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Sealy
22nd December 2008, 03:44 PM
Hey All,

I wrote a letter to dr. Weinstein regarding the BRAIST study which I’ve attached below. There is another study going on in the Netherlands similar to the Weinstein study but the inclusion criteria is different and deals with curves ranging from 20 – 29 degrees and if there is progression of 10 degrees or more doctors will offer the patients a brace and not allow the curve to progress further unlike the Weinstein study which includes curves ranging from 25 - 40 degrees and will allow curves in the uncontrolled group to progress to 50 degrees, at which point surgery will be offered to the patient. The conclusions in the Dutch study are interesting and I thought to share. So much for early screening efforts!

The results of this study will also be valuable for the
screening program for scoliosis. Screening aims at detecting
scoliosis in an early stage of the clinical course to allow
brace treatment to try and prevent further progression of
the curvature and reducing the need for surgery [11].
Recently, we performed a case control study on the effectiveness
of screening for scoliosis. In that study, the case
group consisted of surgically treated IS patients (the condition
screening and early treatment should prevent) and
the control group consisted of a random sample of Dutch
youth. We found no evidence that cases were significantly
less screened than controls [18]. If we had found a positive
effect of screening, that would have implied that bracing
is effective. A RCT on the effectiveness of bracing now
seems even more justified. If bracing shows to be effective,
the screening program needs to be revised. If bracing
doesn't prove to be effective, a screening program is not
applicable, since the availability of an effective early treatment
is one condition for a screening program to be justified
[19].

http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=18430217

Here is the letter I sent to Dr. Weinstein.

Dear Dr. Weinstein,

There is currently a study being conducted by doctors across North America to determine if bracing really is necessary. The study I'm referring to is the Braist Study. Perhaps the need for a "proper" study which includes a randomized control group outweighs the consequences to patients who are randomly selected to be the non brace group and would benefit from early treatment. I have to question what difference it makes to these researchers? Is it not the right of the parents to choose the treatment for their children? The criteria for bracing failure is well known and emphasizes the importance of early treatment. The protocol of "watch and wait" negates this. Upon review of the eligibility criteria for the Braist Study it is evident that this "study" is flawed! It is a well known fact that children with curves above 30 degrees entering the adolescent growth spurt will progress to surgery regardless of which brace they use. The conclusions to this study are self evident. It wouldn’t surprise me in the least if bracing for AIS is completely eliminated and the way paved for early treatment (yes I'm talking 15 and 20 degrees!!!!) with vertebral stapling and other experimental surgical procedures. Who benefits? The children or the doctors? It's a brave new world!

Eligibility
Ages Eligible for Study:
10 Years to 15 Years
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:
·Diagnosis of AIS
·Skeletally immature (Risser grade 0, 1, or 2)
·Pre-menarchal or post-menarchal by no more than 1 year
·Primary Cobb angle between 25 and 40 degrees
·Curve apex caudal to T7 vertebrae
·Physical and mental ability to adhere to bracing protocol
·Ability to read and understand English, Spanish, or French
·Documented insurance coverage and/or personal willingness to pay for treatment
Exclusion Criteria:
·Diagnosis of other musculoskeletal or developmental illness that might be responsible for the spinal curvature
·History of previous surgical or orthotic treatment for AIS

jifi
23rd December 2008, 01:58 AM
Hi there,
I'm realy sorry, but I perfer saying straight away: it makes me feel more than dissy to read this as there seem to be many unlogical conclusions, actually I am shocked!
First of all, reading the study (from the link), all used braces are Boston's. Imho there are more effective braces this, so a study with the Boston brace says just something about the effectiveness of a Boston brace. Recently I was reading this http://www.skoliose-info-forum.de/viewtopic.php?t=9011 (and I hope it makes you happy to read this too - dont wory it's in English as a member from this forum was starting the discussion :D ) Very intresting to me is the part where it's sayed that the effective Braces have an initial correction about 50% of the actual degrees (x-rayed when wearing the brace). How much does a Boston brace correct?
And it makes me said to read 'It is a well known fact that children with curves above 30 degrees entering the adolescent growth spurt will progress to surgery regardless of which brace they use.' no matter how well it is meant (Yes, Sealy I agree with you - it's a bave new world). But sorry, I think those facts are just widely believed, told and teached. They are not nessesarily true. I am just saying nessesarlity because it depends also on a lot of other factors than just those 3O degrees.
Another sentence that made me very sceptical if those doctors know what they re talking about in the study (see Control group): 'The patients in the control group are allowed to attend physical therapy if they want to, because physical therapy alone will not prevent further progression of the curvature.'So - how much and what kind of physical therapy was involved in this study? Surly not Schroth or anything based on three dimensional correction. When will it become widely known how to treat scoliosis sufficiently (with both: Braces & Exercises) to avoid most of the surgeries?!

Sealy
23rd December 2008, 05:52 AM
I don't know which braces are included in either study. I would imagine that Cheneau braces are widely available in Europe and therefore the Cheneau brace would be part of the Dutch study? I can't say. It is common knowledge that curve magnitude and likelihood of progression during the adolescent growth spurt are closely related. I hope the following abstracts are not too technical. The first abstract is for Adolescent Idiopathic Scoliosis and the second abstract is for Juvenile Idiopathic Scoliosis. The protocol by doctors of "watch and wait" until curves progress to the upper limits of the *acceptable* range is a farce! Was there *ever* early treatment with bracing in North America???? NEVER!

