Beruflich Dokumente
Kultur Dokumente
Indications and
Expectations
Abstract
Although hardware removal is commonly done, it should not be
considered a routine procedure. The decision to remove hardware
has significant economic implications, including the costs of the
procedure as well as possible work time lost for postoperative
recovery. The clinical indications for implant removal are not well
established. There are few definitive data to guide whether implant
removal is appropriate. Implant removal may be challenging and
lead to complications, such as neurovascular injury, refracture, or
recurrence of deformity. When implants are removed for pain relief
alone, the results are unpredictable and depend on both the implant
type and its anatomic location. Current literature does not support
the routine removal of implants to protect against allergy,
carcinogenesis, or metal detection. Surgeons and patients should be
aware of appropriate indications and have realistic expectations of
the risks and benefits of implant removal.
Hardware Removal
it as a common procedure, accounting for approximately 5% of all orthopaedic procedures done in the
United States.1 In a Finnish study,
nearly all implants inserted for fracture fixation (81%) were removed after fracture healing.2 Removal of the
implant accounted for 29% of elective procedures and 15% of total orthopaedic procedures performed at
that institution during a 7-year period, compared with a removal rate of
6% of all orthopaedic cases in Finland for the duration of that study.
Despite the significant number of
hardware removals performed, there
is little published information regarding the full cost of the procedure. In addition to the direct costs
(ie, physician and hospital fees), indirect costs include patient lost work
and productivity. These costs have
not been quantified, and only a few
studies of implant removal document patient time away from work.
One study of removal of lower extremity intramedullary nails found
that patients required a mean of 11
days of sick leave.3 Given the finite
resources available for medical care,
research is needed on the economic
costs of elective implant removal.
Additionally, there is a need for research into practice variations regarding hardware removal in the
United States.
Peri-implant Fracture
and Refracture
Internal fracture fixation with either
intramedullary or extramedullary
implants creates a biologic environment that leads to adaptive changes
in bone, with the principal desired
effect of fracture healing. Direct fracture healing does not produce fracture callus; the new osseous channels form across the fracture site in
the environment of rigid internal fixation, which is most commonly
achieved with compression plating.
Indirect fracture healing with callus
formation occurs in the setting of
less rigid fixation, such as intramed114
external fixators for tibial pilon fractures.8 However, Burstein et al9 reported that radiographic evidence of
a screw hole remained after the hole
began to fill in with new bone. New
woven bone eliminated the stressconcentrating effect of the hole
within 4 weeks in a canine model,
even though the hole was still radiographically present. Using single
photon absorptiometry, Rosson et
al10 found that bone mass in young
adult men returned to close to normal 18 weeks after screw removal,
leading them to recommend avoidance of contact activity for 4 months
after screw removal.
Although refracture after plate removal cannot be completely prevented, the available data lead to
several conclusions that can be used
to minimize the risk. (1) Achieving
complete union and remodeling before implant removal decreases the
risk of refracture. (2) Avoiding unnecessary disruption of the vascular
supply to the bone decreases osteopenia. Furthermore, allowing sufficient time for the vascular supply
to recover may correct the initial osteopenia. (3) Screw holes may remain as stress risers for as long as 4
months.
Refracture is rarely reported after
removal of an intramedullary implant. Wolinsky et al11 reported on
551 fractures managed with reamed
intramedullary femur fixation. They
removed 131 nails and reported no
refractures. In a study of femoral
fractures in patients treated with
static interlocked stainless steel
nails, Brumback et al12 compared
111 fractures managed with retained
implants with 103 from which the
implant was removed. No fractures
occurred about the nail or locking
screws in the first group, and only
one patient refractured at the original fracture site in the second group.
The authors concluded that stress
shielding from intramedullary nail
fixation was not clinically evident
once the fracture had united. In addition to radiographic evidence of cir-
Figure 1
Figure 2
A, Lateral radiograph in a patient with a prior tibial fracture that was managed with
an intramedullary nail. A repeat injury caused the nail to break out of the anterior
cortex of the distal tibia. B, The retained nail simplified treatment by allowing
reimplantation and relocking of the nail in the distal tibia without the need to replace
the intramedullary device.
