Review Article

The Use of Highly Cross-linked

Polyethylene in Total Knee
Arthroplasty
Abstract
Paul F. Lachiewicz, MD
Mark R. Geyer, MD

From Duke University Medical

Center, Chapel Hill, NC
(Dr. Lachiewicz and Dr. Geyer) and
the Durham VA Hospital, Durham,
NC, and Chapel Hill Orthopedics
Surgery & Sports Medicine, Chapel
Hill (Dr. Lachiewicz).
Dr. Lachiewicz or an immediate
family member serves as a board
member, owner, officer, or
committee member of the Hip
Society, Southern Orthopaedic
Association, and the Orthopaedic
Surgery and Trauma Society; has
received royalties from Innomed; is
a member of a speakers bureau or
has made paid presentations on
behalf of Zimmer, Covidien, and
Rush-Copley Hospital; serves as a
paid consultant to or is an employee
of Leerink Swann, Gerson Lehrman
Group, Guidepoint Global, and the
Center for Healthcare Education
LLC; and has received research or
institutional support from Zimmer.
Neither Dr. Geyer nor any
immediate family member has
received anything of value from or
owns stock in a commercial
company or institution related
directly or indirectly to the subject of
this article.
J Am Acad Orthop Surg 2011;19:
143-151
Copyright 2011 by the American
Academy of Orthopaedic Surgeons.

March 2011, Vol 19, No 3

Polyethylene wear, with resultant particle-induced osteolysis, is a

cause of late failure of total knee arthroplasty. The causes of both
wear and osteolysis are multifactorial; still, improvements in the
polyethylene liner have been investigated. Available highly crosslinked polyethylene tibial liners and patellar prostheses differ
greatly in the amount and method of irradiation, thermal
treatments, and sterilization techniques they undergo. Several
varieties of highly cross-linked polyethylene reduce the gravimetric
and volumetric wear of tibial liners in knee simulator studies.
However, reduced fracture toughness and the generation of smaller
and possibly more reactive particles also have been reported with
some varieties of polyethylene. Clinical studies of the use of highly
cross-linked polyethylene in total knee arthroplasty are limited. Two
nonrandomized trials of highly cross-linked polyethylene in total
knee arthroplasty have reported a nonsignificant decrease in
radiolucent lines at 2 and 5 years, respectively. The risks of using
highly cross-linked polyethylene include fracture of the liner or of a
posterior-stabilized tibial post, liner dislodgement or locking
mechanism disruption, and possibly more osteolysis. Highly crosslinked polyethylene tibial liners may be considered for younger,
more active patients. However, until additional clinical results are
available, a cautious approach is warranted to the widespread use
of highly cross-linked polyethylene in total knee arthroplasty.

olyethylene wear, with resultant

particle-induced osteolysis, is a
major cause of late failure of total
knee arthroplasty (TKA) and of the
need for revision.1,2 The prevalence
of osteolysis after TKA has been reported at 5% to 20%, at follow-up
times of <5 years to 15 years.3,4 Polyethylene wear and osteolysis after
TKA are multifactorial and associated with implant design, patient
factors, and technical issues. The implant factors include the polyethylene locking mechanismbackside

wear, the design of the posteriorstabilized tibial post, and the method
of polyethylene fabrication and sterilization.3,5 Patient factors, such as
age and activity level, have been implicated in excessive polyethylene
wear. Technical factors may also
contribute to or predispose to excessive polyethylene wear after TKA;
these can include excessive flexion of
the femoral component or hyperextension of the knee, with resultant
impingement and wear of the tibial
polyethylene post, and axial mal-

143

The Use of Highly Cross-linked Polyethylene in Total Knee Arthroplasty

alignment. Previous attempts to improve the knee tibial polyethylene

liner with carbon fibers or increased
crystallinity adversely affected the results of the arthroplasty, despite in
vitro mechanical testing that showed
safety and efficacy.5
Highly cross-linked polyethylene
liners for total hip arthroplasty acetabular components are now widely
accepted as providing decreased
wear 5 to 8 years after surgery.6,7
However, fabrication techniques varied widely among these highly crosslinked polyethylene products, with
resultant differences in measured linear wear and a decrease in mechanical strength; the decrease in mechanical strength has been implicated in
the rare cases of liner fracture.
So-called second-generation highly
cross-linked polyethylenes have recently been introduced to address decreased material strength. These
polyethylenes are sequentially irradiated and annealed or doped with vitamin E.8,9 The use of highly crosslinked polyethylene in TKA was
proposed after its early success in total hip arthroplasty,10 but it has not
been widely accepted for routine use.
Here, we discuss the polyethylene
products now available for implantation, the laboratory simulator testing
of these devices, the early reported
clinical results, and the potential
risks and complications of the use of
highly cross-linked polyethylenes in
TKA.

Total Knee Polyethylene

Products
The 10 manufacturers of TKA products in the United States were asked
to contribute information about their
products to the senior author (P.F.L.)
(Table 1). In regard to sterilization,
polyethylene tibial liners in the past
were sterilized by gamma irradiation, ethylene oxide, or gas plasma.

