PINNACLE® HIP SOLUTIONS

PINNACLE
HIP SOLUTIONS
®
DESIGN RATIONALE
TABLE OF CONTENTS
ADVANCED MODULARITY
Enhanced Options
5
Freedom to Choose
6
Proven Design – The VIP Taper
7
ADVANCED TRIBOLOGY
92% Wear Reduction – ALTRX®9
ADVANCED FIXATION
True Tissue In-Growth
11
Innovative Solutions in Fixation
12
Optimized Fixation with GRIPTION®13
Clinically Proven POROCOAT®14
ADVANCED MATERIALS
DUOFIX® – Enhanced Biological Fixation
15
Enhanced Materials to Optimize Choice
17
Improved Toughness – ALTRX
18
Improved Strength – BIOLOX® delta19
ADVANCED STABILITY
DESIGNED BY SURGEONS
Enabling Motion
21
High Stability, Low Wear – ALTRX LD
22
23
Design Rationale PINNACLE® Hip Solutions DePuy Synthes Joint Reconstruction 3
4 DePuy Synthes Joint Reconstruction PINNACLE® Hip Solutions Design Rationale
ADVANCED MODULARITY
ENHANCED OPTIONS
Our unique approach to modularity gives you more ways to bring together
components and materials for optimized performance. Utilizing the advanced
bearing options of DePuy Synthes Joint Reconstruction PINNACLE® Hip Solutions
allows you to achieve stability, wear reduction and surgical flexibility.
Choose a solution featuring the advanced technologies of ceramic-on-polyethylene
or metal-on-polyethylene.
Design Rationale PINNACLE® Hip Solutions DePuy Synthes Joint Reconstruction 5
Advanced modularity
FREEDOM TO CHOOSE
DePuy Synthes Joint Reconstruction PINNACLE Hip Solutions is designed with a wide
range of acetabular cup options, biological and mechanical fixation alternatives and
advanced bearing technologies. With more options than any competitive product, these
proven, modular solutions provide you with the power to choose without compromise.
PINNACLE allows you to meet the individual needs of patients and their lifestyle.
GRI
PTIO
N
FIX
DUO
MARATHON
AT
CO
RO
PO
PO
RO
CO
AT
MARATHON®
BIOLOX delta
ALTRX
ALTRX
DUOFIX
N
GRIPTIO
Standard
Metal
M-Spec
MARATHON
ALTRX
N
IO
T
IP
GR
DU
OF
IX
POROCOAT
6 DePuy Synthes Joint Reconstruction PINNACLE® Hip Solutions Design Rationale
PROVEN DESIGN – THE VIP TAPER
Variable Interface Prosthesis (VIP)
taper technology contributes to
advanced modularity by supporting
both polyethylene liners and hard
bearing inserts. VIP taper technology
also enables macro – and
microstability by functioning as a
supporting and locking mechanism.
Variable
Interface
Prosthesis
(VIP) Taper
Technology
7
Design Rationale PINNACLE® Hip Solutions DePuy Synthes Joint Reconstruction 7
8 DePuy Synthes Joint Reconstruction PINNACLE® Hip Solutions Design Rationale
ADVANCED TRIBOLOGY
92% WEAR REDUCTION – ALTRX®
1
0.2
0.1
0.0
Standard
Polyethylene
ALTRX
Polyethylene
0.4
0.3
0.4
Wear Reduction
0.3
92% Wear Reduction1
0.2
0.1
0.0
0.8
0.4
0.2
0.0
1
Scratch Resistance
Enhanced Mechanical
Toughness10, 17
80
Volumetric Wear (mm³/million cycles)
Volumetric Wear (mm³/million cycles)
Option
35
45
30
40
33% Wear Reduction4
5
4
25 Option
High-Performance
4
3
3
2
1
0
2
15
10
5
CoCr-on-ALTRX
delta-on-ALTRX
Volumetric wear
with 36 mm heads
0
CoCr-on-ALTRX delta-on-ALTRX
1
0
20
33% Wear Reduction4
CoCr-on-ALTRX
Volumetric wear after heads were
roughened to emulate scratching from
third-body debris
delta-on-ALTRX
Volumetric wear with 36 mm heads
35
30
25
35
Scratch Resistance