115
Hardware Removal
Painful Hardware
Persistent pain after radiographic evidence of fracture union commonly
leads to implant removal. Rates of
implant removal vary based on ana116
tomic location and implant selection. In one study of 55 patients undergoing tension band wiring of
olecranon fractures, 61% required
revision surgery for painful hardware.17 In a retrospective review of
surgically treated patellar fractures,
9 of 87 patients underwent removal
of symptomatic hardware.18
It is important to consider whether
the patient may reliably expect pain
relief after hardware removal. Brown
et al19 examined functional outcomes
after internal fixation of ankle fractures and found lower pain scores and
lower scores on the Medical Outcomes Study 36-Item Short Form for
patients with pain overlying the lateral hardware. Of the 39 patients reporting pain, 22 underwent removal
of hardware, but only 11 (50%) of
those had improved lateral ankle
pain. These data contrast with that of
Jacobsen et al,20 who reported improvement after hardware removal in
75% of patients who had previously
undergone ORIF of the ankle.
Pain relief following femoral intramedullary nail removal is similarly unpredictable. In their retrospective review of 80 patients with
femoral fractures, Dodenhoff et al21
noted that 11 of 17 who underwent
implant removal experienced pain relief. With tibial implants, knee pain
is a common indicator for nail removal. Keating et al22 showed a 45%
rate of complete relief of knee pain
after tibial nail removal; 35% of patients experienced partial relief and
20%, no relief. In a retrospective review of 169 patients, Court-Brown et
al23 noted complete pain relief in
27% and marked relief in 69% after
nail removal. However, 3.2% reported worsening pain after hardware
removal. In another study, 17% of patients noted an increase in knee pain
after tibial nail removal.3 Because the
extent of pain relief varies after hardware removal, the surgeon must exercise caution in attributing persistent pain to retained implants. No
patient should be guaranteed complete pain relief.
Metal Allergy
Implants with nickel or chromium
composition cause allergic responses in a small segment of the population. A review of approximately 50
studies shows the prevalence of metal sensitivity in the general population to be 10% to 15%.28 In fracture
surgery, the incidence of sensitivity
to any of the three ions in stainless
steel (ie, chromium, nickel, cobalt)
seems to be low (0.2%, 1.3%, and
1.8%, respectively).29 Because of
concerns about hypersensitivity to
any of these ions, some authors have
proposed using titanium implants in
patients known to be allergic to the
components of stainless steel.
A patient who has metal sensitivity or a nickel allergy may report
nonspecific deep generalized pain
over the area of injury and implant.
It is very difficult to differentiate
this nonspecific pain from either
pain caused by the local injury or
mechanical pain related to the implant. An example of clinical information that may suggest a metal
sensitivity is the presence of symptoms in a fair-skinned, red-haired
woman with a history of earlobe irritation caused by earrings that are
not 14-carat gold or caused by costume jewelry. The patient also may
be sensitive to medications and
have multiple allergies. Patients
with sensitivity or allergy will express significant relief almost immediately after hardware removal.
It is not yet known whether metal
sensitivity plays a notable role in
implant failure in fracture surgery,
or whether it is merely an unusual
complication for a limited number
of patients. Additionally, it is not
known whether there is a causeand-effect relationship between
metal sensitivity and implant loosening. Currently, there is no evidence of an increased risk of implant
failure in patients with positive skin
patch testing sensitivity.30
Volume 14, Number 2, February 2006
Carcinogenicity
Because younger patients may require insertion of metal implants,
the carcinogenic risk of these implants must be assessed. The association between metallic implants and
tumors has been established in experimental animals.31 In the absence
of chronic infection, the pathogenesis of metal-induced carcinogenesis
may fall into two general categories:
(1) metal-ion binding to DNA and (2)
alteration of DNA and protein synthesis. Because binding is reversible,
other effects are likely to be involved
in carcinogenesis. Evidence points to
reactive oxygen species created during corrosion and their effects on
DNA and proteins as the likely second culprit in metal-induced carcinogenesis.32 Although basic science and animal studies may point
to a correlation between metallic
implants and cancer, one must be
careful not to ascribe carcinogenesis
to retained implants.
