Surgery for removal of metallic implants after fracture union: Is it necessary?
Dr KS Dhillon, MBBS,
FRCS, LLM
Introduction
After fracture union metallic implants used for
stabilization of the fracture serves no purpose, hence in the past it was
advocated that all such implants should be removed. This was partly due fears
of corrosion associated with the commonly used stainless steel alloy implants.
However subsequent research found such claims to be unfounded.
There are two broad class of fixation devices used
in orthopaedic surgery for fixation of limb bones. The first group consists of
wire or pins and the other includes screws, plates and nails. In the past most
of the implants were made of stainless steel alloy, however now titanium alloy
implants are now becoming more popular.
There are no clear guidelines in the medical
literature on indications for removal of metallic internal fixation devices
after fracture union. Surgeons have been making decisions about implant removal
arbitrarily because of lack of evidence based literature to guide them. The
general rule has been that all wires should be removed while plates, nails and
screws may or may not be removed depending on prevailing circumstances.
The presence of metallic implants in the body
usually does not produce any symptoms. However under some circumstance they can
be a source of pain and or limitation of movement of the joints. In such
circumstances doctors are often compelled to remove the implants although not
all such patients will be relieved of their symptoms after the surgery. Surgery
for removal implants is not as innocuous as we often assume.
This review will probe what the current state of
knowledge is regarding the need for implant removal after fracture union.
Types of implants used for
internal fixation of limb fractures
1. Kirschner
wires- These are non-malleable stainless steel wires which come in different
sizes and usually vary in diameter from between 0.7 mm to about 1.6 mm and in
lengths of between 4 to 12 inches. There are usually used to fix small bone
fragments which are not suitable for fixation with other devices such as
screws, plates and nails. Wires are frequently used to fix peri-articular
fractures in children and also in adults, where non-invasive close reduction of
the fracture can be carried out and the fracture stabilized with percutaneous
wires. The frequent sites where wires are used for fixation of fractures include
the elbow, wrist, hand, fingers, foot and the toes.
2. Cerclage
wires- These are malleable stainless steel wires which can twisted around bones
and tied in a knot. They are often used to fix fractures of the patella and the
olecranon. They can also be used at other sites to complement fixation of bones
with other devices.
3. Plates,
screws and nails
Various designs of plates, screws
and nails are available for internal fixation of fractures. These are usually
made of stainless steel alloy or titanium alloy. The stainless steel implants
are iron-carbon alloys with some element of chromium, molybdenum and manganese.
The titanium implants are alloys of titanium, aluminium and niobium.
Indications of implant
removal
There is usually no disagreement among surgeons that
K-wires that are used for temporary fixation of fractures should be removed
after fracture union. K-wires protruding under the skin can cause skin
irritation and pain. They can also migrate, if they are not securely fixed
across two bone cortices, causing damage to other body structures. Cerclage
wires can also cause skin irritation and pain if they are not buried in deep
tissues and under such circumstance they should be removed. Screws that are
subcutaneous and causing skin irritation should be removed.
Deep implants such as plates, nails and screws may
or may not be symptomatic and the removal such implants has been an area of
debate and controversy. The questions that arise are whether the implants will
cause harm if left in the body and do they cause any functional disability.
Do implants cause harm?
Biocompatibility of metallic implants has always
been a concern because of release of biologically active small particles due to
oxidation of metal and the possibility of toxicity of these particles to the
human body. Stainless steel alloys do corrode in the body but the implants
become covered with a layer of fibrous tissue often as thick as 2mm depending
on the amount of corrosive material released and the amount of movement between
the implant and the surrounding tissues. Titanium alloys on the other do not
corrode but they release ions which diffuse into the surrounding tissues [1].
It was believed in the 1970’s and 1980’s that these corrosive materials and
metallic ions may be carcinogenic and predispose patients to cancers. However, experimental
studies have not revealed any association between metallic implants and the
development of any cancers [2]. Presently the possibility of corrosion and cancer
are no longer considered to be an indication for removal of implant [2].
Allergic reactions to metals in the body are rare and data substantiating
implant related allergic reactions is scarce [2].
Another reason why plate removal was recommended in
the past was due to the widely held believe that the presence of plates on the
bone leads to bone atrophy. However, more recent studies have showed that if
the plates are left in the body long enough the density of the bone returns to
normal. Rosson et al studied the bone density in patients with forearm
fractures and found that the bone density returns to normal after 21 months [3].
Similarly studies of tibia after plate removal have failed to show significant
bone atrophy [4]. Hence plates can be left in the body without fear of plates
causing bone atrophy or stress protection.
