Why I decided to brace my daughter with the SpineCor

[concerned dad]

Just when I thought I was ready to accept that the jury was still out I find this
Backtalk - April 1999

I probably wouldnt have posted it here except the author (Winter) speaks with such conviction. (Emphasis added is mine)

regarding Lonstein
"showed with absolute statistical clarity that bracing did alter the natural history"

and regarding Nachemson

"This study also showed, with absolute statistical clarity, that bracing did have a positive effect on the natural history,..."

and the Puerto Rico Study...
"Once again, bracing was shown to have a positive effect, with the non-braced group having three times the failure rate compared to the brace treated group. "

and Finally stating

"These three studies, all high-quality clinical research, answered the question with finality. Yes, bracing can have a positive effect on adolescent idiopathic scoliosis, particularly for progressive curves in growing children between 20° and 40°. "

Well, that's not too wishy washy. This fellow is convinced.

[Pooka1]

Just when I thought I was ready to accept that the jury was still out I find this
Backtalk - April 1999

I probably wouldnt have posted it here except the author (Winter) speaks with such conviction. (Emphasis added is mine)

regarding Lonstein
"showed with absolute statistical clarity that bracing did alter the natural history"

Winter is the coauthor on this paper. Of course he thinks the paper is marked by clarity and conviction. Essentially, he is patting himself on the back. In public. Some would say that is unseemly. Me, I think the guy just thinks he did a bang-up job.

and regarding Nachemson

"This study also showed, with absolute statistical clarity, that bracing did have a positive effect on the natural history,..."

This Nachemson and Peterson paper has real problems, some of which we discussed. Winter likes it because it supports his general position.

and the Puerto Rico Study...
"Once again, bracing was shown to have a positive effect, with the non-braced group having three times the failure rate compared to the brace treated group. "

Same comment as for the Nachemson and Peterson paper.

and Finally stating

"These three studies, all high-quality clinical research, answered the question with finality. Yes, bracing can have a positive effect on adolescent idiopathic scoliosis, particularly for progressive curves in growing children between 20° and 40°. "

Well, that's not too wishy washy. This fellow is convinced.

He certainly is convinced; I'll give you that.

[Mary jane]

My daugher is 17 now and is scheduled for surgery. She had the Spinecor brace for 2 years, but her curve was so bad before we ever found the Spinecor site. She basically used the brace for support to put off surgery, but I think if we would have started the this program brace when we first got a brace it would have helped. My daughter has something called Dysautonomia and because of that she could not wear her Boston brace or the Milwaukee brace that she had made for her when she was 12 and 14. They were too painful and restricted her digestive system. But we did not find the Spinecor system until she was almost 15. I think it would help as much as anything else out there.

[Pooka1]

My daugher is 17 now and is scheduled for surgery. She had the Spinecor brace for 2 years, but her curve was so bad before we ever found the Spinecor site. She basically used the brace for support to put off surgery, but I think if we would have started the this program brace when we first got a brace it would have helped. My daughter has something called Dysautonomia and because of that she could not wear her Boston brace or the Milwaukee brace that she had made for her when she was 12 and 14. They were too painful and restricted her digestive system. But we did not find the Spinecor system until she was almost 15. I think it would help as much as anything else out there.

You might be right about the brace.

I had to look up dysautonomia.

I saw a medical show ("Mystery Diagnosis" or something like that) where a woman was eventually diagnosed with POTS which I see is related to dysautonomia. It was amazing that they finally found a doctor who knew what the heck that woman had! She might not have as it seems to be quite rare.

In re the brace helping, I gather bracing is known to fail with certain connective tissue disorders including Marfan's though I don't know about dysautonomia.

It could be that undiagnosed cases of these conditions skew the success rate of bracing towards less positive percentages. That is just one of several possible confounders in the brace literature in my opinion. If it could be cleaned up, we might see some proof that bracing works, at least for some kids. It might work.

[FixScoliosis]

progression despite bracing

Regarding progression despite bracing, maybe there are differences in the spines and their configuration/alignment themselves that predispose some to progress more than others. I'm currently reading a paper for my blog that has studied this and it seems to have some interesting insight to share. I’ll get back once I have worked my way through it.

[concerned dad]

FOR SALE – One slightly USED SpineCor Brace

FOR SALE – One slightly USED SpineCor Brace

Not really, I was going to post this as a separate thread thinking that it just might raise some eyebrows and get more folks interested in participating in this discussion, then I thought perhaps the moderators might not appreciate the humor.

