XLIF ...

Regards,
Pam

mamamax
12-05-2009, 09:24 AM
Unfortunately, it's well known patients don't always receive the treatment best suited for them. While we'd all like to believe every doctor (MD, DO or DC) and/or surgeon has our best interests at heart, it simply isn't true across the board. I'd venture to guess for every patient who receives the most appropriate brace, the most appropriate hardware/instrumentation, another does not. Not only that, plenty of people push products in which they have a vested interest - whether that's owning stock in the manufacturer, receiving money for promotional spots, or reaping the monetary benefit of research funding.

It IS a business, and it's big business.

A good example of "is it best, or is it profitable?" is demonstrated by the continued use of growth rods vs. VEPTR.

While VEPTR has documented great success (importantly, in treating scoliosis absent Thoracic Insufficiency Syndrome), there are still doctor/facilties who persist in using growth rods - despite guaranteed spontaneous fusion . Look deeper, and you'll find most of those surgeons receive some sort of funding for growth rod studies from growth rods manufacturers.

It's an incredible disservice to patients, and it brings a large responsibility on us to self-advocate.

There's a great blog (http://spineblogger.blogspot.com/) I've been following since inception that demonstrates just how much money drives the spine industry: While not specifically geared toward patients, some of you who like to stay current on technology should enjoy it. Posts in the last few days include XLIF ...

Regards,
Pam

EXCELLENT well thought out comments. I look forward to what we may learn from the BrAIST study regarding bracing (and who may do best with what). This will be the largest such study historically and stands to serve as the most important as well. Some input from Lori Dolan here: http://www.scoliosis.org/forum/showthread.php?t=9641

As for VEPTR (which I admittedly know little to nothing about), maybe fodder for it's own thread ;)

Another good thread topic: Why is there no specific scoliosis agency under NIH that would allow sufficient funding for both surgical and non surgical methods and ultimately establish which method would serve which patient best??

jrnyc
12-05-2009, 09:26 AM
I havent followed all the threads about spinecor...but i do know this...

when has a manufacturer said bad things about their product, unless ordered to tell the truth by a court of law? what is a statement by a manufacturer worth... they certainly dont want to put themselves out of business! it is completely expected that a corporation will defend their product.... to the end!!

jess

Pooka1
12-05-2009, 09:33 AM
I havent followed all the threads about spinecor...but i do know this...

when has a manufacturer said bad things about their product, unless ordered to tell the truth by a court of law? what is a statement by a manufacturer worth... they certainly dont want to put themselves out of business! it is completely expected that a corporation will defend their product.... to the end!!

jess

Not only that but they make calculated decisions about what they can get away with, including paying liable judgment brought by researchers let's say, and still turn a profit.

It's a calculation and as long as the bottom line is improved, they will make decisions that may not be honorable, honest, have integrity, etc..

It's a business. All businesses do this.

txmarinemom
12-05-2009, 09:41 AM
Not only that but they make calculated decisions about what they can get away with, including paying liable judgment brought by researchers let's say, and still turn a profit.

It's a calculation and as long as the bottom line is improved, they will make decisions that may not be honorable, honest, have integrity, etc..

It's a business. All businesses do this.

That's so accurate. Practically every company that manufactures and markets a product has a team that does nothing but analyze "acceptable risk/exposure".

"Can we net at least ____% more than we pay out in claims for defects, deceptive advertising and liability?"

mamamax
12-05-2009, 09:54 AM
The point boils down to: why is anyone conducting a study of a specific bracing method when - they are not fully certified in the application of the method?

From the Manufacturer:

It has come to our attention that an article entitled “The effect of rigid versus flexible spinal orthosis on the clinical efficacy and acceptance of the patients with adolescent idiopathic scoliosis” was published in the May 2008 issue of Spine Journal.[1] The SpineCorporation is the company responsible for production, supply, and training in the use of the SpineCor treatment system and we have serious concerns about the methods and validity of this study. We would like to point out two serious issues in the way in which this study was conducted and we believe these factors invalidate the data of the SpineCor treatment group and therefore the comparative results of the study.

1) The authors in this study and the facility at which patients were treated with SpineCor are not qualified to a proficient standard in the SpineCor treatment system. They should not be providing this treatment therapeutically to patients, let alone conducting research into its efficacy. We believe this to be seriously unethical and detrimental to the patients involved.

2) This treatment centre has not been supplied with enough initial SpineCor components to effectively brace 22 patients. They also have not received enough replacement components necessary to effectively maintain this amount of SpineCor braces. In reference to point 1, the SpineCor brace is a unique treatment system for idiopathic scoliosis that is unlike any other type of spinal orthosis ever developed[2]. It does not share the same treatment principles of 3-point pressure that rigid orthoses use and its use requires specific and extensive training. Training and an expertise in rigid bracing does not transfer to SpineCor; specific training and qualification is necessary. To attain the necessary skills to be a safe and effective SpineCor provider, candidates are required to attend an initial Phase 1 theory course. On completion of Phase 1, providers are eligible to complete a Phase 2 practical training which involves treating patients in front of a qualified SpineCor trainer. Distributors of the SpineCor brace are under a contractual obligation only to supply SpineCor braces and components to Phase 2 certified providers. To remain certified, practitioners must see a minimum number of patients using this system each year or recertification is necessary[3]. These strict systems are in place to ensure quality of treatment and consistency of results.