Essentially implants left behind after fracture healing
do not cause any bodily harm. The next question that needs to be answered is
whether implant produces symptoms or functional disability.
Do implants cause symptoms
and when should they be removed?
There are very few circumstances under which implants
would definitely need to be removed (absolute indications). K-wires can migrate
and cause harm to other body structures and K-wires that are under the skin can
produce pain, hence removal of K-wire would be indicated. Screws that perforate
the joint should be removed because they can damage the joint when the joint is
mobilised. Cerclage wires whose sharp ends are not properly buried under deep
tissues can protrude under the skin leading to pain. Such wires obviously need
to be removed. Implants such as plates adjacent to joints which are imperfectly
positioned can obstruct joint motion and it would be necessary to remove them
to improve joint function. Implants that are loose can migrate or produce
irritation of adjoining soft tissues and such implants would also need to be
removed.
Indication for removal of implants under most other
circumstances is controversial and debateable. Some patients complain of pain
or discomfort in the limb even when the implants are securely fixed and well
positioned. The cause of such pain remains unclear and it is difficult
determine whether the implant is the cause of the pain or it is due the injury
itself [2]. In patients with such pain the results of implant removal are ‘unpredictable
and depend on both the implant type and its anatomic location’ [5].Minkowitz in
a study of 57 patients who had implant removal because of complains of pain
found that only 53% of the patients had complete resolution of pain at one year
follow up[6]. Brown et al studied 126 patients who complained of lateral ankle
pain in the region of the implants. Only 50% (11 out of 22 patients) had
improvement of pain after implant removal. The functional scores were no
different in patient who had and did not have implant removal [7]. The
unpredictability of outcome has to be kept in mind when removal of implants for
pain is contemplated.
Removal of implants involves another surgery which
is accompanied with the risk of anaesthesia related complications as well as
complications associated with the surgery itself. Cost of the surgery and
hospitalization as well as time off work has to be borne in mind. Not only is
the results of the surgery unpredictable, the surgery itself can sometimes be
difficult and frustrating, resulting in broken implants and retrieval
instruments. Surgical complications include bleeding, wound infections,
neurovascular injury, refractures, recurrence of deformity, incomplete removal
of hardware and sometimes poor cosmetic results because incisions for removal
of minimally invasive plate and nails are not so ‘minimal’.
Sanderson et al in a study of 188 patients who had
implant removal found an overall complication rate of 20% and for forearm
implant removal the complication rate was 42%. The nerve injuries that occurred
were all permanent and were produced by junior doctors [8]. Richards et al in a
smaller series of 86 adult patients who had a routine removal of implants in
both symptomatic and asymptomatic patients reported a much lower rate of
complications (3%) which included a nerve injury, a refracture and a haematoma.
However the authors recommended that it would be appropriate to leave
asymptomatic implants in situ [9].
Removals of implants from forearm bones appear to a have
high complication rate. Langkamer et al [10] reported a 40% complication rate
after forearm implant removal. Chia et al [11] reported a 27% and Bednar et al
[12] reported a 10% complication rate following removal implants from the
forearm.
Brown et al reported a 19% rate of significant
complications in patients who had implant removal. They also found that
patients who did not have their implants removed had no ‘appreciable problems’
and the authors recommended that implants should only be removed if there is a
clear indication for the removal [13].
Karladani et al in a study of 71 patients who had
removal of the tibial nail for pain found that only 39 of the 71 patients had
improvement of pain and they were not totally pain free after the surgery. In
14 patients the pain was the same and in 18 patients the pain was worse after
the removal of the nail. Four of the 6 patients who had a previous fasciotomy
were unhappy with the outcome of the surgery to remove the nail. The authors
concluded that the outcome of tibial nail removal for pain is poor and that the
nail should not be removed unless there are convincing reasons to do so [14].
There have been concerns that athletes with implants
in situ, who participate in contact sports run the risk of a refracture because
the implant can act as a ‘stress riser’. Evans and Evans did a retrospective
study of 15 elite rugby players who returned to competitive sports while having
implants in situ. Two of the players’ sustained implant related complications
and the other 13 continued playing for up to 6 years without any symptoms. One
of the players needed removal of wires which produced pain after the tension
band wiring for a fracture of the patella while another player sustained an undisplaced
fracture of the radius and had to be treated in a cast for one month. The
authors concluded that an early return to sports after fracture union is
feasible and it is not necessary to remove the implants which would further delay
return to sports [15].