Advanced Wear Resi
30
25
20
15
10
20
5
15
0
10
3.0
3.09
2.5
2.0
1.5
1.0
0.5
CoCr-on-ALTRX
1.2
delta-on-ALTRX
Volumetric0.0
wear after heads were
roughened to emulate
scratching from
Conventional
DePuy aS
third-body debris Round Head
5
0
3.5
10
90% Wear Reduction4,151%
Fewer Metal Pa
CoCr-on-ALTRX
First 1,000,000 articulation c
delta-on-ALTRX
after implantation
Volumetric wear after heads were
roughened to emulate scratching from
third-body debris
Enhanced Mechanical
Effect of Irradiation Dose
Toughness10, 17
on Toughness1
Effect
of
Irradiation
Dose
Improvement o
80
80
Design
Rationale PINNACLE® Hip Solutions 1 DePuy Synthes Joint
Reconstruction 9
on Toughness
Marathon
35% Greater Toughness
30% Greater Toughness
70
35% Greater Toughness
90% Wear Reduction4, 10
40
High-Performance
6
90% Wear Reduction4, 10
40
Volumetric Wear (mm³/million cycles)
®
5
1
45 *Compared to Pinnacle metal-on-polyethylen
Volumetric Wear (mm³/million cycles)
45
6
0.2 Small Head MoM Group
Stable
Wear
(1-3 m)
Big Head
MoM
Group
0.0
Acc
ALTRX
Polyethylene
Scratch Resistance
4
92%
0.4
2
3
4
0.0
Accumulated Volume Wear of Metal-on-MetalBreak
*Compared to Pinnacle metal-onBreak
Cycles (million)
-0.2
0
1
*Compared to Pinnacle metal-on-polyethylene bearings.
0.1
Standard
Polyethylene
BIOLOX delta-on-ALTRX
BIOLOXHigh-Performance
delta-on-ALTRX Option
bearings
6 provide an alternative
33% Wear Reduction
solution
5 for high-demand
patients.
This low-wear option
4
produces 33 percent less
3
volumetric wear than ALTRX
2
liners with cobalt chrome
heads.41 BIOLOX delta-onALTRX 0is also
less susceptible
CoCr-on-ALTRX delta-on-ALTRX
wear withthird-body
36 mm heads
to addedVolumetric
wear from
debris such as bone cement or
bone fragments.4
0.6
Big Head MoM
0.6
0.4
-0.2
Break-in Wear for 44 mm MoM
(0-1 m)
0
Break-in Wear
0.2 for 28 mm MoM (0-0.5 m)
0.0
-0.2
ALTRX 0
Polyethylene
Standard
Polyethylene
0.2
0.6
Small Head MoM Group
Big Head MoM Group
Volume Loss (mm³)
0.5
0.8
SmallWear
Head Mo
92% Reduction in Run-in
Volume Loss (mm³)
0.3
0.6
1
92% Wear Reduction0.8
0.5
Volume Loss (mm³)
0.4
Volumetric Wear (mm³/million cycles)
Metal-onAltrX
92% Wear Reduction1
0.5
Volumetric Wear (mm³/million cycles)
ear
ction
Volumetric Wear (mm³/million cycles)
1%
Volumetric Wear (mm³/million cycles)
Wear Reduction
0.6
Volumetric Wear (mm³/million cycles)
Wear Reduction
0.6
Volumetric Wear (mm³/million cycles)
nt over
on
ALTRX® is an ultra-low-wear polyethylene and
an advanced option in alternative bearings. The
unique ALTRA-LINK™ manufacturing process is
used to optimize the balance between wear
reduction and mechanical integrity.2 Unlike
annealed polyethylene, ALTRX consistently
eliminates free radicals and oxidative potential.3
80
30% Greater Toughness
Enhanced Mechanical
70
80
51% Wear Reducti
Effect of Irradiation Dose
11 DePuy Synthes Joint Reconstruction PINNACLE® Hip Solutions Design Rationale
ADVANCED FIXATION
TRUE TISSUE IN-GROWTH
At DePuy Synthes Joint Reconstruction, our innovative coating technologies coax
natural bone to grow deep within implant material for secure placement.5–8 Other
fixation alternatives can’t deliver the same stability. Just look to our long-standing
clinical heritage9 and you’ll see why we lead the way in implant fixation.