We just had an appointment with another local (relatively – compared to Montreal) Orthopedic Surgeon. We had still needed to follow up on the MRI recommendation of the first guy we saw.

I made this appointment in early December when we decided not to stay with the first orthopedic guy and we were weighing our options. One of my concerns was the discordance between my daughters Risser 0 and her age and post menarchal status. In my first post at the top of this thread I said that I thought that based on her high curve and low Risser score I figured (based on what little I could glean from the research) that she had a high likelihood of curve progression. I found recent research showing that Risser may not necessarily be as good an indicator of skeletal maturity (and thus curve progression) as some other measures. The fellow we just saw did several studies looking at Tanner Whitehouse Staging and the relationship with IAS curve behavior. As I understand it, Risser is a convenient measure, but not the best. It is convenient because you can measure it with the same xrays as you typically take to assess scoliotic curves.

Anyway, my daughters DSA score from the Tanner Whitehouse scale indicates she is Stage 5. (This scoring looks at a hand xray to assess skeletal maturity) That seems to have quite a bit different prognosis than a high curve and Risser 0. Unfortunately this fellows study was limited statistically by a low number of patients. Never the less, it causes me to pause and rethink the logic of bracing in our particular circumstance.

I have been haunted (not sure if that is the right word, perhaps motivated is better) by a statement Sharon made earlier where she basically questioned if it is ethical to brace a child if we DO NOT know it will help. (This was in response to me questioning the ethics of a random study) So now I find myself wondering if there is much of a risk of curve progression now that I have a different view of her skeletal maturity. I mean, if she were say 18 years old, we wouldn’t be bracing her because she was clearly done growing. Risser 0 suggests MUCH more growth but DSA Stage 5 (and her height, age and post menarchal status) indicates much of her growth has already occurred.

I guess I am less of a Concerned Dad now. We are weighing our options now in light of the new information.

By the way, this fellow we saw was really good. Wonderful with my daughter, really knew his stuff, SRS member, very well published – particularly as it relates to my daughters specific issues, is participating in the Braist Study, very familiar with the SpineCor and…… IN NETWORK for my insurance. He spent almost 1.5 hours discussing this with us. You don’t find many physicians willing to devote that much attention. I don’t want to say publicly WHO he is because I want to discuss some of the things he said, and the chance of me (unintentionally) misquoting him is high enough that I wouldn’t want to put words in his mouth (remember, everything you read on these forums should be taken with a grain of salt). Of course, a Google or a PM would likely get you a name.

[RugbyLaura]

...I don’t want to say publicly WHO he is because I want to discuss some of the things he said...

Looking forward to it!

Laura

[Pooka1]

I found recent research showing that Risser may not necessarily be as good an indicator of skeletal maturity (and thus curve progression) as some other measures. The fellow we just saw did several studies looking at Tanner Whitehouse Staging and the relationship with IAS curve behavior. As I understand it, Risser is a convenient measure, but not the best. It is convenient because you can measure it with the same xrays as you typically take to assess scoliotic curves.

Anyway, my daughters DSA score from the Tanner Whitehouse scale indicates she is Stage 5. (This scoring looks at a hand xray to assess skeletal maturity) That seems to have quite a bit different prognosis than a high curve and Risser 0. Unfortunately this fellows study was limited statistically by a low number of patients.

Yes I came across some info which I posted a while back indicating the Whitehouse Tanner or Tanner Whitehouse and some Roman numeral IIRC was the best indicator of skeletal maturity but I didn't read the study. I'd like to hear what your surgeon says about the magnitude of the discordance.

(snip) I mean, if she were say 18 years old, we wouldn’t be bracing her because she was clearly done growing. Risser 0 suggests MUCH more growth but DSA Stage 5 (and her height, age and post menarchal status) indicates much of her growth has already occurred.

That's the correct way to think about it as far as I know. I'd like to know what the surgeon said.

I guess I am less of a Concerned Dad now. We are weighing our options now in light of the new information.

What do you want us to call you now?

By the way, this fellow we saw was really good. Wonderful with my daughter, really knew his stuff, SRS member, very well published – particularly as it relates to my daughters specific issues, is participating in the Braist Study, very familiar with the SpineCor and…… IN NETWORK for my insurance. He spent almost 1.5 hours discussing this with us. You don’t find many physicians willing to devote that much attention.