Peak Height Velocity as a Predictor of Curve Progression in Idiopathic Scoliosis

Dane Glueck
Shriners Hospital
Vishwas Talwalkar, M.D.
Shriners Hospital
Abstract from the SRS 2005 Annual Meeting


Summary: Peak height velocity (PHV) has been shown to be a significant predictor of scoliosis curve progression. A retrospective review identified 55 adolescent females with idiopathic scoliosis and curves between 20 and 45º. We found that 30º of curvature at PHV is a significant predictive indicator for curve progression to a surgical magnitude. Menarche and Risser grade lag behind PHV. PHV is a more accurate predictor of time of maximal curve progression than the other variables.

Introduction: Peak height velocity (PHV) is a significant predictor of scoliosis curve progression. This study hypothesizes: 1) PHV accurately predicts the timing of maximal curve progression 2) curves greater than 30º at PHV progress to surgical indications.

Methods: A retrospective review identified 55 adolescent females with idiopathic scoliosis and curves between 20 and 45º. Data included: age, height, menarche, Risser grade, and Cobb angle. Progression to surgical magnitude was defined as progression of 10° to 45º. Regression analysis, F-test for variance, and t-test were used for analysis.

Results: Fifty-five patients were followed for a minimum of 2.5 years with an average follow-up of 4.8 years. Fifty curves progressed. Mean PHV was 8.9 cm/yr. Cessation of growth occurred an average of 2.4 years after PHV. Menarche and Risser 1 lagged behind PHV by 4 and 11 months respectively. Maximal curve progression was assessed in relationship to PHV, Risser grade, and menarche in 33 of the 55 patients. PHV grouped patients better for maximal curve progression than either menarche or Risser. 49% (16/33) underwent maximal progression while still at Risser 0, and 15% while at Risser 4. 25 of 28 (89%) patients with curves greater than 30º at PHV progressed to surgical indications. 3 of 22 (14%) that were less than 30º at PHV progressed to surgical indications (p <.0001; sensitivity 89%; specificity 86%; accuracy 88%). 30º curvature before menarche was a sensitive (100%), but less specific (41%), and less accurate (74%) predictor of progression to 45º.

Discussion: 30º of curvature at PHV is a significant predictive indicator for curve progression to a surgical magnitude. Menarche and Risser grade lag behind PHV. PHV is a more accurate predictor of time of maximal curve progression than the other variables.

Last Updated: 03/22/2006




Progression Risk of Idiopathic Juvenile Scoliosis During Pubertal Growth.

Spine. 31(17):1933-1942, August 1, 2006.
Charles, Yann Philippe MD *; Daures, Jean-Pierre PhD +; de Rosa, Vincenzo MD *; Dimeglio, Alain MD *
Abstract:

Study Design. A retrospective study investigated the progression risk of juvenile scoliosis until skeletal maturity or spinal fusion.

Objectives. To define risk factors of curve progression during pubertal growth and analyze the timing of arthrodesis.

Summary of Background Data. Juvenile scoliosis is characterized by a major, extremely variable progression risk. Peak growth velocity is the most critical period. Curve progression related to growth needs to be analyzed critically for an adequate treatment.

Methods. A total of 205 patients, including 163 girls and 42 boys, with juvenile scoliosis were reviewed at skeletal maturity. The scoliosis was divided into juvenile I with an onset of 4-7 years (52 patients) and juvenile II with an onset of 8-10 years (153). Standing and sitting height, weight, Tanner signs, skeletal age, and menarche were regularly assessed. Topographies and Cobb angles of primary and secondary curves were referred to the pubertal growth diagram.

Results. Of 205 patients, 99 (48.3%) were operated on. Of 109 curves <=20[degrees] at onset of puberty, 15.6% progressed >45[degrees] and were fused. Of 56 curves of 21[degrees] to 30[degrees], the surgical rate increased to 75.0%. It was 100% for curves >30[degrees]. Curves >20[degrees], which increased and were operated on, progressed significantly during peak growth velocity (P = 0.0014). Curves that progressed by 6[degrees] to 10[degrees]/y were fused in 70.9%, curves which increased >10[degrees]/y in 100% of cases (P = 0.0001). This risk was highest for primary thoracic curves: King V, III, and II (P = 0.0001). There was no difference between males and females or juvenile I and II.

Conclusions. Curve pattern, Cobb angle at onset of puberty, and curve progression velocity are strong predictive factors of curve progression. Juvenile scoliosis >30[degrees] increases rapidly and presents a 100% prognosis for surgery (curve >40[degrees] to 45[degrees]). Anticipation is necessary if the scoliosis progresses during the first year of puberty. The prediction is difficult for curves of 21[degrees] to 30[degrees] during the first 2 years of puberty. Curve pattern and curve progression velocity are useful to detect which curves are likely to progress. From this retrospective analysis, spinal fusion could have been indicated earlier sometimes. An earlier intervention is probably preferable to obtain better curve reduction on a supple spine, even if a perivertebral fusion is necessary. We use the 3 parameters for operative indications. If an early spinal fusion leads to better curve correction needs to be verified on prospective data.

(C) 2006 Lippincott Williams & Wilkins, Inc.

jifi
24th December 2008, 12:23 AM
Hi Saely,

Now I have doubts that I could have got you wrong; I understood that you wanted to say that the BRAIST study is not valid as it containes too many mistakes and that the last sentences in your letter to Dr. Weinstein express that you are against too early surgeries? Right? (Sorry, English isn't my native tounge and sometimes this leads to silly worries about misunderstanding.)

