Michael
Saleh practices at the University of Sheffield, Great Britain. He has
spent a lot of his time studying external fixation in the treatment
of limb trauma.
From the concept of Ilizarov, he has been led to develop a device that
brings together the biomechanical advantages of the existing systems:
the Sheffield Hybrid Fixator.
Maîtrise
Orthopédique (M.O.): What prompted your interest in external
fixation?
Michael
Saleh (M.S.): I was training with Mr John Sharrard who then became
Professor of Paediatric Orthopaedics. Nobody in Sheffield was really
interested in external fixation and John discovered the Orthofix Fixator
during one of his numerous trips abroad. That was during a visit to
Verona where he had been impressed by the fact that patients were able
to walk in the streets with this fixator. When he came back, he wanted
one of his senior registrars to dedicate his time to this technique.
That is how I became involved in this field and, as is often the case,
it was pure coincidence.
M.O.:
Which usual osteosynthesis method did you use at the time?
M.S.:
We were just starting to use intramedullary nailing for leg fractures
and we were coming off a long period of use of screws and plates. Overall
we were very conservative in Sheffield and our teachers recommended
that we use plaster as often as possible. As far as I was concerned,
I was coming from Dundee in Scotland where there was a good school of
biomechanics and the concept of external fixation is a logical application
of biomechanics.
M.O.:
Have you benefited from the experience of the Italian School of Verona?
M.S.:
Yes, indeed, I have. Two surgeons from Verona visited us shortly afterwards
and I became friends with them. Then I went myself to spend some time
with them. I was very surprised by the speed with which they were treating
complex trauma cases thanks to this external fixator. By comparison,
it took them 3 hours in Verona to do cases which would have taken us
a whole day in Sheffield.
M.O.:
And what results did you obtain with this technique?
M.S.:
Very satisfactory results. Of course, as with any new technique and
with growing experience, one starts to realise the limits of the method.
But precisely, what makes orthopaedics fascinating, is this constant
need to keep pushing the limits further. Thus, when I became a consultant
and was able to use this method for something other than fresh trauma,
i.e. for what we call reconstructive surgery that includes pseudarthroses,
malunions and shortenings, I felt the need to use other devices.
M.O.:
Did you apply external fixation in all cases?
M.S.:
No, we had selective indications. However, taking into account the fact
that 60% of my referral pseudarthrosis cases were infected, it is obvious
that I was more inclined to resort to external fixation rather than
internal. Overall and consistently, I apply one implant for every two
external fixators.
M.O.: External fixation has been blamed extensively for producing
pseudarthroses…
M.S.:
Yes, and that is why I was very interested in what De Bastiani called
"dynamisation" with his fixator. We could criticise today
his theoretical approach but there is no doubt that the system works
and that there are very few pseudarthroses when this method is used.
Often the critics of external fixation do not have much experience of
it and use it in the worst case scenarios, which obviously reinforce
their convictions. But this situation is currently changing and in difficult
cases, surgeons today tend to refer the patient to a colleague specialising
in this field.
M.O.:
You seemed to be satisfied with De Bastiani's fixator. What made you
change?
M.S.:
That change resulted from a number of observations. When I was confronted
with the Ilizarov method, I first thought that it was a primitive method,
and a rather severe one for the patients. But with his tensioned wires
Ilizarov managed things that we could not achieve with monolateral fixation.
We had difficulty with fixation in metaphyseal bone and porotic bones
with our screws. Since wires have a better hold in soft bone we realised
that we would have to use a ring fixator. There were numerous systems
on the market derived from the Ilizarov device, in France, the Séquoia
can be cited as an example. With clinical experience, the strengths
and weaknesses of monolateral devices such as the Orthofix and the ring
systems such as the Ilizarov had become patent and several surgeons
had the idea to combine the advantages of both methods. That is what
led to the introduction of hybrid fixators that combined wires and screws.
M.O.:
In France it seems that some surgeons have been disappointed by the
Ilizarov method…
M.S.:
In Great Britain, internal fixation is preferred wherever possible,
but that is not always feasible. When a deformity calls for a very progressive
correction, when cross-joint fixation is required and where infection
is present, the results of internal fixation are poor and that is particularly
true for nails in metaphyseal problems.
M.O.:
Do you think that this type of method should only be reserved for a
few specialised centres?
M.S.:
This has been the trend until recently but things are changing because
we increasingly see high energy trauma, bone and soft tissue loss and
juxta-articular fractures. In Sheffield, where the surrounding countryside
is very pleasant, there are many hikers and climbers at weekends and
falls with complex fractures of the tibial plateau and pilon occur frequently.
In the past, they would have been treated by internal fixation but with
a lot of serious wound problems. Nowadays we can look after them so
that there are hardly any with infection problems thanks to percutaneous
approaches and good techniques of external fixation. The results are
so satisfactory with this technique that it must become the standard
method and that all general hospitals confronted with trauma should
apply it, and not only specialised centres.
