Kenny Rye, Worthing was one of the early patients. Thereafter followed a quite infamous newspaper article in the Good Health section of the Daily Mail in December 2007 as it was likened to a “contact lens” in his toe – see image for original article.
Kenny Rye, then 39, was diagnosed as having osteoarthritis after having had problems & pain from his big toe, probably caused as a result of a trauma to his foot from a motor bike accident he was involved in some 20 years ago. Mr Rye, from Worthing, researched details about pioneering surgery which used a specialist technique (Synthetic Cartilage Implant) He visited the surgeon whom advised him that his cartilage, the protective tissue which should have ensured smooth movement, was damaged & being pushed out by the bone, causing him friction and pain. With conventional surgery Mr Rye was told he would have to have the toe joint fused together using wires and metal plates which would stop the pain but leave the toe rigid, therefore limiting physical activity and still with the possibility of painful symptoms recurring.
The orthopeadic surgeon had been carrying out an alternative technique in Germany which involved using a PVA Synthetic Cartilage material now known as Cartiva® SCI (Synthetic Cartilage Implant) made from a similar substance to that used to make soft contact lenses but developed so even under pressure and friction it does not wear.
Mr Rye was the first patient in the UK to have this operation. Mr Rye shortly after the procedure said: "It has been a complete success, I had been forced to adapt my lifestyle and give up the running and the long walks but now I am back doing them again, I'm training for a triathlon and I've got my quality of life back. "The more people know about this surgery being available the better. It gives people a real choice."
In 2014 Cartiva Inc asked Mr Rye, being one of the early patients to have this treatment, if he would take part in a small non-scientific collection of data on several long term patients. Mr Rye kindly offered to participate. An MRI scan was taken to check that the implant was still in place & had not worn, the results were positive. Mr Rye’s feedback was that, 7 years on from his operation he was still extremely pleased the results, he had good mobility, and the pain he had experienced prior to the procedure had not returned.
Mr Rye commented “he would have this procedure again if need be (on another toe) & he would highly recommend it to others”.
Osteoarthritis affects seven million Britons. Many people need an artificial replacement joint, but until now the only option for the big toe was fusing the joint. Anne Merrill, 64, a retired office worker from Sheffield, had a ground-breaking new procedure.
My problem began when we went to my son’s wedding in Las Vegas two years ago. I was in our hotel bedroom when I walked into the leg of the bed and stubbed my big toe.
We all laughed at the time and, although it really hurt, I didn’t bother seeing anyone about it. But as time went on it became more and more painful.
Four months later, I finally went to my GP. He first diagnosed gout, then arthritis, and gave me various painkillers and creams. But nothing really helped.
I went to see the doctor six months later. I’ve retired but have a part-time job in Sainsbury’s clothing department, where I am on my feet all day, and the pain was becoming unbearable.
I also had difficulty putting on shoes because it hurt too much to bend my big toe and there was swelling around the joint, too. I could only manage sensible shoes like trainers, Crocs and flats.
Last May my GP referred me to surgeon Chris Blundell. He took some X-rays and told me I had osteoarthritis in my big toe. This is when the cartilage — the spongy tissue which acts as a cushion between the joints — is damaged, so the joint doesn’t work properly and the bones rub against each other.
That was why my toe was so painful. Stubbing it in Las Vegas had started the osteoarthritis off — or made it worse.
Normally they ‘fuse’ the joint with a metal strip to stop the bones moving, but I wouldn’t have been able to bend my toe at all.
Mr Blundell then said there was a new type of implant — a bit like a wine gum — which can be put in to replace the cartilage and keep the joint flexible. He said the treatment was being done as part of a large clinical trial, and I could be one of the first people to have it.
I had a general anaesthetic and an ankle block — injections of local anaesthetic to numb my foot from the ankle down to help with the pain — but after the surgery I was back home by 4.30pm. My big toe was stitched and wrapped up, and for two weeks I had to wear a special protective boot.
But two months on I am walking around without any pain, and I can bend the toe downwards, which means I can wear boots again — even my wellies.
I have to go back to the hospital every six weeks as it’s a two-year study, but I expect I will be getting my heels out much sooner than that. I can’t wait!