Yes, I agree with you; an untreated scoliosis above 30° at PHV will progress for sure. If you read through the link I posted you will find out why I wrote that I don't agree and that a well braced (50% correction) and well treated scoliosis above 30° won't progress to surgery. I intended to share this information as it might not be found easily when searching in English...
Yes, of course it is better to start treatment earlier, but I wont say that it is too late after reaching 30° and still growing.

About the Braces used in the linked study:
If you read the article 'Intervention group' in the 'Methods' section you 'll find out that 'Boston braces will be used for all patients; this brace is used the most in the Netherlands.'
Cheneau braces are not so widely availible in Europe, the treatment here really depends on the country you're living in and unfortunatly even on the level of information of your doctor - e.g. after I was screened in a German primary school I visited an othopaedist that should decide the further treatment of my scoliosis. He didn't even x-ray me and told my parents that everything was o.k. I was starting treatment - brace and physical exercises - with 14 and far above 30°...I do not know how far my scoliosis progressed but in North America I would have been surely a candidate for surgery... I won't consider surgery for me and I think I don't need it as I don't suffer any pain and have relatively little humps... but that's another story.

'Seasonal Greetings' from Europe...;)

tonibunny
24th December 2008, 01:18 AM
Hi Jifi,

At what age were you diagnosed? It says in your profile that you had Infantile Idiopathic Scoliosis - is that correct?

Merry Christmas to you too :)

Toni xx

jifi
25th December 2008, 08:55 PM
Hi Toni
You got me, it is not correct = actually I was filling out that profile a bit lighthearted and I didn t check to what ages those groups are corresponding.
I was diagnosed when I was in primary school, guess I was 6 or 7 years old. But as I said there was no treatment or x-ray until I was 14 (56T, 45L found back some old documents). So I changed to JIS in my profile, or should I better say AIS?
Thanks,
j

tonibunny
25th December 2008, 09:42 PM
Hi Jifi,

If you were diagnosed at 6 then that would be considered Juvenile Idiopathic Scoliosis (if there are no vertebral anomalies, of course - then it would be considered Congenital). You did really well to get to adolescence from that age without the curves deteriorating badly! :)

Hope you're having a good Christmas Day :D

Toni xx

Sealy
29th December 2008, 03:58 PM
I just hope that the "Great Minds in Orthopaedics" don't eliminate bracing before my daughter finishes growing because we've done very well by it! It worries me that in Canada, Ste. Justine Hospital is the only provider for the Spinecor brace. If not for serial casting and bracing with the Spinecor my daughter would have either had spinal fusion before the age of five to correct a 60 degree curvature or would currently be undergoing growth rod surgeries every six months at a great expense to the health care system! My daughter's scoliosis is virtually non existent with the Spinecor brace! Keep in mind that serial casting and the Spinecor are two options which the *majority* of orthopaedic surgeons don't practice or believe in! What do they believe? Surgery? If so, they have failed miserably! BRACING WORKS! No one can convince me otherwise. People often talk about the psychological trauma of wearing a brace, what about the psychological trauma of undergoing surgery every six months!!!!! Deirdre is not suffering psychological trauma, I can assure you of that. It doesn't take an Einstein to see which is the better solution. :D I'll fight tooth and nail before giving up my daughter as a surgical experiment.

Sealy
29th December 2008, 08:35 PM
Oh, and I hope everyone had a lovely Christmas.:xdeer: :D

kiri15
5th January 2009, 01:56 PM
I just hope that the "Great Minds in Orthopaedics" don't eliminate bracing before my daughter finishes growing because we've done very well by it! It worries me that in Canada, Ste. Justine Hospital is the only provider for the Spinecor brace. If not for serial casting and bracing with the Spinecor my daughter would have either had spinal fusion before the age of five to correct a 60 degree curvature or would currently be undergoing growth rod surgeries every six months at a great expense to the health care system! My daughter's scoliosis is virtually non existent with the Spinecor brace! Keep in mind that serial casting and the Spinecor are two options which the *majority* of orthopaedic surgeons don't practice or believe in! What do they believe? Surgery? If so, they have failed miserably! BRACING WORKS! No one can convince me otherwise. People often talk about the psychological trauma of wearing a brace, what about the psychological trauma of undergoing surgery every six months!!!!! Deirdre is not suffering psychological trauma, I can assure you of that. It doesn't take an Einstein to see which is the better solution. :D I'll fight tooth and nail before giving up my daughter as a surgical experiment.

Hi there
I am kiris mum. I so agree with what you have said here. Kiri my daughter (age 16) wears a brace and her back has improved from 48 degrees to 43. Also my son alex had scoliosis from 2years old and wore a brace till he was 10, he now doesnt have scoliosis but a tilt! Under 10 degrees! I have alot of faith in the brace. Kiri was due to have surgery last summer but kiri and I asked if she could possibly try a brace, each time we have been back to the consultant he has been very surprised by the outcome and is now putting the surgery on hold. Kiri does exercise regularly and does yoga which helps. Kiris next appointment is in Feb. The Spinecor sounds brilliant. Keep it up.
Best wishes
Jan (Kiri's Mum)

Sealy
5th January 2009, 08:24 PM
Hi Jan,

I'm so glad you posted! I'm encouraged by your success. Sometimes I feel so alone and surely I'm doing the right thing by taking the nonoperative approach. Fighting scoliosis is bad enough without the added burden and frustration of justifying our chosen path to orthopaedic doctors who could care less! I know many parents whose children have juvenile idiopathic scoliosis and are/were doing brilliantly with bracing and as soon as the curve is reduced to single digit levels, orthopaedic doctors encourage these parents to remove all back support and their children's curve progresses. Often, by the time its caught, it's too late and surgery is the only option. This happens too frequently for my comfort level. It's reckless for doctors to be so cavalier about this condition considering they don't know what causes it in the first place! We do know that growth is a very big risk factor and children who have not started the growth spurt are at high risk! My daughter will continue wearing her Spinecor until she finishes growing. There are no second chances when it comes to scoliosis and I don't intend to play Russian Roulette with her life.