144

Currently, most TKA tibial and patellar polyethylene prostheses are

cross-linked (ie, joined by covalent
bonds) to some degree because all
manufacturers use gamma (<5 Mrad)
or electron-beam irradiation. Four
manufacturers (Aesculap/B. Braun
[Center Valley, PA], DJO Surgical
[Austin, TX], Exactech [Gainesville,
FL], and StelKast [McMurray, PA])
do not provide a specific highly
cross-linked polyethylene for their
TKA components, although most
fabricate one for their total hip arthroplasty components. Two manufacturers (DePuy [Warsaw, IN] and
Wright Medical [Arlington, TN]) provide a moderately cross-linked (5
Mrad) tibial polyethylene liner. Four
manufacturers (Biomet [Warsaw, IN],
Smith & Nephew [Memphis, TN],
Stryker Orthopaedics [Mahwah, NJ],
and Zimmer [Warsaw, IN]) (five products) provide different highly crosslinked tibial polyethylene liners (6.5 to
10 Mrad). One manufacturer, Wright
Medical, does not fabricate a moderately cross-linked tibial polyethylene
for a posterior-stabilized knee prosthesis. Two of these four manufacturers
(Stryker and Zimmer) also provide a
highly cross-linked polyethylene patellar prosthesis.
These products differ in the type of
polyethylene resin used, the method
of irradiation, and the amount of radiation. There are also major differences in the thermal treatments after
irradiation. In addition, each manufacturer has a different proprietary
method of polyethylene fabrication,
sterilization, and packaging. Thus,
the clinical results of these TKA
polyethylene liners cannot be
grouped together, and the results
may have significant differences in
their in vivo wear, prevalence of osteolysis, and complications.
The amount of radiation and
method of irradiation have an important effect on the wear and mechanical properties of the tibial polyeth-

ylene liner in vitro. One laboratory

reported a significant decrease in
wear, with 5 (54%), 7.5 (78%), and
10 Mrad (95%), respectively.10,11
There was no improvement in wear
with higher doses of irradiation.
However, the mechanical properties
(toughness, as measured by small
punch tests) were improved from 5
to 7.5 Mrad only, then decreased
with increasing doses of irradiation.
The thermal treatment and terminal method of sterilization and packaging of these TKA polyethylenes
may be just as important for the
long-term performance of these materials in vivo. Different thermal
treatments are used to form crosslinks and extinguish free radicals.
Some polyethylenes are remelted
(heated above the melting temperature), and some are annealed (heated
to just below the melting temperature). With radiation doses at or near
10 Mrad, remelted highly crosslinked polyethylene exhibits reduced
mechanical and fatigue properties
compared with those of conventional
and annealed polyethylene. However, annealed highly cross-linked
polyethylene has a higher level of
free radicals, and with increased oxidation in vivo after implantation,
there may be reduced mechanical
strength and increased wear with
long-term follow-up. One manufacturer has developed a method to
eliminate the remelting process and
maintain oxidative resistance by sequential irradiation and annealing.
This polyethylene is reported to have
oxidation resistance similar to that
of virgin polyethylene, with maintained mechanical strength and significantly reduced wear for both
cruciate-retaining and posteriorstabilized knee designs.8 The method
of final sterilization and packaging
may also be important because terminal irradiation or packaging in the
presence of oxygen may also lead to
late oxidation in vivo.

Journal of the American Academy of Orthopaedic Surgeons

Paul F. Lachiewicz, MD, and Mark R. Geyer, MD

Table 1
Cross-linked Polyethylene for Total Knee Arthroplasty

Manufacturer
Aesculap/
B. Braun
(Center Valley, PA)
Biomet (Warsaw, IN)

Product
Name

Prosthesis

Tibia/
Patella

Radiation
Dose
(Mrad)

Fabrication/
Sterilization

Resin

Columbus Knee
System

Y/Y

32

E1

Vanguard (CR, CR
lipped, anterior stabilized, PS, PS+)

Y/N

10

DePuy (Warsaw, IN)

XLK

Sigma (CR, PS, HF)

Y/N

DJO Surgical
(Austin, TX)

Foundation, 3DKnee
System

Y/Y

2.5 to 4
(both)

Exactech
(Gainesville,
FL)
Smith &
Nephew
(Memphis,
TN)
StelKast (McMurray, PA)
Stryker (Mahwah, NJ)

Optetrak (PS, CR,

HF)

Y/Y

2.5 to 4

Y/N

7.5

Y/Y

2.5 to 4

Gamma, in argon

GUR 1050

Y/Y

9
(3 3)

Sequential radiation, annealing below melt

temperature 3, packaged in air, gas plasma
Gamma, remelted
>140C, packaged in
air, ETO
Electron-beam, remelted
150C, packaged in
air, gas plasma
Electron-beam, remelted
150C, packaged in
air, ETO

GUR 1020

Wright Medical
(Arlington,
TN)
Zimmer (Warsaw, IN)

XLPE Verilast Legion (CR, PS)

(with Oxin- Genesis II (CR, PS)
ium femur)

