Orthopaedics

X3
Sequentially Annealed Irradiated Polyethylene

Hips

Innovation
Matters
As a pioneer in wear performance technologies, Stryker
Orthopaedics has been dedicated to offering bearing surface
improvements.
Introduced in 1998, the clinical success of Crossfire
Polyethylene has been highlighted in studies such as those
presented by James DAntonio, MD.1
Mean 5-year follow-up.
No structural failures.
72% reduction in total annual wear thus far.
Robert Krushell, MD and Richard Fingeroth, MD also presented
Crossfire data at the 2005 ORS.2
ORS mean 4-year follow-up.
58% reduction of linear head penetration compared with
standard polyethylene.
No oxidation related failures in retrievals up to 5 years.
Steve Kurtz, PhD, et al. presented a poster at the 2005 AAOS.3
Implanted for period of time between 0 and 4.8 years, with
none retrieved for wear or osteolysis.
Minimal creep and wear was observed in retrievals.
In 2005 Bo Nivbrant, MD and PhD, presented mean 4.5 years
RSA data at the 51st annual ORS showing extremely low
in vivo wear.4
90% wear reduction over the 0.05mm/annum suggested as a
clinically safe level.
Traditional crosslinking consists of a two-step process involving
both irradiation and a subsequent heat treatment step. Strykers
patented highly crosslinked and annealing process provides wear
reduction without compromising structural strength.
Building upon the clinical success of Crossfire Polyethylene,
Stryker developed a third generation annealing process with three
sequential irradiation/annealing steps to create X3 Polyethylene.

Strength
Matters
X3 Polyethylene is the first highly
crosslinked polyethylene to offer
simultaneously:

Tensile Properties

Superior Structural Fatigue Strength5, 6

Greater Wear Reduction than first
generation highly crosslinked
polyethylene 7
Oxidation Resistance8, 9
Remelting following irradiation of
polyethylene significantly alters the
crystallinity and crystalline morphology,
with up to a 35% drop in ultimate tensile
strength and a 15% drop in yield stress.
(Figure 1) 5
In contrast, annealing following
irradiation has been shown to maintain
those morphologies leading to preserved
structural strength. (Figure 2) 5, 6

Figure 1: The higher the irradiation dose, the more remelting

compromises the strength of the polyethylene.

1 Million-Cycle Fatigue Test of Acetabular Liners

Figure 2: In laboratory studies of rim loaded thin acetabular

liners made from different crosslinked polyethylene materials,
highly crosslinked (10 MRads of irradiation) remelted liners
fractured 100% of the time before 1 Million cycles, while
70% of the moderately crosslinked (5 MRads of irradiation)
remelted polyethylene liners fractured.

Fractured 10
MRads e-beam
remelted liner
used for structural
fatigue test.

Wear
Matters
Stryker Orthopaedics laboratory testing
continues to be validated by clinical performance for first and second-generation
crosslinked annealed polyethylene
products.10

Wear Rates

In 2005, Grimm, et al. reported that

Duration Polyethylene shows a clinical
wear reduction of 30% over gamma-air
conventional polyethylene.11
Five-year data of Crossfire Polyethylene
reported by DAntonio, et al. shows
better than 70% wear reduction than
conventional polyethylene at the time
of follow-up,1 while 4.5-year RSA data
reported by Nivbrant, et al. revealed a
90% wear reduction over the suggested
clinically safe level.4
97% Wear Reduction
X3 Polyethylene has 97% reduction in
wear over conventional (gamma-inert
sterilized) polyethylene,12 better than
second-generation crosslinked annealed
polyethylene.7

Figure 3 : Further hip simulator testing revealed that for X3

polyethylene ; wear did not vary significantly with head size
or polyethylene thickness in the range shown.13

Oxidation
Resistance
X3 Polyethylene demonstrates high
oxidation resistance under extreme
laboratory conditions (immersion in
5 atmospheres (ATM) of oxygen at 70C
for 14 days).8,9 (Figure 4)

Oxidation Index After ASTM F2003 Accelerated Aging

Figure 4 : Oxidation resistance is shown to be similar to virgin,

unirradiated polyethylene.

