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gerbo
28th October 2005, 11:59 AM
What follows is a letter I have written to both andrew Mills, orthotist and director of firm producing the Spinecor and Dr rivard, the canadian "inventor"

this is followed by the reply by Mr Mills, which i think is of interest to anybody remotely considering spinecor.

Ofcourse, the views of our more experienced members would be very welcome

gerbo



[i]Dear Dr Rivard

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

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

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

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

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

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

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

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

With regards

Gerbo Huisman
Lichfield, UK



Dear Mr Huisman

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

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

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

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

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

I hope this information is useful to you.

Kind regards

Andrew J Mills MBAPO
Managing Director/Orthotist

The SpineCorporation Limited
Springwood House
Foxwood Way
Foxwood Industrial Park
Chesterfield S41 9RN
United Kingdom
Tel No: +44 1246 455381 Fax No: +44 1246 269042
www.spinecorporation.com
info@spinecorporation.com

BeckyH
28th October 2005, 12:10 PM
wow. andrew mills doesn't appear to have a very high opinion of orthotists in the uk does he? it would be interesting to hear what nuffield had to say on the matter as (i know this isn't down to you, gerbo) i feel like we've heard one side of the story...

mills has perhaps ignored the fact that orthotists have worked for decades on hard-bracing and i can understand why something so new is a challenge for them as (when you compare spinecor to traditional bracing) spinecor is very much the new kid on the block and relatively speaking, is unproven.

it'll be interesting to see if dr rivard dose indeed say the same thing or not

sins
28th October 2005, 02:08 PM
To introduce a new system like Spinecor,an orthotist needs to be interested, motivated and have the time to dedicate to the programme.
Unfortunately in the NHS(and similar systems), the system is not best suited to time consuming projects.
Patient throughput is the name of the game.
Many centres in Uk do not brace patients either as they are not convinced of it's usefulness.So basically, why introduce one more brace system which may or may not work.
Mills has highlighted training as the most improtant aspect of successful spinecor brace application. I can understand that!
Unfortunately we still have to look towards America/Canada for innovation in scoliosis treatment.
Medical practice is slow to change.The Boston Brace is the gold standard for bracing.It helps and is well tolerated and is low maintenance.It's been in existence for decades and in a climate of increasing medical litigation, it's essential that any new medical device will deliver on it's promise.
One thing which is very clear is that bracing studies are very unreliable, too many variables like skill of orthotist, training,patient compliance.
It also seems that anyone in the UK considering Spinecor may have difficulty with finding the an orthotist with the credentials to correctly fit and direct the patient's treatment.
I don't think he's being critical of the skills of British orthotists at all,he's simply explaining why "A change in the method of treatment delivery is required for SpineCor to ever become mainstream in the UK".
Sins

Sealy
28th October 2005, 03:57 PM
Gerbo,

There is an SRS meeting in Florida this weekend and one of the presenters is Dr. Rivard - God bless him and keep him in good health because he has to treat my daughter next week :angel: If you notice, the topic he is presenting is the longterm follow up study to the Spinecor :-D


http://www.srs.org/meetings/am05/scientific_program.pdf

andrea
28th October 2005, 08:53 PM
I wrote Mr Mills an email a while ago now, and post his reply below. It's not something I am considering, but if it can be of use to anyone, then I'm happy to put up his reply.

Dear Andrea

Thank you for your enquiry regarding SpineCor treatment. At your daughters current age a plaster or plastic spinal jacket is the only practical treatment option. SpineCor is not normally possible to fit to a child under 5 years of age but this is really dependant on size. I have fitted two children at 4 years who where large for their age. Experience to date has shown SpineCor to be extremely effective at controlling early onset (Infantile/Juvenile) curves often with quite significant reductions at least until around 11 years of age. The real challenge for children with early onset idiopathic scoliosis is getting then through adolescence without significant progression. Success at this point is very dependant on how large the curve is at the onset of the adolescent growth spurt. 25º or less gives a very good prognosis, 40º or greater gives a poor prognosis.



If possible your daughter should switch to SpineCor around 5 years of age, the long tern prognosis for rigid bracing children such as your daughter is not good.



