HEALTH CARE POLICY
Routine joint replacements are more common in the United
States than in any other country. With each case, patient followup brings us
evidence to measure the success of the surgery and to measure against other
techniques and devices used for similar procedures. Are we collecting this
data to the best of our ability?
You are listening to Reach MD XM157, The Channel for Medical
Professionals. Welcome to a special segment to focus on health care policy.
I am your host Dr. Mark Dolan Hill, Professor of Surgery
and practicing general surgeon.
Our guest is Dr. William Jiranek, Associate Professor of
Orthopedics and Chief of The Adult Reconstruction Section of the Orthopedic Surgery
at the Virginia Common Wealth University School of Medicine. Dr. Jiranek currently
leads a campaign across the State Of Virginia to create a statewide joint
registry.
DR. MARK DOLAN HILL:
Welcome Dr. Jiranek.
DR. WILLIAM JIRANEK:
Thanks Mark for having me.
DR. MARK DOLAN HILL:
Dr. Jiranek, two of the most common procedures in terms of
joint replacements are the hip and the knee, and they certainly are growing in
popularity. How much increase has there been in recent years and why?
DR. WILLIAM JIRANEK:
Well, I think that the demographics of the baby boomer
generation of which I am one is, is such that the amount of people over 60 is
increasing at a fairly dramatic level and those are the people at the highest
risk for need for joint replacement due to arthritis and so it creates a huge <_____>
of potential patients out there and we have seen the incidents of joint
replacements go up somewhat and the total joint replacement we expect to
increase by about 3 times by 2020.
DR. MARK DOLAN HILL:
And how frequent is the need for a second surgery.
DR. WILLIAM JIRANEK:
The common thing in our business is about a 1% failure rate per
year so that by 20 years, 20% of the implants will have failed and needed to be
redone.
DR. MARK DOLAN HILL:
And when we talk about failed implants what you really mean.
DR. WILLIAM JIRANEK:
I mean implants that have either become loose, worn out, or
had had problems with instability that have caused the patient a lot of
symptoms and pain and forced the need for further surgery.
DR. MARK DOLAN HILL:
In this country, do we have a national database?
DR. WILLIAM JIRANEK:
We don’t?
DR. MARK DOLAN HILL:
What countries do?
DR. WILLIAM JIRANEK:
The Scandinavian countries, Sweden, Norway, Finland,
Australia, England, Germany. In fact, most of the developed countries in the
world besides the US have registries.
DR. MARK DOLAN HILL:
But why would they have registries and we don’t?
DR. WILLIAM JIRANEK:
Part of it is scale and that they are smaller countries, it
has been little bit easier for them to enforce the idea of collecting outcomes
on their patients, and you know perhaps something that has limited the
development of registries in the US has been the amount of attorney
surveillance and the fear for appraisals due to collection of data,
particularly data, which has to do with not sogood outcomes.
DR. MARK DOLAN HILL:
How depressing that is certainly? Well what are the
advantages of databases?
DR. WILLIAM JIRANEK:
Certainly, if we could identify a product or a surgery that
was causing a failure rate much higher than other gold standard surgeries that
would cause us to examine the procedure, the implant more carefully and see if
we could identify what the failure mechanism was and get it changed and the
timing is important. The reason that you want a 100% compliance of your
database is you can pickup a failure trend much faster and perhaps stop it
before a lot of other patients are in the pipeline get the same device and have
the same problem.
DR. MARK DOLAN HILL:
In the other countries, who overseas the database?
DR. WILLIAM JIRANEK:
They are by and largeoverseen by physicians and in
the case of orthopedics they are almost all orthopedic surgeons. There is
involvement by the government in almost all of the registries to certain
degree, but they still believe that the advisory board should have a lot of
physician input.
DR. MARK DOLAN HILL:
In the United States, would this same process work and also
does the sheer number of United States procedures provide an obstacle in of
itself?