BrAIST24
9th February 2009, 11:27 PM
Hi everyone, I'm Lori Dolan and I'm the Trial Director for BrAIST.

I've been reading these posts with interest, and I've seen the emails you've sent Dr. Weinstein, Sealy.

We are sorry there's so much misinformation out there about this study.

Our primary aim is to see if bracing significantly decreases the risk of curve progression in kids with AIS compared to observation. Some may view observation as unethical - however, observation is essentially what happens when kids don't wear their braces. And maybe they don't wear their braces because we can't give them accurate estimates of their risk for progression.

Wouldn't it be great if you could come in, have an xray taken, and then the doctor could say, based on credible research, your daughter has a 28% risk of her curve progressing to 50 degrees if she wears her brace, but a 40% risk if she doesn't. You could then decide whether or not bracing was the best treatment for you.

We are not trying to prove braces don't work. I'm not a surgeon and I have no interest in promoting surgery or stapling or anything else. I'm a researcher and what I care about is giving families good, solid information concerning risks and benefits of treatments so they can up their own minds.

If this study finds in favor of bracing, then we'll push to increase screening and education about early detection. If it doesn't, then governments can use screening money to work on other problems, like teenage mental health, learning problems, obesity, etc.

I would be happy to respond to any questions about this study - please feel free to contact me thru this forum or via my email - lori-dolan@uiowa.edu

thanks and take care

Lori Dolan

Sealy
10th February 2009, 05:01 AM
Hi Lori,

Thanks for writing in. Maybe you could clear up a few points for me:

If a child with AIS can only hope to maintain curvatures at prebrace levels with conventional bracing, why are parents still advised to wait for curves to progress at all? Why not treat immediately when its assessed to be progressive?

Studies have shown that curves 30 degrees or more have a 100% chance of progressing to surgical levels in AIS. This finding was presented at the 2005 SRS Meeting. Any rational thinking person would say: Hey, maybe we should revise our criteria for bracing from 25 - 40 degrees and treat curves in a lower range rather than conducting The Braist Study two years later (2007) to assess whether bracing is effective in the 25 – 40 degree range knowing perfectly well from the 2005 meeting that curves in the 30 - 40 degree range will fail!


As with any medical condition, in order for early screening to be effective it has to be followed by prompt early treatment and not when the condition is in the advanced stages. The BRAIST study will effectively kill early screening. There are many studies pointing to the benefits of early treatment. You might be interested in reading a recent study conducted in Germany which showed that bracing curves in the early stages was a success!

1: Orthopade. (http://javascript<b></b>:AL_get(this, 'jour', 'Orthopade.');) 2009 Feb 5. [Epub ahead of print]http://www.ncbi.nlm.nih.gov/corehtml/query/egifs/http:--production.springer.de-OnlineResources-Logos-springerlink.gif (http://www.ncbi.nlm.nih.gov/entrez/utils/fref.fcgi?PrId=3055&itool=AbstractPlus-def&uid=19190891&db=pubmed&url=http://dx.doi.org/10.1007/s00132-008-1381-7) Links (http://javascript<b></b>:PopUpMenu2_Set(Menu19190891);)

[Is night-time bracing still appropriate in the treatment of idiopathic scoliosis?]

[Article in German]


Seifert J (http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Seifert%20J%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus), Selle A (http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Selle%20A%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsP anel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus).
Wirbelsäulenbereich, Klinik für Orthopädie, Universitätsklinikum Carl Gustav Carus der TU Dresden, Fetscherstrasse 74, 01307, Dresden, Deutschland, Jens.Seifert@Uniklinikum-Dresden.de (Jens.Seifert@Uniklinikum-Dresden.de).

BACKGROUND: The aim of our investigation was to evaluate the effectiveness of isolated night-time treatment in idiopathic scoliosis. METHODS: Twenty-two children (average age 11.9 years; range 5-12 years) underwent treatment with the"Dresdner night-time brace." We indicated brace treatment in all children with a Cobb angle of 20-25 degrees and also in those with an angle of 15-19 degrees in cases of progression. Over a follow-up period of 25 months, clinical and radiological observations were made. RESULTS: A primary correction of 82.2% was obtained. The mean Cobb angle in an upright position without orthosis before treatment was 20.2 degrees . At the end of treatment, this angle reached 15.8 degrees . Operations were able to be avoided completely. In only three cases with radiographic progression (development of angles >25 degrees ), part-time bracing had to be stopped and changed to full-time bracing. We observed an overall success rate of 86.4% (patients with improved Cobb angles or halted progression). CONCLUSION: We were able to show a positive effect of part-time bracing in selected patients with mild scoliosis and a higher risk of progression. The negative medical and psychosocial consequences of 23-h brace treatment can therefore be avoided in certain patients.

Unregistered
10th February 2009, 04:04 PM
Hi Sealy

This is Christine from NSF. I am having a hard time getting registered here. This forum looks good and would like to become an active user, I will keep trying to get in.

About early screening and treatment (Sealy knows our history) My daughters pediatriction found a curve in my daughter during a routine wellness appt. She was diognosed a 6 yrs old with a 30 degree curve. I was told that surgery would be inevitable. The bracing would not be a good option for her due to lenghth of time in brace and muscle atrophy. We found the Spinecor on a another forum and persued it. We travel to Canada 7 hours away to see Dr Rivard and Colliard at St Justines. My daughters curve is at 1 degree 2 yrs later. The brace is super easy for her to wear and there is absolutley no effect on her quality of life.