Yours sincerely



Andrew J Mills MBAPO

Managing Director / Orthotist



The SpineCorporation Limited

Springwood House

Foxwood Way

Foxwood Industrial Park

Chesterfield S41 9RN

United Kingdom

Tel No: +44 1246 455381 Fax No: +44 1246 269042

Sealy
29th October 2005, 11:41 PM
Andrea,

Thank-you so much for posting that letter! It makes my decision to go in that direction less scary. I have to follow this path because I feel it's the best one... if I'm wrong, I have no one to blame but myself. We also have the Milwaukee close by in the event that her curve starts to progress for any reason. Three days and counting until Deirdre can wear clothes her own size for a change and not clothes that are two sizes too big :-) She has no idea what she's been through, I wonder if she'll ever know how very serious her condition was and how very different her future would be had we not pursued serial casting.

gerbo
29th October 2005, 11:45 PM
Does anyone actually know anybody who wears one of these, and what they are like with regards to wearing-comfort.?? I hear various views, including that specially the straps round the legs can be uncomfortable.

Sealy
29th October 2005, 11:53 PM
Gerbo,

I've read that chafing around the leg area can be a problem, but in general the brace is so much more comfortable to wear than a rigid brace. I'll let you all know how Deirdre adjusts to it, I imagine she'll be wearing it home from Montreal :-)

gerbo
30th October 2005, 12:06 AM
got the feeling that we'll soon will give it a try, the evidence seems so convincing

Sealy
30th October 2005, 10:29 AM
Gerbo,

When I spoke to Dr. Rivard in August, he told me that they're finding that children who have worn rigid braces for long stretches (over six months) don't fare as well as children who have had no prior treatment. I'm sure the age of the child would play a role here. He gave me the impression that even though Deirdre has been in casts for three and a half years and therefore rigid bracing, that this rule should not apply to her given her age. He said that something happens to the vertebrae at the apex of the curve and the damage is usually irreversible with rigid bracing. I'm thinking this could be one of the main reasons why curves revert back to pre-bracing levels once rigid braces are discarded :???: Apparently at Deirdre's age there is still great potential for vertebral healing. If your daugther has been in rigid bracing for a very short time, then there shouldn't be a problem. I'm not trying to scare you, this is just what Dr. Rivard told me.

gerbo
30th October 2005, 12:50 PM
oh great, :( well, will put that point to mr Mills and see what he says

gerbo

gerbo
1st November 2005, 03:56 PM
As we are now seriously considering going Spinecor route, I asked some further questions re what to expect re correction and some other bits

reply as follows

In brace correction is always measured by in brace x-ray on the day of fitting comparing this to an out of brace x-ray taken on the same day or up to 4 week previous. There would be some difficulty, however, in gaining any meaningful comparison if your daughter is currently wearing a rigid brace.
In such cases we advise the rigid brace is removed 3 days prior to evaluation of in and out of SpineCor brace x-rays. Initial brace fitting
cobb reduction does not, however, give the maximum correction possible this in conjunction with a prone or supine non weight bearing x-ray gives an indication of the potential. SpineCor correction is slow progressive change, follow up at 4-6 months gives the best indication of final outcome.


And following a further question



Three hours out of brace is not really enough if she has been wearing a rigid brace 23/7 for 6 months or more. Also films for comparison of her curve(s) WB and WOB need to be ideally the same day but not more than 4 weeks apart. A supine PA X-ray is also really helpful in assessing the potential for SpineCor treatment, I fully understand your wish to avoid unnecessary X-rays but if you really want to have the best advise this is something you need to consider.

SpineCor treatment is potentially less effective if a patient has been in a rigid brace for a long time, basically this is because of muscular atrophy and abnormal neuromuscular feed back which make it more difficult for the patient to respond effectively to the stimulation of the SpineCor brace.
SpineCor is not in its self a support but works by stimulating the patient to change their posture in a way that opens the curve(s), over correction of the patient's postural abnormalities is required for the most effective treatment. Because of this flexibility is also very important and can be compromised by long-term rigid brace wear. These factors need to be considered when assessing a patient's suitability for SpineCor treatment but previous rigid bracing is not necessarily a contraindication.