None of the authors of this paper are certified in SpineCor treatment nor have they ever received significant training in the SpineCor system. Some of the technicians working with these authors at the scoliosis clinic in Hong Kong have received basic introductory training, but they are not certified SpineCor providers and are not considered to have received training to a sufficient standard to use the SpineCor system without supervision.

Pooka1
12-05-2009, 09:57 AM
The point boils down to: why is anyone conducting a study of a specific bracing method when - they are not fully certified in the application of the method?

What is your evidence that this occurred?

There is no undisputed evidence that the Wong researchers were not fully certified to fit the brace unsupervised.

All we have are post hoc pouts from the manufacturer at this point.

mamamax
12-05-2009, 10:04 AM
Sharon - the manufacturer has published a six page outline which establishes the FACTS which further outline specifically how certification is obtained - and further state such certification was NOT obtained. Even better, they outline point by point why this study could never have been successful based upon (1) lack of proper certification and (2) lack of sufficient bracing components and the method of their application.

This statement has been out for quite awhile. If it were a false statement, you can bet it would have been in a court of law by now!

mariaf
12-05-2009, 10:08 AM
[COLOR="Navy"]I think an official word from a manufacturer is an important document (one they certainly know can be used in a court of law).


Just about everything "can" be used in a court of law if someone was inclined to sue, etc. That doesn't mean every claim that is made by a manufacturer is true.

I have worked in the legal field for nearly 30 years and assure you that plenty of claims are made in writing by manufacturers and others - many of which claims are either misleading or not completely true.

I'm not necessarily saying that is the case here - just that this sort of thing happens every single day, so one should not assume, by any stretch, that a manufacturer is telling the truth just because he issues an official word or puts something in writing.

If that were the case, there wouldn't be so many laywers out there making a very nice living.

mamamax
12-05-2009, 10:12 AM
I think no one (in this thread, thus far) - with the exception of myself - has actually studied the six page statement from the Manufacturer who is responsible for the training required in the application of this method.

This being the case - my time is wasted here. Should anyone actually take the time to study the referenced document and wish to discuss it further, please PM me and I'll re-join the conversation.

concerned dad
12-05-2009, 09:45 PM
In the 6 page rebuttal, they say:
1) The authors in this study and the facility at which patients were treated with SpineCor are not qualified to a proficient standard in the SpineCor treatment system. They should not be providing this treatment therapeutically to patients, let alone conducting research into its efficacy. We believe this to be seriously unethical and detrimental to the patients involved.

There is internet archive available to everyone. I looked to see what the Spinecor Website said about providers in China in 2005.

Check it out. Recognize any names?
(Third on the list) (http://web.archive.org/web/20050314063453/www.spinecorporation.com/English/TreatmentCenters/China.htm)

It was apparently “ethical” enough to list his name on the website in 2005.

Pooka1
12-05-2009, 10:15 PM
In the 6 page rebuttal, they say:
1) The authors in this study and the facility at which patients were treated with SpineCor are not qualified to a proficient standard in the SpineCor treatment system. They should not be providing this treatment therapeutically to patients, let alone conducting research into its efficacy. We believe this to be seriously unethical and detrimental to the patients involved.

There is internet archive available to everyone. I looked to see what the Spinecor Website said about providers in China in 2005.

Check it out. Recognize any names?
(Third on the list) (http://web.archive.org/web/20050314063453/www.spinecorporation.com/English/TreatmentCenters/China.htm)

It was apparently “ethical” enough to list his name on the website in 2005.

Good work.

Dr. Wong, in his rebuttal, pointed out that some names, including his, mysteriously disappeared from the Spinecor qualified provided list.

Obviously Spinecor doesn't realize wayback or other web archive machines are out there.

They have now been caught in a blatant lie, sending their credibility to even lower levels (if that is possible).

mamamax
12-06-2009, 07:52 AM
In 2006, Spinecor discontinued distribution to China because those who had enrolled for full certification did not follow up despite repeated requests for them to do so. Naturally their names were removed as certified providers. That information is found on page two of the Spinecor rebuttal.

Without full certification - what were their names doing on a fully certified provider list in the first place? That is my question. Was it once corporate policy to place a provider on the list when full payment for full certification was made (before full certification was obtained)? And has corporate policy now changed to reflect only fully certified providers (regardless of any advance payment made for training) on their web site?

Regarding the disappearance of Rivard and a few others - Searching WaybackMachine for Canada, there is no absence of Rivard and Colliard. When the web pages were updated (2006) there may have been a temporary oversight that was corrected - human error always a factor.

What drama - more fun than the Cardashians. Reminds me of the class action law suit involving pedicale screws and spinal surgery awhile back.

When such controversy arises, and both parties appear to have a valid legal stand that they should be using - but don't ... I wonder - why? Maybe both parties would stand to lose more than they would gain by airing dirty laundry. I don't know - and probably never will.

