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AID,INC Selling Guide
For internal use only.All outside distribution is prohibited.
Integrity Selling Material
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Table of Contents
Page 4 Integrity Guide Overview
Page 5 The APPROACH
Page 6 Approach by Behavior Style
Page 8 The INTERVIEW
Page 9 Current Situation Questions
Page 14 Desired Situation Questions
Page 16 Benefit / Reward Questions
Page 18 Risk / Consequence Questions
Page 20 Urgency / Importance Questions
Page 21 The DEMONSTRATION
Page 22 The VALIDATION
· Metal
· Polyethylene
· Ceramic
· Quick Source Reference Table
Page 27 The NEGOTIATION
· Negotiate the Pinnacle Acetabular System
· Negotiate Polyethylene
· Negotiate BIOLOX delta
· Negotiate Stability & Range of Motion
· Negotiate Metal Wear
· Negotiate aSphere
· Negotiate Ions
· Ions for Dummies
Page 43 References
Page 44 The CLOSE
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Leading Change in a New Environment
To help you with the entire Integrity™ Selling process, tools have been created for each step of
AID,INC. This guide was specifically designed to assist you in customizing your pre-call plan.
Please find the following resources in this Integrity reference:
· Approach section – Tips for a successful approach, as well as examples of approaches for each behavior style
· Interview section – The GAP model and a question library broken down by each type of GAP question, as well as by negotiation topics to allow you to effectively create your Pinnacle pre-call plan
· Demonstrate & Validate sections – Key Pinnacle literature you can use during HCP sales calls to discuss our offerings, advanced materials, and clinical evidence
· Negotiate section – Created to assist you in understanding the needs Pinnacle Hip Solutions can fulfill, the science and data behind each bearing, and conversational examples of ways to handle common objections
· Close section – Tips for a successful close, including examples of “Trial-Close” questions
Approach Interview
Listen
Talk
Practicing AID, Inc. is simply having an organized conversation with customers.Integrity Selling®, AID INC® are trademarks owned by Integrity Solutions, Inc.1
A I D I N C®
Demonstrate Validate Negotiate Close
Time
Approach Interview
Listen
Talk
Practicing AID, Inc. is simply having an organized conversation with customers.Integrity Selling®, AID INC® are trademarks owned by Integrity Solutions, Inc.1
A I D I N C®
Demonstrate Validate Negotiate Close
Time
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APPROACH
Purpose: To Gain Trust and Rapport
and to show appreciation to build trust
Tools: Use your body language and physical appearance to make a positive first impression
APPROACH TIP 1: The HCP should do most of the talking during the Approach phase
APPROACH TIP 2: behaviors to make your HCP most comfortable during conversations
APPROACH TIP 3: Ask questions using behaviors that
APPROACH TIP 4: Remember to ask about personal or work discussions the HCP shares as an opportunity to re-connect in future conversations
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APPROACHES by Behavior Style
Doer: Impatient and driven; pressed for time; result-oriented; bottom line; lower need for establishing relationships.
Approaching Doers:
time for one quick question.
Controller: Lower energy level; detail-oriented; relies on facts, evidence, and data; hesitant to try new products.
Approaching Controllers:
your decisions. May I ask you a few questions on how you make your decisions with regards to your total
get time, I would be interested in your analysis of technologies within total knee replacement. Would you
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Supporter: Cooperative and attentive; wants accurate information before making decision; trusting relationships.
Approaching Supporters:
in medicine was because you really do care about people and truly want to help them.
do whatever I can when those situations come up. I like when I can count on people and I want to be
Talker: Outgoing, enthusiastic, approachable and people-oriented; less interested in details; prefer collaboration.
Approaching Talkers:
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Identify Needs and Problems
Logical
Emotional
GAP
Current Situation
Risks/Consequences
DesiredSituation
Benefits/Rewards
Urgency/Importance
Your solutions are the vehicles that moveHCPs from current to desired situation
INTERVIEW
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patient types.
their options, what are patients saying now about
able to wait to hear how things ended up with ___.
times to obtain the ideal inclination or version intra-
Which of your patients get the most benefit from
Past / Current Behaviors, Concerns & Patient Types
Talkers Supporters Doers ControllersKEY
Current Situation Questions
Desired Situation Questions
Questions
Questions
Questions
Pre-Call Planning GAP Questions Library (see the Integrity Reference for GAP Question definitions)
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What type of information have you required in the
How do you select a safe and effective bearing for
What was your take on the analysis and results of
What forms of data are critical when choosing a THA
What types of research or clinical studies do you like
desires for treatments when it conflicts with the best
selection based on the changing demands of
Can you tell me which forms of data are most
Decision Making
Preferred Information
Talkers Supporters Doers ControllersKEY
Current Situation Questions
Desired Situation Questions
Questions
Questions
Questions
Pre-Call Planning GAP Questions Library (see the Integrity Reference for GAP Question definitions)
INTERVIEW
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MoM products.
What is the bottom line for you when it comes to
Please distill down for me the benefits you see in using a MoM construct vs. metal-on-poly.
What is the algorithm you use for selecting bearings
Alternative Bearings Experiences /Beliefs
Current Situation Questions
Desired Situation Questions
Questions
Questions
Questions
Talkers Supporters Doers ControllersKEY
Pre-Call Planning GAP Questions Library (see the Integrity Reference for GAP Question definitions)
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What percentage of your THA patients receive metal
What is your analysis of the numerous MoM articles
monoblock or resurfacing systems and where do you
Polyethylene
Metal Liners & Heads
Current Situation Questions
Desired Situation Questions
Questions
Questions
Questions
Talkers Supporters Doers ControllersKEY
Pre-Call Planning GAP Questions Library (see the Integrity Reference for GAP Question definitions)
INTERVIEW
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IF YES - Was it with the previous ceramic material, forte, or the newest generation
delta
a metal head vs. ceramic head for your total hip
Ceramic Materials
Economic Buyer
Current Situation Questions
Desired Situation Questions
Questions
Questions
Questions
Talkers Supporters Doers ControllersKEY
Pre-Call Planning GAP Questions Library (see the Integrity Reference for GAP Question definitions)
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your patients from hip replacement.
for your THAs.
What data or clinical studies would you like to have that
What risks that, if you could minimize them, would make
What outcomes would you like to achieve for your patients
What obstacles do you have today that you would like to
could help you.
would like to improve upon.
would be for an implant surface.
General Desires
Current Situation Questions
Desired Situation Questions
Questions
Questions
Questions
Talkers Supporters Doers ControllersKEY
Pre-Call Planning GAP Questions Library (see the Integrity Reference for GAP Question definitions)
INTERVIEW
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receive from a bearing that offers low wear.
many are researching their surgical options on the
low wearing bearing.
elevated metal ions in MoM hip implants.
Bearing Desires
Economic Buyer Desires
Current Situation Questions
Desired Situation Questions
Questions
Questions
Questions
Talkers Supporters Doers ControllersKEY
Pre-Call Planning GAP Questions Library (see the Integrity Reference for GAP Question definitions)
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Would things be simpler for your staff if that
flexibility would help you.
low wear with intra-operative modularity, what
mentioned could impact you.
that adjustment could be achieved.
you described, how would that impact your day-to-
impacts you and your patients.
with a larger head-to-shell ratio compared to your
option in your practice, how could that enhance your
General Benefits (following up on specific desires)
THA Benefits
Current Situation Questions
Desired Situation Questions
Questions
Questions
Questions
Talkers Supporters Doers ControllersKEY
Pre-Call Planning GAP Questions Library (see the Integrity Reference for GAP Question definitions)
INTERVIEW
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it significantly lowered the wear generated, how
alleviated by using a lower wearing bearing.
