attune® knee system - Amazon Web Services

ATTUNE® KNEE SYSTEM
VALUE ANALYSIS BRIEF
VALUE SUMMARY
The ATTUNE® Knee System is designed to address the unmet needs of
patients, surgeons, and hospital providers around the world. Extensive
research and science has gone into the design to help improve functional
outcomes for patients, performance for surgeons, and efficiency for providers.
BENEFITS OF TOTAL KNEE ARTHROPLASTY (TKA)
Total knee arthroplasty helps to relieve pain and restore function and mobility for arthritis pain sufferers. It is widely
recognized as one of the most performed and successful surgical procedures. A review of 350,000 knees in a recent
registry publication found that primary knees had a 93.5% survivorship rate at 12 years.1
In addition, total knee replacement surgery generates net societal savings of approximately $19,000* per patient
lifetime due to reduced disability costs and improved productivity. For all knee replacement surgeries performed in the
U.S. in 2009, aggregate lifetime savings was estimated at $12 billion.2
Data has shown that 98% of working patients return to work following total knee replacement.3
UNMET NEEDS IN TKA
Patient Satisfaction:
• Patient dissatisfaction after knee replacement is
between 10% and 20%. The leading indicator for
patient dissatisfaction is pain.4
2015 Value Based Purchasing measures and
percentage of weight impacting reimbursement
Outcomes
30%
• Pain management is 1 of 10 Hospital Assessment of
Healthcare Providers and Systems (HCAHPS) measures
that impact Medicare reimbursement.5
• Implant companies have an opportunity to work with
hospitals to improve the patient experience and patient
satisfaction.
30%
Efficiency
Operating Room (OR) Efficiency:
• Every minute in the OR costs on average $62.6* The
average knee replacement surgery lasts approximately
1 hour and 12 minutes, equaling $4,464.7*
• Data shows that new OR teams are 9% less efficient than
teams that have been together for more than 5 years.8
• Implant companies have an opportunity to help reduce
the learning curve of OR teams and provide more
efficient solutions to positively impact OR time and
reduce costs.
Patient
Experience
20%
20%
Clinical Process
In 2015, 1.5% of hospital payments from The Centers for
Medicare & Medicaid Services (CMS) will be impacted
by the quality measures in the chart above.5 Each quality
measure carries a slightly different weight. Implant
companies can help hospitals address these measures
by providing products and services that are designed to
improve patient satisfaction and increase system efficiency.
*Note: Cost and Efficiency data is US-specific data and may be different in other geographies.
Value Analysis Brief ATTUNE® Knee System DePuy Synthes 1
PATIENT SATISFACTION
ATTUNE KNEE SYSTEM OVERVIEW
Data shows that as recently as 2009, between 10% and
20% of TKA patients were dissatisfied with their results. This
dissatisfaction included daily activities such as stair descent
and rising from a seated position.4
The ATTUNE Knee System is designed to deliver a high
level of stability and motion. DePuy Synthes Companies
has applied for extensive patent protection in countries
throughout the world for the ATTUNE System implants,
instruments, and surgical methods. In the U.S. alone,
as of this writing, there are 17 patents granted for
key inventions related to the ATTUNE Implants and
Instruments.13
Limitations of Total Knee Patients 1 Year After Surgery
100%
Not limited at all
90%
Limited a little
Limited a lot
80%
Limitation
70%
ATTUNE System Options:
60%
• Available in Rotating Platform (RP) and Fixed Bearing (FB)
50%
• CR and PS implant variants designed to accommodate
Posterior Stabilized (PS), Cruciate Retaining (CR) and
Cruciate Sacrificing (CS) techniques
40%
30%
20%
10%
0%
Kneeling
Squatting
Rising from
a low seat
Stairs
Walking on an
uneven surface
Patient research from 2007 showed that 58% were
“limited a lot” when kneeling, and 38% were “limited a
lot” when squatting after knee replacement surgery.9
What Impacts Patient Satisfaction:
• Instability: Data has shown that activities which
cause a greater force on the knee after TKA lead
to increased problems. This has been attributed to
design deficiencies, procedure related challenges, and
inadequate soft tissue stability.10 Patient dissatisfaction
increases to 28% when patients perform high demand
activities like going up or down stairs.4
• Implant Fit: Tibial base overhang on the posterior
medial side of the resected tibial bone can cause
irritation of the Medial Collateral Ligament (MCL).