Fortunately, this controversy does not effect the efficiency of the brace in the hands of fully certified providers. And that is what I must remember as a patient currently in treatment ;-)

Pooka1
12-06-2009, 09:33 AM
Fortunately, this controversy does not effect the efficiency of the brace in the hands of fully certified providers. And that is what I must remember as a patient currently in treatment ;-)

The Wong article is about AIS.

None of that per se is relevant to your situation other than the general issue of disingenuous Spinecor claims.

I think Spinecor will eventually be used just by JIS patients if it pans out (and it might) and adult patients for pain. You won't be seeing it used for AIS at all eventually except by the hard core alternative therapy aficionados.

mamamax
12-06-2009, 09:56 AM
ok then ...

Fortunately, this controversy does not effect the efficiency of the brace in the hands of fully certified providers. A fact patients currently in treatment, may take comfort in.

I keep forgetting I'm part of a grand experiment - thank you for reminding me Sharon :D

An experiment that is going rather well bty (and has been for other adults since 2005).

And what I said upthread Found Here is totally relevant to all

Pooka1
12-06-2009, 10:16 AM
This DIRECTLY affects AIS patients as the Wong study was done by certified brace fitters and Spinecor is lying about it after the fact.

You are getting pain relief which is very good. I suspect the adult back pain crowd is a far larger market than AIS. I can't understand why Spinecor isn't going all out on that rather than pushing against a wall on AIS. It's inexplicable.

The JIS crowd is relatively small (luckily!) but I hope they start doing studies on that and quit screwing around with AIS where nobody seems to believe their numbers and where we have seen a real life example of incorrect numbers from right on this group. Just like in this case, I suspect enough surgeons remeasured the Cobb angles from Montreal and formed an opinion about the quality of the data coming out of that group.

mamamax
12-06-2009, 10:20 AM
Who can prove that any one party is lying? Can you prove something Sharon? I don't think so. What is your proof - outside your spirited opinion?

Pooka1
12-06-2009, 10:21 AM
Who can prove that any one party is lying? Can you prove something Sharon? I don't think so. What is your proof - outside your spirited opinion?

wayback is my proof.

mamamax
12-06-2009, 10:30 AM
You call that proof? I call that very limited evidence that has been explained with an official response. My thoughts on that Found Here

Spinecor on page two of the rebuttal explains the removal of those in China from the list of certified providers - because they did not follow up on the full certification they signed up for.

So the question becomes - why were they on the list in the first place. If they were fully certified and Spinecor is telling the world that they were not - well, we certainly have a controversy. And not one that will be solved by looking at an archived web page.

Like I said - more fun than the Cardashians and reminiscent of the class action law suit involving pedicle screws and spinal surgery.

Pooka1
12-06-2009, 12:45 PM
The appellate court upheld the dismissal of plaintiffs' law suit against several medical/professional associations. So the plaintiff's claims did not carry the day but nor did the defendants' defense as far as I can tell (they didn't get costs).

http://biotech.law.lsu.edu/cases/devices/193_F3d_781.htm


[11] OPINION OF THE COURT

[12] This is an appeal of the District Court's dismissal under Fed. R. Civ. P. 12(b)(6) of conspiracy and concert of action claims alleged by thousands of plaintiffs in multidistrict litigation involving allegedly defective bone screw implantation devices. The District Court held the claims, insofar as they alleged a conspiracy to violate the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C.A. § 301- 397 (West Supp. 1999), did not state a cause of action upon which relief can be granted. Accordingly, the court granted defendants' motions to dismiss those claims.

[13] The District Court also made several rulings unfavorable to the defendants. The court denied with prejudice their motions to dismiss based on improper pleading and First Amendment protection. Additionally, the District Court denied the motions of several defendants for attorney's fees, costs, and sanctions. These rulings are now challenged on cross-appeal.

[14] We will affirm the judgment of the District Court on all issues.

So the bottom line here is the medical/professional societies were not liable as claimed by plaintiffs whereas in the Spinecor case, there is evidence they certified Wong et al. and then later claimed they didn't when the results were bad for the brace.

The two situations are completely distinguishable, mutually irrelevant, and go counter to what you appear to be alluding to... the case in Spinecor (i.e., the medical societies' position was upheld). If the Spinecor case puts you in mind of the this pedicle screw case then I suggest you haven't read the case. I've posted it if you do want to read the decision.

mamamax
12-06-2009, 12:50 PM
The appellate court upheld the dismissal of plaintiffs' law suit against several medical/professional associations. So the plaintiff's claims did not carry the day but nor did the defendants' defense as far as I can tell (they didn't get costs).

http://biotech.law.lsu.edu/cases/devices/193_F3d_781.htm



So the bottom line here is the medical/professional societies were not liable as claimed by plaintiffs whereas in the Spinecor case, there is evidence they certified Wong et al. and then later claimed they didn't when the results were bad for the brace.

The two situations are completely distinguishable, mutually irrelevant, and go counter to what you appear to be alluding to... the case in Spinecor (i.e., the medical societies' position was upheld). If the Spinecor case puts you in mind of the this pedicle screw case then I suggest you haven't read the case. I've posted it if you do want to read the decision.