Bearing Benefits
Economic Buyer Benefits
Current Situation Questions
Desired Situation Questions
Questions
Questions
Questions
Talkers Supporters Doers ControllersKEY
Pre-Call Planning GAP Questions Library (see the Integrity Reference for GAP Question definitions)
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What could happen if a patient needs to have your
friction fit acetabular cup like the one in the _____
regimen result in sub-optimal outcomes in this new
What happens if you have a failure from a clinically
What is the bottom line for you if you stayed with
Distill down for me the benefits you see in using a MoM construct vs. MoP, please.
going forward.
significant enough for you to consider making a
General Risks
Current Situation Questions
Desired Situation Questions
Questions
Questions
Questions
Talkers Supporters Doers ControllersKEY
Pre-Call Planning GAP Questions Library (see the Integrity Reference for GAP Question definitions)
INTERVIEW
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a hard bearing that does not obtain fluid film
Bearing Risks
Economic Buyer Risks
Current Situation Questions
Desired Situation Questions
Questions
Questions
Questions
Talkers Supporters Doers ControllersKEY
Pre-Call Planning GAP Questions Library (see the Integrity Reference for GAP Question definitions)
For Stryker X3
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Current Situation Questions
Desired Situation Questions
Questions
Questions
Questions
Talkers Supporters Doers ControllersKEY
Pre-Call Planning GAP Questions Library (see the Integrity Reference for GAP Question definitions)
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In future product launches, new HCP and Sales Associate literature will be created specifically to aid
literature piece to use when having general HCP discussions about the entire Pinnacle portfolio.
DESIGN RATIONALE
PINN
AC
LE® H
IP SOLU
TION
S
The Pinnacle Brochure has clearly marked tabs for discussing the following topics with an HCP:
™
™ over Marathon™ LD in stability and
jump distances® and
Ultamet®
® delta®, Gription®,
and DuoFix® coatings
Femoral Solutions, DePuy Institute and a listing of our Design Surgeons Pinnacle Brochure - Cat. No. 0612-69-507
DEMONSTRATION
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The tools used to Validate our products are the specific and detailed HCP literature pieces, such as Surgical Techniques, Design Rationales, White Papers, Peer-reviewed Journal Articles, Clinical Compendiums, as well as DVDs created for surgeons
The following pages contain examples of valuable Pinnacle validation literature.
Design Rationale
0612-20-508
0612-95-505Charles A Engh, Jr., MD; Steven J MacDonald, MD; Supatra Sritulanondha, MPH; Abigail; Thompson,
RN; Douglas Naudie, MD; Charles A Engh, Sr., MD, A comparison of three total hip arthroplasty
bearing surfaces: a randomized trial. Clin Orthopaedics and Related Research (In Press, 2008)
Dowson D, Hardaker C, Flett M, Isaac GH. “A Hip Joint Simulator Study of the
Performance of Metal-on-Metal Joints. Part I: The Role of Materials.” J Arthroplasty.
2004;19(8, suppl 3):118-123.
Dowson D, Hardaker C, Flett M, Isaac GH. “A Hip Joint Simulator Study of the Performance of Metal-on-Metal Joints. Part II: Design.” J Arthroplasty. 2004;19(8, suppl 3):124-130.
Bergman G, Deuretzbacher G, Heller M, et al. “Hip Contact Forces and Gait
Patterns from Routine Activities.” J Biomech. 2001;34(7):859-871.
0612-21-508 0612-72-509
Metal
Survivorship of the Pinnacle® Acetabular Cup System
Pamela L. Plouhar, Ph.D., Vice President Worldwide Clinical Affairs†; Rodrigo Diaz, MD, Manager, Clinical Research†;
Gary Warriner, MSc, Senior Biostatistician†; Kristine Lee, MPM, Senior Technical Writer†
Many factors affect hip survival, including bearing type, material properties, component design, head size, implant alignment, restoration of joint me-
chanics, and patient characteristics such as skeletal morphology, muscle function, and tissue laxity. Some hip systems have a long clinical history, making
it possible to determine the effect that these variables have on device safety and performance. Newer systems with less clinical history include current
generation modular and monoblock metal-on-metal, ceramic, and highly cross-linked polyethylene hip systems. The impact and relative importance of
variables that affect implant survival in these newer systems is emerging. National joint registries and large databases provide valuable information on the
revision rates/survivorship of newer and older implants alike. The data contained within various registries and large databases vary in terms of patient,
surgeon, and institutional specificity. The value of most registries is that they include large cohorts with contributions from all surgeons, irrespective of
experience level. The limitation of registry data is the lack of patient-level detail that might reflect selection, complexity, or comorbidity, and information
on surgeon experience. Examples of these data sources include the Australian Orthopaedic Registry (AOA), the Swedish Registry, and the National Joint
Registry (NJR) for England and Wales.
Typically, a variety of hip systems may be combined into a single broad category (hip replacement) for evaluation in a registry report. Primary total hip
replacement is a well established and efficacious procedure, as demonstrated by the revision rates reported in the National Joint Registry (NJR) for England
and Wales and the Australian Orthopaedic Registry (AOA). The 2009 NJR registry annual report noted a three-year revision rate of 2.6% (95% CI 2.4%-
2.8%) for cementless stems.1 The AOA 2009 annual report noted the yearly cumulative percent revision of primary conventional total hip replacement
(with a primary diagnosis of osteoarthritis, excluding infection) to be 2.8% (2.7, 2.9) at 5 years.2
To evaluate the effect of different variables on device performance, it is possible to look at data available for specific product configurations. Such configura-
tions include bearing materials, head size, and stem-cup combinations.
Effect of Bearing Articulations on Survivorship
The 6th annual report of the National Joint Registry (NJR) for England and Wales, released in 2009, reports results for the following bearing surface
articulations with femoral heads ≤ 32 mm (excluding resurfacing components):1
Three-Year Revision Rate by Bearing Articulation – 2009 National Joint Registry (NJR) for England and Wales
Metal on
Polyethylene
Ceramic on
PolyethyleneCeramic on Ceramic
Metal on Metal
Revision rate (95% CI)1.6% (1.5-1.7%) 1.7% (1.5-2.0%) 2.2% (1.8-2.6%) 1.9% (1.2-3.0%)
Hazard ratio adjusted for age,
gender and physical status1.0 0.8 (0.7-1.0) 0.9 (0.8-1.1) 0.8 (0.5-1.3)
While not statistically significant, it is important to note that the risk of revision (as reflected in the “hazard ratio”) for metal-on-metal articulations was
less at three years postoperatively compared to metal-on-polyethylene articulations, after adjusting for age, gender, and physical activity.