Overhang on the posterior lateral side can result in
impingement with the popliteal tendon. Femoral
component overhang of 3 mm is associated with an
almost twofold increased risk of knee pain more severe
than occasional or mild at 2 years after surgery.11 With
commonly used knee designs, data has shown that 40%
of men and 68% of women have at least one area of
the implant with 3 mm or more of overhang.11
• Anterior Knee Pain: One of the most common
complaints after total knee replacement is anterior
knee pain. Data has shown that up to 25% of patients
have anterior knee pain.12
2 DePuy Synthes ATTUNE® Knee System Value Analysis Brief
• 14 Left and Right Femoral Sizes (includes Standard and
Narrow options)
• 10 Tibial Sizes
• 1 mm Tibial Insert Increments for most commonly used
thicknesses and 2 mm for remainder
• 0.5 mm Patella Thickness Increments
• Medialized Dome and Medialized Anatomic
Patella Options
• Gap Balancing & Measured Resection Techniques
• Advanced materials: AOX™ Polyethylene for all Patella
Components and Tibial Inserts
ATTUNE KNEE US CLASS III PREMARKET
APPROVALS† (PMA):
• PS & CR Femoral Components
• Medialized Dome and Medialized Anatomic Patella
Components
• Rotating Platform Tibial Inserts with AOX Polyethylene
• Rotating Platform Tibial Base
PMA Supplements: P830055/S121, P830055/S127
† P MA approvals for Class III medical devices require higher levels of research
and testing before market introduction. Only 10% of medical devices go
through the PMA approval process. Most knee systems in the US are Class II
devices and are cleared through a substantially equivalent product process
called the 510K.14
INNOVATIVE DESIGN
The ATTUNE Knee System delivers breakthrough discoveries that make the ATTUNE Knee an advancement for hospitals,
patients, and surgeons. Each of these significant technologies was designed to provide function for surgeons in the
operating room and for patients after surgery.
ATTUNE GRADIUS™ Curve
The patented ATTUNE GRADIUS™
Curve is designed with a gradually
reducing femoral radius. This curve
creates a smooth transition during
knee bending and produces high
stability of the knee by minimizing
unnatural sliding of the femur on
the tibia.15
GLIDERIGHT™ Articulation
The patello-femoral interaction
is one of the more challenging
aspects of total knee arthroplasty.22
The GLIDERIGHT™ Articulation
encompasses a trochlear groove
designed to accommodate patient
variation and soft tissue interaction,
and patella components designed
to optimize patella tracking while
maintaining bone coverage.
SOFCAM™ Contact
For the Posterior Stabilized
design, the interaction between
the cam and spine, the articular
surface geometry, and the
collateral ligaments is complex
and essential to the function of
the knee in deep flexion. The
proprietary s-curve design of the
SOFCAM™ Contact provides a
smooth engagement for gradual
femoral rollback and stability in
flexion, while reducing the forces
transferred to the tibial spine.16
INTUITION™ Instruments
The INTUITION™ Instruments were
developed to deliver efficiencies
for all stakeholders and an intuitive
surgical process. Advanced composite
materials and modular designs allow
lighter instruments, less trials, and less
instrument trays while providing intraoperative flexibility for the surgeon.23
These innovative instruments work
with the advancements in the implant
design to help balance the soft tissues
and precisely control the implant
position and fit for each patient.
LOGICLOCK™ Tibial Base
Differentiated to current offerings,
surgeons are able to match the
femoral size to the insert size
every time to achieve the highest
conformity and optimized stability
in early flexion.17 The LOGICLOCK™
Tibial Base allows surgeons to use
a tibial base that can be upsized
or downsized two sizes versus
the insert. No other Fixed Bearing
device provides this insert to femur
matching in every case.18, 19, 20, 21
AOX™ Polyethylene
AOX™ Polyethylene has an
advanced blend of polyethylene resin
and a proprietary COVERNOX™
Antioxidant. AOX Polyethylene is
uniquely designed to deliver optimal
wear resistance and long term
oxidative stability.