X3

Proven Gen-Flex
(CR, PS, HF)
Triathlon (uni, CR,
PS)
Scorpio (CR, PS)

A-Class

Advance Medial Pivot

(CR only)

Y/N

Prolong

NexGen (CR, PS,

HF)

Y/Y

6.5

Durasul

Natural Knee II (CS)

Y/Y

9.5

Gamma, in nitrogen

GUR 1020

Gamma, vitamin E doping <130C, packaged

in argon, terminal 3
Mrad sterilization
Gamma, remelted
155C, packaged in
vacuum, gas plasma
Gamma, no oxygen;
nitrogen flush packaging (both)
Gamma, vacuum

GUR 1020

Gamma, vacuum, full

remelt, packaged in air,
gas plasma

GUR 1020

GUR 1050,
GUR 1020
GUR 1020 (tibia)
GUR 1050
(patella)
GUR 1020

GUR 1020

GUR 1050

GUR 1050

CR = posterior cruciateretaining, CS = cruciate substituting, ETO = ethylene oxide, GUR = granular, PS = posterior stabilized, HF = high
flexion, Mrad = megarad (kGy), N = no, uni = unicompartmental, XLPE = cross-linked polyethylene, Y = yes

Polyethylene Wear in Total

Knee Arthroplasty
Polyethylene wear of the tibial component liner of TKA occurs by two methods: fatigue damage (pitting and delamination) and adhesive and abrasive
wear5,9 (Figure 1). Wear of the polyethylene patella component presumably
occurs through the same mechanisms.
Polyethylene pitting and delamination
March 2011, Vol 19, No 3

are accelerated by oxidation secondary

to residual free radicals produced
through the sterilization of the polyethylene by gamma irradiation. Most
manufacturers sterilize their components by gamma irradiation in a vacuum or an inert gas (ie, nitrogen, argon), by gas plasma, or by ethylene
oxide gas. However, the rate and severity of oxidation of the polyethylene in
vivo, and thus the rate and severity of

future delamination are not known.

Adhesive and abrasive wear of the
tibial polyethylene remains the major
source of particulate debris from
modern TKA and the predominant
late cause of osteolysis and loosening. Adhesive wear is caused by the
orientation and strain hardening of
the polyethylene surface. Abrasive
wear is caused by the rubbing action
of the surface of the femoral compo-

145

The Use of Highly Cross-linked Polyethylene in Total Knee Arthroplasty

Figure 1

Photograph of a retrieved
conventional polyethylene tibial
component liner demonstrating
severe delamination.

nent and third-body particles, such

as bone cement and bone fragments.
Abrasive wear produces larger polyethylene debris particles than does
adhesive wear because of the cutting
action on the polyethylene surface.
These processes may also occur on
the backside of a tibial liner with
both mobile-bearing and modular
fixed-bearing prostheses.
Thermal treatment, when performed above the melt temperature
(>140C), reduces or eliminates the
concentration of free radicals in the
polyethylene, thereby possibly preventing oxidation and its resultant
embrittlement in vivo.9 Thus, higher
cross-linking of the tibial (and patellar) polyethylene and melting to
eliminate free radicals should decrease delamination and adhesive
and abrasive wear in vivo over the
long term.
Two approaches to reduce wear
that have limited effect on the mechanical properties include sequential irradiation and annealing or doping with vitamin E below the melting
temperature.

Laboratory Simulator
Wear Testing
In the absence of extensive clinical
data, the results of in vitro testing of

146

highly cross-linked polyethylene liners in a knee simulator may provide

some insight or useful information
for the practicing surgeon who is
considering the use of these materials. Several of these moderately or
highly cross-linked tibial polyethylene liners have been tested in knee
simulator models; however, the studies reveal numerous limitations.
At least three different models of
knee simulator are reported on. The
complex motion pattern of the knee,
which includes rolling, sliding, and
rotation, may not be accurately reproduced by these knee simulators.
In addition, the absolute wear measurements in the different studies
may not be comparable. The studies
also differ in the number of specimens tested, number of million cycles, and load and gait conditions. In
several studies, the polyethylene is
experimentally aged by heat treatment or exposure to oxygen for a
certain number of days. Most of the
studies assume that the knee alignment and ligament balance are optimal and that there is no third-body
debris (eg, cement, bone particles) in
the lubricating solution.
The strengths of the knee simulator
studies are the comparisons of the
highly cross-linked polyethylene to
the control, conventional polyethylene, and the ability to study adverse
clinical situations (eg, axial malalignment, ligament imbalance, scratched
femoral components) in a relatively
large number of specimens.
One study tested GUR 1050
compression-molded polyethylene
treated by electron beam irradiation
of 9.5 Mrad, followed by melting at
150C for 2 hours (Durasul, Zimmer) with a cruciate-retaining total
knee femoral component (NaturalKnee II, Zimmer).12 The control
group was GUR 4150 compressionmolded polyethylene sterilized by
gamma irradiation of 2.5 to 4 Mrad
in an oxygen-free package. These tib-

