Last month in the rooms we introduced a new communication method with GP’s. It’s called “Argus“, and it is a secure electronic communication system that we now use to write to GP’s about their patients. In our practice we’re focussed on GP’s being the coordinators of their patient’s care, and so regular and rapid delivery of information is paramount.
Argus allows us to communicate almost instantaneously with your local doctor. We write about 50 letter as a week, and whilst that may not sound like many, Argus is a tremendous time saver. Previously, every letter was typed, printed, folded inside an envelope and a stamp put on it, and then taken to the letter box, usually in batches. Then there would then be a 2-3 day delay before they were delivered, opened, and given to your GP. Often the letters are scanned, and then put in the bin. What a waste of time, money and paper!
What happens from now is that the moment a letter is typed we send it electronically to your GP, and in most cases it appears almost instantaneously in your notes. No wasted paper, no time delays, and it’s stored electronically in your file free from scanning or filing errors. Often my report will get to your doctor before you do!
Argus is secure. It satisfies the National Secure Message Delivery standard, and is compliant with Australian eHealth. I wouldn’t use it if it wasn’t. It’s probably more secure than mail. Argus was recently bought by Telstra Health, and is now installed and running smoothly in our rooms.
If you want to ensure that I can communicate with your GP as efficiently as possible, please ask your GP to send your referral to me via Argus (firstname.lastname@example.org). That way all future correspondence will be via this method. Otherwise, ask your GP to put their Argus address in your referral and I’ll add them to my address book. If they don’t have Argus, maybe you could ask them to consider installing it or one of the alternatives.
There is no such thing as “bloodless” surgery – let’s make that clear. There is, however, blood loss that is insignificant, like when you cut yourself shaving, and then there’s significant blood loss such happens after major trauma cases with multiple fractures. As surgeons, often responsible for that blood loss, we try as much as we can to minimise blood loss, and hence the need for transfusion. And before you ask, if you’ve lost red cells, then there is nothing available yet that can replace the oxygen carrying capabilities of those red cells like, you guessed it, red cells.
Placing a patient on a well padded and designed operating table is often the first step in minimising blood loss. The “Jackson table” is, in my opinion, currently the best table for large posterior spinal cases. It allows the abdomen to hang free and the pads are soft and well positioned. Other positions, such as on the side, can also be used for different approaches which minimise blood loss simply due to their anatomy. An ALIF, for example, can be an operation that involves very small amounts of blood loss just by it’s approach.
Many of us practice “minimally invasive surgery”. This is poorly defined as everyone has a different opinion of what it means, but in principle it is about doing an operation through a smaller incision than how it was done before. Whilst it may appear like these techniques lose less blood, often the blood loss is kept hidden. Muscles are still being retracted and dissected, and bones are being cut, both of which lead to blood loss, but because the skin incisions are so small, often that blood is kept inside the skin. In the long term the body with resorb that blood, but in the short term effectively that blood is out of your circulation and so it still lost to you.
It’s important to tell your surgeon what medications and supplements you’re taking. Many of these can increase blood loss, and cause postoperative epidural haematomas that may press on the spinal cord. We also often use a medication called tranexamic acid, which has been proven to reduce blood loss during your operation.
Like many other surgeons I use a machine during my large operations called a “cell saver”. This takes the blood that you have lost, washes it, and allows us to give you back your red cells. It doesn’t give you back all your blood, like platelets and clotting factors, but it does give you back your oxygen carrying red cells.
When it’s needed
Of course, despite our best efforts, a blood transfusion is sometimes necessary after elective procedures. In trauma cases where we’re often dealing with multiple fractures and abdominal bleeding, transfusions save lives. Fortunately in Australia we have a very safe and efficient blood donor system run through the Red Cross. Yesterday I gave my 98th donation, and if you’re able to, I recommend you consider donating as well. Every time you give blood, you can just about guarantee that your blood is going to someone who may die without it. I’ve even learnt something about my own blood. My platelets are a very rare type (HLA 1bb 2bb), with less that one percent of the population having the same, and they can be used to treat Neonatal Alloimmune Thrombocytopenia, a rare but often catastrophic bleeding disorder of newborns.