Design Rationale PINNACLE® Hip Solutions DePuy Synthes Joint Reconstruction 11
Advanced Fixation
INNOVATIVE SOLUTIONS IN FIXATION
Our advanced GRIPTION®, POROCOAT® and
DUOFIX® porous coatings promote biological
tissue in-growth for enhanced fixation.5-8, 10-15
In-growth – 4 weeks10
In-growth – 8 weeks10
In-growth – 12 weeks10
11 DePuy Synthes Joint Reconstruction PINNACLE® Hip Solutions Design Rationale
OPTIMIZED FIXATION WITH GRIPTION®
GRIPTION Technology is a cementless coating specifically engineered to maintain a
clinically advantageous 63-percent porous, 300-micron pore structure to maximize
both short- and long-term fixation.5 This allows for greater tissue growth and
revascularization onto and around an implant.5–8
Combined macrotexture and microtexture topographies can provide a favorable
mechanical loading environment for bone reconstitution and enable greater cell
adhesion and proliferation.5–8 GRIPTION Coating has demonstrated a predicted
coefficient of friction of 1.2 in lab testing, offering substantial improvement over
standard porous coatings and suggesting a 20 percent improvement over a
contemporary tantalum cementless interface.10
Design Rationale PINNACLE® Hip Solutions DePuy Synthes Joint Reconstruction 11
Advanced Fixation
CLINICALLY PROVEN POROCOAT®
POROCOAT Porous Coating encourages more biological fixation to bone. Our
proprietary POROCOAT Porous Coating is composed of commercially pure titanium
sintered metal beads, which allow bone to affix biologically into the porous coating.
11 DePuy Synthes Joint Reconstruction PINNACLE® Hip Solutions Design Rationale
DUOFIX® – ENHANCED BIOLOGICAL FIXATION
Our DUOFIX Fixation System is a combination of POROCOAT Porous Coating and highly
amorphous hydroxyapatite (HA). DUOFIX uses tiny, spherical beads to maximize surface
area for immediate stability and fast, deep biological tissue in-growth into the porous
coating. Plasma spray flame applications provide a consistent layer of HA to accelerate
osteointegration and aid in achieving early fixation.11-15
DUOFIX also helps to seal the acetabulum against particulate debris, reducing the
chance of component loosening.11-15 This coating technology encourages long-term
fixation of the acetabular cup to the host bone.
Design Rationale PINNACLE® Hip Solutions DePuy Synthes Joint Reconstruction 11
11 DePuy Synthes Joint Reconstruction PINNACLE® Hip Solutions Design Rationale
ADVANCED MATERIALS
ENHANCED MATERIALS TO OPTIMIZE CHOICE
DePuy Synthes Joint Reconstruction PINNACLE Hip Solutions materials offer
mechanical integrity, wear resistance and oxidative stability. Our advanced modularity
and range of solutions allow you to match the components to your patient’s needs –
more important than ever, considering today’s patients are demanding far more from
implants than previous generations.
Design Rationale PINNACLE® Hip Solutions DePuy Synthes Joint Reconstruction 11
60
60
40
0.6
0.8
20
1
92% Wear Reduction
92% Wear
Reduction1
0.5
0.5
Volume Loss (mm³)
10
IMPROVED TOUGHNESS – ALTRX
0
0.4
3X-Annealed
Polyethylene 0.3
ALTRX
0.4
0
10.0 Mrad
ALTRX
7.5 Mrad
0.3
0.6
0.4
0.2
0
Wear Resistance
0.0
45
0.0
Standard
Polyethylene
92% Wear Reduction
Standard
ALTRX
Polyethylene
50
40
92% Reduct9
Break-in Wear for 44
B
Break-in Wear for 28
B
01
12
Accumulated Volu
Cyc
ALTRX
Polyethylene
*Compared to Pinnacle
*Compared
metal-on-polyethylene
to Pinnacle metal-on-polyeth
bearings.