Have you considered he spent so much time with you because you are somewhat familiar with the bracing literature? Did you mention any of the points you have made here to him? What does he think about the bracing literature?

I don’t want to say publicly WHO he is because I want to discuss some of the things he said, and the chance of me (unintentionally) misquoting him is high enough that I wouldn’t want to put words in his mouth (remember, everything you read on these forums should be taken with a grain of salt). Of course, a Google or a PM would likely get you a name.

That's a very good point. I try to qualify statements that I relay from our surgeon. When he is absolutely clear, though, I just say it (like the 95% of kids who don't need physical restrictions after fusion who still will have no problems. It would have been hard, if not impossible, for me to miss that point.)

Very glad things are looking up for you, The Dad Formerly Known as Concerned (depicted by an unpronounceable symbol?)

[Pooka1]

Forgot to say...

(snip)
I was going to post this as a separate thread thinking that it just might raise some eyebrows and get more folks interested in participating in this discussion,

I think the thread would be much more valuable if more folks would weigh in with their thoughts on the bracing literature.

then I thought perhaps the moderators might not appreciate the humor.

This place is effectively unmoderated IMHO.

[concerned dad]

Word of the day - "Equipoise"

Before we get into any discussion of what a particular doctor says about the topic of bracing perhaps we should pause to remember something. We all put a lot of weight to what we are told by our physicians. But on the topic of bracing in AIS there is much debate in the medical community. While I was trying to understand the whole rational for the BrAIST study, I came across a paper from the folks in Iowa (they are the strong proponents of the BrAIST study). Anyway, the link to the abstract is here but if you’ll permit me, I’ll try to sum up what I think they are saying.

Apparently some physicians who were asked to participate on the BrAIST study declined on ethical grounds. One way to remove (or reduce) the ethical concerns would be to survey a bunch of specialists and see how much they agreed on the topic. If there was poor agreement (they used the word ‘equipoise’ - just to make me feel stupid and break open a dictionary) then ethical considerations would be diminished.

So, they sent a survey to a bunch of physicians who deal with AIS. They asked them to consider a bunch of scenarios of expected outcome for different curve amplitudes, menarchal status and curve type – for both braced and unbraced patients. For example, in one of the scenarios they asked for the doctors to predict outcome for a premenarchal girl with a thoracic curve greater than 35 degrees with and then without bracing. So, this would reflect that particular physicians opinion on what the outcome would be in that specific case.

So, what were the results? They sent out 423 surveys and received back 82 from doctors willing to participate in the survey. An interesting aside, they note that of those 82, four bozos (my word, not theirs) had bracing failure rates that were higher than observation failure rates for all scenarios – so they excluded these responses. Anyway, they didn’t further report on the 82 respondents except to say that since the response rate was so low, the analysis wouldn’t be too meaningful.

They then decided to create an expert panel of 29 of the most experienced of the 82 who responded. They looked at the responses to the scenarios from the 29 experts and concluded that they basically didn’t agree much on anything. (they did agree on something – see below). They used this disagreement of the experts to conclude that a state of ‘equipoise’ exists and a random bracing study was both ethical and called for. Fair enough.

OK, why did I want to share this? Two things; One – if we look hard enough it would be easy to find a doctor who would tell us whatever we wanted to hear about the matter. There is a lot of valid variation of opinion on bracing with the experts.

The second point though is that the experts agreed on ONE thing. (Actually several things but all related to menarchal status - This ‘agreement’ was not 100% but it was the strongest consensus of opinion). That is:

More than 80% of the experts indicated that bracing would have a small effect on postmenarcheal patients with thoracic curves (for both small and large curves), postmenarcheal patients with small thoracolumbar/lumbar curves, and postmenarcheal patients with small double major curves. The respondents were very close to agreement (77% and 79%) that bracing would have only a small effect on postmenarcheal patients with either large thoracolumbar/lumber curves or double major curves.

Since my daughter falls within this window of consensus, it is making me further question bracing in our particular circumstance. My problem is, I am not a big ‘consensus’ guy, I’d rather see real data.

As another aside, since they didn’t demonstrate equipoise on the menarchael issue, I thought it interesting that they omitted any discussion about why they are still enrolling post menarchael (1 yr) in the BrAIST study. (This goes to the question of, is it ethical to put a kid in a brace if you don’t think it would help as opposed to the question of withholding brace treatment in a kid where you do think it would help).