Value Analysis Brief ATTUNE® Knee System DePuy Synthes 3
THE ATTUNE KNEE SYSTEM IS DESIGNED TO
ADDRESS INSTABILITY
Knees become unstable when the femur is able to slide forward on the polyethylene insert, similar to a ball on a flat surface.15
Force is applied
on the ball
Force is applied
on the ball
The ball becomes
unstable and
slides forward
The ball is
stabilized by
the conforming
surface
VS.
Flat surface allows the ball to
slide forward
Conforming surface keeps the ball from
sliding forward
How to Achieve Implant Stability:
Increasing the conformity between the femoral
component and insert can help improve implant stability.24
A perfectly stable knee would have a conformity ratio of
1 (the insert would perfectly conform to the femoral like a
ball in a socket). A completely unstable knee would have
a conformity ratio of 0 (like a ball on a flat surface).
While walking
down stairs
high anterior
forces are
placed on the
knee
The knee
becomes
unstable and
slides forward
Some manufacturers have a relatively flat polyethylene insert design
allowing the rounded knee to slide forward. This type of knee has a
conformity ratio that is closer to 0.15
Reduced implant conformity in deeper flexion is necessary
to allow the knee to rotate in flexion. Abrupt changes in
conformity while the knee is flexing may allow the femoral
to slide forward on the tibial insert. For this reason, a
gradual reduction in conformity is needed, as it improves
implant stability while allowing the freedom to rotate in
deeper flexion. A gradual reduction in conformity has
been shown improve implant stability while allowing the
freedom to move.15
The Goal: The goal of a TKA design is to have a high
level of conformity in flexion during gait (0–70 degrees),
allow for rotational freedom in deeper flexion, and
mitigate any abrupt changes in conformity.
4 DePuy Synthes ATTUNE® Knee System Value Analysis Brief
The ATTUNE Knee is Designed for Motion
and Stability:
The chart below shows how the ATTUNE Knee provides
more stability while still allowing rotational freedom in
deeper flexion.17 This is accomplished through a gradually
reducing radius (ATTUNE GRADIUS Curve) on the femoral
component paired with a mating tibial insert. The result is
a balanced level of motion and stability that more closely
matches that found in the native knee.24 This aids in patient
performance during dynamic activities such as going up
and down stairs.17 Other manufacturers have abrupt
changes in their design (highlighted by the purple arrows).
FLEXION
ANGLE17
0º
15º
30º
60º
90º
120º
Abrupt
Change
ATTUNE CR FB
Knee Conformity
0.88
0.83
0.77
0.66
0.67
0.35
None
ATTUNE CR RP
Knee Conformity
0.99
0.93
0.87
0.74
0.76
0.40
None
Smith & Nephew®
Genesis® II CR FB 0.59
Conformity
0.32
0.32
0.32
0.21
0.21
11º
Biomet®
Vanguard® CR FB 0.47
Conformity
0.47
0.30
0.30
0.21
0.21
25º
Zimmer®
NexGen® CR FB
Conformity
0.54
0.54
0.54
0.31
0.31
0.31
37º
Stryker®
Triathlon® CR FB
Conformity
0.38
0.22
0.22
0.22
0.22
0.11
10º
THE ATTUNE KNEE SYSTEM IS DESIGNED TO
ADDRESS IMPLANT FIT
2500
Tibial
Sizes
Insert Thickness
Increments
ATTUNE Knee
14
10
1-2 mm Increments
Zimmer® Persona™ 18
21
9
1-2 mm Increments
Stryker® Triathlon® 19
8
8
2-3 mm Increments
Biomet® Vanguard® 20
10
9
1-2 mm Increments
Smith & Nephew®
Journey 2™ 21
10
8
1-4 mm Increments
• The ATTUNE Knee reduces the number of implant
stock keeping units (SKUs) versus Persona™ by 66%
(442 vs. 1,312).18
Extensive Size Offering for Diverse Population:
The chart below depicts the ATTUNE Knee femoral sizing
line overlaid on the measurements of the patients studied.