Clinical Data on the Pinnacle® Acetabular Cup System
The Pinnacle Acetabular Cup System performed as well or better than other hip systems based on the yearly cumulative revision rates (which ranged from
1.6 to 6.8 revisions at 5 years) seen in the 2009 Australian Orthopaedic Registry Annual Report (AOA).2 This registry report is consistent with a 5-year
survivorship of 99.9% reported in a clinical study conducted by Kindsfater et al. of 1,183 subjects. In this study 2% of bearings were ceramic on polyeth-
ylene; 35% were metal-on-metal bearings (MoM); and 63% were metal-on-polyethylene bearings.3
Pinnacle Acetabular Cup System – Various Bearing Combinations using Corail®, Summit®, and S-ROM® Hip Stems
2009 Australian Orthopaedic Registry (AOA)
Corail Hip System Summit Hip System S-ROM Modular Hip System
Yearly cumulative revision rates2.6% at 5 years 1.6% at 5 years 3.7% at 5 years
In March 2010, using information from the National Joint Registry (NJR) for England and Wales, a Kaplan Meier survivorship analysis was conducted on
11,471 primary Pinnacle Acetabular Cups. This analysis examined the survivorship of metal-on-metal (MoM) bearings with Corail, Summit, and S-ROM
hip stems. Subject mean age was 66 years (range 17-97).4
Pinnacle Acetabular Cup System – MoM Survivorship with Revision for Any Reason as the Endpoint
2009 National Joint Registry (NJR) for England and Wales
1 Year 2 Years 3 Years 4 Years 5 Years 6 Years
MoM Survivorship 99.1% 98.5% 98.0% 97.5% 96.8% 96.4%
Femoral head size has also been shown to impact survivorship.3 Accordingly, NJR data specific to 28, 36, and 40 mm femoral heads using the Pinnacle
Acetabular Cup System with a metal-on-metal (MoM) articulation was also analyzed. The Corail, Summit and S-ROM hip stems were all included in the
Kaplan Meier survivorship analysis.4
Comparison of Median
Serum Cobalt Levels
Median μg/L1 In-Vivo Year
Ultamet® 12 0.73 2
Metasul® 2,8 1.1 1
Ultima® 5,11 1.3 1.6
Sikomet-SM21® 3,9 1.5 1
M2A™ 4,10 1.55 5
Birmingham™ 6,11 2.1 1.3
Cormet® 7,11 3.0 1.3
References1. Sample Method : Serum except Sikomet-SM21 (Whole Blood)
2. METASUL™ is a registered trademark of Zimmer, Inc.
3. Sikomet-SM21is a registered trademark of Sikov Medizintechnik, GmbH.
4. M2A-38 and M2A-Magnum are a trademark of Biomet Orthopaedics, Inc.
5. ULTIMA® and Ultamet® are registered trademarks of Depuy Orthopaedics, Inc.
6. Birmingham is a trademark of Smith & Nephew
7. Cormet is a registered trademark of Corin Group PLC.
8. W. Brodner,et al., Elevated serum cobalt with metal-on-metal articulating surfaces. J Bone Joint Surg Br 79 (1997), p. 316
9. Schaffer et al. Increased blood cobalt and chromium after total hip replacement. J Toxicol 1999
10. Rasquinha, et al. Serum metal levels and bearing surfaces in total hip arthroplasty. J Arthroplasty 21(6 Suppl 2):47-52, 2006
11. M.T. Clarke,et al, Levels of metal ions after small and large-diameter metal-on-metal hip arthroplasty J Bone Joint Surg Br 85 (2003), p. 913
12. C. Anderson Engh Jr., et al. 2008 John Charnley Award ~ Metal ion levels after metal-on-metal total hip arthroplasty: A randomized trial. Clin Orthop Related Res. October 2008
UPDAT
ED
VALIDATION
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Material Rationale
CMC
matrix-compositeceramic
BIOLOX® delta
Advancing High
Stability and Low Wear
A Better Alternative
Today’s high demand patient cohort is frequently unwilling
to give up their vocation or avocation simply because they
have had a hip replacement. A variety of bearing choices
has been developed to address the needs of this popula-
tion. Each has unique advantages as well as disadvan-
tages. Projecting which bearing surface would be best for
a given patient makes decision making difficult for the hip
surgeon of 2007.
Prior to 2007, three classes of bearings were available,
metal on metal, ceramic on ceramic, and metal on plastic.
Metal on metal has outstanding wear characteristics and
the advantage of large head technology to prevent dis-
location. However, concerns over ions prevent universal
adoption. Possible hypersensitivity reactions, specula-
tion over carcinogenic potential, and resistance to using
this bearing in childbearing women or patients with renal
disease may limit its widespread use.
Ceramic on ceramic bearings have the lowest wear in the
laboratory. The wear products released are inert and well
tolerated by patients. However, there may be potential
for fracture with this type of bearing. Revision following
fracture is very difficult as the extremely hard ceramic
particles are difficult to remove and will damage subse-
quent bearings. The squeaking recently associated with
this bearing is another potential problem, which will limit
its use. The cause of squeaking in this bearing is currently
unknown. For surgeons concerned about the fracture risk
in a ceramic on ceramic bearing, the added disadvantage
of squeaking makes this bearing currently unattractive.
Highly cross-linked polyethylene is the third class of
modern bearings. It is a bearing all hip surgeons are very
familiar with. A variety of liner options makes this the most
versatile bearing available. However, the potential for poly-
ethylene-induced osteolysis remains. In addition, the in
vivo wear rates of all cross-linked polyethylenes have not
diminished wear to the extent that was initially predicted in
the laboratory.
From the above discussions one can clearly see why the
hip surgeon of 2007 has difficulty deciding which bearing
is best for their patient. An improved second-generation
cross-linked polyethylene may be an attractive alternative
until a specific bearing system proves superior. Until then
an improved second generation cross-linked poly (AltrX™)
may be the best option for the surgeon with concerns
about the ion issues of metal on metal and the squeaking
and fracture issues of ceramic on ceramic.
In my practice, I want a bearing surface that will meet the
demands of my active patients while preserving intraop-
erative versatility to deal with the challenge of stability,
leg length and offset. AltrX altra-linked polyethylene is an
attractive option for me and my patients.
AltrX is a second generation cross-linked poly made from
a different resin than Marathon® cross-linked polyethyl-
ene. A change from 1050 resin to 1020 resin allows higher
radiation doses (7.5 megarads) to be used. This leads
to greater cross-linking, further reduction in free radicals,
and improved wear. Despite the use of higher radiation,
mechanical integrity similar to a well-established product
such as Marathon® is maintained3. This is accomplished
by placing ram-extruded polyethylene bars made from
1020 resin in a foil package to prevent oxygen exposure.
This bar is then irradiated with 7.5 megarads. The bars
are then remelted in an Argon convection oven and cooled
just below the melting temperature. This controlled ther-
mal environment allows the material to recrystallize which
leads to better mechanical properties. This two-step
remelting and annealing process effectively eliminates free
radicals to a level similar to non-radiated polyethylene3.
Laboratory data has shown a 53% reduction in wear
with AltrX compared to Marathon. This equates to a
92% overall reduction in wear compared to conventional
polyethylene3– a significant improvement that may limit the
prevalence of osteolysis in active patients.
This improvement can be enhanced through the use of
a Delta ceramic head in combination with the AltrX liner.
Delta heads have improved wear characteristics and
greater resistance to third body debris compared to cobalt
chrome heads. Jennings et al. demonstrated 40% less
volumetric wear with ceramic on a cross-linked poly than
those with cobalt chrome heads.1 In addition, McKel-
lop et al. noted better resistance to third body debris for
roughened Delta heads on cross-linked poly – an 82%
reduction compared to roughened cobalt chrome heads.2
My current protocol for hip bearings is
as follows:
I use Delta ceramic on AltrX polyethylene in
my high demand, active patients.
In other patients, I use AltrX with a cobalt
chrome head.
As more information concerning hard bear-
ings is forthcoming, this may cause me to
reevaluate this protocol.