I agree that I may have been speaking of apples and oranges - somehow the apple did remind me of the orange :-)

The orange - certainly deserving of its own thread.

The Spinecor controversy remains to see final proof one way or the other (real or imagined).

Pooka1
12-06-2009, 12:55 PM
I found this short page about this subject

http://www.sheller.com/SubPage.asp?SubPageID=76

in case anyone's interest is peaked. Unfortunately the link on the page to a timeline of pedicle screw problems is broken.

The large AcroMed settlement dealt with defective screws, not screws in general.

Pooka1
12-06-2009, 12:58 PM
Got it using wayback...

http://web.archive.org/web/20080504000531/http://www.spine-surgery.com/Pedicle_Screw/pedicle1.html

Only goes through 1998 though. It would be good to see what happened after 1998 to the present.

mamamax
12-06-2009, 12:59 PM
The appellate court upheld the dismissal of plaintiffs' law suit against several medical/professional associations. So the plaintiff's claims did not carry the day but nor did the defendants' defense as far as I can tell (they didn't get costs).

http://biotech.law.lsu.edu/cases/devices/193_F3d_781.htm





That was an interesting case - most of the original plaintiffs were referred to local courts (as I remember). Its not so much the respondents that concern me in such cases - as it is the patients. Were you able to find the actual final court document? Here is an original court document (circa 2000 which I believe was appealed):

http://www.state.il.us/court/Opinions/AppellateCourt/2000/1stDistrict/July/HTML/1982670.htm

The ruling in 2000 was: Accordingly, the judgment of the trial court granting summary judgment in favor of plaintiffs is affirmed. Plaintiffs being: Atlantic Mutual and Centennial Insurance companies vs. American Academy of Orthopedic Surgeons and Scoliosis Research Society


My point is (the apple/orange thing): controversy - happens.

I would like to see any actual court documents following 2000 on this one - just color me curious.

Pooka1
12-06-2009, 01:08 PM
That was an interesting case - most of the original plaintiffs were referred to local courts (as I remember). Its not so much the respondents that concern me so much in such cases - as it is the patients. Were you able to find the actual final court document? Here is the original (circa 2000 which I believe was appealed):

http://www.state.il.us/court/Opinions/AppellateCourt/2000/1stDistrict/July/HTML/1982670.htm


This appears to be the related case of the societies' insurers not wanting to pay out on the underlying case which I think is moot because the societies won that case. Not really sure though.

mamamax
12-06-2009, 01:46 PM
And I'm not sure either - can't seem to pull up any original court documents following 2000 - when judgment was awarded to the insurance companies, according to this original court document in 2000:

http://www.state.il.us/court/Opinions/AppellateCourt/2000/1stDistrict/July/HTML/1982670.htm


Quite a controversy when reading this document with a keen eye.

If there exists no following court documents - then this would have been the final ruling handed down in 2000.

Pooka1
12-06-2009, 04:15 PM
The bottom line is that pedicle screws are not fundamentally flawed and are arguably the most important breakthrough in being able to straighten and derotate spines back to a normal position while almost completely avoiding pesudoarthroses

whereas

Spinecor is looking to be fundamentally flawed as a treatment of AIS (so far) though not as a treatment for JIS or pain in adults (so far).

You are an example where it has helped your pain. We will see if it halts your progression (if you had any) after you come out of the brace.

mamamax
12-06-2009, 04:29 PM
Fundamentally - pedicle screws are class III devices - do you know the definition of that?

Anyway, my point is - controversy happens - everywhere.

Spinecor treatment is only looking to be flawed because you say it is - not necessarily because it is.

Any treatment today can only be defined as successful or unsuccessful over the course of the majority of the patient lifetimes involved ... we have a long way to go before establishing that.

In the meantime, of course, we are all entitled to our opinions - and our personal choices.

Pooka1
12-06-2009, 04:35 PM
[COLOR="Navy"]Fundamentally - pedicle screws are class III devices -

That's wrong. You read that in one of the old papers. Check its status now.

Pedicle screws work as advertised. Spinecor does not.

mamamax
12-06-2009, 04:43 PM
ok - I do see they have been upgraded to Class II .. that is good, they must have gone through changes to make them safer - very good news. Spinecor is Class I bty and does work for many.

A recall in 2008 I see .. controversy - everywhere!:eek:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=73336&CREATE_DT=2008-10-28

Pooka1
12-06-2009, 05:06 PM
FDA - Pedicle screws are safe and effective for scoliosis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=888.3070

Let's see if Spinecor can show the same eventually.

mamamax
12-06-2009, 05:22 PM
FDA - Pedicle screws are safe and effective for scoliosis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=888.3070

Let's see if Spinecor can show the same eventually.

In reading that FDA document: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=888.3070

It looks like they can be considered either Class II or Class III depending upon their use. For example: Class III when used in conjunction with fusion in the treatment of degenerative disc disease.


(b)Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

(2) Class III (premarket approval), when intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

Pooka1
12-06-2009, 05:28 PM
I said they have been found to be safe and effective for scolisois. They are Class II for scoliosis.