So why don’t you consider giving blood? You’ll be saving someone’s life, and one day you might need the gift that a donor made for you.
The “take home” message from my post about the YODA studies was that Infuse was as effective as autologous bone graft at establishing a fusion. There were concerns raised though about the number of people who were reported as having being diagnosed with a cancer, and on the surface of it there was good reason to be suspicious. BMP’s stimulate cells to grow, and that’s what cancers do – they grow uncontrollably. Suspicions though are one thing – research was required.
Take any group of people and you can expect a certain proportion to be diagnosed with cancer over a period of time. Therefore, to see if a drug “causes” (increases the risk of) cancer, you need to compare a treated group to an untreated group and look at how many get diagnosed with cancer over several years.
First out of the blocks with a study was, once again, Eugene J. Carragee, who you may remember was the instigator of the first paper that focussed on the possible risks of using Infuse, that triggered off the YODA studies. His paper, published here, looked at the data from a study that was used to trial a combination of a new non-compressible matrix with a high dose of Infuse. In the trial, they compared two groups of people having spinal fusions. One group received the high-dose infuse, and the other used their own autologous bone graft. As part of the study they were tracked for several years, so Carragee, et al, looked at the number of people who were diagnosed with a cancer in both groups. What did they find?
“The incidence rate of cancers was 6.8-fold greater in the rhBMP-2/ CRM group compared with the control group (p = 0.0026).”
WHAT? The people receiving Infuse had an almost 7 times risk of getting cancer than those that didn’t! “Infuse causes cancer!”
Well, settle down for a minute. There’s a couple of things to look at here. Firstly, the total number of patients in the study was 463, which whittled down to 292 by the five year mark. The number of patients with a cancer across that whole group was 17, which means that the risk of cancer for the whole group was only 5.8% over five years. There is also some dispute about how to even measure cancer incidence; if one person gets two cancers, is that one cancer “event”, or two?
This leads to the second point. Looking at table 1, one patient was diagnosed with a basal cell carcinoma, squamous cell carcinoma of the skin, and chronic myelogenous leukaemia. That one patient accounted for 7 of the cancer events in the Infuse group. Another 3 events was one patient who had multiple SCC’s. As an Australian it’s easy to see that if someone presents with a BCC or an SCC, they are then more closely followed to recurrences of those tumours. BCCs and SCCs are also very common, so it could be that, given the small number of people in the study, the Infuse group were “unlucky” to have two patients with multiple tumours. Or it could be the other way around…
Lastly, the dose of Infuse was extremely high. Usually when we use Infuse, the dose is either 8.4mg or 12mg. The dose in the study was 40mg – three to five times the usual dose. Clearly, even if it does have some mild carcinogenic effect at 40mg, that may not apply at the lower doses used in Australia.
So that brings us to the other study, “Risk of Cancer After Lumbar Fusion Surgery With Recombinant Human Bone Morphogenic Protein-2 (rh-BMP-2).” written by a gastroenterologist and oncologist – in other words, people least likely to have a conflict of interest. This paper looked at all lumbar fusions performed in the USA over a five year period where the Medicare record were complete and who didn’t already have a cancer diagnosis: that left them with only 146,278 patients to analyse! They then looked at any patients who later developed one of the 26 most common cancers, and compared them to the use of a rhBMP, either -2 or -7. Generally it is thought that the bulk of the use was for rhBMP-2. So what did they find?
Overall, there was no association of rhBMP admin- istration with cancer incidence (hazard ratio: 0.98, 95% confidence interval [CI]: 0.95–1.02). Similarly, when individual cancer sites were considered, there were no significant differences between the 2 groups.
In simple terms, they found there was no association between use of a rhBMP and cancer.
So we have two studies to look at. One looked at high dose rhBMP and only 292 patients. The other was retrospective, but it looked at 146,278 patients and included all types of lumbar fusion surgery, all doses, all techniques. Which do I put more credence to? The latter study.