WHY I USE ALTRX™ AS A BEARING SURFACEThomas K. Fehring, MD
Ortho Carolina
Charlotte, NC
DePuy introduced the first FDA-cleared crosslinked
polyethylene, Marathon™, in 1998. Engineered to
balance mechanical and wear properties, Marathon
performs well clinically.5,10 Marathon is produced
from GUR 1050 polyethylene ram extruded bar
that is moderately crosslinked at 5 Mrad of gamma
irradiation. Next, the crosslinked polyethylene bar
is stabilized using a patented remelting process to
eliminate free radicals.
Today’s active patients place high demands on total
hip replacements. These patients require longer life
expectancy from their implants; therefore lower
wear rates are needed.7 Crosslinked polyethylene
provides lower wear rates than conventional (non-
crosslinked) polyethylene, however, according to
some research, the wear particle size in crosslinked
polyethylenes is more biologically active.7 In
an attempt to reduce these biological effects,
particularly with more active patients, several
orthopaedic implant manufacturers have produced
new generations of lower wear crosslinked
polyethylenes. DePuy recently developed a new
polyethylene, AltrX™ to further reduce wear
while maintaining good mechanical integrity and
oxidative resistance. AltrX polyethylene is the result
of substantial scientific research and engineering
development.
Design Rationale
The design goal with AltrX was to lower bearing
wear as much as possible without compromising
mechanical integrity. Marathon uses GUR 1050,
the UHMWPE historically used in hip systems.
Since Marathon has performed well clinically, the
next generation of DePuy crosslinked polyethylene
needed to match or exceed the mechanical properties
AltrX™ AltraLinked Polyethylene
for the Pinnacle Acetabular Cup System
by Mark D. Hanes, Ph.D. – DePuy Orthopaedics, Inc. and Susan G. Capps, Ph.D. – BENSOL | February 2007
of Marathon material. In orthopaedic polyethylene
research and development, it is known that
increasing irradiation levels increases crosslinking
and therefore wear resistance. However, increased
radiation also decreases mechanical properties
such as toughness.3,6,7 Considering the design
goals and the behavior of different polyethylene
materials, DePuy research scientists began the
AltrX development process with an UHMWPE
that offered greater inherent mechanical strength
than GUR 1050 since mechanical strength
degrades after irradiation. GUR 1020, historically
used in knee systems, is inherently stronger than
GUR 1050; therefore, a higher irradiation dose
will cause higher levels of crosslinking and wear
resistance while maintaining the mechanical
strength of Marathon GUR 1050. With an
irradiation dose of 5 Mrad, GUR 1050 and GUR
1020 have similar wear properties but GUR 1020
has superior mechanical properties. Based on these
facts, the question was asked “how high could the
irradiation dose be increased on GUR 1020 and
preserve the advantageous mechanical properties
while improving the wear properties above that of
GUR 1050?” Also, “could the Marathon remelting
process be used to eliminate free radicals in GUR
1020 and therefore produce an oxidatively stable
polyethylene?” These questions were answered
affirmatively during the development of AltrX and
the AltraLink™ Process.
AltraLink™ Process
The AltraLink Process is a unique material
enhancement process that optimizes the balance
between wear resistance, mechanical integrity
and oxidative resistance. It does not create a new
Compatibility Guide
1
INTRODUCTION
As technology and surgical techniques have evolved
since the turn of the millennium, surgeon and
patient expectations have also evolved about implant
durability and expected activity level after total hip
arthroplasty. Traditionally surgeons have had the
onus of selecting the prosthetic joint, but with the
advent of easily obtainable information from multiple
sources, patients have become part of the decision-
making process. The “Millennium Patient”, as coined
by Thomas Schmalzried, MD, is said to be one who
is informed and active, with expanded expectations
about their lifestyle after hip surgery. Although this
may seem daunting, and often times poses challenges
to a surgeon during an office visit, the surgeon should
keep in mind that most patients are only seeking honest
answers from their physician. If a surgeon can take the
time to explain the decision making process in total
hip arthroplasty to their patient, it only strengthens
the doctor-patient relationship. The goal of this paper
is to develop a decision-making framework between
the physician and a patient contemplating THR.
CASE STUDY
S.R. is a 31 year-old female patient that came into the
office complaining of severe and debilitating bilateral
hip pain. Approximately 18 months prior she was
scheduled for an outpatient laparoscopic procedure,
but unfortunately due to complications, had to be
resuscitated in a critical care setting for 4 weeks.
During her course of treatment she received high
doses of corticosteroids. The onset of her pain has been
gradual, but she currently walks with crutches and
takes 4-6 tablets of hydrocodone daily for pain. She is a
kindergarten teacher and is planning on getting married
in 10 months. Her radiographs are Figures 1a, 1b, and 1c.
A Time for Each Bearing,
a Bearing for Each Time
Why polyethylene still matters
Alexander C. Gordon, MD
Assistant Clinical Professor | Illinois Bone and Joint Institute
Department of Orthopaedic Surgery
Flattening of
femoral headCollapse of weight
bearing area
Figure 1a: AP view of both hips demonstrating preserved joint spaces.
Figure 1b : Lateral view of right
hip with crescent signs and subtle
collapse of weight bearing area of
subchondral bone consistent with
post-collapse osteonecrosis.
Figure 1c: Lateral view of left hip
also demonstrating flattening,
consistent with post-collapse
osteonecrosis.
0612-28-500
0612-17-508
0612-77-506
0612-86-505
0612-55-505
0612-92-508
0612-16-507
Polyethylene and Ceramic Introduction:
A single acetabular system
that accommodates a variety of
liner and head size options can
be advantageous in total hip
arthroplasty.
Methods:- 1,183 Primary, Consecutive, Multi-liner,
Acetabular, Pinnacle® Cup THA’s
- Performed Between 2000 & 2006
- 16 Surgeons
- 9 Different Cemented & Uncemented
Stems Implanted
- 463 Left, 546 Right, 87 Bilateral
- Mean Follow-up: 2 Years
- Total Patients: 1,183
- 622 Females & 561 Males
- Mean Age: 62 Years
- Range: 18 to 91
- Mean BMI: 30
- Range: 16 to 65
Results:- At 5 Years, Acetabular Cup
Survival Was 99.9%
- 0% Aseptic Loosening
- 17 Dislocating Hips:
- 76% — 28mm Heads
- 18% — 32mm Heads
- 6% — 36mm Heads
- 11 Re-operations Where A Stable
Cup Was Retained
- 5 Hips Treated Conservatively
- 1 Cup Revised For Instability
@ 2 Weeks Post-op
- 12 Additional Re-operations:
- 5 Hematomas
- 3 Femoral Fractures
- 2 Stem Loosenings
- 1 Superficial Infection
- 1 Modulus Mismatch
Conclusion:- Outstanding Mid-Term Survival
- Differences Between Patients, Surgeons,
Femoral Stems, Head Size, & Articulation
Types Did Not Affect Survival
- Re-operation For Instability Was Aided By
An Acetabular System That
Accommodates A Variety Of Liner & Head
Size Options
- 11 Out Of 12 Re-operations For
Dislocations, Stability Achieved With Cup
Retention2007 AAOS Annual Meeting
San Diego, CA
February 14 - 18, 2007
Poster #P077
Kirk Kindsfater, MD
Orthopaedic Center of the Rockies
Fort Collins, CO
William P. Barrett, MD
Valley Orthopaedic Associates/
Proliance Surgeons
Renton, WA
James E. Dowd, MD
Jordan-Young Institute
Virginia Beach, VA
Carleton B. Southworth, MS
DePuy Orthopaedics, Inc.