Had the curve not been found early or we waited and watched this special little girl would have had to have surgery. Now I know we are not out of the woods yet but we are giving it our all.

The moral of my story is EARLY SCREENING AND TREATMENT is imperative to help these kids

BrAIST24
10th February 2009, 10:02 PM
Hi Sealy -

There are many small curves out there that do not progress at all. That's why many clinicians wait until 25 degrees or before that if they've documented 5 degrees of progression. We've seen many curves in this range spontaneously improve. Therefore, I think some caution is appropriate to avoid unneccesary treatment. By the way, the current inclusion criteria for BrAIST is 20-40 degrees. This change was just approved last month by our oversight board.

There are many studies out there concerning curve progression and the use of braces. Unfortunately, many of them are seriously flawed from a scientific point of view. Perhaps you remember when tonsillectomies were routine practice, or tubes in ears, or antibiotics for every cold symptom? These were all practices that were thought to be effective but turned out to be based on tradition and poor research. Another example is the use of hormone replacement therapy after menopause. We all thought it was a good option for many women until good, controlled research came out.

I would say that it's a good guess that many curves in the 30-40 degree range in growing kids will continue to progress to surgical range. However, the question is "does bracing decrease this risk substantially?"

We can't say at this point that BrAIST will kill early screening. It all depends on the outcome, not only of BrAIST, but on all other studies and cost data to date. No one should be basing policy on the results of one research study. The US Preventive Services Task Force (without the influence of orthopaedic surgeons) stated in 2004 “. . . there is inadequate evidence to determine whether brace therapy limits the natural progression of the disease in a significant proportion of cases, as most studies suffer from selection bias, lack of internal control groups, inadequate follow-up, small sample sizes and lack of health outcome measures.”

So you could say that BrAIST actually provides hope that screening will continue because it will provide additional evidence about the ability of early treatment to alter natural history. This study will be especially credible (if we continue to follow the protocol correctly) since it will not suffer from the limitations noted above.

I have read a lot of the literature coming out of Europe concerning physical therapy and bracing. I commend the dedication of these clinicians to conservative treatment and I look forward to reading results of large-scale controlled trials from their institutions. We need as many people as possible working on this question in order to build a solid body of evidence.

Have a good day,

Lori

titch
11th February 2009, 12:28 AM
Thank you so much for signing up and giving us more information on this Lori :)

I personally suspect that it isn't just down to what size of curve, and what age / stage of development it becomes apparent at, but also what form of curve it is. I know that studies have shown (and admittedly I don't know if or in what ways they were flawed) in the past that your typical tlso is less effective on higher thoracic curves, and may be ineffective altogether on particularly high ones whereas a milwaukee brace may work.

I suspect also that a lot comes down to the orthotist and the specifics of the brace. It's purely anecdotal but it seems that children who have serial casting often have signifcantly more reduction with casts by one person than they do with ones by another. I think the Cheneau brace may be becoming more widely available now, but until recently as far as I know it was only available in one place, made by one orthotist. I have the sense that it is an art as much as a science, and that when studies either support or fail to support the use of braces, it could be down to the skill (or perhaps more accurately the training, because I would not want to call into question the skills of orthotists as a whole, I'm sure that they're all trying their best to help) of the orthotics department, and the orthoses they are allowed to use.

While it was a very different thing, as it was post-operative, the brace which I had was plain useless. I don't even know how they sized me for it - I asked when the guy came along with it and was told I'd have been measured on the table for waist size. Initially it didn't fit because my stomach was so distended due to swelling from the anterior, and then it didn't fit after it went down because my waist was a full 14 inches smaller than my bust and 13 smaller than my hips, and the brace, being an off the shelf job that was merely cut to length and to fit under my bust, was for a roughly 6 inch difference. My understanding, which again may be flawed, is that at least some centres routinely used off the shelf TLSOs, with at best some custom padding. It would seem likely to me that if this is the case, they would have a poor compliance rate and a poor success rate even amongst the compliant!

In any case, more information can only be a good thing - my worry lies mostly in the fact that bracing is a dark art, and even if it proves to work for enough people to make continued investment worthwhile, will it be possible to understand why it has worked in those cases and not others? Having said all that, I do understand that it is tremendously difficult to try to control for everything.

Can I ask how children are assigned in terms of either bracing or non-bracing?

And again, :welcome2: and thank you for your time here :)

Unregistered
11th February 2009, 12:28 AM
Hi Lori

Out of curiousity which types of braces are in your study? Are you studying the TSLO or Spinecor?
Thank you so much for joining in this conversation.

Sealy
11th February 2009, 04:38 AM
I'm almost certain that the study by dr. Vishwas dealt with braced children. I still remember the presentation.





There are many small curves out there that do not progress at all. That's why many clinicians wait until 25 degrees or before that if they've documented 5 degrees of progression. We've seen many curves in this range spontaneously improve. Therefore, I think some caution is appropriate to avoid unneccesary treatment. By the way, the current inclusion criteria for BrAIST is 20-40 degrees. This change was just approved last month by our oversight board.


I'm glad the BRAIST Oversight Committee extended the criteria to 20 degrees!