Many of my patients have either been to a chiropractor, or ask me if they should go and see one. Some of them are aware that there is some discrepancy between mainstream medicine and chiropractic theory, but aren’t sure of the specifics. Here’s why I have problems giving an opinion on the matter.
Firstly, there’s two broad categories of chiropractors. There are those who tend to be younger, who are struggling to define their art form in terms of evidence and reproducibility. They tend to encourage sensible evidence based principles, concentrate on strengthening the spine, and treat spine-related symptoms. They are to be encouraged, because it is through them that chiropractors may gain some credibility in the medical community.
Now let’s talk about the others – the “straights”; the vitalistic, intuitive, metaphysical practitioners who remain separate from the mainstream community, and who are determined to remain that way. The irony is that they are also the one’s wanting to introduce chiropractors to primary health care roles. I’m reminded of the desire to simultaneously have and eat cake.
A short history lesson… A gent by the name of DD Palmer apparently cured a man’s deafness in 1895 by performing a manipulation on his neck, and this is the miracle upon which DD made his mark, and from which chiropractic began. A connection was made, in the minds of some, that diseases come from malalignments within the spine. Not just some, but all. They figured that by fixing these malalignments, or “subluxations”, a person could be cured of all sorts of ailments. Sounds simple, huh? Sounds like a concept that’s plausible and attractive, especially for those seeking “natural” therapies.
So here’s the kicker. There are simply no nerves, no pathways at all, that link the cervical spine to the parts of the ear to do with hearing. There is a cervical (neck) nerve branch that supplies sensation to the skin near the outer part of the ear, but no neck nerve at all within the middle or inner ear. So how does a manipulation of the neck affect hearing? Well, it can’t. No way. It’s just not plausible. No matter how hard you want to believe it, it just not possible.
When the Wright brothers built the first successful powered aeroplane, they formed the basis for the development of aircraft we see today, and people can still build replicas of the plane and fly it. The scientific principles haven’t changed – techniques and understandings have deepened, but the Wright Flyer can still fly today.
Likewise, if DD Palmer was able to cure deafness in 1895, then modern chiropractors should be able to do this as well – they should be able to fly the first plane. According to my checks, there is little evidence that this trick hasn’t been performed since. Why not? DD Palmer did it, so why aren’t chiropractors curing deaf people world wide? Surely that should be the first therapy taught to young chiropractors!
If you want another reason to doubt the concept, then what about high quadriplegics, like Christopher Reeve, who had perfect hearing, but a non-functioning spinal cord. Not malaligned or subluxed – not functioning at all. So when you hear someone tell you this story, just remember that you’re hearing it without using your spinal cord.
Some chiropractors insist that adjusting the spine can, indeed, fix your hearing, your diabetes, your child’s autism and asthma, and “enhance” your immune system. They invented the concept of “innate intelligence” to explain it, which is some sort of life force that cannot be seen, does not follow nerve pathways, yet can somehow be manipulated and adjusted by cracking a person’s neck or back. How is it that something, that cannot be seen or touched or imaged, be “adjusted”? How can you know that the supposed “adjustment” is being performed correctly, healing the “innate”, when it cannot even be measured? You’ll need to ask a chiropractor that. It’s a convenient and intuitive concept, but completely without evidence. None. And much evidence to the contrary. It’s a fairy tale, designed to make people believe.
Many chiropractors claim that they can help with middle ear infections in children, but once again, there are simply no nerves that come from the neck and go to the drainage tube (Eustachian tube) of the middle ear. They are simply not connected. No nerves in the cervical spine goes to or comes from the Eustachian tube. Is it the “innate” again? It must be, because it’s not anatomy.
At some point you’ll probably come across the term subluxation. This is a chiropractic subluxation which implies an abnormal movement of the facet joint. It is not visible on X-ray or MRI studies. This is opposed to the subluxations that I treat, which are demonstrable with imaging. If the chiropractic subluxation was the cause of disease, then why aren’t people with adolescent idiopathic scoliosis riddled with disease? After all, their spines are abnormally curved in all sorts of directions and have abnormal and unbalanced movements. Long term studies of these patients however show no difference in their health compared to the general population (unless the curvature impacts on their breathing, but this is only for people with very large curves). In the UK, the General Chiropractic Council stated that the chiropractic vertebral subluxation complex “is an historical concept” and “is not supported by any clinical research evidence that would allow claims to be made that it is the cause of disease or health concerns.” So throw that out as well. If you want to respect your chiropractor, ask them to never speak of subluxation.