Warsaw, IN
Marilyn J. Cassell, RN
DePuy Orthopaedics, Inc.
Warsaw, IN
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Engh, C. Anderson, et al. “A Randomized Prospective Evaluation of Outcomes After Total Hip Arthroplasty Using Cross-linked Marathon and Non-cross-linked Enduron Polyethylene
liners.” J Arthroplasty;21 (6 Suppl 2): 17.
Ceramtec, BIOLOX delta – Nanocomposite for Arthroplasty, The Fourth Generation of Ceramics, Scientific Information and
Performance Data, MT080013-US-750-0802
Collier JP, Currier BH, Kennedy FE, et al: Comparison of cross-linked polyethylene materials for orthopaedic applications.
Clin Orthop 2003; 414: 289-304.
Engh, C. Anderson, et al. “ A Comparison of a Second and a Third Generation Modular Cup Design”. Journal of Arthroplasty Vol. 25 No. 4, 2010.
Rack R, Pfaff HG. “A New Ceramic Material for Orthopaedics.” Proceedings of the 5th
International CeramTec Symposium, G. Thieme Verlag, Stuttgart, 2000. 141-145
VALIDATION
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Source Quick ReferenceTECHNOLOGY VALIDATION MESSAGE VALIDATION SOURCE
Pinnacle Hip Solutions
99.9% Survivorship at 5 YearsKindsfater, K., W.P. Barrett, J.E.Dowd, C.B. Southworth and M.J. Cassell. “99.9% midterm survival of the Pinnacle multi-liner acetabular cup in a prospective multi-center study.” Poster Presentation #P077, AAOS, San Diego, CA. Feb. 14-18, 2007.
Pinnacle Hip Solutions
Zero incidence of lysis and backside wear withVIP taper vs. mechanical locking mechanism
Cara C.Powers, MD; Henry Ho, MS; Sarah E. Beykirch, BS; Cathy Huynh, BS; Robert H. Hopper, Jr., Ph.D.; C. Anderson Engh Jr. MD; Charles A. Engh MD “A Comparison of a Second and Third Generation Modular Cup Design: Is New Improved?” J Arthroplasty, Article in press as of September 2009.
Pinnacle Hip Solutions
Positive Pinnacle clinical outcomes in Australian Orthopaedic Association (AOA)
National Joint Replacement Registry
Revision Rates of Primary THA in AOA Registry (link below):
www.dmac.adelaide.edu.au/aoanjrr/publications.jsp?section=reports2009
Ultamet Metal-on-Metal Articulation
Lowest published ions in the C. Anderson Engh Jr., et al. 2008 John Charnley Award ~ Metal ion levels after metal-on-metal total hip arthroplasty: A randomized trial. Clin Orthop Related Res. October 2008.
Ultamet Metal-on-Metal Articulation
0.24% incidence of adverse metal response
The implant data from this multi-center metal-on-metal study can be found in the Advancing High Stability and Low Wear Clinical Guide (0612-17-508 Rev. 2).
aSphere 80% in-vitro reduction in wear debris Based on internal testing, this data can be found in the aSphere Design Rationale (0612-20-508).
aSphere 77% in-vitro reduction in associated ions Based on internal testing, this data can be found in the aSphere Design Rationale (0612-20-508).
MarathonIntroduced in 1998 as the
first FDA cleared cross-linked polyethylene in the industry
www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances
Marathon 95% in-vivo wear reduction at 5.7 yearsC. Anderson Engh Jr., MD et al. “A Randomized Prospective Evaluation of Outcomes After Total Hip Arthroplasty Using Cross-linked Marathon and Non–cross-linked Enduron Polyethylene Liners.” J Arthroplasty. 21 (6 Suppl 2); 17-25, 2006.
AltrX 92% in-vitro wear reductionY.-S. Liao, K. Greer, et al. “Effects of Resin and Dose on Wear and Mechanical Properties of Cross-linked Thermally Stabilized UHMWPE.” Society for Biomaterials, the 7th World Biomaterials Congress, Sydney, Australia, 2004.
AltrX BIOLOX® delta vs. metal heads
Y.-S. Liao, K. Greer, A. Alberts. “Effect of Head Material and Roughness on the Wear of 7.5 Mrad Crosslinked-Remelted UHMWPE Acetabular Inserts.” Orthopaedic Research Society 54th Annual Meeting, San Francisco, CA, 2008.
Gription friction vs. Trabecular Metal
J. Minter, et al. “Characterization of a New Rougher Porous Coating for Revision Reconstructive Surgery.” Orthopaedic Research Society 54th Annual Meeting, San Francisco, CA, 2008. Brett Levine. “A New Era in Porous Metals: Applications in Ortho-paedics.” Advanced Engineering Materials 2008, No. 9, pp. 788-792
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The following section is designed to allow you to address the most common needs or objections of an HCP, by utilizing the various sections below.
Please refer to the appropriate page when preparing your call plans:
Page 28 Negotiate the Pinnacle®Acetabular System
Page 30 Negotiate Polyethylene
Page 36 Negotiate Metal Wear
Page 38 Negotiate aSphere
Page 40 Negotiate Ions
Page 42 Ions for Dummies Reference
NEGOTIATION
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Negotiate the Pinnacle® Acetabular System
Needs
with 180° coverage of:
Porocoat: 30 years of clinical success in stability and
for bone in-growth
Gription:
porous, 300-micron pore size, smaller at substrate
2,3
system for the last 10 years and in one study showed
4
survivorship at 5 years5
Features & Benefits
liner types within one shell
2
proper alignment of the insert and liner prior to
impaction
cradles the liner, leaving a gap between the shell and
liner
minimum, to distribute the load across the entire liner-
shell interface
and RoM
NEGOTIATION
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Objections
I am apprehensive about switching to a new system
accommodate multiple bearings while optimizing the head-to-shell ratio.
The extensive modularity of both the primary & revision systems promotes
confidence, having the widest range of options in response to any intra-
operative finding. For example, if you need to revise a metal liner or metal
delta
head while leaving the well fixed shell in place.
After being the only modular bearing system for ten years, our
competitors are now releasing more modular systems. However, they
6
delta
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Negotiate Polyethylene
Needs
Features & Benefits
Marathon® poly was introduced in 1998 as the first FDA
cleared cross-linked poly in the industry and continues to
have very successful clinical outcomes. Engh et al showed
poly liners.7
As the leader, DePuy improved on this already clinically
which was designed for high demand patients.
eliminate free radicals, resulting in an oxidatively stable
material, with excellent mechanical integrity.
irradiated at 7.5 Mrads to maximize Wear Resistance
without sacrificing the Mechanical Integrity we enjoy
with Marathon polyethylene
resistance and mechanical integrity
AltrX
WearResistance
Oxidative Stability
Mechanical Integrity
when compared to Marathon.2
polyethylene and decreases the risk of failures due to
impingement or rim loading.8
polyethylene liners designed to enhance stability with
liners are available in lateralized and face changing
designs, allowing you to achieve high stability without
compromising wear resistance.
NOTE: Reduced wear claims are based on the results
of in-vitro hip wear simulator tests which have not
been shown to quantitatively predict clinical wear
performance.
NEGOTIATION
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Objections
If Marathon poly is performing well clinically why did DePuy introduce AltrX?
DePuy was the first company to receive FDA clearance
and offer a cross-linked polyethylene, Marathon. We
patient and are committed to continue delivering high
stability, low wear solutions for you and your patients.