ial liners were also aged and oxidized

in an air convection oven for 35 days
to simulate 5 years of aging oxidation. Three groups of tibial liners
(unaged and aged conventional polyethylene and aged highly crosslinked polyethylene) were tested in a
knee simulator under so-called normal gait conditions for 5 million cycles. Wear was measured by both
gravimetric (weight loss) and volumetric (coordinate measuring) methods. During 5 million cycles of simulated gait, the aged conventional
tibial polyethylene had large areas of
delamination; however, the unaged
and aged highly cross-linked polyethylene liners showed no delamination. The gravimetric analysis
showed 9.6 3.6 mg per million cycles for aged conventional and 8.8
1.5 mg per million cycles for unaged
conventional polyethylene. The aged
highly cross-linked polyethylene
showed a weight gain (bovine serum
fluid absorption) for the first 3 million cycles, followed by wear of 0.7
1 mg per million cycles (Figure 2).
The total (medial and lateral) volumetric wear measurements showed
that the aged highly cross-linked
polyethylene liner had approximately one third the wear of the
aged and unaged conventional polyethylene liners. The limitations of
this study included the small number
of liners tested and the operation of
the knee simulator at a nonphysiologic frequency.
This highly cross-linked polyethylene was also studied in two adverse wear condition models. In one
study, four explanted, artificially
roughened femoral components were
tested against unaged polyethylenes
in the same knee simulator for 2 million cycles.13 The wear rate was 80%
lower for the eight highly crosslinked liners than for the conventional liners. This study attempted to
simulate in vivo wear when the femoral component may become

Journal of the American Academy of Orthopaedic Surgeons

Paul F. Lachiewicz, MD, and Mark R. Geyer, MD

scratched or roughened with use. In

another study, the femoral component was positioned in the knee simulator to mimic a tight unbalanced
posterior cruciate ligament.14 The
aged highly cross-linked and unaged
conventional polyethylene liners
showed no delamination at 0.5 million cycles, whereas the aged conventional polyethylene liners showed delamination at 50,000 cycles.
Another study compared the wear
of electron beam 6.5 Mrad irradiated
and melted GUR 1050 polyethylene
(Prolong, Zimmer) to 2.5 to 4 Mrad
gamma irradiated-in-nitrogen GUR
1050 polyethylene with a posterior
cruciateretaining knee prosthesis
(NexGen CR, Zimmer) in a knee
simulator model for 7 million cycles.15 Both polyethylenes were unaged, the tibial base plate had four
screw holes, and backside wear was
allowed. By gravimetric analysis, the
combined articular and backside
wear was significantly less for the
highly cross-linked polyethylene (4.6
2 mm3 per million cycles) than for
the conventional polyethylene (23
6 mm3 per million cycles). This
highly cross-linked polyethylene has
not been tested in a posterior cruciatesubstituting design or when severe axial (5 to 7 varus) or coronal
malalignment of the components exists.
One study compared polyethylene
gamma irradiated in air to sequentially irradiated and annealed (9
Mrad) highly cross-linked polyethylene (X3, Stryker Orthopaedics)
and 6.5 Mrad (Prolong, Zimmer)
electron-beam, remelted and gas
plasmasterilized polyethylene in the
same knee simulator after accelerated aging (oxygen bomb for 14
days) under two malalignment conditions (7 varus, 80:20 medial/
lateral load distribution, 9 tibial internal rotation; and 5 varus, 70:30
medial/lateral load distribution, 4
tibial internal rotation, respecMarch 2011, Vol 19, No 3

Figure 2

A graph demonstrating the average gravimetric change in the three groups

for the duration of the study. The aged and unaged conventional inserts
displayed a steady wear rate, with an average weight loss at 5 million cycles
of 49 12 mg and 40 9 mg, respectively. The highly cross-linked
polyethylene inserts showed an initial average weight gain of 4 mg for the
first 3 million cycles and remained relatively unchanged thereafter.
WIAM = warm-irradiation by means of adiabatic melting. (Reproduced with
permission from Muratoglu OK, Bragdon CR, Jasty M, OConnor DO, Von
Knoch RS, Harris WH: Knee-simulator testing of conventional and crosslinked polyethylene tibial inserts. J Arthroplasty 2004;19[7]:887-897.)

tively).16 None of the highly crosslinked aged liners showed visible delamination or severe wear over 5
million cycles of testing. Both types
of highly cross-linked polyethylene
wore significantly less than did the
control polyethylene. However, the
overall wear rates for the electronbeam, remelted polyethylene were
higher than those for the sequentially
irradiated and annealed polyethylene
(4.13 0.8 versus 1.83 0.4 mg/
million cycles; P < 0.01).
At least three other knee simulator
studies of the sequentially irradiated
and annealed highly cross-linked
polyethylene tibial liner (X3) have
been published. One laboratory
studied both 9-mm cruciate-retaining
and posterior-stabilized tibial liners
to 5 million cycles and measured
gravimetric and volumetric wear, visual damage, and tensile properties
before and after aging. 8 The

cruciate-retaining liner had 68% less

wear, and the posterior-stabilized
liner had 64% less wear, than did the
conventional unaged polyethylene.
Visual wear damage to the tibial post
was much less with the highly crosslinked polyethylene. There was no
difference in the mean size or morphology of the wear particles produced between the conventional
polyethylene (0.31 m) and the
highly cross-linked polyethylene
(0.29 m).
A second study tested the cruciateretaining liner to 10 million cycles
with a different simulator and a different femoral component.17 The
wear rate of the sequentially irradiated and annealed (9 Mrad) polyethylene was reduced by 86% compared
with that of the conventional (3
Mrad) polyethylene. The third study
compared six different polyethylene
liners, including three highly cross-