Chris Blundell is consultant orthopaedic surgeon at the Northern General Hospital, Sheffield. He says:
The big toes take about 70 per cent of the body’s weight, so there are enormous pressures acting on a relatively small joint. It is, therefore, not surprising that there are high rates of wear and tear, and osteoarthritis in this area as people get older.
The pain often leads to patients walking or moving differently, which puts extra stress and strain on other joints, such as the knee.
It can also lead to a more sedentary lifestyle, which can place sufferers at risk of weight gain and cardiovascular disease.
The current treatment for severe osteoarthritis of the big toe is arthrodesis, or fusion, in which we insert a metal strip into the joint between the two bones and fuse the bones together with screws so that they no longer rub against each other. This is usually performed on younger people.
Pioneering procedure: Anne has been left with just a small scar from the operation which took 30 minutes.
Although fusions do get rid of the pain, the toe is permanently rigid and no longer bends at the joint. In older people, osteoarthritis can be treated on occasions by removing the toe joint altogether.
This new toe implant, made by the American company Carticept, provides a new surface in the joint to stop the ends of the bones rubbing. It is circular, about the size of a large pill, and made of hydrogel, the substance used in contact lenses, which is 60 per cent water and 40 per cent polymer.
The material is designed to have flexibility similar to that of human cartilage, and is strong enough to withstand the load put on the joint. It’s a relatively new material and is being looked at for use in other joints.
The big advantage over fusion is that the implant preserves the joint, which means that the toe can be bent. The procedure takes about 30 minutes.
First, an inch-long incision is made above the joint, so the ends of both bones are exposed. The end of the bone that -connects the toe to the foot is then drilled to create a small pocket so that we can insert the implant. Because it is similar to cartilage, it cushions the joint on both sides.
Once the implant is in place, the incision is stitched and the patient goes home.
We are one of four hospitals in the UK which are carrying out these procedures as part of a research study. About 12 people in the UK have had the operation so far.
For more information on toe arthritis from Arthritis Research UK visit arthritisresearchuk.org
Painful big toe? Don’t want a fusion? These Sheffield surgeons may have the solution using an American implant with a difference.
Big toe arthritis is a very common condition affecting adults of all ages but most commonly becoming apparent in middle age. In arthritis, the glossy cartilage that lines the joint surfaces wears away, often leaving a painful, stiff and swollen big toe joint. Arthritis is different from a bunion, where the big toe becomes bent towards the lesser toes and the swelling is on the inner border of the foot.
In big toe arthritis, the swelling is more on the top of the foot and is associated with a stiff big toe joint. The medical term for this condition is hallux limitus which, translated into English, means ‘big toe limitation’.
Relief simply abounds
Often the pain starts during or after prolonged activity or exercise but, because the condition usually progresses, the symptoms gradually start to appear after less strenuous activity. Therefore, the pains start to restrict activities such as recreational walking and dancing. For women, the stiffness can interfere with the ability to wear high heels as this pushes the toe upwards and causes more pain as the bony swelling at the top of the toe (osteophyte) causes impingement.
Treatment starts with avoidance of activities that provoke the pain. As the pain worsens, simpler activities that cannot be avoided cause pain. Sometimes footwear changes and insoles can make a difference either by changing the way the foot moves or by accommodating for swelling.
If the pain persists after all these options have been tried, then surgery can be considered. Traditional surgical treatment involves either removing the swelling on the top of the joint (cheilectomy – cheilosis is Greek for ‘lips’ so this involves removing the ‘lips’ of the joint) or by formally stiffening the joint (meaning a fusion or arthrodesis). However, if the pain arises from deep within the joint rather than the ‘lips’ knocking into one another, a cheilectomy often fails to provide a welcome relief. A fusion will remove the pain but permanently stiffens the joint, and can impede activities that require a flexible big toe.
The Cartiva solution
So the Americans have come to the rescue with a device called Cartiva, which is made from a material similar to that used in making contact lenses. This has been used several thousand times around Europe but its use in the big toe has never been properly assessed until recently, hence the involvement of Chris Blundell and Mark Davies, two leading foot and ankle surgeons based in Sheffield.