I don't know why you brought up pedicle screws on this thread about Spinecor. Apples and oranges in terms of proven safety and efficacy... pedicle srews have proven themselves for scoliosis.

That said, I predict Spinecor will be found safe and effective for pain in adults and possibly JIS but we will have to wait and see what the future holds.

mamamax
12-06-2009, 05:35 PM
I was simply discussing the document you brought up to illustrate safety - which in my case (degenerative disc disease) does change the ball game to Class III, it appears (from the FDA document you presented).

I brought pedicle screws up to illustrate that controversy exists everywhere (evidenced as recent as 2008 in a large recall). Your comments about Spinecor, and your personal, rather spirited, opinions remind me of that.

At the end of the day - treatment choice is a matter of personal choice, and if we let controversy become our guiding light - we would get nowhere.

Pooka1
12-06-2009, 05:37 PM
But pedicle screws are not controversial. Spinecor is. That's why it was a non sequitor in this thread.

And when did I ever say people can't choose their treatment?

Pooka1
12-06-2009, 05:47 PM
I was simply discussing the document you brought up to illustrate safety - which in my case (degenerative disc disease) does change the ball game to Class III, it appears.



No I don't think you can assume pedicle screws are necessarily class III for DDD when the cause of the DDD is scoliosis. I think it means they are class III for ONLY DDD.

And anyway, if pedicle screws are safe and effective for people with scoliosis plus DDD there there is no issue. You have to ask a reputable experienced surgeon.

mamamax
12-06-2009, 05:56 PM
But pedicle screws are not controversial. Spinecor is. That's why it was a non sequitor in this thread.

And when did I ever say people can't choose their treatment?

Well I define a recall of 6472 units for all systems in 2008 a little controversial (but that's just me) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=73336&CREATE_DT=2008-10-28

While you have never specifically said that people cannot chose their own treatment - your comments sometimes indicate that you find certain treatment choices (such as Spinecor), fodder for spirited debate which near borders on ridicule. I do understand you are just spirited ;-)

Pooka1
12-06-2009, 06:04 PM
Well I define a recall of 6472 units for all systems in 2008 a little controversial (but that's just me) http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/resCollection_2.cfm?ID=73336&CREATE_DT=2008-10-28


That is a recall of devices from one company out of how many companies? It is likely a fraction of all the screws being used at that time. For example my one kid who was fused before that recall didn't get that hardware. For all we know very few people got that hardware of the total.

Corvairs were "unsafe at any speed" but that doesn't mean cars are not a good product.

Pedicle screws are arguably the best breakthrough in spinal fusion in the last several years, even according to that Kiester surgeon guy some on this group seem to like. These screws are the reason my kid now has imperceptible rotation when before you couldn't miss it.

mamamax
12-06-2009, 06:23 PM
Yep - putting it into perspective, it is a (like I said) a rather small controversy.

You'll get no argument from me that instrumentation continues to improve - far superior to even 40 years ago, when I was twenty.

You said earlier that in your opinion, Spincor is controversial. I would say that controversy is - in the eye of the beholder.

mariaf
12-06-2009, 07:43 PM
The JIS crowd is relatively small (luckily!) but I hope they start doing studies on that and quit screwing around with AIS where nobody seems to believe their numbers and where we have seen a real life example of incorrect numbers from right on this group. Just like in this case, I suspect enough surgeons remeasured the Cobb angles from Montreal and formed an opinion about the quality of the data coming out of that group.

Well said, Sharon.

txmarinemom
12-06-2009, 09:53 PM
Yep - putting it into perspective, it is a (like I said) a rather small controversy.

You'll get no argument from me that instrumentation continues to improve - far superior to even 40 years ago, when I was twenty.

I'd just like to qualify that spinal hardware - and methods of instrumentation - have come leaps and bounds in *20* years (lights years from 40), and further every 5 years than bracing (success-wise) has come in its entire *existence*.

Surgery/instrumentation isn't limited to fusion as you know it.

In the last 5 years (longer for some, like Maria's David) VBS has shown REAL results ... results that have held ... are STILL holding. Titanium Rib has become a viable option for kids facing young fusion that allows "fusionless temporary fusion"; stabilization that allows full growth until the real deal.

As a child diagnosed with JIS, do I wish VBS had been around in 1979? You bet. I can't manage to work up the same longing for Spinecor in '79.

The braced child in me - and the fused adult - views Spinecor as just another brace, and I haven't seen proof otherwise.

And I'm still not convinced *any* of them work on many of us.

Pam

Pooka1
12-07-2009, 05:40 AM
And I'm still not convinced *any* of them work on many of us.


Neither are many orthopedic surgeons.

mamamax
12-07-2009, 05:42 AM
The braced child in me - and the fused adult - views Spinecor as just another brace, and I haven't seen proof otherwise.

And I'm still not convinced *any* of them work on many of us.

Pam

Regarding bracing (in general), right here in this forum we find many for whom bracing has worked - and many for whom bracing has not worked. The how and the why of that, yet to be established. Hopefully, the largest bracing study in history will help establish those facts (BrAIST). At this time, Spinecor is not included in the BrAIST study which is limited to TLSOs only. Still, this study does hold promise for understanding much more than we do now regarding bracing in general.