Am I boring you folks yet?

[Pooka1]

(snip)
As another aside, since they didn’t demonstrate equipoise on the menarchael issue, I thought it interesting that they omitted any discussion about why they are still enrolling post menarchael (1 yr) in the BrAIST study. (This goes to the question of, is it ethical to put a kid in a brace if you don’t think it would help as opposed to the question of withholding brace treatment in a kid where you do think it would help).

Excellent point.

I suspect they want to include all potential confounders in the large study. It's still a fifth of the surgeons who apparently think the jury is out on bracing post menarche girls. And it may turn out that some portion of this population does respond to brace treatment so best not to exclude them completely from the study.

And to me, Equipoise will always be a champion thoroughbred who was also quite dreamy...

Equipoise

[concerned dad]

Sometimes (most times) I forget where I learn something.

I just reread this old post from Linda and that may be why we persued the assessment of skeletal maturity.

Hi Shebee...

You might want to see if you can get someone to evaluate your daughter's skeletal maturity, because if she has had her period, especially if she started a year or more ago, it's unlikely that the brace will be of much help.

Regards,
Linda

Thank you Linda. And Sharon, thank you as well because I think we discussed this someplace on another thread dealing with Risser issues.

Now, my daughters skeletal maturity assessment doesnt indicate she is completely done growing, just likely past her major growth spurt.

And, the fellow we spoke with mentioned that he felt the main problem with the 1995 Nachemson SRS study was not only the stratification of curve types, but the assessment point where they viewed a 6 degree increase as a failure (for both braced and non braced patients). He said (my paraphrasing), for example, a 20 degree curve going to 26 degrees out of brace isnt necessarily a bad thing. What would be more important would be to assess how many went on to surgery OR how many increased to a curve angle that is a proxy for surgery (ie 50 degrees).

What I find somewhat frustrating is why someone cant go back into the data and figure that out. Perhaps (I am not sure) in that study once a patient progressed 6 degrees they considered it a failure of observation and put the child in a brace. If that is the case then it would not be possible to salvage any data.

[concerned dad]

Bingo

Bingo! I found this buried on another thread. I knew someone had to at least attempt to salvage something from the "failed" SRS bracing study that took 10 years to complete and is apparently dismissed by so many physicians who now find it ethical to participate in the current BrAIST study.

I need to read this a second time, but it addresses the question of what happens if we forget about the 6 degree increase thing (which meant that observation was a failure and is a main critisism of the study) and look at surgery and progression of curves. After a first read, I can tell you the paper looks very interesting. I'm going to grab some celery sticks and have another run through it. Emphasis added below is mine.

Sorry, but I have to disagree. Why would reputable scoliosis surgeons continue to prescribe custom made TLSO braces for kids with curves between 20-40 degrees? If you believe the anti-surgery folks, these surgeons have a lot to gain by having patients who fall into the surgery parameters. Bracing is not a perfect option, but nothing is. When braces are used in the correct population, and manufactured correctly, they can be very effective:

Spine. 2007 Sep 15;32(20):2198-207.Click here to read Links
A prospective study of brace treatment versus observation alone in adolescent idiopathic scoliosis: a follow-up mean of 16 years after maturity.
Danielsson AJ, Hasserius R, Ohlin A, Nachemson AL.

Department of Orthopedics, Sahlgrenska University Hospital, Göteborg, Sweden. danielsson.aina@telia.com

STUDY DESIGN: The Swedish patients included in the previous SRS brace study were invited to take part in a long-term follow-up. OBJECTIVE: To investigate the rate of scoliosis surgery and progression of curves from baseline as well as after maturity. SUMMARY OF BACKGROUND DATA: Brace treatment was shown to be superior to electrical muscle stimulation, as well as observation alone, in the original SRS brace study. Few other studies have shown that brace treatment is effective in the treatment of scoliosis. METHODS: Of 106 patients, 41 in Malmö (all Boston brace treatment) and 65 in Göteborg (observation alone as the intention to treat), 87% attended the follow-up, including radiography and chart review. All radiographs were (re)measured for curve size (Cobb method) by an unbiased examiner. Searching in the mandatory national database for performed surgery identified patients who had undergone surgery after maturity. RESULTS: The mean follow-up time was 16 years and the mean age at follow-up was 32 years The 2 treatment groups had equal curve size at inclusion. The curve size of patients who were treated with a brace from the start was reduced by 6 degrees during treatment, but the curve size returned to the same level during the follow-up period. No patients who were primarily braced went on to undergo surgery. In patients with observation alone as the intention to treat, 20% were braced during adolescence due to progression and another 10% underwent surgery. Seventy percent were only observed and increased by 6 degrees from inclusion until now. No patients underwent surgery after maturity. Progression was related to premenarchal status. CONCLUSION: The curves of patients with adolescent idiopathic scoliosis with a moderate or smaller size at maturity did not deteriorate beyond their original curve size at the 16-year follow-up. No patients treated primarily with a brace went on to undergo surgery, whereas 6 patients (10%) in the observation group required surgery during adolescence compared with none after maturity. Curve progression was related to immaturity.