40
35
Oxidative Resistance10, 16
3.0
Scratch Resistance
Scratch Resistance
25
45
2.5
45
X34, 10
90% Wear Reduction
90% Wear
Reduction4, 10
0
Metal-onStandard
Polyethylene
6
4
33% Wear Reduction
33% Wear
Reduction4
5
5
4
4
Metal-on-ALTRX
3
3
2
1
0
2
1
0
CoCr-on-ALTRX
CoCr-on-ALTRX
delta-on-ALTRX
delta-on-ALTRX
Femoral
Volumetric wear with
Volumetric
36 mm wear
headswith 36 mm
14 heads
Acetabulum Preservation
12
23% Less Bone Removed
30
1.0
25
0.5
20
0.0
15
10
40
30
20
2.0
6
1.5
1.0
10
5
0
0
0.5
CoCr-on-ALTRX
delta-on-ALTRX
0.0
H
delta-on-ALTRX
Wear
8
Effect of Irradiation
Effect of Irradiation
Dose
Dose
on Toughness
on1 Toughness1
80
70
0
60
50
40
30
20
10
10
0
0
3X-Annealed
Polyethylene
3X-Annealed
ALTRX
Polyethylene
45
80
70
70
Conventional 60 DePuy ASR™ 60
Technology
ALTRX
Wear Resistance
Wear Resistance
80
30% Greater Toughness
30% Greater Toughness
70
®
11 DePuy Synthes Joint Reconstruction PINNACLE
Solutions Design Rationale
OptimizedHipOptimized
45
20
1
2
3
4
5
Weeks15
of Accelerated Aging
10
Impact Toughness (kJ/m³)
Impact Toughness (kJ/m³)
50
2.5
Volumetric wear after
Volumetric
heads were
wear after heads were
roughened to emulate
roughened
scratching
to emulate
from scratching from
45.7% More
third-body debris third-body debris
Femoral Head
35% Greater Toughness
35% Greater Toughness
2
Conventional 180˚ 60 ASR XL
Hemispherical Cup
3.0
25
CoCr-on-ALTRX
Head Preservation
4
80
Impact Toughness (kJ/m³)
70
30
5
6
Enhanced Mechanical
Enhanced Mechanical
10, 17
10, 17
Toughness Toughness
80
0
A
3.5
35
Preservation
Bone Preserved
Bone Removal
35
1.5
Volumetric Wear (mm3/million cycles)
5
Volumetric Wear (mm³/million cycles)
10
High-Performance
High-Performance
Option
Option
6
40
50
40
30
20
Impact Toughness (kJ/m³)
15
40
2.0
Volumetric Wear (mm³/million cycles)
20
Volumetric Wear (mm³/million
cycles)
Oxidative
Potential
30
Volumetric Wear (mm³/million cycles)
Volumetric Wear (mm³/million cycles)
60
30
0.8
Small Head MoM
Small Head MoM Grou
20 Group
Big Head MoM Group
Big Head MoM Group
0.6
10
0.4
0
Metal-on0.2
Marathon
0.0
0.2
0.2
Remelted in an argon convection,
ultra-low-wear
ALTRX is mechanically tough.0.0It also
-0.2
-0.2
0.1 radicals0.1
consistently eliminates
free
and oxidative potential, unlike annealed polyethylene.
Optimized
on-
70
Volumetric Wear (mm³/million
Volumetriccycles)
Wear (mm³/million cycles)
10
0.6
Volumetric Wear (mm³/million cycles)
20
40
30
Wear Reduction
Wear Reduction
Volumetric Wear (mm³/million cycles)
30
50
Volume Loss (mm³)
Advanced 50Materials
Volumetric Wear (mm3/million cycles)
70
Impact Toughness (kJ/m³)
Impact Toughness (kJ/m³)
er
70
50
40
30
20
10
10
0
0
10.0 Mrad
10.0
ALTRX
Mrad
7.5 Mrad
ALTRX
7.5 Mrad
60
50
40
30
20
10
0
IMPROVED STRENGTH – BIOLOX® delta
The advanced technology of BIOLOX delta ceramic heads provides high-stability, low-wear
articulations, which are especially relevant with more active patients. BIOLOX delta heads
are available with or without titanium sleeves for both primary and revision surgeries.