147

The Use of Highly Cross-linked Polyethylene in Total Knee Arthroplasty

linked liners, in a third, different

knee simulator to 5 million cycles.18
All three highly cross-linked polyethylene liners had significantly lower
wear rates compared with the conventional polyethylene; however, the
sequentially irradiated and annealed
polyethylene had the lowest wear
rate.
One laboratory used the Leeds
knee simulator (Leeds/Prosim Knee
Wear Simulator; Simulation Solutions, Stockport, UK) to test non
cross-linked GUR 1020, moderately
(5 Mrad) cross-linked GUR 1050,
and highly (10 Mrad) cross-linked
GUR 1050 and annealed polyethylene liners with both cruciateretaining, fixed-bearing prostheses
and
rotating-platform,
mobilebearing prostheses for 5 million cycles.19 In lower cross-shear conditions (20 rotation), which are more
representative of the knee joint, the
highly cross-linked polyethylene had
a 33% reduction in gravimetric wear
compared with the conventional
polyethylene. However, the highly
cross-linked polyethylene had higher
wear under abrasive conditions, with
a deliberately scratched femoral
component. This finding conflicts
with the results of other studies and
may be related to the amount of
abrasion of the femoral component
and the method of testing. With the
Leeds knee simulator, rotatingplatform, mobile-bearing knees had
a lower wear rate compared with
that of the fixed-bearing knees, and
this wear was reduced with a moderately cross-linked polyethylene. This
studys conclusions are limited by the
use of different molecular weight
polyethylenes for the conventional,
moderately, highly cross-linked polyethylenes.
One biomechanical study has been
published of the fatigue strength of a
simulated posterior-stabilized tibial
post fabricated from GUR 1050,
which was gamma-irradiated to 8.5

148

Mrad, then doped with vitamin E,

which improves the mechanical
strength and fatigue crack propagation of highly cross-linked and
melted polyethylene.8 This vitamin
Edoped polyethylene showed bending fatigue strength comparable to
that of conventional unaged polyethylene and improved strength comparable to that of aged conventional
polyethylene. However, this vitamin
Edoped polyethylene has not been
tested in abrasive conditions or under ligament imbalance or axial malalignment conditions. To date, there
are no published reports of fatigue
testing of highly cross-linked polyethylene patellar components.

Clinical Results
Few reports have been published of
the clinical or radiographic results of
highly cross-linked polyethylene tibial liners, and none of highly crosslinked patellar prostheses in TKA. A
reliable, validated method of measuring in vivo wear of tibial polyethylene liners is not presently available.
A highly cross-linked polyethylene
tibial liner (Durasul) has been available for use since February 2001.
One retrospective cohort study compared a series of 100 cruciateretaining and -sacrificing (ultracongruent liner) TKAs with a
conventional polyethylene liner, sterilized by gamma irradiation in nitrogen, with 100 knees of identical design with Durasul highly cross-linked
(9.5 Mrad) polyethylene liners.20 It
was unclear from the study whether
the patella prosthesis implanted was
also fabricated of highly cross-linked
polyethylene. The patient groups
were similar, and evaluation was by
a physical examination and conventional radiographs only. The mean
follow-up time was 91 months
(range, 82 to 101 months) for the
conventional polyethylene liners and

75 months (range, 69 to 82 months)

for the highly cross-linked liners.
There was no significant difference
between the groups in the number of
revisions done for tibial component
loosening. However, 20 tibial radiolucent lines were seen (20 patients)
with the conventional polyethylene
compared with 2 tibial radiolucent
lines (2 patients) with highly crosslinked polyethylene). There were no
cases of early catastrophic failure related to either polyethylene liner.
This study was limited by its retrospective and nonrandomized design,
as well as by the absence of a measure of activity level. There were also
numerous confounding variables, including mode of fixation (cemented
or press-fit), patellar resurfacing status, and posterior cruciate ligament
status. It is reasonable to assume that
this particular TKA with the Durasul
highly cross-linked polyethylene tibial liner is safe for use at a mean
6-year follow-up time, but no advantage to conventional polyethylene
has been demonstrated by the results
of this single study.
Another variety of highly crosslinked polyethylene (6.5 Mrad), (Prolong) has been available since August
2003. Minoda et al21 reported a prospective, consecutive series comparing
113 cruciate-retaining knees (99 patients) with conventional polyethylene
tibial liners with 89 cruciate-retaining
knees (83 patients) with Prolong highly
cross-linked polyethylene tibial liners.
The groups were comparable in terms
of patient age, sex, and preoperative diagnosis, although the conventional
polyethylene group had less preoperative range of motion. Patellar resurfacing was performed only in patients
with rheumatoid arthritis. At 2-year
follow-up, there were no clinical or radiographic differences between the two
groups. Tibial radiolucent lines were
more frequently seen in the conventional polyethylene group (9.7%) than
the highly cross-linked polyethylene