The table below is data showing the probability of progression compiled by the SRS. According to the data, a large percentage of children ages 10 -15 with curves above 20 degrees are at high risk of progression. I have yet to see literature showing a great number of self correcting or spontaneoulsy resolving curves in AIS.



http://www.scoliosis-australia.org/images/doc_table.gif

I can't say there is a shortage of bracing studies! One stands out in my mind.

http://www.ejbjs.org/cgi/reprint/77/6/815

Sealy
11th February 2009, 05:01 AM
Hi Sealy

This is Christine from NSF. I am having a hard time getting registered here. This forum looks good and would like to become an active user, I will keep trying to get in.




Hey Christine!!!! :D It's great to see you here!

concerned dad
11th February 2009, 01:17 PM
Lori,
Thanks very much for participating on the forum and helping us understand the BRAIST trial. This is my first post here, however I have posted several times on a different forum (scoliosis.org).

I do have some questions for you. I want to start off by saying that when I first began looking into the topic 2.5 months ago I soon came to vilify you (it took me sometime to come around, sorry). I was reading the literature on brace trials trying to figure out what to do with my daughter (Diagnosed in late November with a 38 degree curve). I initially was under the impression that there was no issue with bracing. I started digging into the literature on bracing efficacy. I was very upset that you excluded the Nachemson data from your meta-analysis paper. It didnt make sense to me why you would design a study to exclude the largest previous study of its kind. It looked like you used data selection to make your point. With the help of some of the posters on the other forum and after digging through the papers I saw what the problems were with that Nachemson paper. Personally, I've come around to agree that the BRAIST study is ethical. However, and this is a point you might want to consider, while my daughter meets all the criteria for inclusion, I still would not want to enroll her in the study. You made your case to the satisfaction of the medical community, but it is not compelling enough to motivate myself as a parent to participate. And we are the folks you need to convince.

Anyway, I do have 2 questions for you about the study.
1. Since your "equipoise" paper failed to demonstrate disagreement for post-menarchal girls, why are you still enrolling patients 1 year post menarch? That was an interesting paper and showed the current state of the lack of agreement in the US orthopod community, however they did seem to mostly agree on that issue.

2. Since one of the problems with the Nachemson paper was discovered after the fact regarding the stratification of curve types, is it possible that you may have similar invalidating results. Specifically I am concerned/interested in the issue of assessing maturity using Risser. Sanders makes a pretty good case that Tanner Whitehouse staging is significanly better at assessing when the curves are at their max acceleration stage. So, my question is, are you using other techniques to measure maturity in addition to Risser. (My daughter is Risser 0 but Tanner Whitehouse Stage 5 -> different prognosis for the two different measurements that would have screwed with the results of the trial perhaps)

Finally, many of us have decided on using the SpineCor brace for our children. After looking at the literature and seeing the anecdotal results other parents are having for thier kids, it is pretty compelling. This may be a hurdle for your BRAIST study. We are going to Montreal for treatment. Part of that decision was based on reading your papers showing the lack of evidence that the TSLO worked. Compared to the results shown in papers Coillard wrote, well, it seemed like an obvious choice for us. It seems like the US orthopedic community has dismissed the SpineCor. Is there something out there we should know about (besides the Wong paper)?

Anyway, this note is a bit disjointed. I am sitting in a hotel 'business center'. Thank you for the work you are doing for our kids.

BrAIST24
11th February 2009, 08:27 PM
Hello everyone:

To answer Titch's question, this is a randomized trial. That means that kids are randomly assigned to either bracing or observation. This is absolutely the best way to assign treatments from a scientific view. By doing this, all of the variables we'll want to take into account should be balanced between the two treatments. Because of randomization, and other high-quality elements we've built into the protocol, whatever difference in outcomes we see between the groups is due to the treatment, not due to characteristics of the sample or of the research design.

Guest - we are limiting this study to TLSOs. There are not enough orthotists in the North America who prescribe SpineCor braces for this study to give them a fair evaluation. We have orthotists using Wilmington, Boston and Rosenberger braces. One of our orthotists is starting to add some of the components of the Cheneau brace into the current customized Boston brace that he currently uses. This study was not designed to be able to find a definitive difference between braces types, but we will include variables such as curve correction and "dose" of the brace into our models of curve progression.

Sealy -

If you're talking about Dr. Vish Talwalker, he is one of the investigators in our study. The table you present is well known to scoliosis researchers - Dr. Weinstein was one of the people who helped compile the data that went into the table.

It's hard to say how many spontaneously correcting curves there are out there. We have seen 5 or 6 here in the past few months, and I've heard from other centers that they've seen this too. I imagine the number is not great, but it does happen, especially in kids with relatively small curves. The other thing to remember is that there is error involved in each measurement - this error can come from positioning, different radiological techs, and also from different clinicians doing the measurement. The literature reports error of 5-10 degrees - therefore, our mysterious shrinking curves could be due to error and not biology. Like a lot of things in healthcare, it's just tough to know.

You provided the URL for the Nachemson study. This is the best study out there concerning bracing and AIS and there is a lot to commend it, including a standardized protocol and adequate follow-up. I know Dr. Danielsson, who conducted the 15-year follow-up of that study, very well.

Dr. Nachemson was on the protocol planning committee for BrAIST. He felt it was a worthy, although very difficult, undertaking. He felt there were still questions to answer.

As Concerned Dad noted, I have written about the flaws of the Nachemson and Peterson study. These flaws create some doubt about the conclusions. As a matter of fact, BrAIST was designed to avoid many of the problems in the Nachemson design.

The systematic review that Dr. Weinstein and I published was specifically geared to address the risk of reaching surgical indication after bracing and observation. That is the only reason why I did not include Nachemson and Peterson. Dr. Danielsson's follow-up paper, which did include surgery as an outcome, had not yet been published.