The femoral sizes were developed to minimize instances
of component overhang (i.e. greater number of patients
above the line rather than below).
• The standard sizing line (purple) shows coverage without
overhang is achieved for approximately 70% of patients.25
Femoral Medial/Lateral Measurement (mm)
• The narrow femoral sizes (green line) shows coverage
without overhang is achieved for approximately 30% of
patients.25
Subject Data
ATTUNE® Knee - Standard
ATTUNE® Knee - Narrow
80
75
70
65
60
55
40
45
1000
500
50
0.92
0.96
1
1.04
1.08
1.12
1.16
1.2
1.24
1.28
1.32
Tibial Asymmetry26
The native tibia does have slight asymmetry (the medial side is 1.09 times larger
on average than the lateral side).26 However, due to wide variations in patient
anatomy, asymmetric designs may result in increased overhang for a number of
patients.26,27 This is demonstrated by the shading to the left of the average line.26
ATTUNE Fixed Bearing Knee: The ATTUNE Knee
System was designed with 10 symmetric tibial base sizes
to address proper tibial coverage without overhang. In a
review of 14,700 tibial bones, the ATTUNE Fixed Bearing
Knee resulted in the greatest average coverage of the tibial
plateau (84%), followed by, 83% with Genesis® II, 81%
with Persona™, and 80% with the SIGMA® Knee.26
ATTUNE Rotating Platform Knee: The ATTUNE Rotating
Platform Knee design was shown to have improved tibial
coverage versus the fixed bearing designs.26 The ATTUNE
Rotating Platform Tibial Base had 86% coverage without
overhang.26 Because the polyethylene insert rotates with
the femoral, the rotating platform base can be freely
rotated on the tibia to maximize tibial coverage without
affecting patella tracking.
The colors represent the
average amount of bone each
tray does not cover on the
tibia. Blue is 0 to 1 mm and
Red is 4–5 mm.
90
50
1500
50
Maximizing Options and Efficiency:
• The ATTUNE Knee accommodates patient variation by
offering a wider breadth of sizes compared with almost
all other systems in the market.
85
Number of Patients
2000
Femoral
Sizes
Persona™
Tibial Base Sizes and Shape: It is important in TKA
surgery to have a tibial base design that covers as much
proximal tibial bone as possible without overhang. Proper
coverage without overhang is necessary to reduce the risk of
subsidence and to avoid excessive overhang, which may lead
to soft tissue irritation and patella tracking complications.26
Data has shown that having more tibial base sizes is most
important in achieving tibial plateau coverage.27
Average
Femoral component overhang of 3 mm is associated
with an almost twofold increased risk of knee pain more
severe than occasional or mild at 2 years after surgery.11
To address this and other sizing challenges, the ATTUNE
Knee System sizing is based on extensive research using
a global database of patients.25 From this analysis, DePuy
Synthes Companies created a sizing portfolio to meet the
needs of the diverse worldwide patient population. There
are 10 sizes of femoral and tibial components sizes and 4
additional narrow femoral component sizes.
55
60
65
Femoral Anterior/Posterior Measurement (mm)
70
75
When proper rotation is set
for the tibial base, the ATTUNE
Knee Tibial Base provides
better coverage without
overhang as compared
to Zimmer® and Smith &
Nephew®. The Rotating
Platform Base provides
improved coverage compared
to the fixed bearing designs.26
Value Analysis Brief ATTUNE® Knee System DePuy Synthes 5
THE ATTUNE KNEE SYSTEM IS DESIGNED TO
ADDRESS ANTERIOR KNEE PAIN
The ATTUNE Knee System was designed to help address
one of the most common complaints after total knee
replacement: anterior knee pain. Data has shown that up
to 25% of patients experience anterior knee pain.12
Some of the design factors that may impact anterior knee
pain include:28
1. The design of the patella component
2. The shape of the trochlear groove
3. The thickness of the femoral component
Patella Design: With many current systems, patella
implants are designed as a central dome which does not
reflect the shape of the native patella. This creates the
need to manually offset the implant on the bone during
implantation. Offsetting the central dome leaves exposed
bone which may cause soft tissue disruption.