C
MC
matrix-composite
ceramic
Design Rationale PINNACLE® Hip Solutions DePuy Synthes Joint Reconstruction 11
22 DePuy Synthes Joint Reconstruction PINNACLE® Hip Solutions Design Rationale
ADVANCED STABILITY
ENABLING MOTION
Optimized head-to-shell ratios across a full spectrum of sizes proportionally increase
jump distance and stability, and reduces the chance of dislocation. A smooth range of
natural motion is yet another key benefit for patients.
159°
10
Design Rationale PINNACLE® Hip Solutions DePuy Synthes Joint Reconstruction 22
Advanced stability
Volumetric Wear (mm³/million cycles)
Wear Reduction
92% Wear Reduction
HIGH STABILITY, LOW WEAR – ALTRX LD
ALTRX LD liners are large-diameter, ALTRA-LINK polyethylene liners
designed
to enhance
stability with inner diameter (ID) sizes of 40, 44 and
28 mm MoM
Ultamet XL
As demonstrated
run-in phase
48 mm.
Theseduring
large-diameter
liners are available in lateralized and facechanging designs. With a focus on wear reduction, ALTRX LD liners are
potentially less susceptible to higher wear as a function of head size.18
High Stability, Low Wear18
p
um
ce
Di
n
sta
28 mm
45.7% More
Femoral Head
Preservation
Wear
J
14 mm
28 mm
Marathon
48 mm
ALTRX LD
22 DePuy Synthes Joint Reconstruction PINNACLE® Hip Solutions Design Rationale
DESIGNED BY SURGEONS
Our advanced PINNACLE System was designed in conjunction
with a team composed of the following surgeons:
William P. Barrett, MD
Proliance Surgeons, Seattle, WA
Director, Center for Joint Replacement
Renton, Washington
Daniel Berry, MD
Professor of Orthopaedics
Mayo Medical School
Chairman, Department of Surgery
Mayo Clinic
Rochester, Minnesota
Thomas Fehring, MD
Co-Director, OrthoCarolina
Hip and Knee Center
OrthoCarolina
Charlotte, North Carolina
William Griffin, MD
Co-Director, OrthoCarolina
Hip and Knee Center
OrthoCarolina
Charlotte, North Carolina
Gregory Brick, MD
Assistant Clinical Professor
Harvard Medical School
Boston, Massachusetts
John Callaghan, MD
Professor, Department of Orthopaedics
University of Iowa College of Medicine
Iowa City, Iowa
Thomas Schmalzried, MD
Associate Director
Joint Replacement Institute
at Orthopaedic Hospital
Assistant Professor of
Orthopaedic Surgery
Chief of Joint Replacement
Harbor-UCLA Medical Center
Los Angeles, California
Charles Engh, MD
Clinical Associate Professor
University of Maryland
School of Medicine
Baltimore, Maryland
Design Rationale PINNACLE® Hip Solutions DePuy Synthes Joint Reconstruction 22
REFERENCES
1. Liao YS, Greer K, et al. “Effects of Resin and Dose on Wear and Mechanical Properties
of Cross-Linked Thermally Stabilized UHMWPE.” Society for Biomaterials, the 7th World
BiomaterialsCongress, Sydney, Australia, 2004.
2. Hanes MD, Capps SG. ALTRX® ALTRALINK® Polyethylene for the PINNACLE Acetabular Cup
System. DePuy Orthopaedics, Inc. Warsaw, IN February 2007.
3. Comparison Of Crosslinked UHMWPE Stabilized by Sequential Annealing or by Remelting, +*Greer,
K W; *Sharp, M, +DePuy Orthopaedics, Warsaw, IN
4. Liao Y-S, Greer K, Alberts A. “Effect of head material and roughness on the wear of 7.5 Mrad
crosslinked-remelted UHMWPE acetabular inserts.” Presented at the 54th annual meeting of the
Orthopaedic ResearchSociety. San Francisco, CA; March 2-5, 2008. Poster 1901.