M.O.:
Where did you learn the Ilizarov method?
M.S.:
I tried his method on my own on 4 cases then I went to Kurgan to spend
two weeks in the centre where Ilizarov worked. Later on I spent some
time with Jean-Marie Hardy in Brive in the centre of France and I was
so impressed by his work that I invited him to come to Sheffield. I
also visited Spinelli in Rome. My accumulated knowledge came from all
these centres.
O.: How long did it take you to come to the hybrid fixator?
M.S.:
Quite a long time. I started using the Orthofix monolateral fixator
in 1987 and the Ilizarov rings in 1988. In practice, while I was using
one of these systems, I sometimes regretted not having the advantages
of the other one, until I realised that the two systems were complementary.
The wires were more effective in the metaphyseal region but not easy
to place in the diaphysis. The efficacy of wires is due to their crossing
angle that must be wide enough. This is difficult to achieve safely
in the diaphyseal part of the leg. In addition, wires placed in the
diaphysis often penetrate muscles. By contrast, the 6 mm screws of the
Orthofix device were well tolerated in the diaphysis sometimes lasting
up to 18 months without loosening. Thus, the technical requirements
were as follows: wires that work well in the metaphysis and screws that
work well in the diaphysis. Based on the number of hybrid systems that
appeared, it seems that a lot of surgeons must have come to the same
conclusion.
M.O.:
Why do you say that wires are more effective than screws in the metaphysis?
M.S.:
I realised it after a particular case. We had a woman who had been hospitalised
for 18 months with a distal femur fracture and I had asked Jean-Marie
Hardy to assist me in the application of a Séquoia External Fixator.
Whilst inserting the first wire, I realised that it could be pushed
into the bone practically without drilling. I told Jean-Marie "This
will not work" and he replied "Just wait a bit, tension the
wires and you will see". That is what we did and we inserted four
distal femoral wires. Two days later, this woman walked and she consolidated
her pseudarthrosis in four months. I tried to get an explanation for
wire efficacy and the engineers I asked about the subject did not have
a satisfactory explanation; on the contrary, they insisted that 6 mm
screws should perform better than wires.
M.O.:
What do you think about it?
M.S.:
We have progressed on this question. A screw has a very strong fixation
on a diaphyseal cortical bone but placed in a cell-like environment,
as is the case in metaphyseal cancellous bone, its grip is mediocre.
In addition to this mediocre grip, the screw of a monolateral fixator
undergoes very severe cantilever stresses. Following the repetitive
demands of cyclical loading during walking, it ends up loosening. In
contrast, a transfixing wire connected on each side to a ring distributes
stresses more evenly since the wire's elastic modulus is closer to that
of metaphyseal bone. Thus wires allow better compliance between bone
and metal and the assembly performs better.
The problem is more complicated: when screws attached to a monolateral
bar are connected to wires on rings, the overall device does not always
give good results and that is what we wanted to avoid. We wanted the
stresses to be distributed evenly from each side of the fracture site.
We came to the conclusion that the only way it could be achieved was
to have rings on both sides: to fix the wires and to fix the screws.
That is our true innovation and that is the reason for developing the
Sheffield Hybrid Fixator.
M.O.:
But why is a device with metaphyseal ring connected with two rods to
diaphyseal screws not satisfactory?
M.S.:
We have carried out a series of comparative biomechanical studies of
various assemblies. Amongst all the variations reviewed, there was in
particular an ideal Ilizarov assembly and a Sheffield Hybrid Assembly.
The ideal Ilizarov assembly included four rings and with 2 wires crossing
at 900 to each other on each ring placed between them, this formed an
idealised device, which would not have been possible to do clinically
due to the risks of neurovascular injury. The Sheffield Hybrid Assembly
included a metaphyseal ring with wires and a diaphyseal ring with screws,
both rings being attached by 3 reduction units. In other hybrid systems,
the metaphyseal ring was connected to the diaphyseal screws by different
configurations of rods. It appeared that the ideal Ilizarov and the
Sheffield Hybrid outperformed all the other assemblies. When the others
were loaded axially, they produced an angular deformity as a result
of the cantilever stresses. The Ilizarov and the Sheffield devices did
not produce any angulation when loaded and to the contrary, demonstrated
an even distribution of stresses that we call "beam loading"
support. Thus, hybrid systems that connect metaphyseal wires to diaphyseal
screws with tubes or oblique rods do not escape cantilever stresses.
M.O.:
And what about in clinical practice?
M.S.:
Our experience is supportive. Patients that have had other fixators
before the Sheffield were telling us that the latter was less heavy.
At first this confused us because the weights were similar but in fact,
the even distribution of load around the leg gives an impression of
lightness and increased comfort.
M.O.:
Do you think that the good clinical results are associated with a better
distribution of stresses?
M.S.:
In traditional fixators, the assembly can be so rigid that all the stresses
go through the frame and there is no stimulation of the fracture site.