Journal of the American Academy of Orthopaedic Surgeons

Paul F. Lachiewicz, MD, and Mark R. Geyer, MD

group (4.5%), but this difference was

not statistically significant. This study
was limited by lack of randomization
and by the short follow-up time.
One study compared 8 retrieved
highly cross-linked polyethylene tibial liners (Durasul) with 71 retrieved
conventional polyethylene liners.22
Both polyethylene liners demonstrated substantial surface changes,
scuffing, and scratching. No significant difference was seen between the
highly cross-linked and conventional
polyethylene liners in terms of the total optical damage score. This study
evaluated a small number of highly
cross-linked liners, most of which
were in vivo for <1 year. Large-scale
surface deformation did not occur in
any liner. Further retrieved specimens with much longer follow-up
times will be required to determine
the in vivo efficacy of highly crosslinked polyethylenes.
The ultimate advantage of highly
cross-linked polyethylene tibial liners
or patellar prostheses will be demonstrated only in properly designed
prospective randomized studies. According to the Web site www.Clini
calTrials.gov (a service of the National Institutes of Health), there are
at least four prospective randomized
trials comparing conventional with
moderately or highly cross-linked
polyethylene that have started or are
about to begin recruitment.

Clinical Risks and

Complications of Highly
Cross-linked Polyethylene
Potential risks exist with the use of
moderately or highly cross-linked polyethylene in TKA. The additional irradiation dose and, in some products,
thermal stabilization (remelting), can
adversely affect the mechanical properties of polyethylene, resulting in reduced strength, fatigue resistance, and
fracture toughness. In vitro testing of
March 2011, Vol 19, No 3

standardized highly cross-linked specimens show reduced fracture toughness

and resistance to fatigue crack propagation compared with conventional
polyethylene.23,24 How these factors
might clinically affect the locking
mechanism of modular tibial components is uncertain. No reports exist
of catastrophic failure of two designs
of highly cross-linked polyethylene
tibial liners in cruciate-retaining or
-sacrificing (ultracongruent liner)
prostheses at short- to medium-term
follow-up.
However, concern exists regarding
the mechanical strength of tibial
posterior-stabilized posts and patellar prosthesis cement fixation pegs
used with highly cross-linked polyethylene. Doping the polyethylene with
vitamin E has been proposed to retain the strength of highly crosslinked polyethylene, but no clinical
studies yet document the efficacy of
this process.8 Although numerous
case reports have been published of
fractures of tibial posts fabricated of
conventional polyethylene, only one
report describes fracture of a highly
cross-linked polyethylene tibial post
(X3 Scorpio, Stryker) in two
posterior-stabilized knee prostheses.25 Both occurred in female patients, at 8 and 16 weeks after surgery, respectively, with sudden onset
of pain, instability, and effusion. In
both cases, it was postulated that
these post fractures were the result of
subtle component malposition,
with impingement of the femoral
component on the tibial post in extension, as well as the result of flexion instability. The tibial liners were
revised from 10 to 15 mm and 12
to 18 mm, respectively, but no
follow-up was reported. It remains
unclear how subtle this malposition
was if an increase of 5 mm and 6
mm, respectively, in polyethylene
thickness was required. This specific
tibial polyethylene is fabricated with
three cycles of sequential 3-Mrad ir-

radiation and annealing below the

melt temperature.
The scope of the problem of fatigue fracture of the tibial post is unknown, but it could limit the use of
highly cross-linked polyethylene to
posterior cruciate ligamentretaining
or sacrificing (deep dished) designs.
Fracture of one or more fixation
pegs of a highly cross-linked cemented polyethylene patellar prosthesis has not been reported, but the
senior author (P.F.L.) is aware of a
case of a fracture of a Durasul patella prosthesis.
A second concern with the use of
moderately and highly cross-linked
polyethylene in TKA is the size and
biologic activity of the particles produced in a wear simulator study. Reports related to this issue are conflicting. Fisher et al19 studied wear
debris produced in the Leeds knee
simulator with conventional GUR
1020 polyethylene and moderately
cross-linked GUR 1050 polyethylene
(5 Mrad), using both fixed-bearing
and mobile-bearing knee designs. Although wear rates were lower with
the GUR 1020, the wear debris particles were smaller with the moderately cross-linked GUR 1050 polyethylene than with the conventional
GUR 1020 polyethylene, with both
mobile-bearing and fixed-bearing designs. Analysis of both designs and
both polyethylenes showed that
>95% of particles generated were <1
m. However, the moderately crosslinked polyethylene had a higher
number of particles <0.1m.
In another part of the study, when
the wear debris and lubricant from
the simulator were co-cultured with
human macrophages, the amount of
tumor necrosis factor- (TNF-) was
measured. With moderately and
highly (10 Mrad) cross-linked polyethylene, the amount of TNF- produced was greater than with both the
conventional polyethylene and the
human macrophages (control group)