To be able to establish for whom bracing will work, and for whom it will not (without years of trial and error) would be a huge step forward - I don't know that the BrAIST study will be able to do that - but it could be a step in that direction.

One can only imagine what the next 40 years will bring towards advances in both surgical and non surgical treatments. Hope we are all here to see it - and hope I'll still be able to put together a coherent sentence to discuss it :-)

Pooka1
12-07-2009, 05:48 AM
Regarding bracing (in general), right here in this forum we find many for whom bracing has worked -

Nobody has shown this. And it certainly isn't "many."

mamamax
12-07-2009, 06:02 AM
Maybe I should develop a list Sharon :D

LindaRacine
12-07-2009, 09:46 PM
Maybe I should develop a list Sharon :D

Save your time. If someone wore a brace, and has not had to have surgery, there's no proof that the brace was the cause of that result. It's entirely possible that the person who was braced wouldn't have needed surgery in the first place, and there's also no guarantee that they won't need surgery in the future.

txmarinemom
12-07-2009, 10:22 PM
Nobody has shown this. And it certainly isn't "many."

No. It isn't many, and I'd LOVE to see the list - and who followed and verified every outcome.

txmarinemom
12-07-2009, 10:28 PM
Save your time. If someone wore a brace, and has not had to have surgery, there's no proof that the brace was the cause of that result. It's entirely possible that the person who was braced wouldn't have needed surgery in the first place, and there's also no guarantee that they won't need surgery in the future.

Exactly. I wore a brace (inconsistenly) and my curve barely moved. I finally had surgery for progression of pain; not curvature.

In your expert compilation of bracing stats, Mamamax, on which side of the fence would *I* fall? Would I have remained stable from 10 to 18 absent any brace since I only had bracing in sight of my parents?

Ballet Mom
12-08-2009, 03:10 AM
Damn, where to start.....?

txmarinemom,

Your post from the archives:


My old films are long gone, but I *think* my thoracic (structural) curve was about 35° when I was diagnosed. It's held steady at ±50° (staying within the ±5° variation for the Cobb) in adulthood.

http://www.scoliosis.org/forum/showthread.php?t=6437&highlight=diagnosed&page=4 Post #55
/
/


As a child diagnosed with JIS, do I wish VBS had been around in 1979? You bet.

Unfortunately, with a 35 degree thoracic curve at diagnosis, you wouldn't be eligible for VBS (except with growing rods).


Exactly. I wore a brace (inconsistenly) and my curve barely moved. I finally had surgery for progression of pain; not curvature.

You apparently were diagnosed at 35 degrees at almost eleven years of age. You didn't wear your brace and you must have progressed to just over 50 degrees as would be expected, and then held there until you chose surgery for pain relief.



In your expert compilation of bracing stats, Mamamax, on which side of the fence would *I* fall? Would I have remained stable from 10 to 18 absent any brace since I only had bracing in sight of my parents?

I would throw your data out due to bracing non-compliance. No doubt the studies are full of non-compliance failures such as yours, making the bracing data look worse than it is for those who actually are compliant.

Ballet Mom
12-08-2009, 03:24 AM
Originally Posted by txmarinemom
And I'm still not convinced *any* of them work on many of us.


Neither are many orthopedic surgeons.


Your references for this assertion?

Ballet Mom
12-08-2009, 03:45 AM
Save your time. If someone wore a brace, and has not had to have surgery, there's no proof that the brace was the cause of that result. It's entirely possible that the person who was braced wouldn't have needed surgery in the first place, and there's also no guarantee that they won't need surgery in the future.

I really don't believe that growing kids who are rapidly progressing suddenly just stop progressing, and therefore one can conclude that successful bracing wasn't due to the brace. Progression of the curve seems to me to be a function of growth. Unless they stop growing, the curve continues unless they have a brace that is able to stop it.

I have posted many studies on this forum showing that most of the people who have worn braces successfully don't progress past the initially diagnosed curve size. Over the years, they do revert back to the original curve size but they usually do not progress beyond it.

The studies also show that most people under 40-50 degrees do not continue to progress when they are adults. And most of these surgeons state that fact, and you certainly all believe what the surgeons state! Why not believe them in this?

I think it's a shame that you have these preformed opinions about bracing in your mind when you think you might be working on bracing studies. Perhaps you should exclude yourself from these pediatric bracing studies. It's called bias.

This forum really just needs to be true to itself and state that it is a surgical forum for scoliosis. Obviously in your minds bracing doesn't work and never will and everyone else should just move along.

Might I suggest http://www.scoliosis-support.org for parents bracing their kids and spinekids for kids being braced http://www.spinekids.com.

mamamax
12-08-2009, 05:36 AM
Save your time. If someone wore a brace, and has not had to have surgery, there's no proof that the brace was the cause of that result. It's entirely possible that the person who was braced wouldn't have needed surgery in the first place, and there's also no guarantee that they won't need surgery in the future.

I don't think we have any hard proof of that statement, outside of personal opinion. If I were to make a list - I would probably begin with Joe O'Brien's family.

http://www.scoliosis.org/forum/showthread.php?t=8765

txmarinemom
12-08-2009, 01:29 PM
I'm not entirely sure what you were trying to convey in your post, Ballet Mom, but there are some clarifications to make ...