There are fewer than 30 human
cases of implant-associated tumors
in the literature. The limitations of
such case reports is that the denominator is not known, making it impossible to quantify risk. Moreover,
it is extremely difficult to differentiate correlation from causation when
trying to establish a relationship between implants and tumors. Generally, sarcomas related to implants
tend to be high-grade and occur
many years after initial placement of
the device.33 There is no consensus,
however, that implants pose a significant risk for local tumor development. The overall risk, if any, appears to be very low.
The great majority of data related
to cancer risk and metallic implants
is found in the total joint literature.
Gillespie et al34 reported a 70% increase in hematopoietic cancers over
the general population in their retrospective review of 1,358 total joint
patients over a 10-year period. Those
results have not been duplicated in
other studies, however. In the largest
Metal Detection
In this era of heightened security at
venues ranging from airports and
sporting events to hospital emergency departments and high schools, patients frequently inquire about the
possibility that an implant will set
off a metal detector. In 1992, Pearson
and Matthews36 tested a variety of
arthroplasty and fracture implants.
They postulated that only those implants with sufficiently high iron
content would be detected and that
because modern implants have little, if any, iron, detection is unlikely. In 1994, Beaupre37 corrected that
earlier assertion, explaining that
316L stainless steel is actually 60%
iron. Detection depends on an objects permeability (ability to temporarily disrupt a magnetic field) and
conductivity. Because modern processing techniques limit permeability and conductivity, the potential
for detection is very low.
The incidence of implant detection during security screening may
be low, but many orthopaedic surgeons provide their patients with
wallet cards containing a short
statement providing documenta117
Hardware Removal
Figure 3
Pediatric Patients
The general practice at many institutions is to offer removal of implants
118
Surgical Complications
Any surgical procedure carries inherent risks, including wound complications, iatrogenic injury, and anesthetic complications. In their report
on implant removal in 86 patients,
Richards et al44 noted a 3% complication rate, including one refracture,
one radial nerve injury, and one hematoma. Sanderson et al45 reported
an overall 20% complication rate in
their series of 188 patients. The
most common complication was infection, followed by nerve injury.
They recommend senior surgeon supervision of forearm hardware removal; unsupervised junior surgeons
produced three permanent nerve injuries.45 Langkamer and Ackroyd46
reported on 55 patients who had
forearm plate removal. They noted a
40% complication rate, including 4
infections, 5 poor scars, 17 nerve
problems, 1 delay in wound healing,
References
Evidence-based Medicine: There are
no level I or level II evidence-based
studies in the articles referenced.
Citation numbers printed in bold
type indicate references published
within the past 5 years.
1.
2.
3.
4.
Summary
Hardware removal, although a common operation, should not be undertaken lightly and should not be a
routine procedure. Although it is
clearly indicated in some instances,
the habitual removal of implants is
not supported by the literature and
exposes the patient to unnecessary
costs and complications. Even in patients reporting implant-related
pain, removal of that implant does
not guarantee relief and may be associated with further complications,
including infection, refracture, nerve
damage, and worsening pain. Additionally, patients may request or surgeons may recommend removal on
unproved grounds, such as protection from neoplasm or reduction of
stress shielding. No data suggest
that implant removal accomplishes
these objectives or that retained implants increase the risk of neoplasm
or cause stress shielding. As with
any surgical procedure, it is important to understand the expected benefits from the procedure as well as to
know the inherent risks. More research is needed regarding the timing and expected benefits of removing implants as well as the direct and
indirect costs of the procedure.
Volume 14, Number 2, February 2006
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Hardware Removal
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related
to
internal
fixation.
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Jago RD, Hindley CJ: The removal of
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Kahle WK: The case against routine
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Chapman MW: Principles of internal
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Green NE, Swiontkowski MF: Skeletal Trauma in Children, ed 3. Philadelphia, PA: Saunders, 2003, vol 3, pp
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Richards RH, Palmer JD, Clarke NM:
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Sanderson PL, Ryan W, Turner PG:
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Langkamer VG, Ackroyd CE: Removal of forearm plates: A review of the
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