149

The Use of Highly Cross-linked Polyethylene in Total Knee Arthroplasty

alone, but this was statistically significant only compared with the human macrophages.19 However, the
clinical significance of these particles
in vivo and their relationship to radiographic osteolysis is still unknown.
Another knee simulator study measured wear particle size and morphology and the number of particles
produced after 5 million cycles of six
different tibial polyethylene liners,
including three highly cross-linked
products (X3 CR, Durasul ultracongruent, and Prolong CR), one experimental 5-Mrad mobile-bearing liner,
and two conventional liners (one
mobile-bearing and one congruent).26
Most particles were round, smooth,
and submicron in size. There were
small but statistically significant differences in the size and shape description of analyzed wear particles.
A significantly lower number of particles per million cycles was reported
for the X3, Durasul, and 5-Mrad
mobile-bearing liners; the lowest
number of particles produced were
with the X3 polyethylene.
In a third knee simulator study of
mildly (3.5 Mrad) and highly (7
Mrad) cross-linked polyethylene
tested against cobalt-chromium and
zirconia femoral components, the
particle size, morphology, and number produced were measured.27 No
differences in particle size or morphology were reported. However, a
fourfold decrease was shown in the
number of particles with increased
cross-linking. In a 1-year in vivo
study of synovial fluid aspirated
from four highly cross-linked polyethylene (Prolong) knees and three
conventional polyethylene knees,
Iwakiri et al28 reported a substantially less total number of particles
and concentration of particles in the
highly cross-linked knees.

150

Summary

References

In an effort to reduce polyethylene

wear and periprosthetic osteolysis,
moderately and highly cross-linked
polyethylene tibial liners are available for use in a wide variety of
modular TKA prostheses. Some laboratory wear simulator testing has
demonstrated a significant reduction
in wear under normal and accelerated wear kinematics, but results are
somewhat conflicting. However, data
exist showing that the highly crosslinked polyethylene wear particles
are smaller and possibly more biologically active. Two early clinical
studies have demonstrated the safety
of at least two types of highly crosslinked polyethylene at 2 and 5 years,
respectively. The results of appropriately powered prospective randomized trials with sufficient follow-up
will be required to demonstrate efficacy.
Catastrophic fracture of one design
of a posterior-stabilized tibial post
has been reported. Although a cautious approach to the use of these
highly cross-linked tibial and patellar
polyethylene components is recommended, their use in younger or
more active patients may be considered. Cruciate-retaining and ultracongruent designs may be more
appropriate for use with highly
cross-linked polyethylene tibial liners. Although knee simulator testing
of some highly cross-linked products
has shown excellent wear reduction
and fracture resistance, particular
caution with the use of posteriorstabilized components and thick liners is recommended because their use
may place increased stress on the
locking mechanism and tibial post.
Surgeons should be cognizant of the
importance of axial alignment and
ligament balance to help prevent
overload and possible failure of these
polyethylene liners.

References printed in bold type are

those published within the past 5
years.
1.

Sharkey PF, Hozack WJ, Rothman RH,

Shastri S, Jacoby SM: Insall Award
paper: Why are total knee arthroplasties
failing today? Clin Orthop Relat Res
2002;(404):7-13.

2.

Lachiewicz MP, Lachiewicz PF: Are the

relative indications for revision total
knee arthroplasty changing? J Surg
Orthop Adv 2009;18(2):74-76.

3.

Fehring TK, Murphy JA, Hayes TD,

Roberts DW, Pomeroy DL, Griffin WL:
Factors influencing wear and osteolysis
in press-fit condylar modular total knee
replacements. Clin Orthop Relat Res
2004;(428):40-50.

4.

Berry DJ: Recognizing and identifying

osteolysis around total knee arthroplasty.
Instr Course Lect 2004;53:261-264.

5.

Wright TM: Polyethylene in knee

arthroplasty: What is the future? Clin
Orthop Relat Res 2005;440:141-148.

6.

Bragdon CR, Kwon YM, Geller JA, et al:

Minimum 6-year followup of highly
cross-linked polyethylene in THA. Clin
Orthop Relat Res 2007;465:122-127.

7.

Geerdink CH, Grimm B, Vencken W,

Heyligers IC, Tonino AJ: Cross-linked
compared with historical polyethylene in
THA: An 8-year clinical study. Clin
Orthop Relat Res 2009;467(4):979-984.

8.

Wang A, Yau SS, Essner A, Herrera L,

Manley M, Dumbleton J: A highly
crosslinked UHMWPE for CR and PS
total knee arthroplasties. J Arthroplasty
2008;23(4):559-566.

9.

Oral E, Malhi AS, Wannomae KK,

Muratoglu OK: Highly cross-linked
ultrahigh molecular weight polyethylene
with improved fatigue resistance for total
joint arthroplasty: Recipient of the 2006
Hap Paul Award. J Arthroplasty 2008;
23(7):1037-1044.