DR. WILLIAM JIRANEK:
Sure. It is a huge obstacle, which is why we don’t have it,
I mean, with a can-do country and we don’t have something that you know on
first glance seems very easy and we should have them. I think certainly we
focussed initially on the procedures that are very common and that they are lot
being performed and hip and knee replacements certainly fits into that.
If you have just joined us, you are listening to a special
segment focussed on healthcare policy on ReachMD XM157. I am your host Dr.
Mark Dolan Hill and our guest is Dr. William Jiranek, Associate Professor of
Orthopedics and Chief Of The Adult Reconstruction Section of Orthopedic Surgery
at the Virginia Common Wealth University School of Medicine. We are discussing
the utility of a national registry to monitor joint implantation.
DR. MARK DOLAN HILL:
Doctor, how does the
database impact a patient’s willingness or a physician’s willingness to embrace
new technology.
DR. WILLIAM JIRANEK:
Well, I think if we knew that surveillance was going to be a
bigger part of our life just like anything else and life will be a little bit
more careful about the things we do. So, I would think that you would be a
little more careful with new technology a little bit more discerning about what
the signs behind the new technology is?
DR. MARK DOLAN HILL:
Well right now, as physicians are we using the data from
overseas to guide us with respect to using products here in the United States.
DR. WILLIAM JIRANEK:
We are. We have stopped the use not with any degree, but by
physicians learning this data it has affected some of the practice pattern.
So, there is no question that some of the data has affected us. The other problem
is that there are different ways of doing things and the implants are not all
the same in the other countries as they are here.
DR. MARK DOLAN HILL:
This does not seem to make a common horse sense to me why we
don’t use our own data and our own database here in the United States and using
other countries database to determine what we are doing.
DR. WILLIAM JIRANEK:
We do use our database. We have our Medicare database that
we are able to mind and get some reasonable data, but that involves a certain
segment of our population only the people over 65 will qualify and there are
holes in that data as well.
DR. MARK DOLAN HILL:
If they are prosthetic devices taken off from market
overseas, how much lag time is there if at all before we take it off the market
here?
DR. WILLIAM JIRANEK:
I think it can be considerable lag time. In other words,
say Sweden says this type of bone cement we do not think is suitable for use.
How long would it take us in the US to respond to that. I think it has been
variable with different products because the second they say that the
manufacture of the product has a counter argument of why it may not indeed be
that product and I won’t say that the second problem is that information is not
disseminated to all of our orthopedic surgeons in any defined mechanism. So,
some surgeons may find out about it, but not all of them, but there is no
national reporting of this to all the physicians across the country and I think
the lag time is considerable, but I cannot give you a definite amount.
DR. MARK DOLAN HILL:
How do you justify another orthopedic surgeon's keeping a
prosthetic device on the market here in the United States when perhaps it has
been pulled in other countries?
DR. WILLIAM JIRANEK:
Well, I think that the way it is justified is you know you
are not guilty until you are proven guilty and so a lot of people want to
verify that the science that was used in the other countries is indeed correct
and that product does deserve to be removed. Now I do think that people do
that and I do think that we make decisions based on the other registries data,
but I think that it is probably not immediate and it is probably not as
valuable as if somebody in your own country will say and look. I have seen all
of these failures. Here is the data. We need to do something.
DR. MARK DOLAN HILL:
Is the relationship perhaps a tab too cozy between some
orthopedic surgeons and the prosthetic device makers?
DR. WILLIAM JIRANEK:
I think that that was a reasonable criticism 2 years ago. I
think since the department of justice has been investigating the orthopedic
implant manufactures that is starting to change and I think is probably going
to create a fairly widespread change, so I would say that the relationship is
perhaps a little more arm’s length than it was 2 years ago.
DR. MARK DOLAN HILL:
Since we don’t have a national database, how can we improve
our outcome?
INCOMPLETE DICTATION
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