Unfortunately, with a 35 degree thoracic curve at diagnosis, you wouldn't be eligible for VBS (except with growing rods).

It may surprise you to know I'm extremely familiar with current (and past) criteria for VBS.

You clipped my words from a Nov 2007 post, and at that time they were absolutely stapling 35° curves. Betz's group didn't publish the revised VBS corrolaries that specified the addition of the hybrid rod until March 2008.

My curve at surgery was ±50. It measured 48-53° well into adulthood. If it was actually ±35° at age 10 (I did say "I think" in my post ... it could have been higher: I never recall a lower number), it really could have been as high as 40° with the margin of error.

At the closest end, we're talking 8° movement with non-compliant bracing, and even if it moved 15° out of brace, it's tough to argue the brace was doing much for me. Let's say I'd been compliant: Correction wouldn't have been expected as Bostons do not correct. At best, they may hold some curves.


I would throw your data out due to bracing non-compliance. No doubt the studies are full of non-compliance failures such as yours, making the bracing data look worse than it is for those who actually are compliant.

FYI - I was largely compliant for the first year I had my brace - and my curve still moved.

That said, I'd probably throw my data out of a bracing study too, but I'm curious: What categorizes me as a non-compliance failure to you? I moved less in non-compliance than compliant patients often do.


You didn't wear your brace and you must have progressed to just over 50 degrees as would be expected, and then held there until you chose surgery for pain relief.

The statement "... you must have progressed to just over 50 degrees as would be expected, and then held there until you chose surgery ..." is inherently flawed by the fact 50° curves aren't expected to stop.

As I've said before, some curves will move regardless of treatment - and some will stabilize no matter what. It's fairly obvious mine falls in the latter category.

I'm sorry you feel there's so much anti-bracing angst here. Until I see some convincing data on bracing (and as Linda pointed out, there are near insurmountable - in my opinion - unknowns and variables) that proves otherwise, I just don't have much faith in it. When it comes to AIS, that faith drops to almost nil.

That said, I really do hope it works for you. The two sentiments aren't mutally exclusive.

Best regards,
Pam

mariaf
12-08-2009, 02:41 PM
Damn, where to start.....?

txmarinemom,

Your post from the archives:


/
/



Unfortunately, with a 35 degree thoracic curve at diagnosis, you wouldn't be eligible for VBS (except with growing rods).



Just to clarify, a child with a 35 degree curve is not automatically disqualified as being a candidate for VBS alone. Since 35 degrees is the cutoff, it could go either way. My educated guess is that they would look at curve flexibility, amount of growth remaining, and possibly other factors - and then decide.

Even now, with the revised criteria, some kids at 35 have been candidates for VBS - and others have not. So to say that Pam would not have been a candidate at 35 degrees is not necessarily true.

Ballet Mom
12-08-2009, 04:36 PM
I'm not entirely sure what you were trying to convey in your post, Ballet Mom, but there are some clarifications to make ...

It may surprise you to know I'm extremely familiar with current (and past) criteria for VBS.

It doesn't surprise me at all.


You clipped my words from a Nov 2007 post, and at that time they were absolutely stapling 35° curves. Betz's group didn't publish the revised VBS corrolaries that specified the addition of the hybrid rod until March 2008.

Do you recognize this? It's from post #51 just several posts above this one. It is not clipped from a 2007 post. They haven't been stapling 35 degree thoracic curves for at least a year and a half or more.


As a child diagnosed with JIS, do I wish VBS had been around in 1979? You bet. I can't manage to work up the same longing for Spinecor in '79.

The braced child in me - and the fused adult - views Spinecor as just another brace, and I haven't seen proof otherwise.

And I'm still not convinced *any* of them work on many of us.

Pam
/
/


That said, I'd probably throw my data out of a bracing study too, but I'm curious: What categorizes me as a non-compliance failure to you? I moved less in non-compliance than compliant patients often do.

You didn't wear your brace as directed. Fortunately, they now have sensors to use to determine that.

You progressed from roughly 35 degrees to roughly 50 degrees (even though it was made to sound that your curve didn't move while being non-compliant in your first post). That fails in both the amount of progression and also reaching surgical territory. Two different methods of determining failures.

I believe if someone was wearing a brace compliantly and they had the amount of progression you did, it would be considered a brace failure and should be included in a study.


The statement "... you must have progressed to just over 50 degrees as would be expected, and then held there until you chose surgery ..." is inherently flawed by the fact 50° curves aren't expected to stop.

It's not inherently flawed, I'm simply stating that if you don't wear your brace as prescribed when you have a progressive curve, you must expect that you will progress.

A +/- 50 degree curves is within the 40 to 50 degree range of curves that is stated as not necessarily progressing. I think you have to be cautious when you are on the borderline of study results.


I'm sorry you feel there's so much anti-bracing angst here.

It is not just my feeling that there is so much anti-bracing angst here. It is quite obviously here to any unbiased observer. I wonder why the three of you want so badly to convince parents and kids coming on this forum that all hope is lost with bracing and you might as well just give up. Think about how many people you have negatively influenced. But, you are the ones that have to live with that on your consciences.