10.

Akagi M, Asano T, Clarke IC, et al:

Wear and toughness of crosslinked
polyethylene for total knee replacements:
A study using a simulator and smallpunch testing. J Orthop Res 2006;
24(10):2021-2027.

11.

Asano T, Akagi M, Clarke IC, Masuda

S, Ishii T, Nakamura T: Dose effects of
cross-linking polyethylene for total knee
arthroplasty on wear performance and
mechanical properties. J Biomed Mater
Res B Appl Biomater 2007;83(2):615622.

12.

Muratoglu OK, Bragdon CR, Jasty M,

OConnor DO, Von Knoch RS, Harris

Journal of the American Academy of Orthopaedic Surgeons

Paul F. Lachiewicz, MD, and Mark R. Geyer, MD

WH: Knee-simulator testing of
conventional and cross-linked
polyethylene tibial inserts. J Arthroplasty
2004;19(7):887-897.
13.

14.

15.

16.

17.

Muratoglu OK, Burroughs BR, Bragdon

CR, Christensen SC, Lozynsky A, Harris
WH: Knee simulator wear of
polyethylene tibias articulating against
explanted rough femoral components.
Clin Orthop Relat Res 2004;(428):108113.
Muratoglu OK, Bragdon CR, OConnor
DO, Perinchief RS, Jasty M, Harris WH:
Aggressive wear testing of a cross-linked
polyethylene in total knee arthroplasty.
Clin Orthop Relat Res 2002;(404):8995.
Muratoglu OK, Rubash HE, Bragdon
CR, Burroughs BR, Huang A, Harris
WH: Simulated normal gait wear testing
of a highly cross-linked polyethylene
tibial insert. J Arthroplasty 2007;22(3):
435-444.
Hermida JC, Fischler A, Colwell CW Jr,
DLima DD: The effect of oxidative
aging on the wear performance of highly
cross-linked polyethylene knee inserts
under conditions of severe malalignment.
J Orthop Res 2008;26(12):1585-1590.
Tsukamoto R, Williams PA, Shoji H,
et al: Wear of sequentially enhanced
9-Mrad polyethylene in 10 million cycle
knee simulation study. J Biomed Mater

March 2011, Vol 19, No 3

Res B Appl Biomater 2008;86(1):119124.

of highly crosslinked polyethylene. Clin

Orthop Relat Res 2004;(429):68-72.

18.

Utzschneider S, Harrasser N, Schroeder

C, Mazoochian F, Jansson V: Wear of
contemporary total knee replacements: A
knee simulator study of six current
designs. Clin Biomech (Bristol, Avon)
2009;24(7):583-588.

24.

Cole JC, Lemons JE, Eberhardt AW:

Gamma irradiation alters fatigue-crack
behavior and fracture toughness in
1900H and GUR 1050 UHMWPE.
J Biomed Mater Res 2002;63(5):559566.

19.

Fisher J, McEwen HM, Tipper JL, et al:

Wear, debris, and biologic activity of
cross-linked polyethylene in the knee:
Benefits and potential concerns. Clin
Orthop Relat Res 2004;(428):114-119.

25.

Jung KA, Lee SC, Hwang SH, Kim SM:

Fracture of a second-generation highly
cross-linked UHMWPE tibial post in a
posterior-stabilized scorpio knee system.
Orthopedics 2008;31(11):1137-1139.

20.

Hodrick JT, Severson EP, McAlister DS,

Dahl B, Hofmann AA: Highly
crosslinked polyethylene is safe for use in
total knee arthroplasty. Clin Orthop
Relat Res 2008;466(11):2806-2812.

26.

Utzschneider S, Paulus A, Datz JC, et al:

Influence of design and bearing material
on polyethylene wear particle generation
in total knee replacement. Acta Biomater
2009;5(7):2495-2502.

21.

Minoda Y, Aihara M, Sakawa A, et al:

Comparison between highly cross-linked
and conventional polyethylene in total
knee arthroplasty. Knee 2009;16(5):348351.

27.

22.

Muratoglu OK, Ruberti J, Melotti S,

Spiegelberg SH, Greenbaum ES, Harris
WH: Optical analysis of surface changes
on early retrievals of highly cross-linked
and conventional polyethylene tibial
inserts. J Arthroplasty 2003;18(7 suppl
1):42-47.

Williams PA, Brown CM, Tsukamoto R,

Clarke IC: Polyethylene wear debris
produced in a knee simulator model:
Effect of crosslinking and counterface
material. J Biomed Mater Res B Appl
Biomater 2010;92(1):78-85.

28.

Iwakiri K, Minoda Y, Kobayashi A,

et al: In vivo comparison of wear
particles between highly crosslinked
polyethylene and conventional
polyethylene in the same design of total
knee arthroplasties. J Biomed Mater Res
B Appl Biomater 2009;91(2):799-804.

23.

Bradford L, Baker D, Ries MD, Pruitt

LA: Fatigue crack propagation resistance

151