Marathon polyethylene.2
As the leaders in bearing technology we continuously
challenge ourselves to deliver advanced solutions for
your high demand patients.
Objection from X3 User: I like to maximize the head-to-shell ratio to enhance stability and optimize range of motion. With X3 I am able to use a 36 femoral head with a 48 neutral liner. What are my options with AltrX?
I understand maximizing head-to-shell ratio for your
patients is critical to enhance stability and range of
lateralized liner. This provides up to 142° range of
motion and 19 mm jump distance.
Objection from X3 User: I am concerned that remelting weakens the polyethylene.
Other than Stryker, DePuy and the other manufacturers
remelt to eliminate free radicals, since this is the only
proven way to ensure oxidative stability and that the
mechanical strength of the poly will not be compromised
over time. We have proven the mechanical integrity
over Marathon, the mechanical integrity is unchanged
1020 resin.
Company Brand Joint Resin (GUR)Radiation
Source Dose Stabilization Process Sterilization
BiometHip 1050 Gamma 5.0 Mechanical anneal ETO
E-Poly Hip 1050 Gamma 10.0 Vitamin E stabilized Gamma
DePuyMarathon® Hip 1050 Gamma 5.0 Remelt Gas Plasma
Hip 1020 Gamma 7.5 Remelt in Argon Convection Gas Plasma
Smith & Nephew Hip, Knee 1050 Gamma 10.0 Remelt ETO
Stryker Hip, Knee 1020 Gamma 9.0 Sequential thermal anneal Gas Plasma
Zimmer Longevity® Hip 1050 E-Beam 10.0 Remelt Gas Plasma
Zimmer Prolong™ Knee 1050 E-beam 6.5 Remelt Gas Plasma
Co
mp
etit
ive
Co
mp
aris
on
poly bearings. Tell your customers this powerful example: “The
18
16
14
12
10
8
6
4
2
028 mm 32 mm 36 mm 40 mm 44 mm 48 mm
Co
mp
ress
ion
Str
eng
th
What is the Wear Resistance?
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Negotiate BIOLOX delta
Needs
Features & Benefits
forte was entirely alumina
delta is the new 4th generation ceramic
material matrix composite:
matrix act like airbags to absorb impact forces
counteract their propagation
the crack path to neutralize its energy
TOUGHNESS
due to the Zirconia particles & Strontium Aluminate
crystals
STRENGTH
delta is considerably higher
than previous ceramics. The bending strength is not
affected by multiple autoclave sterilizations.
delta is one of the most wear resistant bearings
in orthopaedics because:
from 3rd body wear particles
delta to
offer significant wear reduction regardless of the liner
material
constructs, due to their smooth hard surface
delta is a great alternative for patients known
to be sensitive to CoCr
NEGOTIATION
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Objections
I am concerned about the fracture risk of ceramics
Based on the fracture risks of previous ceramic materials,
I can understand your trepidation.
delta
that utilizes a matrix composite instead of a purely
alumina composition like the commonly used cream-
forte.
Zirconia particles in the aluminum oxide matrix act like
airbags by absorbing impact forces and producing local
pressure peaks to counteract crack propagation.
Strontium Aluminate crystals prevent cracks & crack
propagation by neutralizing the crack path and energy.
I want the lowest wear bearing for my THA patients
delta
to metal heads, promotes fluid film lubrication. This
fluid barrier between bearing surfaces results in a wear
reduction regardless of the liner selected. Additionally,
delta has the benefit of resisting
scratching or damage from 3rd body debris.
Airbag Function Crack Deflection
Plat
elet
Zirconium Oxide
Aluminum Oxide
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Negotiate Stability & Range of Motion (RoM)
Needs
Features & Benefits
morbidity and mortality rates are significantly higher as
compared to primaries 9,10,11
Heads are available in various neck lengths to allow you
to restore appropriate femoral neck sizes, offset, and leg
length, while reducing impingement risks, all without
Pinnacle shells and Ultamet liners offer 2mm of
lateralization to decrease the risk of dislocation and
increase RoM or stability
Ultamet MoM offers a high femoral-head-to-acetabular-
cup ratio that optimizes stability and range of motion
For example:
stem has up to 146° RoM
up to 159° RoM2
MoM bearings.5
With regards to stability, Gription offers a very high
2,3
Dislocations are a primary cost driver for hospitals and
healthcare payers. Larger diameter MoM bearings have
the potential to reduce these costs by reducing the risk of
dislocation.9,10,12
NEGOTIATION
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Objections
I am concerned about hard bearings, why should I risk it?
DePuy is committed to high stability in THA. Dislocation
is a major contributor to revisions, adversely impacting
hospitals, but much more importantly, the patient.
Based on our conversation, may I have 10 minutes of
your time to share how I believe Pinnacle can address the
See FEATURES & BENEFITS around:
length without losing RoM
DePuy designed the Pinnacle system to offer the patient:
head-to-shell ratios
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Negotiate Metal Wear
Needs
Features & Benefits
DePuy Ultamet MoM offers surgeons and patients the
benefit of reduced wear. Less wear can lead to lower
failure rates or fewer premature revisions.
result in lower wear due to advanced manufacturing
processes
generation
hard-on-hard bearings allowing the fluid to bear the
sliding forces rather than the surfaces of the head and
liner 13
reduces wear
Based on laboratory studies, Pinnacle MoM bearings
have been shown to offer remarkably High Stability and
Low Wear.2
Research has shown that acetabular shells like Pinnacle
may deflect in hard bone especially if the acetabulum is
under-reamed by 2mm or more. However, Dr. William
Griffin demonstrated that all deflection was eliminated
when a CoCr insert such as Ultamet was impacted into
a deflected shell. He also demonstrated in cadavers that
the shell deflection disappeared after approximately 4
hours as the bone relaxed.14
NEGOTIATION
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Objections
I am concerned about metal wear
team has completed extensive research to understand
the factors leading to increased wear in a MoM hip
prosthesis. From this tribology, DePuy designed and
which have numerous features that work to reduce metal
Decreasing wear can lower the risk of premature
surface roughness, high carbon content and optimized
diametrical clearance, aid in maximizing fluid film
lubrication between the head and liner, which can
potentially lead to even further reduction of wear debris
exposure to the patient.
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Negotiate aSphere™
Needs
Features & Benefits
DePuy is redefining metal-on-metal bearings with
aSphere M-Spec metal heads within Pinnacle Hip
Solutions.
DePuy aSphere M-Spec features precision contoured
femoral heads, using technology borrowed from the
optics industry.
This contouring approximates the shaping that occurs
naturally during the in-vivo run-in wear phase. The
following reductions resulted as compared to the industry
leading Ultamet metal-on-metal:
The Pinnacle aSphere M-Spec heads pre-contoured zone
encompasses the areas of greatest and most frequent
contact during routine activities.
The symmetric nature of the aSphere M-Spec head does
not require special orientation by the surgeon to ensure
the articulation zone is in the proper location.
The DePuy aSphere M-Spec Femoral Heads are available
in the same sizes of 36, 40 and 44 options as the DePuy
by optimizing the head-to-shell ratios.
The DePuy aSphere M-spec maintains the proven 80 –
120 micron clearance at the cup rim optimal for fluid film
lubrication.
NOTE: Reduced wear claims are based on the results
of in-vitro hip wear simulator tests which have not
been shown to quantitatively predict clinical wear
performance.
NEGOTIATION
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Objections
If you can’t even see a difference between M-Spec and aSphere, could it really make that much of a difference?