It does all make sense, doesn't it??? :woe: :woe: :woe: (meaning, feeling rather insecure and just praying doing the right thing......)

Sealy
2nd November 2005, 05:01 PM
Gerbo,

Deirdre had 5 x-rays yesterday !!! I was really surprised !!! They did a P/A, lateral and prone postion x-ray (laying down with face down). After the fitting, they did another lateral and P/A x-ray. I'm comforted by the thought that digital x-rays have half the radiation of normal x-rays and also she was wearing a full lead body jacket with openings in the centre to allow view of the spine. I'm hoping/going to insist that the next follow-up appointment in five weeks time only include one P/A and no lateral. It's my understanding that lateral x-rays can be done once a year.

I wouldn't be discouraged by Mr. Mills letter ! Children who have been braced with rigid bracing and switch to spinecor don't do poorly - it's really a case by case thing. It's my understanding that the inbrace correction after three months is the correction that can be expected once the brace is discarded.

gerbo
3rd November 2005, 09:15 AM
Originally posted by Sealy@Nov 2 2005, 04:01 PM

I wouldn't be discouraged by Mr. Mills letter ! Children who have been braced with rigid bracing and switch to spinecor don't do poorly - it's really a case by case thing.
I am not worried now, the relevant factors, neuro muscular control, muscle atrophy and flexibility are the area's we have been specifically working on through physio, gymwork, swimming and dancing, so I do not think we will have a problem there.

I am trying to book a(private) appointment with mr Mills now for assesment of potential, feel quite excited about it really

Sealy
3rd November 2005, 02:28 PM
I'm really excited too !!! When is the appointment ? I can't wait to hear what kind of correction they get. :-D

gerbo
3rd November 2005, 03:17 PM
thanks celia, hopefully 16/12, awaiting confirmation

gerbo
3rd November 2005, 03:36 PM
16/12 it will be, just confirmed, getting really nervous now :-? :-?

Sealy
3rd November 2005, 06:23 PM
Gerbo,

She'll be fine ! Given the statistics, chances of progression are very small. Does Mr Mills hold clinics ? I thought he was the president of the company ?

gerbo
3rd November 2005, 06:38 PM
he is the director of the company, but a practising orthotist as well, and in that capacity does do clinics (in conjunction with consultants in both cambridge (old british university city) and sheffield (home of british cutlerly (I think))

RosieRich
5th November 2005, 12:08 AM
Hi Gerbo
I have been following your posts with interest as I think the spinecor brace could be the way forward in bracing. I first read about spinecor when Megan was first diagnosed in April and was very diappointed to discover that the Nuffield in Oxford had discontinued it's use. When we asked our orthotist about it the only answer we had was that the results weren't very good but I think lack of time/training may have played a key part. The whole concept with the brace working with the body to use the muscles to help correct the curve just makes so much sense to me.
Good luck with your appointment with Mr Mills.

gerbo
5th November 2005, 04:41 PM
Originally posted by RosieRich@Nov 4 2005, 11:08 PM
the only answer we had was that the results weren't very good but I think lack of time/training may have played a key part.
this is the very clear message i got from Mr Mills. You could argue, he would say that, having a major financial interest in the succes of the spinecor, but still, I'd like to think he is genuine and trust worthy


Did you write about megan in any previous posts? How old is she, what curve and where. Which brace and how much correction in brace? any additional treatment?

take care

gerbo

RosieRich
5th November 2005, 07:16 PM
We've posted a few threads, but probably not given a full story in any of them.
To sum up, we noticed something wasn't right last Christmas (Megan's back felt lop-sided) but it took until April to get an appointment at the Nuffield, Oxford. We saw the registrar and had X-rays. A curve of 31 degrees at L-2 (Lumber curve :???: ) was diagnosed with a compensating upper curve of 21. A week later she went for an MRI which only showed the scoliosis. It took until June to get the brace, a made to measure TLSO (we were getting very fustrated with the time everthing took). No X-ray in the brace so we don't know what kind of correction she is getting. She was physically held straight whilst plaster cast.
Saw the consultant in September (Mr Bowden). He was happy with her correction in the brace and discouraged us from having any X-rays until Feb. His argument for not taking in-brace X-rays was that the results wouldn't change how Megan was being treated. Had a couple of re-adjustments to the brace since then and had one session with the physio. She went through a set of 5 exercises for Megan to do each day. We try and swim every week and generally keep her as active and fit as possible.
She adapted to the brace remarkably well and her compliance is excellent (23 hours a day/out for sport).
Our biggest worry is that her curve progressed prior to getting the brace and we won't know whether the brace is working until the X-rays after the Feb ones. Also the amount of muscle wastage is quite alarming despite trying to keep her exercising.
Sorry this has turned into a bit of a ramble!