5. Bobyn JD, Pilliar RM, Cameron HU and Weatherley GC. “The Optimum Pore Size for the Fixation
of Porous-Surfaced Metal Implants by the Ingrowth of Bone.” Clinical Orthopaedics and Related
Research Vol. 150, 1980.
6. Svehla M, Morberg P, Zicat B, Bruce W, Sonnabend D and Walsh WR. “Morphometric and
Mechanical Evaluation of Titanium Implant Integration. Comparison of Five Surface Structures.”
Journal of Biomedical Materials Research Vol. 51, No. 1, July 2000: 15-22.
7. Pilliar RM. “Powder Metal-Made Orthopaedic Implants with Porous Surface for Fixation by Tissue
Ingrowth.” Clinical Orthopaedics and Related Research 1983:176.
8. Cook SD, et al. “Interface Mechanics and Bone Ingrowth into Porous Co-Cr-Mo Alloy Implants.”
Clinical Orthopaedics 1985: 193.
9. Engh CA, et al. “Cementless Total Hip Arthroplasty Using the Anatomic Medulary Locking Stem:
0-10 Year Results Using a Survivorship Analysis.” Clinical Orthopaedics and Related Research 1989:
249.
10. Data on file at DePuy Orthopaedics, Inc.
11. Capello WN, D’Antonio JA, Manley MT and Feinberg JR. “Arc-Deposited Hydroxyapatite-Coated
Cups: Results at Four to Seven Years.” Clinical Orthopaedics and Related Research Vol. 441,
December 2005: 305-312.
12. Hermida JC, D’Lima DD, Steklov N and Colwell CW Jr. “Outcome of an Acetabular Design with
Hydroxyapatite Coating on a Rough Substrate.” Clinical Orthopaedics and Related Research Vol.
441, December 2005: 298-304.
13. M oilanen T, Stocks GW, Freeman MA, Scott G, Goodier WD and Evans SJ. “Hydroxyapatite Coating
of an Acetabular Prosthesis: Effect on Stability.” Journal of Bone and Joint Surgery [Br.] Vol. 78, No.
2, March 1996: 200-205.
14. Fujisawa A. “Investigation for Bone Fixation Effect of Thin HA Coated Layer on Ti Implants.” [Article
in Japanese] Kokubyo Gakkai Zasshi Vol. 72, No. 4, December 2005: 247-253.
15. Thanner J, Karrholm J, Herberts P and Malchau H. “Porous Cups With and Without HydroxyapatiteTricalcium Phosphate Coating: 23 Matched Pairs Evaluated With Radiostereometry.” Journal of
Arthroplasty Vol. 14, No. 3, April 1999: 266-271.
16. X3 data reported by Orhun Muratoglu from Mass General Hospital during a Grand Rounds
Presentation at the Dartmouth-Hitchcock Medical Center on May 16th, 2007. http://www.dhslides.
org/ortho/ortho051607/msh.htm
17. Orthopaedic Research Society, 2007, P1784.
18. Liao Y-S, Alberts A, Keefer R, Greer K. “Effect of Head Size on the Wear of GUR 1050 5-Mrad and
GUR 1020 7.5-Mrad Crosslinked-Remelted Polyethylene.” Presented at the 55th annual meeting of
the Orthopaedic Research Society. Las Vegas, NV; February 22-25, 2009. Poster 2333.
22 DePuy Synthes Joint Reconstruction PINNACLE® Hip Solutions Design Rationale
BIOLOX® delta is a trademark of CeramTec GmbH.
WARNING: In the USA, this product has labeling limitations. See package insert for complete information.
CAUTION: USA Law restricts these devices to sale by or on the order of a physician.
Not all products are currently available in all markets.
DePuy Orthopaedics, Inc.
700 Orthopaedic Drive
Warsaw, IN 46582
T. +1 (800) 366-8143
www.depuysynthes.com
© DePuy Synthes Joint Reconstruction, a division of DOI 2013
EO-129 (Rev. 1) 08/13