DePuy had to adopt technology from the optics industry
in order to produce aSphere M-Spec Femoral Heads. We
already had the lowest ion levels of any MoM bearing
work to further reduce in-vitro wear and release of ions
in patients.
The fruit of the work performed by DePuy researchers is
metal ions as compared to the industry leading Ultamet
metal-on-metal.2
Smith & Nephew – R3 Objection: DePuy’s metal-on-metal features dangerously small clearances (equatorial clearance of 80-120 microns and polar clearance of 40 microns) where as R3 features a 200-300 microns of diametrical clearances.
Several peer reviewed publications have demonstrated
that small clearances do in fact lead to a reduction in
metal wear and ions. In fact Smith & Nephew designing
surgeon, Mr. Derek McMinn, has produced data for the
past two Orthopaedic Research Society meetings which
validate smaller clearances vs. larger clearances consistent 15,16,17
Biomet – Magnum Objection: Pinnacle metal-on-metal does not offer the optimized head to shell ratio which is featured with the Magnum.
Pinnacle aSphere M-Spec metal-on-metal not only offers
the potential for three times less metal ion exposure
than the Magnum, it also provides the advantages of
head-to-shell advantage is optimized at the 36mm head
are minimal with regards to the benefit of stability. Above
sensitivity to cup placement.18
Thank you for your time and for listening to the many
ways in which DePuy demonstrates our commitment to
increasing stability while lowering bearing wear.
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Negotiate Ions Ions for Dummies
Needs
Features & Benefits
When an HCP communicates concerns of adverse
reactions to metal like “hyper-sensitivity”, ask whether
the concern is related to metal sensitivity or reactivity.
reactivity can have circulating Co and Cr ion levels in
loading of misaligned cups.19, 20, 21
delta heads will reduce the metal wear patients are
exposed to since significantly more wear is released from
the metal head compared to the metal liner in a MoM
bearing.7
If concerned about metal reactivity, clarify that not
all MoM implants are created equal. The literature on
adverse outcomes from MoM implants is directed toward
monoblock or resurfacing designs specifically. Metal
reactivity from monoblock systems is more specifically
linked to poor cup placement, with excessive inclination
of dislocations, edge loading, and impingement.22,23,24,25
2010 AAOS research defined the minimal Co and Cr ion
24,25
The M-Spec heads-on-Ultamet liners have the lowest
published MoM ion levels in the industry at 0.73 ppb.26
This is an entire magnitude lower than the upper limits
for concern found in the AAOS papers referenced.
Additionally, Dr. MacDonald found that the pre-
implantation levels of Co and Cr in this same cohort
ranged from 0.1 to 0.3 ppb.26
NEGOTIATION
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Objections
I use mostly Poly-on-Metal since I have concerns that patients could have an adverse Metal-on-Metal response.
you. May I ask you a question regarding the exact nature
that has been reported for decades, not specific to MoM
more recently being reported with high levels of metal
delta-on-
As you know, there has been a substantial amount of
literature recently reporting MoM patients with clinical
symptoms associated with high metal ions levels. If
it would stand out that the adverse outcome is almost
entirely related to monoblock or resurfacing designs, not
modular MoM systems like Pinnacle.
Two papers at the 2010 AAOS linked metal reactivity to
monoblock systems in misalignment.
Our Ultamet modular MoM was found to have the
lowest published ion levels in the industry at 0.73 ppb.
These results put Pinnacle MoM a full magnitude lower
than the upper limit threshold of ion levels for metal
reactivity clinical symptoms as presented in the 2010
AAOS meeting.
In the absence of a patient having true metal sensitivity,
Pinnacle MoM is the least likely MoM bearing on the
market to lead to metal reactivity according to the
industry comparison studies.
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Ions for Dummies This section provides key definitions and science you should understand about ions
Metal Sensitivity
high levels of Metal-on-Metal wear. This lymphocytic
associated cystic masses or “pseudotumor.” Onset
of symptoms is usually within a few years.i These
reactions are not specific to hip implants, and are 25,27,28,29
Metal Reactivity
Metal reactivity describes the reported reactions
seen with very high levels of metal wear from MoM
bearings improperly positioned at high inclination
angles or excessive anteversion. This is also be called
a foreign body, macrophage inflammatory, or adverse
local tissue response due to the large CoCr particles
created from edge loading.25,30 Patients with this
reaction have circulating Co and Cr ion levels that
can be elevated to double digit parts per billion 31,32 Both metal reactivity and sensitivity can
cause osteolysis, groin pain, and decreased RoM.33
Cancer Risks
The cancer risk for metal-on-metal bearing
is no greater than that associated with a
metal-on-polyethylene bearing.34,35
Reactivity with Monoblocks
The vast amount of literature on adverse outcomes
from MoM implants has been concentrated on
monoblock or resurfacing designs specifically. The
reasons for the difference between monoblock and
modular MoM systems are multifactorial in nature.
There is a growing body of literature that specifically
links the metal reactivity in monoblock systems to poor
cup placement. Increased inclination angles above
45 degrees and anteversion above 20 degrees can
result in increased risks of dislocation, impingement,
edge loading, and reduced range of motion.25,27,28,29
2010 AAOS
There is emerging evidence that clinical symptoms
will not occur unless the patient is found to have
or chromium ions in serum and blood.16,17
pre-implant ion levels may also serve as a good baseline
point for discussion, as multiple factors, including
diet, can contribute to the CoCr ions in the body.
Ultamet MoM was found to have less than 0.73 ppb
industry.26 MacDonald found that the population base-
line for circulating CoCr ion levels averaged between
0.15 to 0.3 ppb. Therefore, Pinnacle Ultamet MoM
minimally increases the baseline ion levels. Another
study found the incidence of an adverse local response
from a MoM bearing when using an Ultamet liner 2
NEGOTIATION
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References
1. Integrity Selling for the 21st Century, Ron Willingham References on the Design Rationales and Clinical Compendium, etc
2. Data on file DePuy Orthopaedics, Inc.
Zimmer website www.Zimmer.com
4. Kindsfater, K., Barrett, W., Dowd, J., Southworth, C., Cassell, M. Midterm Survival of the Pinnacle Multi-liner Acetabular Cup in a Prospective Multi-Center Study. Proceedings of the 74th Annual Meeting of the American Academy of Orthopaedic Surgeons; 2007 February 14-18. Poster No. P077.
5. Survivorship of the Pinnacle® Acetabular Cup System
6. Australian Orthopaedic Association National Joint Registry Annual Report 2009. Retrieved from: http://www.dmac.adelaide.edu.au/aoanjrr/documents/aoanjrrreport_2009.pdf
7. C. Anderson Engh Jr., MD et al. “A Randomized Prospective Evaluation of Outcomes After Total Hip Arthroplasty Using Cross�linked Marathon and Non–cross�linked Enduron Polyethylene Liners.” J Arthroplasty. 21 (6 Suppl 2); 17�25, 2006.
8. Orthopaedic Research Society, 2007, P1784
9. Mahomed, N. N. et al.: Rates and outcomes of primary and revision total hip replacement
10. Bozic KJ et al. The epidemiology of revision total hip arthroplasty in the United States. In press, J Bone and Joint Surg Am 2008.
11. Gary Warriner, MSc, Senior Biostatistician†; Kristine Lee, MPM, Senior Technical Writer†Joaquin Sanchez-Sotelo, George J. Haidukewych and Carol J. Boberg. “Hospital Cost of Dislocation after Primary Total Hip Arthroplasty.” J. Bone Joint Surg. Am. 88:290-294, 2006.