[Pooka1]

Some questions I have...

1. This is a subset of the larger group which we know stacked patients unevenly. This needs to be addressed in a non-cursory fashion at some point. Also, there is plenty else going on that limits drawing many robust conclusions besides that.

2. Have some of the patients got the surgery in some other country? If so, it wouldn't show up in the National surgery database.

3. In addition to stating who has and hasn't had surgery by 16 years out (average), I would like to know how many of those patients are above the 35*- 40* point which is still sub-surgical but can be expected to progress a degree a year and almost certainly require surgery at some point? For all we know, the same fraction in the braced and observation group will require surgery at some point.

My general comment is there are some ways to present the data that cut to the chase and some ways that don't. For example, it is obvious that Spinecor needs to present the percentage of patients who need one or more weaning periods and be very clear that anything represented as the "magic" two years post bracing is in fact that. Yet that goes unreported to date. Or just presenting the distribution of various types of curves in each study group. I think certain published studies would have been rejected for publication had these graphs been present.

It is odd to me that lay, untrained, no-account yahoos like myself can immediately see some apparently valuable ways to crunch the data that these seasoned researchers apparently have not. This is not my field and it could very well be I'm missing boatloads of material. Who knows. What I do know is this bracing literature is a miasma and plenty of surgeons agree with that.

On the other hand, this seems like a very intractable area of research so I'm not blaming the researchers for the lack of robust results. I think most of them are trying and operating in an intellectually honest manner. Some things are inherently hard to nail down and this seems like one of them.

[concerned dad]

interesting excerpts from the paper
from
A Prospective Study of Brace Treatment Versus
Observation Alone in Adolescent Idiopathic Scoliosis
A Follow-up Mean of 16 Years After Maturity
Aina J. Danielsson, MD, PhD,* Ralph Hasserius, MD, PhD,† Acke Ohlin, MD, PhD,†
and Alf L. Nachemson, MD, PhD*

The main result of this long-term follow-up is that, if patients are located at an early stage by scoliosis screening and treatment is started early, 93% of the patients will have a curve size less than 45° and no patients will be operated on after maturity, regardless of whether they are treated with a brace or observation (My comment here for clarification, I think when the say observation, they mean observation for the first 6 degrees, then bracing). However, patientswho were braced from the start had a significantly smaller curve size, at the same level as at the time of detection.

and a very thought provoking observation/question

As 70% of the observed patients during the original study period did not require any other treatment, 70% of the initially braced patients can therefore be regarded as having been treated unnecessarily. One major question is as follows: is it worth overtreating such a high percentage of patients to realize the goal of “saving” only 10%
of the patients from surgery, the percentage in the group of observed patients?

and this answers some of the questions in Sharons post above

After a mean of 16 years after maturity and at a mean age of 32 years, the advantage of early bracing versus observation in patients with AIS and a curve size of 25° to 35° was seen during adolescence and not during the time after maturity. No patients in either group, bracing from inclusion or observation as the intended treatment, underwent surgery after maturity. Six patients (7%) had a curve size exceeding 45°, 1 in the initially braced group and 5 in the initially observed group (not significant),with none exceeding 48°. Patients braced from the start had a significantly smaller curve magnitude at follow-up, but the difference between the groups was within themeasurement error. Our present results do not change the principal conclusion of the original SRS study: that well-performed brace treatment prevents curve progression during adolescence in patients with moderate AIS, while observation as the intended treatment allowed 70% of patients to escape any treatment at all and left 10% with surgical treatment and 20% with brace treatment.

That last sentence is pretty interesting.