Some chiropractors go so far as to claim that by adjusting the spine they can “boost” the immune system, to the point that you do not need vaccination. This is a very attractive sounding claim, but again, seriously flawed. There is simply no proof for the claim. Nada. And what if by “boosting” the immune system, it brings about auto-immune disease like rheumatoid arthritis? Do you want someone doing that to you? The only proven way to reduce the risk of many deadly infectious diseases is – you guessed it – vaccination.
The vitalistic chiropractors claim to address the body as a whole (vitalism), and that conventional doctors only see the body as a sum of parts. Doctors are fully aware of the entire body functioning as a whole, and any claim to the contrary is just nonsense. I’ve seen chiropractors claim that the SF-36 score (a whole-body health score) is only used by holistic or vitalistic practitioners like themselves, but even a quick browse of the literature shows that scores like this are used all the time by all branches of medicine. Contrary to their claim, conventional doctors receive an education that covers all aspects of the human body. To become a highly specialised spinal surgeon I’ve had to pass exams in fields as diverse as immunology, renal physiology, biomechanics, radiology, epidemiology, anatomy, pharmacology and pathology. Who is “holistic” now?
Let’s be honest, if your chiropractor mentions the words innate or subluxation, or attempts to provide you treatment that isn’t directly related to spinal complaints, then you’re dealing with a non-evidence based practitioner. That may be fine for you, if that’s what you’re looking for. Enjoy it. But please don’t expect it to produce anything more than the placebo effect. If that’s what you’re willing to spend money on, then that’s your choice.
As you may appreciate, there are many chiropractors actively seeking to establish themselves as evidence based practitioners. They are to be encouraged, and if they can produce good evidence, then I’ll be the first to applaud them.
Only once a treatment modality, no matter what it is (chiropractic, physiotherapy, homeopathy, and conventional medicine) can describe it’s mechanism of action, its effectiveness and its safety profile, will it, can it, should it, be accepted. Life is too short, and dare I say, the health dollar is too limited. Show me the evidence, and I will embrace.
Yesterday I was interviewed by a journalist from The Age, and it really shouldn’t have come as a surprise to learn that the article hasn’t reflected the message I thought I was quite clearly giving her.
Here’s the background: Medtronic, a large medical device company, brought to the market Infuse, which is a Bone Morphogenic Protein (rhBMP-2 to be precise). This is soaked into collagen sponge and placed around fusion sites, and it works on the cellular level to transform cells to make bone. Simple enough. It has been used widely, by myself and most other spinal surgeons, to help the body fuse a spinal level.
Eugene Carragee, a prominent Stanford surgeon, raised concerns about Infuse in 2011. In response to those concerns, Medtronic sponsored a large project in order to address these concerns. In doing so, they set a new standard in “in the emerging era of open science“. In fact, they exceeded expectations – not one but two independent groups of researchers were granted access to every last morsel of data that the company had regarding Infuse. Completely independently, the two groups analysed the data and published their findings recently here and here.
It gives a surgeon and any researcher interested in Infuse confidence knowing that two independent groups produced such similar results, and yet at the same time, each group emphasised different aspects of their results.
it’s as good as bone graft to create fusion – that’s the key message to take home people. When a patient’s own bone can’t be used, then we now know that without a doubt Infuse will do as good a job.
When used in the anterior neck, it’s associated with increased complications – surgeons have know about this for many years now and it’s no longer used there.
complications such as retrograde ejaculation are about as common with Infuse as with bone graft.
there is no appreciable increase in the risk of cancer with Infuse – this was a great concern, and although the cancer rates were very slightly higher in the Infuse patients compared to bone graft, it was not higher than the normal population, and after four years there was no difference at all. I suspect this will turn out to be a statistical anomaly. Medtronic are continuing to research this area.