jfkimberly
5th November 2005, 10:30 PM
Is the lower curve only at L2? Like there's something wrong with that vertebra so her spine is sharply angled right there? Or is that the apex of a longer curve?

I'm off to find out if you've posted Megan's age...

Oh, and no need to apologize. We're good at rambling here. You fit right in. *grin*

ETA: Ah, there it is. 9 years old... hmm... What does her curve look like?

RosieRich
5th November 2005, 10:47 PM
Sorry- i should have said it's the apex of the curve. I'm not sure where it starts and finishes but her X-ray looked like a backwards S. She also has vertebra that looks like it's 2 not one, but the consultant was sure that it wasn't causing the scoliosis.

jfkimberly
5th November 2005, 11:10 PM
Originally posted by RosieRich+Nov 5 2005, 04:47 PM--></div><table border='0' align='center' width='95%' cellpadding='3' cellspacing='1'><tr><td>QUOTE (RosieRich &#064; Nov 5 2005, 04:47 PM)</td></tr><tr><td id='QUOTE'>Sorry- i should have said it&#39;s the apex of the curve. I&#39;m not sure where it starts and finishes but her X-ray looked like a backwards S.[/b]
Oh, that&#39;s good... I was thinking it was caused by a hemi- or wedge vertabra, which would cause a sharper curve. A "backwards S" implies a more gradual curve consistent with idiopathic scoliosis. Bracing is more likely to be effective in idiopathic curves.

<!--QuoteBegin-RosieRich@Nov 5 2005, 04:47 PM
She also has vertebra that looks like it&#39;s 2 not one, but the consultant was sure that it wasn&#39;t causing the scoliosis.[/quote]
Did the consultant agree with you about the possible block vertebrae but discounted the possibility that it contributed to her curves, or did he disagree that it was there at all? Is it in/around the area of either curve?

Gosh, I&#39;m so full of questions. Sorry&#33;

RosieRich
7th November 2005, 10:54 PM
We were a bit confused as when we saw the registrar he commented that she had 6 vertebrae where she should have had 5 (in the lumbar region) and then when we saw the consultant he said it wasn&#39;t an extra one it just looked like it but wasn&#39;t the cause of the scoliosis. Confusing? :???:

jfkimberly
8th November 2005, 06:45 AM
Yes. It is confusing. So the registrar and consultant gave different opinions about what it was? Hmm. I wonder what looks like an extra vertebra...

titch
8th November 2005, 09:24 AM
I was told at RNOH by a registrar that I have 6 lumbar vertebrae, then at QMC Mr Webb said that actually I don&#39;t, that it&#39;s relatively common in girls to be missing a set of ribs, and that generally speaking there are oddities to the sacrum if you&#39;ve got 6 lumbar vertebrae. It&#39;s quite possible that it&#39;s the same thing in this case, but they do commonly count based on the ribs unless they are aware of this (there are all sorts of odd things that can happen with the ribs - they most often start on T1, but in some people they start on C7).

jfkimberly
8th November 2005, 11:16 AM
Wow. I thought the basic structure would be the same for everybody, barring complications. Is it very common for the ribs to start on C7?

titch
8th November 2005, 11:56 AM
I don&#39;t know how common - I know it has been suggested as being slightly more common in certain conditions and autoimmune disorders than it is in the general population, but I don&#39;t know if that was borne out by further research (I have read among other things that cervical rib is more common in people with scleroderma). Mr Webb said that missing a set of ribs was more common in women than men - so again, one can wonder whether it is any relation to the fact that scoliosis is more common in females.