I can understand why you might not choose randomization as a method of decision making. It's not for everyone - it's really only suited to patients/families who truly don't have a preference for treatment. One of the preliminary studies we did was to find out how many families would opt for randomization - we concluded that the rate would be approximately 25%. And indeed, BrAIST has an overall 21% randomization rate.

You're correct about the equipoise paper - we did see agreement in outcomes/benefits of bracing for most presentations including post-menarchal girls. So, this tells us that the community tends to agree that the benefits of bracing are lower in post-menarchal girls. But we still don't know if their estimates were correct, only that they were in agreement. Additionally, girls at <1 year post-menarche are frequently indicated for bracing in the US. Therefore, we wanted to include these girls in BrAIST. The equipoise study was only one piece of evidence we used to make our case for the ethics of this trial. We can talk some more about this later if you're still interested.

We wanted to base the inclusion criteria for BrAIST on current indications. When we were planning this study, Jim Sanders hadn't yet finished the analysis of his digital bone age data. Dr. Sanders is also an investigator in BrAIST, and we are indeed looking at digital bone age - we just didn't use it as an inclusion criteria. All subjects in BrAIST have a left hand film at each visit.

Concerning SpineCor braces, I know that a lot of families are looking for clinicians who are experts in fitting and maintaining these braces. We have had two families here in Iowa who were initially interested in BrAIST, but decided they would like to try a SpineCor instead. And who can blame them?! The advertisements show a beautiful young girl in a ballet pose - much better than the typically unhappy pictures you see in textbooks of girls confined in a TLSO. SpineCor braces had not been out long when this study was designed - and there was very little literature concerning their effectiveness. I do not have any personal experience with this brace, but what I've heard anecdotally from a handful of orthopaedic surgeons involved in BrAIST is that both they and their patients were uncomfortable with the SpineCor and that they were not able to replicate the results of Drs. Colliard and Rivard. Likely there is a big learning curve involved in working with these braces.

Whew. You guys are wearing me out! I'm glad to answer your questions.

Thanks much for letting me have some time

Lori Dolan

Sealy
11th February 2009, 09:53 PM
Thank-you so much for taking the time! I know someone in your position cannot easily reply to direct questions and consequently one is forced to skirt around issues. I can sympathize. I was going to ask you since you know Vishwas Talwalkar, M.D.whether you could ask him if the following retrospective study consisted of children wearing a TLSO? I’m almost certain it was since it was a retrospective study and more importantly early treatment is alive and well in North America. But I'll let it go.

Peak Height Velocity as a Predictor of Curve Progression in Idiopathic Scoliosis

Dane Glueck
Shriners Hospital
Vishwas Talwalkar, M.D.
Shriners Hospital
Abstract from the SRS 2005 Annual Meeting


Summary: Peak height velocity (PHV) has been shown to be a significant predictor of scoliosis curve progression. A retrospective review identified 55 adolescent females with idiopathic scoliosis and curves between 20 and 45º. We found that 30º of curvature at PHV is a significant predictive indicator for curve progression to a surgical magnitude. Menarche and Risser grade lag behind PHV. PHV is a more accurate predictor of time of maximal curve progression than the other variables.

Introduction: Peak height velocity (PHV) is a significant predictor of scoliosis curve progression. This study hypothesizes: 1) PHV accurately predicts the timing of maximal curve progression 2) curves greater than 30º at PHV progress to surgical indications.

Methods: A retrospective review identified 55 adolescent females with idiopathic scoliosis and curves between 20 and 45º. Data included: age, height, menarche, Risser grade, and Cobb angle. Progression to surgical magnitude was defined as progression of 10° to 45º. Regression analysis, F-test for variance, and t-test were used for analysis.

Results: Fifty-five patients were followed for a minimum of 2.5 years with an average follow-up of 4.8 years. Fifty curves progressed. Mean PHV was 8.9 cm/yr. Cessation of growth occurred an average of 2.4 years after PHV. Menarche and Risser 1 lagged behind PHV by 4 and 11 months respectively. Maximal curve progression was assessed in relationship to PHV, Risser grade, and menarche in 33 of the 55 patients. PHV grouped patients better for maximal curve progression than either menarche or Risser. 49% (16/33) underwent maximal progression while still at Risser 0, and 15% while at Risser 4. 25 of 28 (89%) patients with curves greater than 30º at PHV progressed to surgical indications. 3 of 22 (14%) that were less than 30º at PHV progressed to surgical indications (p <.0001; sensitivity 89%; specificity 86%; accuracy 88%). 30º curvature before menarche was a sensitive (100%), but less specific (41%), and less accurate (74%) predictor of progression to 45º.

Discussion: 30º of curvature at PHV is a significant predictive indicator for curve progression to a surgical magnitude. Menarche and Risser grade lag behind PHV. PHV is a more accurate predictor of time of maximal curve progression than the other variables.

Last Updated: 03/22/2006

RugbyLaura
11th February 2009, 09:54 PM
Wow! This is amazing. Thank you so much, Lori, for taking the time to answer our questions. What you are doing is of enormous importance and I eagerly await the results of your study.

I'd be interested to know why your handful of orthopedic consultants said that "both they and their patients were uncomfortable with the SpineCor". My daughter was prescribed a Spinecor brace at age 9, after her curve was measured at 38 degrees. Last Friday (age 11) her curve was measured at 24 degrees. We are very comfortable with Spinecor!

Is their (Spinecor's) marketing to blame? You mention that "the advertisements show a beautiful young girl in a ballet pose - much better than the typically unhappy pictures you see in textbooks of girls confined in a TLSO." Is this view of a braced child hard for surgeons to accept? My daughter is a beautiful young ballet dancer and the brace does seem to be working.