‘We were part of a multinational team which compared the Cartiva implant with traditional joint fusion and this study – the largest ever undertaken for the big toe joint – has now been completed. Although the formal results will not be released until the summer, we are happy that this operation keeps the joint moving and reduces pain significantly,’ says Mr. Blundell, who was the one of the lead investigators for the study.
Furthermore, Mr. Davies, who was responsible for recruiting most of the patients to the trial in Sheffield and carried out many of these operations, says: ‘I am confident that this product, which after all is made from the same hydrogel polymer put onto people’s eyes all around the world, is very safe. We saw no ill effects from it at all. The procedure is simple to perform and is carried out as a day-case procedure in our hospitals.’
Mr. Blundell adds: ‘The operation is performed either with a local anaesthetic or with the patient asleep. After the procedure, we ask patients to rest for a couple of weeks, keeping their foot elevated most of the time while the wound completely settles. ‘Once we are happy that the soft tissues are healing well, people can get on with walking about, although we don’t like people to do sport or strenuous activity on the new joints until they are six weeks post-operation.’
‘Delighted with the outcome’
One patient who was part of the study and had her operation three years ago was asked if she would have it done again. She says: ‘Certainly! In fact I have no pain at all and would very much like my other big toe doing as that is now getting painful.’ She had her operation as a day case under an ankle block. ‘I had no pain after the first day and am delighted with the outcome.’
Mr. Davies was asked whether everyone with an arthritic big toe was suitable for a Cartiva implant. He says: ‘As with most medical devices, not everyone will benefit. For example, those who have extremely stiff big toe joints or patients with excessive demands on their feet – such as long-distance runners or heavy manual workers – could potentially have less benefit due to excess stresses placed on the joint.’
FOR MORE INFORMATION
If you have a painful big toe because of arthritis and you do not wish to have a fusion, you may want to get in touch with Chris Blundell or Mark Davies for a consultation. Visit www.sheffieldorthopaedics.com or www.cartiva.net. To arrange a private appointment with either expert, their secretary can be reached on 01142 632144 or firstname.lastname@example.org.
ORIGINAL ARTICLE HERE
Please note - we would like to correct a statement within this article at the end that says this procedure is not available on the NHS. It is available both on the NHS & privately.
Daily Mail - September 15, 2014
By Carol Davis
Around half a million Britons have arthritis of the big toe — now, a new implant can end the pain and stiffness this causes. Val Cornwall, 67, a retired carer from Hillingdon, Middlesex, had the operation in February 2011.
In December 2010, Val Cornwall was diagnosed with arthritis of the big toe.
When my right big toe started feeling very painful five years ago, I wasn’t too surprised. I used to be a hairdresser, then gave it up to look after my sons and my husband, Ron, who is severely disabled after a major stroke 20 years ago, so I’ve spent a lot of time on my feet. But, within a few weeks, the pain became so bad that walking hurt.
It was really sore and swollen underneath the joint, where the big toe meets the foot, and on the inside of the foot, too. I saw my GP who diagnosed osteoarthritis — where the cushioning cartilage between the toe and foot bones wears away. While he didn’t know why my right toe hurt particularly, I could only think that, when I’d moved Ron, I’d put a lot of weight through my right side.
He referred me to a podiatrist on the NHS, whom I saw a few months later. I had a steroid injection straight into the joint, which ended the pain for a few months — but then it came back, so I had another one.
I switched to comfortable shoes, as the podiatrist had advised, giving up high heels and wearing stiff-soled shoes so my foot didn’t rock, but, even then, the pain was always there. And it was getting worse — it would wake me at night, and using the stairs hurt, because I had to bend my toe. I took paracetamol when it was bad, but I didn’t want to keep having steroids because I’d heard that, long term, they could have side-effects such as weight gain.
In December 2010, I was referred to Andy Goldberg, at the Royal National Orthopaedic Hospital in Middlesex. There, X-rays confirmed I had arthritis of the big toe. Mr. Goldberg said I had the option of surgery to fuse the joint in place to stop the pain — this would mean fixing the long foot bone and the first toe bone together using plates or screws, so that bone would grow over the joint. This would get rid of the pain, but I wouldn’t be able to bend my toe.
