DESIGN RATIONALE - Biomet

DESIGN
RATIONALE

INTRODUCTION
THE VANGUARD COMPLETE
KNEE SYSTEM WAS ENGINEERED
TO FIT THE ENTIRE POPULATION,
REGARDLESS OF RACE, GENDER
OR STATURE.
Beginning with the AGC ® and continuing with the Maxim ®
and Ascent, Biomet’s total knee systems have a long and
rich clinical heritage. With the introduction of the Vanguard
Complete Knee System, Biomet has taken this proven
clinical heritage and combined it with state-of-the-art
design features to produce the most comprehensive
total knee system available. With the introduction of
Microplasty ® and Premier instrumentation platforms and
advancements such as our patented Slidex ® Technology,
the Vanguard Complete Knee System is the surgeon’s
ally in exceeding the demands of today’s active joint
replacement patient.
ADVANCING TECHNOLOGY
When designing the Vanguard Complete Knee System,
every feature in the femur, patella and tibia was reviewed
for potential performance enhancement in all patient
populations. Many clinically successful features found in
earlier Biomet ® total knee systems remain the same in the
Vanguard Complete Knee System. However, many more
features were added.
Patella/Femoral Joint
The Vanguard femoral component has four main design
features incorporated into the sagittal profi le:
• Rounded sagittal profi le
• Deeper, swept-back trochlear groove
• Longer trochlear groove
• Wide proximal trochlear groove
Each of these variables improves lateral release rates,
extensor moment arm, patella alignment and patella tracking,
while reducing the potential for patellar tendon irritation.
Rounded Sagittal Profi le
Two distinct femoral designs have evolved over time: an
anatomic (box-like) femoral profi le and a more swept-back
(rounder) sagittal profi le.

A round sagittal profi le as found in the Vanguard knee may
be more forgiving to the retinaculum by not over tensioning
the soft tissues.
Anatomic (Gold) vs. Swept-back (Gray) Sagittal Profi le
Deeper/Swept-back Trochlear Groove
The trochlear groove is a critical design feature for patella
performance. Translation of the trochlear groove posteriorly
in the femur has shown to resist patella crepitus and clunk. 1
The Vanguard trochlear groove has been designed to
sweep back posteriorly for better patellar performance.
Longer Trochlear Groove
The trochlear groove has also Standard Trochlear Groove (Gold)
been lengthened to further
support the patella in deep
fl exion. This longer trochlear
groove also better supports
the quadriceps tendon. In
deep fl exion, a shorter
trochlear groove, as in the
Maxim ® knee, will articulate
Deeper and Longer Trochlear
on the quadriceps tendon at
Groove (Gray)
the junction of the trochlear
groove and posterior stabilized
(PS) box at 75 to 80 degrees of
fl exion. In the Vanguard knee, the
junction does not articulate with
30
the quadriceps tendon until 105
to 120 degrees of fl exion.
% of Females
20
10
0
Size 55
Wider Proximal Trochlear Groove
Patellar capture during
fl exion must be balanced
0–15°
with the need for less
patellar constraint in
extension. The Vanguard
knee provides for this
balance through a widened
trochlear fl oor to reduce Q-angle
constraining forces in
extension and a 6.5 degree valgus angulation of the patella
track. “Valgus angulation has been shown to reduce the
patellar shear stresses.” 2
In addition to a wider proximal trochlear groove, the
Vanguard knee offers a comprehensive approach to
patellofemoral mechanics that includes femoral retinacular
relief, a lateralized trochlea and a clinically proven dome
patellar component. The aggregate of these features
produces a component that provides for excellent
patellar tracking (within 0–15 degrees of valgus) regardless
of the patient’s Q-angle. 3 Retinacular relief minimizes
soft tissue tension, reducing the potential need for a
lateral release.
The narrow anterior fl ange maintains a small profi le to
reduce the likelihood of femoral overhang. To further
address overhang, the Vanguard knee features rounded
corners on the anterior fl ange. Proper femoral fi t with
respect to overhang is a primary concern for patients with
smaller anatomies, most commonly found in the female
population. The Vanguard knee addresses this by offering
a femoral component that grows medial/lateral in 2.4mm
increments between its smallest six sizes, which have shown
to be the most commonly utilized sizes for female patients.
Size 57.5 Size 60 Size 62.5 Size 65 Size 67.5 Size 70 Size 72.5 Size 75 Size 80
Most Commonly Used Femoral Sizes Based on 1,611 Vanguard Knees Implanted in Females 3
1