12. Berry DJ, von Knoch M, Schleck CD, et al. The cumulative long-term risk of dislocation after primary Charnley total hip arthroplasty. J Bone Joint Surg Am 2004; 86-A:9-14.
Chan FW, Bobyn JD, Medley JB, Krygier JJ, Tanzer M. The Otto Aufranc Award. Wear and
14. Matthew Squire, William Griffin, J. Bohannon Mason, et al. “Acetabular Component Deformation with Press-Fit Fixation.” JOA Vol. 21 No. 6 Suppl. 2 2006.
15. Metal Ion levels in low clearance hip resurfacings Hena K. Ziaee1, Joseph Daniel1, Chandra Pradhan2, Derek McMinn2 1Research, The McMinn Centre, Birmingham, United Kingdom; 2The McMinn Centre, Birmingham, United Kingdom [email protected]
16. Dowson D, Hardaker C, Flett M, Isaac GH. A hip joint simulator study of the performance of metal-on-metal joints: part I: the role
17. Dowson D, Hardaker C, Flett M, Isaac GH. A hip joint simulator study of the performance
18. Cuckler, JM, Moore, KD,Lombardi Jr., AV, et. al. Large verses Small Femoral Heads
19. Jacobs JJ and Hallab NJ. Loosening and osteolysis associated with metal-on-metal bearings: A local effect of metal hypersensitivity? J Bone Joint Surg 88A: 1171 – 1172, 2006.
20. Survivorship of the Pinnacle® Acetabular Cup System
21. Pamela L. Plouhar, Ph.D., Vice President Worldwide Clinical Affairs; Rodrigo Diaz, MD, Manager, Clinical Research;
22. De Haan R, Campbell PA, Su EP, De Smet KA. Revision of metal-on-metal resurfacing arthroplasty of the hip: the influence of malpositioning of
De Haan R, Pattyn C, Gill HS, Murray DW, Campbell PA, De Smet K. Correlation between inclination of the acetabular component and metal ion levels in metal-on-metal hip resurfacing replacement. J Bone Joint Surg Br. 2008 Oct;90(10):1291-7.
24. Hart A, Bandl A, Lenihan J, Magglore P, Sampson B, & Skinner J. High blood cobalt levels can be used to predict failure of metal on metal (MOM) hips, 2010 AAOS Podium no. 007, New Orleans, LA
25. Campbell PA, Van Orsouw M, Singh Gill H, DeSmet KA. Interpretation of Metal Ion Levels after Metal-On-Metal Hip Resurfacing, 2010 AAOS Poster P100, New Orleans, LA
26. C. Anderson Engh Jr., et al. 2008 John Charnley Award ~ Metal ion levelsafter metal�on�metal total hip arthroplasty: A randomized trial. Clin Orthop Related Res. October 2008.
27. Svensson O, Mathiesen EB, Reinholt FP and Blomgren G. Formation of a fulminant soft-tissue pseudotumor after uncemented hip arthroplasty.
28. Hallab, N., Merritt, K., Jacobs, J.J: Metal sensitivity in patients with
29. Willert H-G, Buchhorn GH, Fayyazi A, Flury R, Windler M, Köster G, and Lohmann CH. Metal-on-metal bearings and hypersensitivity inpatients with artificial hip joints. A
Pandit H et al. Pseudotumours associated with metal-on metal hip resurfacings. J Bone and Joint Surg 90-B: 847-851, 2008.
Langton DJ, Jameson SS, Joyce TJ, Webb J, Nargol AV. The effect of component size and orientation on the concentrations of metal ions after resurfacing
De Haan R, Pattyn C, Gill HS, Murray DW, Campbell PA, De Smet K. Correlation between inclination of the acetabular component and metal ion levels in metal-on-metal hip resurfacing replacement. J Bone Joint Surg Br. 2008 Oct;90(10):1291-7.
Jacobs JJ and Hallab NJ. Loosening and osteolysis associated with metal-on-metal bearings: A local effect of metal hypersensitivity? J Bone Joint Surg 88A: 1171 – 1172, 2006.
Tharani, R. Dorey, F. J. and Schmalzried, T.P.: The risk of cancer following total
A ulakh T and Richardson JB: Metal-On-Metal: What is the risk of cancer? Second annual comprehensive course on total hip resurfacing arthroplasty. Los Angeles, CA, October, 2008.
De Haan R, Campbell PA, Su EP, De Smet KA. Revision of metal-on-metal resurfacing arthroplasty of the hip: the influence of malpositioning of
Hart A, Bandl A, Lenihan J, Magglore P, Sampson B, & Skinner J. High blood cobalt levels can be used to predict failure of metal on metal (MOM) hips, 2010 AAOS Podium no. 007, New Orleans, LA
Campbell PA, Van Orsouw M, Singh Gill H, DeSmet KA. Interpretation of Metal Ion Levels after Metal-On-Metal Hip Resurfacing, 2010 AAOS Poster P100, New Orleans, LA
Callahan Metal An analysis of cup positioning in total hip arthroplasty:
40. Schmalzried TP, Guttmann D, Grecula M, Amstutz HC. The relationship between the design, position, and articularwear of acetabular components inserted without cement and the development of pelvic osteolysis. J Bone Joint Surg Am. 1994 May;76(5):677-88.
41. C. Anderson Engh Jr., et al. 2008 John Charnley Award ~ Metal ion levelsafter metal�on�metal total hip arthroplasty: A randomized trial. Clin Orthop Related Res. October 2008.
42. Willert H-G, Buchhorn GH, Fayyazi A, Flury R, Windler M, Köster G, and Lohmann CH. Metal-on-metal bearings and hypersensitivity in patients with artificial hip joints. A
Jacobs JJ & Hallab NJ. Loosening and osteolysis associated with metal-on-metal bearings: A local effect of metal hypersensitivity? J Bone Joint Surg 88A: 1171-72, 2006.
44. Pandit H et al. Pseudotumours associated with metal-on metal hip resurfacings. J Bone and Joint Surg 90-B: 847-851, 2008.
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CLOSE
Purpose:To get a mutually beneficial decision that moves you to the next incremental step
Note: Asking for a commitment on your pre-call plan objective is easier when you have:
for “opinions” rather than for decisions
“At this point, what have I not fully explained?”
“Who might have some decision input that we haven’t gotten agreement from?”
“Do you feel confident at this point that the benefits of this product outweigh the costs?”
“What should I now know about your decision process for making a change like this?”
“Do you think this will create the desired outcome we discussed?”
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Close Tip 1: Restate how benefits will outweigh the costs
Close Tip 2:
comprehensively and now need to ask questions to find out if there is an issue
received a negative response, find out what variable, if it were to change, might lead the HCP to want to talk about this again with you
to reopen discussions, such as:
“Do you still have the same needs that we previously discussed?”
“Had I misinterpreted your level of interest?”
“Have I sufficiently proven everything you need to believe you’ll get the desired benefits?”
“Have questions or concerns popped up in your mind that we haven’t discussed before?”
“Do we need to bring anyone else into the discussion we haven’t yet?”
“What can I do at this point to best serve you?”
Close Tip 3:
& behaviors impact your close
time to close, being pushing, and revealing that your desire to make the sale outweighs
There are many suggestions in the Integrity Selling for the 21st Century by Ron Willingham should you need direction on how to make progress in the area of your selling beliefs and behaviors
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