However, assemblies such as the Ilizarov can also be very rigid but
can nonetheless consolidate perfectly. The Ilizarov's rigidity seems
to be due to the wires deforming under load. The more the assembly is
loaded, the more the wires tend to deform. This provokes increased rigidity
in the system and greater stability for the fracture. That is what we
term the "self-stiffening" effect. The issue is to know what
is the right amount of rigidity. In assemblies such as Ilizarov, since
stiffness increases with the load, a feedback reaction may be taking
place. This reaction makes the patient adjust the load going through
the fracture site subconsciously. At the end of the day, experimentally,
only assemblies such as the Ilizarov and Sheffield demonstrate this
self-stiffening effect that does not exist with other hybrid assemblies.
With other hybrid systems, rigidity decreases with load. I actually
think that the Ilizarov magic lies in the even distribution of stresses,
i.e. in beam loading, and in the self-stiffening effect of the assembly.
M.O.:
What do you think of bone transport?
M.S.:
This is a technique derived from the Ilizarov concepts of limb lengthening.
Since bones can be lengthened by distraction, this principle could also
be applied to make up for bone loss within a limb. By comparison with
other techniques, this method is very attractive and has created a lot
of enthusiasm but mastering the technique is a long process. I have
dedicated a lot of my time to it and I use it as a salvage method in
clinical situations which would have previously led to amputation.
M.O.:
Have you ever met Ilizarov?
M.S.:
I met him on many occasions. First at international congresses where
I was not ready to accept the amazing things he was showing us. Then
in Kurgan where it was more convincing to see him in his hospital. In
particular, I remember an operation day when all theatres were in use
but Ilizarov, who was not operating himself, went from one theatre to
the other to give advice. He often approved with "Da, da"
but there were also some "Niet, niet" when assemblies were
either too stiff or or not stiff enough. He had charisma and seemed
to understand straight away the type of problem and its solution. When
I think about it retrospectively I realise how unstable assemblies caused
pin site infections, which have been responsible for the bad reputation
that external fixation has got. If things are managed as well as Ilizarov
used to do it with stable mountings, pin site infections are rare.
M.O.:
Was everything that Ilizarov presented to these congresses confirmed?
M.S.:
I have seen quite a few clinical cases that confirmed his oral presentations
at European congresses. I have also seen high level experimental work
that would have merited publication in Western medical journals. Having
said that, practice conditions in Siberia are peculiar and not always
transferable to Western countries. The fixators often caused pain; patients
stayed in hospital for long periods and practised a sort of group therapy
with group exercises, adult and children together, to allow them to
put up with their device. I do not think that our patients and health
system could cope with the same prolonged hospitalisation.
M.O.: Have you got any tolerance problems with the Sheffield?
M.S.:
We quickly noticed that patients used less analgesics with our fixator
than with Ilizarov frames. This is probably due to diaphyseal screws
as they do not transfix muscles. Then we had patients who cycled with
their assembly on and who did not complain about it. One of them came
back to see me six weeks later. He told me that I was going to tell
him off because he had hit his fixator and there was no more space between
the ring and the skin, as was the case after leaving the hospital. I
knew that when the fixators fail the ring moves and may compress the
skin but when trying to move this particular ring I did not manage it.
I asked him what he had been doing for these past few weeks and he told
me that, prior to the accident he had enjoyed cycling. He had not been
able to ride since the accident. With the fixator on, his pain had reduced
and he had started cycling and timing himself doing a circuit trying
to go faster and faster. This is when I realised that the space between
the skin and the fixator had disappeared because of muscle hypertrophy.
I had never seen this before with muscle hypertrophy occurring in a
patient with an external fixator Since then, apart from cases of articular
fracture, we allow patients to go back to their normal routine. We have
many examples such as this one. For example there was this climber who
had sustained a very severe tibial pilon fracture and to whom, given
the extent of the damage, I had suggested an arthrodesis of the ankle.
I did not know that dorsial flexion of the ankle was so important for
climbers and the patient refused the arthrodesis and asked me what I
would have done if the fracture were not so comminuted. I explained
to him that I would have attempted to restore the joint surface of the
tibial plafond and that I would have neutralised this fixation with
a Sheffield Hybrid Fixator. He told me to try this plan on his fracture
and we did. I then saw him again with pictures of himself climbing with
his fixator. He consolidated in five months and took up his climbing
vigorously once again - even climbing the difficult side which he had
fallen off. His x-rays are not very good but the function is excellent.
These anecdotes are not here to prove that I am a good surgeon but they
demonstrate that when the fixation is good, patients can do their physiotherapy
during the consolidation and rehabilitate quicker. That is really the
surgical challenge of the 21st century: to give the traumatised limb
its function back and the patient his independence and ability to work
and achieve. The issue is not only to bend one's knee to 90° but
it is also to be able go back to work without worrying about one's fracture
while it is consolidating normally.
Maîtrise
Orthopédique n°99 - 2000, december