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Clinical Performance of a Durasul Highly Cross-Linked Polyethylene

Acetabular Liner for Total Hip Arthroplasty at Five Years
Lawrence D. Dorr, Zhinian Wan, Cambize Shahrdar, Leighellen Sirianni, Myriam Boutary and Andrew Yun
J Bone Joint Surg Am. 87:1816-1821, 2005. doi:10.2106/JBJS.D.01915

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Clinical Performance of a Durasul

Highly Cross-Linked Polyethylene
Acetabular Liner for Total Hip
Arthroplasty at Five Years
BY LAWRENCE D. DORR, MD, ZHINIAN WAN, MD, CAMBIZE SHAHRDAR, MD,
LEIGHELLEN SIRIANNI, OPA-C, MYRIAM BOUTARY, BS, AND ANDREW YUN, MD
Investigation performed at the Arthritis Institute, Inglewood, California

Background: Highly cross-linked polyethylene is currently the most common articulation surface used for total hip ar-
throplasty. The hypothesis of the present study was that the Durasul highly cross-linked polyethylene acetabular liner
would have less wear at five years than would a conventional polyethylene liner used in association with the same to-
tal hip replacement system.
Methods: Forty-three consecutive patients (fifty hips) underwent total hip replacement with an uncemented titanium
porous-coated metal cup and a Durasul liner that was mated with a 28-mm cobalt-chromium femoral head. Thirty-one
patients (thirty-seven hips) were followed for at least five years. Thirty-five other patients (thirty-seven hips) underwent
total hip arthroplasty with the same system but with a conventional polyethylene liner, and these patients also were
followed for five years. Clinical assessment was performed with use of the Harris hip score and a patient self-
assessment examination. Radiographic analysis included measurements of acetabular component position, fixation,
and osteolysis. Femoral head penetration of the Durasul liners was compared with that of the conventional liners.
Results: The clinical results as determined on the basis of Harris hip scores and patient self-assessment examina-
tions did not differ between the Durasul group and the control group. The mean bedding-in penetration was 0.054 ±
0.07 mm for the Durasul group and 0.059 ± 0.154 mm for the control group. The subsequent penetration, with elim-
ination of the bedding-in wear, resulted in a linear wear rate of 0.029 ± 0.02 mm per year for the Durasul group, com-
pared with 0.065 ± 0.03 mm per year for the control group (p < 0.005). The annual penetration at one and five years
was 0.074 mm and 0.011 mm, respectively, for the Durasul group, compared with 0.151 mm and 0.04 mm, respec-
tively, for the control group.
Conclusions: While the qualitative wear pattern of the highly cross-linked polyethylene liner was the same as that of
the conventional polyethylene liner, the annual linear wear rate was 45% of that seen with the conventional polyethyl-
ene liner. Therefore, we believe that these early data support the continued use of this highly cross-linked polyethyl-
ene liner for total hip arthroplasty.
Level of Evidence: Therapeutic Level III. See Instructions to Authors for a complete description of levels of evidence.

R
ecent advances in polyethylene preparation have resulted
in the development of highly cross-linked polymers that
have substantially reduced secondary oxidation and
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wear of the polyethylene in the laboratory setting1. Despite the
greater polyethylene longevity that has been suggested by lab-
oratory testing, a history of clinical failures of modified poly-
ethylenes that also were preceded by optimistic in vitro results
has made the orthopaedic community appropriately cautious
regarding this new polyethylene2,3. The hypothesis of the
present study was that the penetration of a metal femoral head
into an electron beam-irradiated, ram-extruded, highly cross-
linked polyethylene acetabular liner during the first five years
of clinical use would be less than the penetration into a con-

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TABLE I Demographic Data
Polyethylene Age (yr)
Durasul (n = 37) 60.2 ± 16.2
Conventional (n = 37) 65.1 ± 10.8
P value 0.136
ventional polyethylene liner used with the same total hip ar-
throplasty system. The patterns of wear associated with this
polyethylene were also compared, both qualitatively and quan-
titatively, with the established patterns associated with conven-
tional polyethylene.
Materials and Methods
he United States Food and Drug Administration ap-
T proved the use of the Durasul highly cross-linked poly-
ethylene liner (Zimmer, Warsaw, Indiana) in February 1999,
and forty-three consecutive patients (fifty hips) underwent
total hip replacement with use of this insert between March
and May 1999. Data were collected prospectively at the time of
scheduled patient visits for clinical and radiographic follow-up.
