Good afternoon.
Allow me to introduce myself. My name is Pascal-André Vendittoli. I am an orthopedic surgeon and professor at the University of Montreal. I receive funding from the Fonds de la recherche en santé du Québec. My research program involves the clinical assessment of new arthroplasty technologies for the lower limb. The inclusion of new technologies in clinical practice is a key aspect of my research program.
I will attempt to explain how we assess new technologies and their benefits in an orthopedic context. As you will see, what I will explain can apply to all areas of health care. We will mainly be discussing the use of new implant technologies. When it comes to implants, we are not talking about medication, but technological tools and devices which are implanted in certain patients, which engender a major proportion of health costs.
This is not unique to Canada. Across the whole world, the use of implants and their introduction into clinical practice are different from what is done for medication. Indeed, the various design and marketing stages medications must go through do not apply here. Some very innovative people in the field working in Sweden, including Henrik Malchau, have developed a strategy to introduce new technologies which they've called “Stepwise Introduction of Innovation into Orthopedic Surgery.”
This technological development includes four main stages: preclinical assessment of the implants, clinical assessment with specific methods to permit the assessment of these implants in the short term, the use of randomized controlled trials using patients, and finally, the marketing stage, during which the effect of these implants will be observed in patients, through registries, in populations such as Canada's.
When faced with a clinical problem for which a new technology is available, as clinicians, we must ask ourselves the two following questions. What results are we obtaining from the treatments we are currently using? What costs and risks are associated with the new treatment being offered? As you can imagine, if in most cases we have a very effective treatment for the condition, the new implant will have to be highly effective and outperform the treatment that is currently being used.
In most cases, when it comes to orthopedic surgery, we have very effective treatments. Take for example a total hip replacement. As you no doubt are aware, that treatment has the same cost-effectiveness as coronary bypass surgery. In all the countries of the world, it is used as an indicator to measure the effectiveness of a health care system.
Here are two examples of implants that have been on the market for over 25 years: a Corail femoral stem and a CLS stem. We have results from patients who received the implant 15 and 20 years ago with a success rate of approximately 98%, which means a failure rate of only 2%. These implants, for example, are quite inexpensive. In fact, the price is around $1,200; the price varies according to the annual rate of inflation.
However, manufacturers are currently developing new implants of all shapes and forms. For example, several of these implants are approved by Health Canada each year then marketed. As you can imagine, these implants are far more expensive than conventional implants and are put onto the market without any assessment of their clinical value.
Let us look at a very simple example. The Accolade implant was marketed by the Stryker company about seven years ago. After only five years, its failure rate was 5%. That femoral stem had been approved by Health Canada although its initial cost was two to three times that of conventional implants. If you consider that its failure rate is about four to five times higher than that of an implant being used for the last 15 to 20 years, you can see monster costs for the health care system.
The company recalled this implant in 2013 and replaced it by the Accolade II stem, which was just approved by Health Canada once again. You must understand that manufacturers are putting implants on the market here in Canada and elsewhere in the world in order to maximize their own profits even if their implants have not demonstrated that they are more beneficial than other established products.
Here are some other examples. Some implants look alike and the photographs seem identical. With respect to hip resurfacing, a Smith & Nephew implant demonstrated excellent results. After 10 years of follow-up, the failure rate was only between 2% and 5%. Since then, the company has marketed a similar product whose failure rate is 20% after five years. For the health care, that means many revisions, with all the associated costs, for an implant that was not sufficiently tested in a clinical setting before being marketed here.
There are many other examples. I could spend a whole hour showing them to you. There are cone-shaped modular stems that will fracture, and implants that cost the health care system a great deal, without presenting any proven clinical advantage. They were approved by Health Canada because they resembled older implants which had worked quite well.
We find ourselves in a situation of chaotic innovation in the world of implants. If you look at the graph and compare it to the first one I showed you, you will see that we have very few preclinical tests. These implants are being put on the market rapidly in order to meet manufacturers' needs and maximize their profits. Then, clinically speaking, we attempt to assess their performance retroactively. This has major repercussions on the Canadian health care system, on patients and their health.
Formerly, the patient enjoyed major benefits and faced minor risks, whereas today's patients receiving implants based on new technology are receiving few benefits and being exposed to much higher risks. You cannot see my slide on the screen, but I will continue to try to show it to you. My PowerPoint document does not seem to be going forward.
Please look at the bottom line with the short columns. For example, the number of hip implants inserted in Canada has slightly increased, whereas the costs have increased far more rapidly over the last 10 years, without any noticeable improvement of the care patients received or the quality of the surgeries.
So who is benefiting from this change, if not the manufacturers and those who sell the implants to the Canadian government and the provinces? At this time, the choice of implants is left up to surgeons and hospitals. It's much more about what is fashionable than scientific knowledge. Therapeutic choices made by Canadian doctors, when using implants, have no basis in science and should be monitored by organizations.
We should turn the clock back and develop a government plan to move from the chaotic introduction of implants and new technologies towards phased innovation, meaning premarket trials that include preclinical tests, high precision metrics using small groups of patients, and technological methods which I will explain to you, as well as clinical studies. Once the implant is approved for use, national registries would obviously be most useful.
One example of high precision metrics available in orthopedics is testing through radiophotometry or stereophotometry. During the surgery, tiny tantalum beads are inserted in the bone, which allows the measurement of the implants' performance in the very short term. A two-year follow-up—