Traditional Patella Design
Patella component
medialization (~3 mm)
Lateral bone can impinge
on femoral component
Patella Options:
Unresurfaced Patella: The ATTUNE Trochlear Groove
is designed to be similar to the trochlear groove of the
native knee.29 This allows the ATTUNE Knee to be used
with an unresurfaced patella.
Medialized Dome: This patella component provides
optimal bone coverage and improved tracking compared
to central dome designs.30
Unresurfaced Patella
Medialized Dome Patella
Medialized Anatomic
Patella
Medialized Anatomic: This patella features a
conforming lateral facet and a domed medial facet. This
results in decreased patella tilt and improved extensor
mechanism efficiency.31
Trochlear Groove:
Exposed bone
ATTUNE Medialized Dome
Patella Design
Improved coverage
without impingement
Medialized dome
(~3 mm)
Dome is medialized
without leaving
bone exposed
The shape of the ATTUNE Knee Femoral Component is
designed to complement the patient’s natural anatomy.
The ATTUNE Knee System has a proportional trochlear
groove angle that changes based on femoral size. In
addition, the trochlear groove allows the patient’s
soft tissues to control patella tracking for the first 30°
and then it funnels the patella into the center of the
groove after 30°. This is similar to how the native knee
functions.22
Reduced Implant Thickness/Bulk:
The patella components within the ATTUNE System are
designed with a dome that is offset medially. This offset is
designed to reflect the natural patella shape and enhance
patello-femoral function. The asymmetric design allows
for more opportunities to use a larger size patella to
provide optimal bone coverage. The small and consistent
increments between component sizes give surgeons
flexibility to avoid overstuffing the patellar joint.
To accommodate the native soft tissues surrounding the
anterior portion of the knee, the ATTUNE Knee has a
reduced femoral component profile.32 This, in addition
to 0.5 mm patella thickness increments, helps keep the
patella from being overstuffed, which may lead to anterior
knee pain.
Knee Systems with a Medialized Patella
ATTUNE Knee
Yes
Persona™ 18
No
Triathlon
Yes
® 19
Vanguard® 20
No
Journey 2™
No
21
6 DePuy Synthes ATTUNE® Knee System Value Analysis Brief
The ATTUNE Knee (Gray) has less metal than other predicate knee systems (Yellow).
THE ATTUNE KNEE IS DESIGNED TO
ADDRESS EFFICIENCY WITH INTUITION INSTRUMENTS
The INTUITION Instruments Reduce the Effort
From Start to Finish:
DePuy Synthes Companies set out to create a new set of
innovative tools based on unmet needs, which required a
new way of thinking about instrument designs.
Single layer trays and
composite materials help
reduce instrument weight
by 51% compared to
current instrumentation23
Designed Clarity:
Orthopaedic instruments should provide clear and
accurate information to reduce confusion and shorten the
learning curve for OR teams. Design features including red
actuators, high-contrast markings, and quick set/release
functions make the INTUITION Instruments clear and easy
to use from the moment the user picks them up.
Designed clarity for reduced
learning curve and more
certainty
High contrast markings to
increase visibility
Red actuators indicate key
surgical functions
Engineered polymers to
reduce overall weight
Precise Control:
Efficient Path:
With the inclusion of highly engineered polymers,
weight was reduced by 51% as compared to current
instrumentation.23 This reduction was designed to
help hospitals comply with requirements for manual
handling of heavy objects.33 By minimizing the number of
instruments and trays, the effort and cost associated with
the management of instruments are reduced.34
Efficient path through
fewer and lightweight
instruments
The INTUITION Instrumentation combines the surgical
process with implant options to allow the surgeon to
balance the soft tissues and precisely control the implant
position and fit for each patient. With the 4-in-1 cutting
block, the surgeon has precise control to fine tune the
implant position through
1.5 mm A/P adjustments
with a removable posterior
saw capture for flexion gap
assessment. In combination with
the consistent 3 mm increments
between femoral sizes and the
1 mm increments in tibial insert
thicknesses, the INTUITION
Instruments help deliver stability
and motion.