However, he then said he was about to take part in a trial of a new implant, called Cartiva, which was made of a material like putty, and would fit between the bones to stop them rubbing together — the implant would act as a shock absorber, like cartilage.
I’d still be able to move my big toe to walk and balance, but the pain would go. It sounded great. I had the 40-minute operation under general anaesthetic in February 2011, and left the hospital with painkillers the next morning. I could put weight on it even then, using a crutch, though it was bandaged. I wore a protective shoe for six weeks.
Even going upstairs to the bathroom wasn’t a problem — the pain in my big toe had simply gone. Now, I’m as active as ever. My husband is in a nursing home and it’s great to be able to visit him without worrying about how much the walk will hurt. I’m just delighted that the dreadful pain in my toe has gone for good.
Andy Goldberg is consultant orthopaedic foot and ankle surgeon at the Royal National Orthopaedic Hospital in Middlesex.
Arthritis of the big toe, or hallux rigidus, affects about one in 40 Britons over the age of 50.
We walk with a rocking motion, pushing off with the big toe with every step.
Over time, the cushioning cartilage that stops the ends of the bones rubbing together can wear away, and the joint becomes stiff and painful.
The condition can run in families, or may start with an injury to the big toe — there may also be inflammation, caused by conditions such as rheumatism and gout, and this inflammation can eat away at the cartilage.
Once the cartilage starts to wear away, the body responds by forming extra bits of bone, or spurs, which may also grow in the damaged joint, restricting its movement and making it more painful and stiff.
It can help to lose weight and reduce the load, or to try special footwear (with a rocker sole that allows a rocking movement as you take a step) or a stiffened sole to protect the toe.
Painkillers can help and so can steroid injections. But it can get progressively worse — if all else fails, we can offer corrective surgery to remove the bony spurs in some cases. Or we can replace the joint, or fuse the end of the foot bone to the toe bone.
This means it’s rigid, and can no longer move, so the toe is no longer painful. It’s successful in 80 to 90 per cent of cases, but many patients don’t like the idea of having a rigid big toe. Some people have to change their gait slightly, and it makes it hard for women to wear high heels.
The Cartiva implant was developed in the US. It’s 9 to 10 mm across and about 1.5 cm in height. It compresses slightly to fit snugly into the bone, which keeps it in place.
The implant slides into the end of the foot bone and acts like cartilage, cushioning the joint so it glides smoothly.
A clinical trial on Cartiva, which recruited 236 patients across the UK and Canada, has concluded and is promising, though we don’t have full results yet.
Like all surgery, this carries risks, including bleeding and infection, and the risk of pain, swelling, or numb areas. There is also a theoretical risk of rejection — the body responds to a foreign object with inflammation, pain and swelling.
The operation takes about 40 minutes under general anaesthetic.
First, I make a 6cm incision on top of the toe, protecting an important nerve and tendon by moving them to one side. I open up the joint, and clear away any bony spurs using surgical pliers and other instruments.
Then, I put a guide wire into the central point of the metatarsal, or long foot bone, where the bones rub together, and check its position using X-ray.
I use a drill bit to take out a section of the top of the metatarsal bone 1mm smaller than the implant, removing some of the damaged cartilage, too. Then I put the implant into place, compressing it so that, once it’s inserted, it expands and fits snugly into the bone.
Then I close the incision using dissolvable stitches. The patient goes home that day or the next with a special protective surgical shoe, which they wear for six weeks.
We hope the implant will last indefinitely and that once we have full trial results, it will be recommended by the National Institute for Health and Care Excellence (NICE) and be available on the NHS.
‘Any forefoot surgery is likely to leave the patient with swelling, which can last six to 12 weeks,’ says Mark Herron, consultant foot and ankle surgeon at the Wellington Hospital in London.
‘As well as standard operative risks such as a small risk of deep vein thrombosis, there is a risk of infection. We judge any implant — and Cartiva is of course an implant — on how well it survives over ten years.
‘While patients may want to consider Cartiva as an option, they should be aware that we do not yet have that information over ten years, and so there is still a degree of unpredictability since this is so new.’
ORIGINAL ARTICLE HERE