Routine removal of implants in the paediatric
patients is a common practice among many orthopaedic surgeons [16]. Kahle in
arguing against routine removal of implants in children did a retrospective
survey of 138 patients who had removal of implants and found a complication
rate of 13%. Seven percent of the patients had an incomplete removal of the
implant and 1.4% had a refracture. The study showed no evidence to support the
policy of routine removal of implants [17].
Davids et al in a retrospective survey of 801
children with 1223 implants removed over a 17 years period reported a 12.5%
complication rate of which 6% were major and 6.5% minor complications [18].
There appears to be no compelling reason to remove
implants in children as is the case in adults after fracture union when the
patient is asymptomatic.
Routine implant removal after fracture surgery consumes
a remarkable portion of resources allocated for elective orthopaedic surgery
and is a potentially reducible consumer of hospital resources in trauma units
[19].
The medical literature provides only level IV or
level V evidence regarding removal of implants after fracture healing. Vos DI
et al [20] have carried out a prospective multicentre clinical cohort study to
evaluate the outcome of implant removal after fracture healing. The study
included 288 adult patients, 146 patients had removal of upper limb implants and
142 patients had removal of lower limb implants. Removal of implants of the
clavicle, humerus, radius/ulna, tibia and femur was included.
The most frequent indication for implant removal was
pain (63%) and limitation of joint motion (56%).
For removal of femoral nails, extension of the scar
was necessary in 62% of the patients and for tibial nails in 35% of the
patients. For removal of upper limb implants the estimated blood loss was
between 0 to 300 ml and the operating time varied between 3 mins to 90 mins.
For removal of lower limb implants the blood loss was between 0 ml to 500 ml
and the operating time was between 13 mins to 120 mins.
Thirty percent of the patients had one or more
surgery related complications. The complications included post-operative
bleeding (11%), refractures (1%), nerve injuries (6) other complication in 9%
of the patients. The complication rate for upper limb procedures was 22% while
for the lower limbs it was 37%.
The number of patients with pre-operative complaints
who had complete follow up was 214 (88%) and 6 months after the surgery the
number of patients with complaints was reduced to 49% (P<0.0005). Despite
the significant number of patients (39%) who had improved after implant removal
there were 8 patients, who had no pre-operative complaints but developed 25 new
post-operative complaints such as paraesthesia, pain, loss of strength and
limited joint motion.
There appears to be no indication for removal of
implant in patients, both adults and children, when there are no symptoms. In
symptomatic patients the outcome of implant removal is unpredictable and the
patient should be advised accordingly if implant removable is contemplated. In
about half the patients the symptoms will not improve after the surgery.
Furthermore the surgery is not innocuous and between 3% to over 40% of the
patients can develop complications depending on the type and location of the
implant.
Conclusion
In
the past routine removal of implants after fracture union was a common
practice. This was because the metallic implants used for stabilization of the
fracture served no purpose after the fracture had united and there were fears
of carcinogenic toxicity of ions release form oxidative corrosion of the stainless
steel alloy implants that were
commonly used for fracture stabilisation. However subsequent research has
found that such claims are unfounded. Fears of bone atrophy and stress
shielding related to the implants have also been found to be unfounded provided
the implants are left in situ long enough. Hence implants need not be removed
for these reasons.
However
under some circumstances there are definite indications for removal of
implants. There is no controversy or debate about removing K-wires, Cerclage
wires, implants that penetrate joints and those that are imperfectly position
and obstruct joint motion.
In most other situations the indications for
removal of implants are relative. Even stable infected implants,
before fracture union occurs, are often left in situ but infected
implants after fracture union should be removed to control infection. Implants
that are loose which can sometimes migrate and cause symptom may have to be
removed.
Deep
seated stable implants are usually asymptomatic and most authors recommend that
they should be left in situ even in children. Removal of implants is not as
innocuous as is often believed. Besides anaesthesia related complications there
are surgery related complications in 3% to over 40% of the patients. Implant
removal is also associated with increased cost and time off work.
In
many patients who complain of pain around the site of the implant the actual
cause of the pain is often not known and it could be due to effect of the
injury rather than the implant itself. In symptomatic patients removal of
implants resolve the symptoms in only about 50 % of the patients.
Before
undertaking surgery to remove implants, it is imperative that the surgeon informs the patient about complications that can arise from the surgery. The patient also needs to be made aware about the unpredictability of the
outcome of such surgery. Most authors are of the opinion that asymptomatic
implants should not be removed and in other situations the implants should only be removed if there is a definite
compelling reason to do so.
References
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