X3 Polyethylene maintains mechanical

properties after accelerated oxidative
age laboratory testing. No statistical
difference was found for tensile-yield
strength, ultimate tensile strength, and
elongation.14 (Figure 5)8, 9

Tensile Properties Before and After ASTM F2003

Accelerated Aging

Figure 5

X3. . . The Power of Technology

The first highly crosslinked polyethylene to offer simultaneously :
Structural fatigue strength better than conventional polyethylene 5,6
97% wear reduction;12 greater than first generation highly crosslinked polyethylene 7
Oxidation resistance similar to virgin polyethylene 8,9

References
1.

DAntonio, et al., 5 Year Experience with a Highly Crosslinked Polyethylene, AAOS Podium
Presentation, Washington, DC 2005 (paper publication pending).

2.

Krushell and Fingeroth, Early Wear of a Crosslinked Polyethylene Liner Versus a Conventional
Polyethylene Liner: A Case-Controlled Study, AAOS Poster Presentation, Washington, DC 2005
(paper publication pending).

3.

Kurtz. S., PhD, et al., AAOS Poster Presentation, Material Property Variation and Clinical
Performance of Retrieved Crossfire Liners, 2005.

4.

Nivbrant, B., MD, PhD, ORS Poster 0282, Extremely Low In Vivo Wear for Non-Remelted CrossLinked PE After 4.5 Years A RSA Study, 2005.

5.

Wang, A., Manley, M., Serekian, P., Wear and Structural Fatigue Simulation of Crosslinked UltraHigh Molecular Weight Polyethylene for Hip and Knee Bearing Applications, Crosslinked and
Thermally Treated Ultra-High Molecular Weight Polyethylene for Joint Replacements, ASTM
STP1445, Kurtz, S.M., Gsell, R., and Martell, J., Eds., ASTM International, West Conshohecken, PA
2003, pp. 151-168.

6.

Essner, A., et al., Acetabular Liner Function Fatigue Performance of Crosslinked UHMWPE, 51st
Annual ORS paper No. 0245, Washington, DC 2005.

7.

Stryker Orthopaedics Test Report: RD-03-082.

8.

X3 UHMWPE maintains mechanical properties after accelerated oxidative aging. No statistical

difference was found for Tensile Yield Strength, Ultimate Tensile Strength and Elongation as measured
per ASTM D638 before and after exposure to ASTM F2003 accelerated aging (5 Atmospheres (ATM)
of oxygen at 70C for 14 days). Tensile Yield Strength was 23.5 0.3 MPa and 23.6 0.2 MPa,
Ultimate Tensile Strength was 56.7 2.1 MPa and 56.3 2.3 MPa and Elongation was 267 7% and
266 9% before and after accelerated oxidative aging, respectively.

9.

X3 UHMWPE resists the effects of oxidation. No statistical difference was found for Tensile Yield
Strength, Ultimate Tensile Strength, Elongation, Crystallinity and Density as measured per ASTM
D638, D3417 and D1505 before and after ASTM F2003 accelerated aging (5 ATM of oxygen at 70C
for 14 days). Tensile Yield Strength was 23.5 0.3 MPa and 23.6 0.2 MPa, Ultimate Tensile Strength
was 56.7 2.1 MPa and 56.3 2.3 MPa, Elongation was 267 7% and 266 9%, Crystallinity was
61.7 0.6% and 61.0 0.5% and Density was 939.2 0.1 kg/m3 before and after accelerated oxidative
aging, respectively.

10. Essner, A., et al., The Clinical Relevance of Hip Joint Simulator Testing: In Vitro and In Vivo
Comparisons, Wear, No. 259, pp. 882-886, 2005.
11. Grimm, B., et al., Wear Performance of a Crosslinked Polyethylene for Total Hip Arthroplasty Measured
In-Vitro and by a Prospective Randomized Clinical Study at 5-year Follow-up, EFORT Podium
Presentation, Lisbon, Portugal 2005.
12. Stryker Orthopaedics Trident Acetabular Inserts made of X3 UHMWPE,
721-00-32E, show a 97% reduction in volumetric wear rate versus the same insert fabricated from
N2\Vac gamma sterilized UHMWPE, 620-00-32E. The insert tested was 7.5mm thick with an inner
diameter of 32mm. Testing was conducted under multi-axial hip joint simulation for 5 million cycles using
a 32mm CoCr articulating counterface and calf serum lubricant. X3 UHMWPE Trident Acetabular Inserts
showed a net weight gain due to fluid.

Cit Centre
Grand-Rue 90
1820 Montreux
Switzerland

13. Stryker test report: RD-04-029.

t : +41 21 966 12 01
f : +41 21 966 12 00

14. Stryker test report: RD-03-081.

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