Author: John Cunningham

Back pain, spinal surgery and where we’ve got it wrong.

Spinal surgery remains a powerful tool when used judiciously

The science of spinal surgery is much more advanced than biased commentators would like to admit, writes orthopaedic surgeon John Cunningham. As published today in Medical Observer:

In the last few weeks we’ve been bombarded with reports of what some consider to be the best treatments for back pain, and almost every time someone has mentioned spinal surgery, it has been in disparaging terms.

Apparently, the gloves are off when it comes to my profession, with an Australian vascualar surgeon who was commenting on a Lancet study that said back pain was often mistreated, claiming in the media last month that it was “almost certain” the medical industry influenced surgical decisions.

Armchair critics abound, it appears.

The truth is that the science of spinal surgery is much more advanced than biased commentators would like to admit.

Here I will declare my bias in that I only ever offer patients operations when the best available evidence supports that decision, with a diagnosis established by taking a careful history, a thorough examination and after assessing the results of judiciously ordered investigations and interventions.

That offer takes into account the patient’s wishes, their comorbidities, their functional status, psychological status and everything else that makes up an individual.

Spinal surgery is not easy, it’s not straightforward, and it’s notoriously difficult to generalise about. Experienced spinal surgeons do not, however, practice in a cowboy fashion.

The current best practice is that for trauma, both cervical and thoracolumbar, scoliosis and tumours we follow guidelines and treatment algorithms that are supported by solid evidence.

For the degenerative conditions that are currently being thrust before us, the best available studies are the SPORT trials. They show that people with degenerative spondylolisthesis, disc herniations and spinal canal stenosis who had surgery did better functionally than those who were managed non-operatively.

I’m not saying that surgery is for everyone, but that’s what the best available evidence tells us – warts and all.

The harsh reality is that back pain is a symptom and always has been a symptom. It has only been in recent times that it has become a diagnosis in the eyes of some.

By simplifying the complaints of many hundreds of thousands of patients a year to the umbrella term ‘back pain’, and vigorously promoting recipe medicine, many patients with surgically correctable pathology could miss out on a cure.

Choosing Wisely Australia, via the Faculty of Pain Medicine of the Australian and New Zealand College of Anaesthetists (ANZCA), quite rightly stated that surgery was not recommended for uncomplicated axial chronic low back pain (UACLBP).

In other words, when you have back pain that is not due to a structural defect, only in the axial spine, not claudicant, and not radicular, then surgery is not recommended. I don’t disagree.

However, the symptoms that accompany surgically treatable conditions are often confused with or dismissed as UACLBP.

Symptoms such as neurogenic claudication, sciatica, and the pain of tumours and sagittal imbalance are all concepts that any back physician should be familiar with, and be confident to differentiate from UACLBP. In spine “everything is in the history.”

If we want to do the best for our patients (and we do) then discussing back pain and surgery in the same paragraph makes a mockery of both the diagnosis and the treatment.

By losing the nuance and the subtlety of the causes of pain of spinal origin, and grouping all under the umbrella of ‘back pain’ we are doing patients and ourselves a disservice.

Spinal surgery can and is a very powerful tool that can help patients significantly, often restoring their level of function dramatically equivalent to that restoration commonly following hip and knee replacement.1

We’re all here to help our patients and it’s up to each of us to know our limitations and also our strengths.

We know spinal surgery works when applied judiciously, intelligently, with precision, with skill, and with heart.

 

1. Mokhtar SA, McCombe PF, Williamson OD, Morgan MK, Sears WR. Health related quality of life: A comparison of outcomes following lumbar fusion for degenerative spondylolisthesis with large joint replacement surgery and population norms [Journal Article] Spine J. 2010 Apr;10(4):306-12.

2018 Wings For Life World Run – Three months to go!

Most of you would know that I have to deal with many people every year who have suffered spinal trauma, and some who have suffered a cord injury. Many of those have become the most inspirational people I have ever met. But did you know you can help them directly? The Wings For Life World Run is an annual fun run to raise money for spinal cord injury research via the Research Foundation. As a participant it’s an extraordinary event where the finish line is whenever, or should I say wherever, the catcher cars catch you. It is run simultaneously all across the globe so the start time in Melbourne is 9pm, usually on what feels like the chilliest night of the year. You soon heat up though as the kilometres start to tick over!