Value Analysis Brief ATTUNE® Knee System DePuy Synthes 7
ADDITIONAL EFFICIENCY SOLUTIONS
AVAILABLE FOR THE ATTUNE KNEE
TRUMATCH® Personalized Solutions:
Digital Templating:
TRUMATCH® Personalized Solutions is DePuy Synthes
Companies patient-specific instruments that are designed
from a patient’s CT scan. TRUMATCH Personalized
Solutions instruments are designed to uniquely fit a
patient’s anatomy and must be ordered separately from
the ATTUNE Knee.
Digital Templating is a pre-operative templating tool
that can help size the implant and reduce the number
of instruments needed in the operating room on the
day of surgery.
• TRUMATCH Solutions was designed to increase
procedural efficiency by reducing the number of
instrument trays, eliminating up to nine surgical steps
compared with traditional knee replacement, and
delivering the guides sterile and ready to use, which
may decrease hospital costs.35
• Digital templating eliminates the need to generate x-ray
films, potentially reducing costs.
• Digital templating increases OR efficiencies through
reduced trays and instruments and decreases OR
complexities.
These intra-operative efficiencies can reduce the surgery
cycle time.38*
• TRUMATCH Cutting Guides and TRUMATCH Pin
Guides are less invasive than standard instrumentation
and do not puncture the Intramedullary (IM) canal.
Not puncturing the IM canal has been associated with
decreased blood loss and reduced OR costs.36, 37*
TRUMATCH Solutions is a patient specific instrument system that is
available for use with the ATTUNE Knee at an additional cost.
Digital templating is a service offered by DePuy Synthes Companies for total
joint cases.
*Note: Cost and Efficiency data is US-specific data and may be different in other geographies.
8 DePuy Synthes ATTUNE® Knee System Value Analysis Brief
DePuy Synthes Companies offer additional programs and services that compliment the ATTUNE Knee
Replacement System. This offering is known as the DEPUY SYNTHES ADAVNTAGE™ Program.
Offering customized, measurable solutions
that help achieve Triple Aim performance
Learn How We Can Help You:
· Educate more patients
· Increase efficiencies
· Improve outcomes and patient satisfaction
· Help lower costs through rebates/inventory
Visit us at depuysynthesadvantage.com*
*The DEPUY SYNTHES ADVANTAGE™ website is intended for visitors from the United States only.
Value Analysis Brief ATTUNE® Knee System DePuy Synthes 9
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Palm Beach, FL.
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Patient Survey. Boston, MA.
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Mathis, K. B. (2005). Does total knee replacement restore normal knee
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Bone and Joint Surgery, 92(5), 1115-21.
12.Parvizi, J., Mortazavi, J., Devulapalli, C., Hozack, W. J., Sharkey, P. F., &
Rothman, R. H. (2012). Secondary resurfacing of the patella after primary
total knee arthroplasty: does the anterior knee pain resolve? The Journal of
Arthroplasty, 27(1), 21-26.
13.DePuy Synthes Companies. (April, 2014). Data on File: ATTUNE Patent
Review. Warsaw, IN.
14.US Food and Drug Administration. Learn if a Medical Device has been
Cleared by FDA for Marketing. June 2014. Available from: http://www.fda.
gov/medicaldevices/resourcesforyou/consumers/ucm142523.htm
15.Clary, C. W., Fitzpatrick, C. K., Maletsky, L. P., & Rullkoetter, P. J. (2012).
Improving dynamic mid-stance stability: an experimental and finite element
study. Orthopaedic Research Society, 58th Annual Meeting, Poster Number
1044, San Francisco, CA.
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