Until I see some convincing data on bracing (and as Linda pointed out, there are near insurmountable - in my opinion - unknowns and variables) that proves otherwise, I just don't have much faith in it. When it comes to AIS, that faith drops to almost nil.

That is your opinion, which is a very small sample size by the way.

And since when is science so small that they aren't able to figure out these unknowns and variables at least for AIS? It seems to me that most of the major ones could be figured out fairly easily. That said, there are always outliers, of course.

I wish everyone on the board the best also, both bracing and surgical.

Ballet Mom
12-08-2009, 04:40 PM
Just to clarify, a child with a 35 degree curve is not automatically disqualified as being a candidate for VBS alone. Since 35 degrees is the cutoff, it could go either way. My educated guess is that they would look at curve flexibility, amount of growth remaining, and possibly other factors - and then decide.

Even now, with the revised criteria, some kids at 35 have been candidates for VBS - and others have not. So to say that Pam would not have been a candidate at 35 degrees is not necessarily true.


Once again, it's thoracic curves that are cut off at this point. They got better results with lumbar curves, just like bracing gets better results with lumbar curves.

Pooka1
12-08-2009, 04:58 PM
Pam will correct me if I'm wrong but Pam's curve got to about 50* when she was a teenager and then didn't advance for about two decades (until she was fused for pain).

If that is correct, if even a 50* curve can be stable and not increase the expected 1* per year for about two decades then any curve less than that can easily stop on its own and stay stable. This is will always be the Achilles heel in uncontrolled bracing studies and even in individual patients if you can eventually show say 15% or whatever are held by brace who would have otherwise progressed.

But I am with Pam on her point about this possibly being an intractable subject to study. Some conditions are so variable that it is virtually impossible to predict with any certainly what a given patient's curve will do including a teenager with a 50* curve that was stable for about two decades and might have been stable forever absent her fusion for pain.

Perhaps I'm missing something?

txmarinemom
12-08-2009, 05:40 PM
Perhaps I'm missing something?

You're not missing anything on my end, Sharon.

Ballet Mom, I'm still confused: You clipped that post from NOV 2007, as far as I can tell. They WERE (and are, in some cases *still*) stapling 35° curves.

What exactly is your point?

Pooka1
12-08-2009, 05:48 PM
Okay I'm glad I got that right.

So furthermore, if Pam got to at least 35*-40* at 10 years old then was largely compliant from 10 to 11 years old and then not compliant, that means she was likely NOT wearing the brace as directly during her growth spurt. She reached 50* probably at the end of her growth spurt and then stayed there for about 20 years.

That is NOT what is thought to be likely. That is, if she got from 35/40* to ~ 50* in say a year, that is NOT the kind of trajectory that is then expected to stop in its tracks and be completely stable for two decades. And if that can happen without a brace then anything can happen without a brace. That is the problem.

LindaRacine
12-08-2009, 08:21 PM
I really don't believe that growing kids who are rapidly progressing suddenly just stop progressing, and therefore one can conclude that successful bracing wasn't due to the brace. Progression of the curve seems to me to be a function of growth. Unless they stop growing, the curve continues unless they have a brace that is able to stop it.

I have posted many studies on this forum showing that most of the people who have worn braces successfully don't progress past the initially diagnosed curve size. Over the years, they do revert back to the original curve size but they usually do not progress beyond it.

The studies also show that most people under 40-50 degrees do not continue to progress when they are adults. And most of these surgeons state that fact, and you certainly all believe what the surgeons state! Why not believe them in this?

I think it's a shame that you have these preformed opinions about bracing in your mind when you think you might be working on bracing studies. Perhaps you should exclude yourself from these pediatric bracing studies. It's called bias.

This forum really just needs to be true to itself and state that it is a surgical forum for scoliosis. Obviously in your minds bracing doesn't work and never will and everyone else should just move along.

Might I suggest http://www.scoliosis-support.org for parents bracing their kids and spinekids for kids being braced http://www.spinekids.com.
Just because you believe something doesn't make it so. I suspect that you are the one with bias. Many professionals now agree that prior bracing studies are all flawed.

Despite the fact that I now have come to understand that the studies are flawed, I would personally encourage my kid to try brace treatment if they fell within treatment protocol. Just because there is no proof that something works doesn't mean that it absolutely doesn't work.

Before you continue to try to trash my reputation, you might want to do a little more investigation of my beliefs.

txmarinemom
12-08-2009, 08:40 PM
Many professionals now agree that prior bracing studies are all flawed.

It would be wonderful to see some definitive answers come from Braist, but no one ever seems to be mention the unbiased goal of the study: It's every bit as dedicated to showing bracing isn't effective.

The quest is (again, that pesky word) evidence.

mariaf
12-08-2009, 08:50 PM
Once again, it's thoracic curves that are cut off at this point. They got better results with lumbar curves, just like bracing gets better results with lumbar curves.

Once again, it is NOT necessarily the case that a thoracic curve of 35 degrees would not qualify for VBS alone - it is right at the cutoff and could go either way.