The other wonderful thing about the race is that all the costs are covered by company donations, with Red Bull being the major supporter. That means that 100% of your donation or entry fee goes directly to spinal cord research. How good is that?

So, who’s going to come running with me? Or help with fundraising? Or donate?

Wings for Life #WorldRun

Last night I again completed the Wings for Life #WorldRun, a unique simultaneous international “fun run” to raise money for spinal cord research. Instead of a fixed finish line, a chaser car follows the pack and gradually passes the runners, ending their race. It’s an interesting way to approach a run and also raises money for a great cause, obviously close to my heart. A bit like putting your money where your mouth is, or in my case, my legs.

I must say last night’s rain and cold was helping no one! Last year I made 13km; this year only a smidge over 10km. Two of my registrars also took part and did 16 and 21km! I’m taking the option of claiming “old age” compared to them, as well as any other excuse I can think of…

One hundred percent of all donations go to research, with Red Bull and the other sponsors picking up the cost of staging the event. If you’d like to donate, please go to this page to do so. I don’t need to tell you it’s a worthy cause again, do I?

All the best,

John

 

What’s an orthopod like you doing in a joint like this?

I was honoured this year to be awarded the Order of Australia Medal for service to medicine, and to the promotion of immunisation. The most common question I’ve been asked, however, is how or why an orthopaedic surgeon became so interested and involved in immunisation. As many of you would know, I have several degrees to my name, and the one that sparked my interest in this field was the Masters of Clinical Epidemiology. For those of you who know what epidemiology is, please stop yawning. For those of you that don’t, it’s the study of how medical research is carried out, and how it is analysed and conclusions reported. You may now commence yawning.

The thing is, the vaccination rates in Australia have been steady for many years, somewhat lower than the ideal 95%, and also alarmingly low (<50%) in some communities. Despite the best efforts of professional vaccination researchers, nothing seemed to have an effect on this rate. Children were suffering and in some cases dying because they were not vaccinated, or worse, because the people around them were not.

Enter Meryl Dorey and the Australian Vaccination Network (AVN). Meryl sold a message of false concern for children’ health, and often promoted herself as an “expert” in vaccination. Far from it, she and her ilk would misquote research, use unlikely stories of “vaccination damage” and, of course promote, the discredited idea that vaccination was responsible for a whole range of diseases. This last idea has been proven false more times than I’ve had hot dinners. She even suggested that “battered baby” syndrome was due to immunisations and not domestic violence. The sad truth is that Meryl and people like her spread misinformation and fear to parents who often didn’t know any better.

This all came to a head about five years ago when she made it onto national television at the same time as a real immunisation expert, as well as the parents of a child who had died of whooping cough (she was too young to be immunised). A Facebook group, Stop the AVN, was formed and shortly afterwards I joined it. The rest, as they say, is history. We lobbied, we cajoled, we argued and we lobbied some more. We exposed the media to the lies the AVN spread and effectively had it banished from the news. No longer was Meryl an “expert” but now she was an “anti-vaxxer”. The membership plummeted, the income fell, and the AVN is now only a shadow of it’s former self.

Of course, others have tried to step into the breach and get a slice of the money and fame, but for a couple of years now they have been duly recognised by the mainstream as charlatans, liars and not people whose words can be trusted. Judy Wilyman, who was awarded a PhD by the University of Wollongong, has been widely criticised for the content of her thesis, and for writing a document based on false assumptions about vaccination. It was never examined by anyone with real expertise in immunisation. My thoughts can be read in an opinion piece in the Australian, which you can read here. She is still emailing myself, journalists and UoW academics demanding that someone pay her attention.

Sadly for her, no one has.