If you’ve had a fusion with Infuse, there is not need for concern. I will continue to use it, as well as similar products, when appropriate, with the patient’s consent. The journalist and the editors clearly have a newspaper to sell, and boring science is always outweighed by sensationalism.
Medtronic should be commended on what they have done with the YODA project. With complete transparency, they have opened up their data for not one but two independent reviews, and the results are difficult to argue with. They have set the standard by which other companies must now live up to – a new era of open science.
Over the next few months many of you will hear about a paper that has just been published in the European Spine Journal. The study, from the University of Southern Denmark, suggest that back pain can be cured with a 100 day course of antibiotics, and certainly they provide some good evidence for that. Certainly some surgeons are calling for a Nobel prize, but I don’t think it’s that significant yet. Maybe if you operate on a lot of people with back pain it’s significant, but those of you who know me, know that surgery for back pain is a last resort.
So, what about the study?
Well, it looked at people who had Modic type 1 changes on their MRI after having a disc herniation, whether or not they had surgery for the herniation. A prior study from the same team, and others, showed that many disc herniations (about half) are infected with a very low grade bacteria called Proprionibacterium acnes which also causes… yep – acne. It has a peculiar ability to be benign enough not to produce an acute inflammatory reaction, but at the same time it produces propionic acid, which is known to be able to dissolve bone. Wow. What a bug.
Now, modic type 1 changes are only about 10-40% of modic changes, the other types being 2, the most common, and 3, the least common. Modic type 1 changes appear dark on the T1 films, and bright on the T2 films, and represent oedema. One way of remembering this is that type 1 changes appear the same as the CSF. See below.
An example of Modic Type 1 changes
Anyway, back to the study. They randomised the participants into three groups. One group received a placebo, and the other two received the antibiotic (amoxicillin–clavulanate (500 mg/125 mg) tablets three times a day, at 8 h intervals, for 100 days) in two difference doses. They found that the antibiotic subjects improved remarkably well, usually beginning at 6-8 weeks after commencement, after 100 days, and it appears that the improvement lasted out to one year – well after the antibiotics had ceased being taken. Within the placebo group not much changed at all. In addition, the amount of modic change visible on their MRI’s also decreased, which supports the notion that it is due to a chronic low grade infection.
Were there problems with the antibiotics? Mostly gastrointestinal of nature – loose bowel movements and increased flatus. Thanks for asking.
So what does that mean? Well, if I had type 1 modic changes and back pain, I’d be considering this study carefully. However, as a public health measure, we need to realise that this isn’t the cure for ALL back pain – maybe only 10 to 40% of back pain patients. We know that back pain has many causes, but I think it’s just amazing that this subset may have found a cure. Of course, we need to see that these results can be repeated. Hold back on the Nobel prize for now…
There’s information on spinal conditions, prevention, exercises for your back, and descriptions of operations. There’s text pages, videos and brochures. I ask you to have a look and give me some feedback. Too much? Anything else you’d like to see? Can you find things easily, or not?
My car was recently in getting some work done and we had a Ford Territoy as a loan car. Having not driven civilian 4WD’s much before, I was disappointed to see how much space around the car you can’t see. There’s huge blind spots front and rear, and not much help without a reversing camera.
Some of you will remember my four rules about looking after your spine. Four rules never really sat too well with me. Even though it’s an even number and the square of two, it needed to be five – i’m a decimal kind of guy after all. So after much deliberation, and some common sense, I’ve figured out my FIVE rules for looking after your back.
1. Don’t smoke.
2. Lose weight.
3. Do “Core” Exercises.
4. Maintain good posture, and lift things with a good technique, and at last
5. Avoid aggravating activities. This is the one that took me some time to realise needed to be in here. How many times do people say that their back is fine until they do gardening / lift an engine block / etc. It sounds simple, but if you can avoid those activities that cause back pain, then that’s a very simple and drug free way of looking after your back. Some activities can’t be avoided, sure, but try and not do the things that hurt. Does that mean you’re getting old? Well, how do I say it? I know – I wont.