Perhaps when you have concluded your TLSO study, you could be persuaded to look at Spinecor?

I am delighted that you are here with us and look forward to your further input.

Laura

concerned dad
11th February 2009, 09:58 PM
Thanks much for letting me have some time

Lori Dolan

Are you kidding me? Thanks for taking the time to answer our questions. And indeed you do a good job at addressing our querries.

I do have another one for you though. Is is correct to assume that if during the course of this trial it becomes evident from your preliminary data that bracing is indeed efficacious, would you stop the trial?

I dont suppose you could share how many people you have participating or, when perhaps you expect to publish results. Hopefully it will not take as long as the Nachemson study. Likely not 'in time' to help any of the (adolescent) kids being braced now but I suppose it takes time to do it right.

Finally, I wonder if you ever saw the following data from a Random Trial started by Dr. Rivard. This was buried on the SRS.ORG website. Apparently never published. Emphasis added at the bottom is mine. We were discussing this on the other Scoliosis forum in late December. I would be curious to hear your thoughts.

INTERIM RESULTS OF A PROSPECTIVE RANDOMISED STUDY OF THE NATURAL
HISTORY OF IDIOPATHIC SCOLIOSIS VERSUS TREATMENT WITH THE SPINECOR
BRACE.
The objective of this prospective randomised study was to compare the natural history of Idiopathic Scoliosis patients to
those treated with a SpineCor brace with a Cobb angle between 15 and 30 degrees. A cohort of 65 patients were
randomly assigned to a control non-treated (n=36; age=12 years; Cobb angle:20±5 degrees) or treated group with the
SpineCor brace (n=29; age=12 years; Cobb angle : 22±5 degrees). Inclusion criteria included an initial Cobb angle
between 15 and 30 degrees, Risser 0, 1 or 2, high risk of progression (increase of Cobb angle of 5 degrees or more within
the last 6 months), girl or boy and no significant malformation of the spine. Each patient underwent a comprehensive
evaluation (radiological and clinical) prior to commencing the study, at 4 month intervals during treatment and follow-up.
From both groups there were 3 patients who withdrew. For the remaining 33 control subjects there was a mean Cobb
angle of 26±8 degrees and for the treated group, 20 are still in treatment with a mean Cobb angle in brace of 15±7
degrees. The remaining 6 patients, in the treated group, have been weaned from the brace but for less than 1 year.
Table 7 : Percentage of patients improved, stable and worsened at the last available visit.

..................Improved.......Stable.......Wors ened
Control (n=33) 12.............45...............42
Treated (n=20) 76.............14................5

This is the first prospective randomised study on Scoliosis patients investigating the Cobb angle between 15 and
30 degrees. This interim evaluation reveals a strong tendency where 42 percent of the control group worsen,
compared to the treated group who showed a worsening of only 5 percent. This interim result which shows this large
difference in worsening between treated and non-treated patients questions the logic of continuing this prospective
randomised study.

BrAIST24
18th February 2009, 05:11 PM
Hello -

Sealy, I've emailed Dr. Talwalkar about the PHV study, but haven't heard back from him yet.


RugbyLaura - I really don't know why people were uncomfortable with the brace, but I'm glad to know that your daughter is doing well. My comment about the advertising was only to say that I can see why parents and patients would be so anxious to try the SpineCor if activities like ballet are possible while wearing the brace. I have never heard anyone say they're uncomfortable with this depiction of a person with scoliosis.

Concerned Dad - We do have a set of formal stopping rules for BrAIST. After 1/3 of the required sample has reached an endpoint, we are required to present the data to the NIH and the Data Safety Monitoring Board. These data could show: 1) Bracing is so much better than observation we should stop the trial; 2) Observation is so much better than bracing we should stop the trial; 3) The outcomes are so similar between the two groups we'll never be able to find a significant difference so we should stop the trial; or 4) The outcomes are different and we should continue the trial.

We need 384 subjects and right now we have 102. This trial will probably take another 5 years.

I heard Dr. Rivard present some results from the trial you mention at a meeting in Greece. I have not seen anything in print. I really can't speculate on the validity of this work based on this abstract. Sorry.

Thanks folks.

Lori Dolan

mamamax
26th November 2009, 12:46 AM
Hi Lori ~

I think it's wonderful that you have taken time from your busy schedule to stop by here and offer us more information on the Braist Study.

I noticed at the government web site http://clinicaltrials.gov/ct2/show/NCT00448448 that there will be some fairly sophisticated monitoring - wear time measured using a temperature monitor. I think that's great as compliance has been one of the largest controversies in bracing studies. From what I've been reading, when compliance is good the Boston Brace has reported some impressive results. So I do look forward to the results of the Braist Study. While this study will be limited to TSLO braces, certainly the resulting information could be very valuable to all regarding bracing in general.

I'm not familiar with all the different TSLO braces, I'm an adult wearing the Spinecor brace (introduced in 1993/2005 for adults) and with my brace the protocol involves a schedule of monitoring and adjustment. Is protocol similar with the TSLOs in this study - and if so how frequently?

Thanks again for all the information you have given us!

mamamax
3rd December 2009, 01:24 AM
:wave:

I received an email from Lori today and posted the info (with her permission) over at NSF.

Sharing here also:

http://www.scoliosis.org/forum/showthread.php?p=86687#post86687

tonibunny
3rd December 2009, 02:17 AM
Well done Mamamax, that ought to make for some interesting discussions! :)