The collection of data for publication was approved by our
institutional review board, and patients gave informed con-
sent to participate in the study. Twelve patients (thirteen hips)
were eliminated from the study: four patients (four hips) died
for reasons that were unrelated to the hip surgery, four pa-
tients (four hips) were lost after less than one year of follow-
up, and four patients (five hips) had revision of the cup in
the first two years because of the recall of the InterOp acetab-
ular shell (Sulzer, Austin, Texas). Thus, the study group com-
prised thirty-one patients with thirty-seven hips (including
fourteen men [seventeen hips] and seventeen women [twenty
hips]). Demographic data for these patients are presented in
Table I. The diagnosis was osteoarthritis for twenty-nine
hips, osteonecrosis for six, and developmental dysplasia for
two. Activity was categorized as unlimited activity, active
community ambulation (the ability to walk six to eight blocks),
limited community ambulation (the ability to walk two to
three blocks), household ambulation (the ability to walk in the
home and yard), or wheelchair-bound4.
Thirty-five patients (thirty-seven hips) who had been
managed with the same cup and stem, but with a conven-
tional polyethylene liner, constituted the control group. These
patients were drawn from a pool of seventy-nine patients
who had had the operation in the six months prior to those
who had received the Durasul liner. The selection was blinded
with regard to wear. These patients were matched to the pa-
tients in the Durasul group with regard to age, weight, and
gender (Table I). The groups could not be exactly matched
with regard to gender because the pool was depleted by pa-
tients who had a recalled and/or revised InterOp cup, who
had to be excluded. Before matching, patients who had an In-
terOp cup that had been recalled and patients who had had a
revision were excluded.
All hips in both groups were evaluated with a postoper-
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Weight (kg) Male:Female Ratio (no. of hips)
82.5 ± 17.7 17:20
78.5 ± 12.7 17:20
0.277 0.816
ative radiograph made at six to twelve weeks and two or more
additional postoperative radiographs, for a total of at least
three radiographs. Hopper et al.5 demonstrated that at least
three radiographs are necessary to quantify the precision of
wear rate measurements. Not every patient in both groups re-
turned for each annual examination (Table II).
With regard to the femoral implant, thirty-two hips
with a Durasul liner and thirty-three hips with a conventional
polyethylene liner received an Anatomic Porous Replacement
uncemented stem (Zimmer), four hips with a Durasul liner
and four hips with a conventional polyethylene liner received
an Apollo cemented stem (Zimmer), and one hip with a Du-
rasul liner received an Anatomic Medullary Locking congeni-
tal dysplastic hip stem (DePuy, Warsaw, Indiana). A 28-mm
cobalt-chromium femoral head was used in every hip in both
groups. Both types of liners had a posterior hood of 10°, with
the apex of the hood placed at the four o’clock position in
left hips and at the eight o’clock position in right hips. The
Durasul liner was machined from ram-extruded bars of
GUR1050 polyethylene. The polyethylene was preheated to
125°C in air and then was treated with electron-beam irradia-
tion (9.5 Mrad). The preforms were then melted and annealed
over two hours to quench remaining free radicals. After ma-
chining, the components were sterilized in ethylene oxide for
packaging. The conventional polyethylene liners (Sulene; Zim-
mer) were manufactured from 1020 resin (stearate-free) and
were packaged in an oxygenless environment. The acetabular
metal shell in all hips was the InterOp cup, which was a 3.5-
mm-thick, walled, titanium-alloy shell with a sintered tita-
nium cancellous structured porous coating.
The clinical outcomes for all patients were followed pro-
spectively. The Harris hip score was recorded preoperatively,
at six months and one year postoperatively, and at the time of
the most recent follow-up. Specific scores for pain and limp
were determined with use of this scoring system. A patient
self-assessment examination (Orthographics, Salt Lake City,
Utah) was used to determine the activity level of each patient
TABLE II Annual Number of Hip Radiographs
Durasul Conventional
Year (no. of hips) (no. of hips)
1 28 22
2 22 20
3 29 27
4 14 24
5 23 17
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and to grade the result of the operation (excellent, good, fair,
or poor).
A supine anteroposterior hip and pelvic radiograph and
a Lauenstein lateral radiograph were made postoperatively at
six weeks, three months, one year, and at each annual follow-
up visit that the patient attended. All radiographs were made
by the same two technicians throughout the study period. Ac-
etabular abduction and version were measured with previ-
ously described methods6. Two-dimensional femoral head
penetration was manually measured with use of the method
described by two of us (L.D.D. and Z.W.)7, which has been
found to have an intraobserver error of 0.1 mm for two mea-
surements (unpublished data). This method was validated as
being more accurate for the evaluation of clinical radiographs
than computerized methods are, at least for total wear of <1
mm, by both Barrack et al.8 and Ebramzadeh et al.9.