But what of the positive side? Beginning with a newspaper campaign called “No Jab No Play” restricting day care to immunised children, the Federal Government took the scheme one level further and implemented “No Jab No Pay”, closing a loophole that vaccination refusers were using to get government payments that they were not entitled to. As a result, vaccination rates have risen more than they have in ten years because there’s less parents refusing vaccination, but also because those who found it difficult to get their children vaccinated are now much more motivated to do so.

Vaccination has finally been given the priority it deserves. Denialists, liars, fear mongers and rogues have been put in their place. Children are safer now than they were a year ago.

And we will count the number of lives saved by the small graves that will not need to be dug.

John

Metal or PEEK? Pass me the Cellular Titanium…

To many of you having a spinal fusion, you may not be aware of the enormous biomedical engineering research and design effort that goes into the every implant used. Titanium and its alloys are metals which have a long track record of being biocompatible. We use titanium throughout the skeleton for trauma, dentists use it for implants, and of course we use it for the screws and rods for fusions.

For reasons that may be historic, however, for many years we’ve been using PEEK – a form of plastic – in the interbody space where the disc is removed. By itself it does not cause any artefact when X-rayed, and has some other theoretical advantages too. Some doubt has been cast though on the effectiveness of PEEK and whether or not it may inhibit bone formation – the exact opposite of what we want to create a fusion.

I’ve been very fortunate this year to have been involved with a Dutch/German company called EIT who asked me to help design their interbody cages for PLIF. The cages are made using a 3D printing technique called Selective Laser Melting and then treated with a process that roughens the surface making it more attractive for osteoblasts, and that’s what you want to make a fusion. You can see an explanatory video here.

The new cages are safe to use, don’t require any changes to surgical technique, and have minimal impact on post operative imaging, which is often a concern with solid metal implants. As you can see below, even with PEEK cages below, there is significant “noise” from the tantalum markers inserted into the PEEK. The EIT titanium cage inserted at the level above though has none of this noise and it’s relatively east to see the fusion progressing.

This is a cage that bone grows towards, and through, and I believe represents the next step in fusion technology.I’m now using EIT titanium cages for PLIF, TLIF and ACDF procedures, and have been very satisfied with the results.

John

Declaration: I do not receive any royalties from EIT but obviously have a research and development agreement with them.

Towards faster, secure communication

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 (argus@cunningham.com.au). 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.

It’s the way of the future.

John

We’re moving!

So, not the most exciting post you’ve ever read, but you’ll be wishing you remembered it when I don’t answer the door next year! From 1 January 2015, I’m packing up my rooms and moving to:

Epworth Medical Centre
Suite 2.7
173 Lennox St
Richmond VIC 3121

Phone and fax numbers will not change – the Telstra people promise.

As well, from February 2015, we will also be offering appointments on Monday mornings at:

Medical Specialists on Collins
Level 4
250 Collins Street
Melbourne VIC 3000

Give blood, save a life

Towards bloodless surgery…

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.

Positioning

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.

Incision

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.

Medications

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.

Reuse, recycle

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.

Infuse (rhBMP-2) and the C-word

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.

It is highly unlikely that rhBMP-2 causes cancer.

Name the Virus!

There once was a Dave who thought it would be desirous,

That instead of decorating his lab with a bearded iris,

He’d run a competition

to help fund completion

of his study, so he made “Name the Virus“.

As you probably realise now, I’m not very good at limericks, but to be fair, “virus” isn’t the easiest word to rhyme.  “Name the Virus” is a funding opportunity you have to help the Florey Institute raise funds to complete some of their projects.  For the first time, YOU can donate money and be rewarded by the scientists of the Institute.    Apparently cookies are offered, and if you donate enough, you can also decide the name of one of their virus vectors!  For only $2,500…

You get to “Name the Virus”!

As each viral vector is created it will be named. The Name must be 10 letters or less and be socially acceptable. E.g. If the name “noodles” was chosen the viral vector would be called “pNoodles” and this name will appear in any publications or presentations in which it is used. Each rewardee will be sent a copy of the “map” of the viral vector they named.

Of course, there’s rewards for smaller amounts to, all the way down to $20.

Surely some of you reading this could spare a few bob to help Dave take over the world… oops!  I mean Name the Virus.