We attempted to measure penetration on the radio-
graphs of hips with Durasul liners after five years of follow-up
with use of the Martell computer method10,11. One-hundred
and twelve follow-up radiographs from thirty-six hips were
TABLE III Annual Linear Wear Rate According to the Method of Sychterz et al.12
Annual Linear Wear Rate* (mm/yr)
Year Durasul
1 0.02 ± 0.01
2 0.05 ± 0.042
3 0.035 ± 0.029
4 0.031 ± 0.021
5 0.025 ± 0.01
Mean 0.029 ± 0.02
*The values are given as the mean and the standard deviation.
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Fig. 1
Illustration showing the total penetration of
Durasul and conventional polyethylene lin-
ers (in mm), beginning with the bedding-in
penetration at six to twelve weeks on the
left side of the graph and continuing to Year
5 on the right side of the graph. The wear
curve for conventional polyethylene liners
becomes linear after the first year, and the
wear curve for the Durasul liners becomes
linear after the second year. The standard
deviations for the penetration at each time-
period are given in Table IV.
measured with the computer method, with eighteen of these
hips having five years of follow-up. The radiographs of five
hips could not be measured at five years because they had
been mailed from out of town and were not adequate for com-
puter measurements. Unfortunately, these thirty-six hips had
such a small amount of wear that, on the basis of computer
measurements, forty-nine (43.8%) of the 112 radiographs
demonstrated a negative vector of wear (with the vector of
wear pointing away from the cup surface) and sixty-three
(56.3%) demonstrated a positive vector of wear. Likewise,
among the eighteen hips with five years of follow-up, eight
(44%) had negative wear and ten (56%) had positive wear.
Negative wear is a measurement error associated with the
computer technique that is caused by the distortion of the cir-
cular femoral head and blurring of the edges of the femoral
head and the acetabular cup that occurs on clinical radio-
graphs. Therefore, the true centers of the femoral head and ac-
etabular shell are not correctly located and a measurement
error occurs. The error is greater in association with smaller
amounts of wear. The number of negative measurements in
Conventional P Value
0.091 ± 0.08 <0.005
0.083 ± 0.045 0.001
0.059 ± 0.034 0.004
0.062 ± 0.032 0.003
0.053 ± 0.023 0.002
0.065 ± 0.026 0.005
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TABLE IV Mean Total Penetration
Mean Total Penetration* (mm)
Year Durasul
Bedding-in period 0.054 ± 0.07 (0-0.29)
1† 0.074 ± 0.07 (0-0.27)
2 0.150 ± 0.09 (0-0.351)
3 0.161 ± 0.125 (0.01-0.625)
4 0.181 ± 0.082 (0.04-0.635)
5 0.192 ± 0.085 (0.06-0.473)
*The values are given as the mean and the standard deviation, with the range in parentheses. †Year 1 total penetration includes bedding-in
penetration.
these hips detracts from the evaluation of the true wear.
The initial bedding-in penetration of the femoral head
was measured on the six-week to three-month radiographs.
Sychterz et al.12 calculated subsequent penetration of the fem-
oral head by subtracting the bedding-in penetration from the
total penetration. The annual linear wear rates for the Durasul
liners and the comparative data for conventional polyethylene
liners are reported with use of the method described by Sy-
chterz et al.12.
Total penetration included the bedding-in value. The
total penetration can be expressed for each individual year,
and we have newly defined this measurement as “annual pene-
tration.” This pattern of penetration defines the time of run-
ning-in creep13-15 and the steady state of annual penetration by
each year. It differs from the annual linear wear rate because
the annual linear wear rate reflects the mean of several years
whereas “annual penetration” describes the amount of pene-
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Conventional P Value
0.059 ± 0.154 (0.02-0.41) 0.51
0.151 ± 0.167 (0.01-0.67) <0.005
0.191 ± 0.098 (0.04-0.40) 0.465
0.23 ± 0.153 (0.02-0.73) 0.016
0.28 ± 0.166 (0.05-0.87) 0.003
0.32 ± 0.187 (0.02-0.91) <0.005
tration for an individual year. The annual penetration was ex-
pressed as a mean value for all of the patients in the study who
returned to the clinic in that year, and therefore the standard
deviation could not be calculated. The standard deviation
could have been calculated if each patient returned each year
so that the penetration on the radiographs of individual pa-
tients could be tracked.
Radiographs were evaluated with regard to fixation and
osteolysis on pelvic and iliac oblique views of the acetabulum
according to established methods6,16-18. All measurements were
made by a single research physician (Z.W.).
Statistical analysis was performed for all data with use of
SPSS software (SPSS, Chicago, Illinois). Univariate regression
analysis was used to evaluate the relationship, if any, between
penetration and the variables of age, gender, weight, diagno-
sis, the duration of follow-up, and acetabular inclination and
anteversion. The 95% confidence level was used to determine
Fig. 2
Bar graph showing the annual penetration
that occurred during each year, from Year 1
through Year 5. For conventional polyethyl-
ene liners, the amount of running-in pene-
tration in Year 1 represents the creep and
the penetration in Years 2 to 5 represents
a steady state of wear. For Durasul liners,
the annual penetration in Years 1 and 2
represents the running-in creep and the
penetration in Years 3 to 5 represents a
steady state of wear. Standard deviations
cannot be calculated for these measure-
ments, as explained in the text.
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significant differences. The amount of penetration, the annual
rate of penetration, and the cup position are expressed as the
mean and the standard deviation.
Results
Clinical Assessment
t the time of the final follow-up, the Harris hip score was
A 94 ± 8 points (range, 70 to 100 points) for the thirty-
seven hips with a Durasul liner compared with 96 ± 7 points
(range, 70 to 100 points) for those with a conventional poly-
ethylene liner. At the time of the final follow-up, the self-
assessment examination revealed thirty-three excellent, two
very good, one good, and one fair result in the Durasul group
compared with twenty-nine excellent and eight very good re-
sults in the control group. In the Durasul group, activity was
categorized as unlimited ambulation for twenty-six hips, ac-
tive community ambulation for four, limited community am-
bulation for three, and household ambulation for four. In the
control group, activity was categorized as unlimited ambula-
tion for twenty-nine hips, active community ambulation for
six, limited community ambulation for one, and household
ambulation for one.
Radiographic Assessment
All sockets were fixed without cement and without screws.
The mean inclination angle was 38° ± 5.3° (range, 28° to 50°)
for cups with Durasul liners and 39° ± 6.3° (range, 28° to 59°)
for cups with conventional polyethylene liners (p = 0.39). The
mean anteversion was 19° ± 6.7° (range, 7.5° to 29°) for cups
with Durasul liners and 18° ± 4.7° (range, 9° to 27°) for cups
with conventional polyethylene liners (p = 0.71). There was
no evidence of osteolysis, progressive radiolucent lines, or
component migration in any of the hips.
The annual linear wear rates as determined with the
method of Sychterz et al.12, which eliminates the bedding-in
value, are provided in Table III. For each year, the linear wear rate
for the conventional polyethylene liners was higher than that for
the Durasul liners. The five-year annual linear wear rate was
0.029 ± 0.02 mm per year for Durasul liners and 0.065 ± 0.026
mm per year for conventional polyethylene liners (p < 0.005).
The cumulative five-year penetration of Durasul and
conventional polyethylene liners is shown in Table IV and Fig-
ure 1. The conventional polyethylene liners had a linear curve
after Year 1, whereas the Durasul liners had a linear curve after
Year 2.
The annual penetration is a simplified method of ex-
pressing the penetration that occurs each year. The annual
penetration of Durasul and conventional polyethylene liners
in Years 1 through 5 is shown in Table V and Figure 2. The
steady state was reached after Year 1 for conventional polyeth-
ylene liners and after Year 2 for Durasul liners. The annual
penetration for conventional polyethylene liners had a steady
rate of 0.04 mm per year from Year 2 through Year 5. The an-
nual penetration with a Durasul liner varied from 25% to 40%
of that for a conventional polyethylene liner after the steady
state is reached.
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TABLE V Annual Penetration
Annual Penetration (mm)
Year Durasul Conventional
1 0.074 0.151
2 0.076 0.04
3
4
0.011
0.02
0.039
0.05
5 0.011 0.04
At five years, no hip with either a Durasul or a conven-
tional liner was an outlier for the osteolysis threshold of 0.10
mm per year13,19, with all liners having a wear rate at or below
this level. With the numbers available, univariate regression
analysis did not demonstrate that age, gender, weight, activ-
ity, cup abduction, or cup anteversion had any influence on
penetration.
Discussion
urasul liners have the same qualitative pattern as conven-
D tional polyethylene liners do with regard to the bedding-
in and running-in periods to a steady state of wear13-15. In the
present study, the steady state was reached after two years in
hips with Durasul liners and after one year in hips with con-
ventional polyethylene liners. This finding suggests that Du-
rasul highly cross-linked polyethylene adapts more slowly to
penetration of the metal femoral head. This slower rate of ad-
aptation did not appear to have any adverse consequences. Di-
gas et al.20 used radiostereometric examination to study the
penetration of 28-mm metal femoral heads into Durasul all-
polyethylene cemented cups. At two years postoperatively, the
mean total penetration was 0.13 mm in that study, compared
with 0.15 mm in the present study. In Year 3, the mean pene-
tration was 0.01 mm in that study, compared with 0.011 mm
in the present study. Thus, the running-in period was two
years in both studies.
Although qualitatively the same, the quantitative wear
patterns of Durasul and conventional polyethylene liners were
different. The hypothesis of the present study was confirmed:
Durasul liners had less wear at five years than conventional
polyethylene liners did. The annual linear wear rate with con-
ventional polyethylene liners continued to decrease to Year 5,
largely because all of the running-in creep penetration (0.151
mm) occurred in Year 1. Durasul liners had the same total
amount of running-in penetration (0.150 mm), but this oc-
curred over two years, which allowed the linear wear rate to be
steady at Years 4 and 5. The mean annual linear wear rate of
Durasul liners (0.029 mm per year) was 45% of that of the
conventional polyethylene liners (0.065 mm per year). Our
wear data for Durasul liners show an approximately 80% re-
duction in linear wear when compared with the wear rates for
conventional polyethylene liners as reported in studies by Sy-
chterz et al.12 (0.17 mm per year), Dowd et al.13 (0.18 mm per
year), and Pedersen et al.14 (0.14 mm per year).
The annual penetration concept is used to establish a
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steady state of wear by measuring the yearly penetration with-
out the influence of running-in creep. Therefore, this method
is different from the traditional linear wear rate, which elimi-
nates bedding-in penetration but includes the running-in
creep. Eliminating running-in creep provides a clearer picture
of the amount of actual wear, whereas the traditional method
combines wear and creep. With this method, conventional
polyethylene liners reached a steady state of 0.04 mm per year
beginning with Year 2 (Table V). Durasul liners reached a
steady state of wear after the running-in period of two years
and then had an annual penetration of 0.01 mm to 0.02 mm
(between 25% and 40% of the values for conventional poly-
ethylene) between three and five years. The annual penetra-
tion remained steady for both Durasul and conventional
polyethylene in Years 3, 4, and 5.
The limitations of the present study are that it was not
randomized, it included only thirty-seven hips, and only
twenty-three hips were available for study at five years. How-
ever, our data showed the same qualitative and quantitative
patterns as did the data in the randomized study by Digas et
al.20, and the total number of hips in the present study is simi-
lar to that in other studies on cross-linked polyethylene11,20.
These data should be considered as early results. Time is
needed to observe whether the rate of wear will remain steady
and below the osteolysis threshold of 0.10 mm per year13,19,21.
While the long-term effects of the altered mechanical proper-
ties of highly cross-linked polyethylene remain unknown, the
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data to date are promising in that the early penetration and
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ventional polyethylene and the wear rates are well below the
osteolysis threshold and seem to have reached a steady state af-
ter the second year. Because of these findings, we are recom-
mending the further use of this type of liner to our patients. 
Lawrence D. Dorr, MD
Zhinian Wan, MD
Leighellen Sirianni, OPA-C
Myriam Boutary, BS
Andrew Yun, MD
Arthritis Institute, 501 East Hardy Street, 3rd Floor, Inglewood, CA
90301. E-mail address for L.D. Dorr: patriciajpaul@yahoo.com
Cambize Shahrdar, MD
The Orthopedic Clinic, Willis Knighton Hospital, 8001 Youree Drive,
Suite 600, Shreveport, LA 71115
In support of their research or preparation of this manuscript, one or
more of the authors received grants or outside funding from Zimmer.
None of the authors received payments or other benefits or a commit-
ment or agreement to provide such benefits from a commercial entity. No
commercial entity paid or directed, or agreed to pay or direct, any bene-
fits to any research fund, foundation, educational institution, or other
charitable or nonprofit organization with which the authors are affiliated
or associated.
doi:10.2106/JBJS.D.01915
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