Articulation Features
Coronal Geometry Features
The Vanguard knee system
provides a fully congruent
(coronally), moderately
dished articulation, which
reduces polyethylene
stresses while still allowing
physiological motion.
The patented 1:1 condylar
1:1 Tibial-Femoral Contact
geometry provides surgical
fl exibility by allowing tibial-femoral interchangeability.
The Vanguard cruciate retaining (CR) and posterior
stabilized (PS) femurs have complete size interchangeability
with their respective primary bearings.*
Increased Range of Motion
The Vanguard knee
has been designed to
accommodate patients
who require an above
average range of motion.
The femoral posterior
condyle geometry will
allow for 145 degrees of
fl exion. The Vanguard
knee is able to achieve this
145 Degrees Range of Motion with
Primary Bone Cuts
high range of motion without the need to resect an
additional 2mm of posterior condyles. The Vanguard
tibial bearings have a deeper anterior relief to minimize
the potential for patella impingement during high fl exion.
To increase contact area with axial rotation, the Vanguard
knee features a rotated bearing surface articulation. As
compared to a linear articulation, a rotated articulation
increases the contact area by 13 percent. 3
High Flexion Patellar Tendon Relief
Rotated Tibial Articulating Surface
The coronal geometry features a softened intercondylar
(medial and lateral) edge. This radius enhancement produces
increased contact area for the patella when articulating
on the condyles in fusion. Finite element analysis has
demonstrated a 25 percent reduction in patella contact
pressure compared to the Maxim ® Total Knee design. 3
Proportional Posterior Condyles
The posterior condyles grow
proportionally in size. This provides
better bone coverage and reduces
overstuffi ng the fl exion gap in
smaller femurs or undersizing the
posterior condyles in larger femurs.
Better coverage of the posterior
condyles aids in achieving high
fl exion and restoring femoral offset.
The posterior condyle geometry has also been optimized
to provide larger contact areas in deep fl exion. Larger
contact areas will dissipate forces more effectively. 4
Finite Element Analysis Demonstrates a Gradual Dispersion of Forces
Along the Patella 3
2
*With the exception of the Vanguard Anterior Stabilized (AS) Bearing.

Intermediate Femoral Sizes
The Vanguard knee has introduced four additional
intermediate sized primary femoral components to
enhance the traditional femoral offering.
Ten Vanguard femoral component sizes, combined with
nine Vanguard tibial component sizes, while maintaining
complete interchangeability among all sizes, provide
intraoperative fl exibility to fi t varying patient anatomies of
both the femur and the tibia independently. The end result
is a complete knee system that is the most fl exible on the
market, allowing a custom fi t for the entire population,
regardless of race, gender or stature.
Mid-fl exion cam engagement avoids cam/post contact
during high cycle activities but ensures stability during high
moment activities.
Enhanced Anterior Lip
To help resist paradoxical anterior femoral slide during gait,
the anterior lip of the tibial bearing is more prominent.
This is achieved by moving the anterior radius posteriorly.
The anterior lip provides resistance for the femoral condyles,
preventing anterior slide. This cradling effect controls the
femoral component on the articulating surface without
sacrifi cing freedom of rotation. The combination of 45
degrees cam engagement with (anterior lip) stability
optimizes cam/post engagement, limiting premature wear
of the tibial post.
Ten Femoral Sizes
More Prominent Anterior Lip (Dark Gray)
Specific Posterior Stabilized
Design Features
A multitude of design features affect the performance
of a cam and spine type of posterior stabilized knee.
The following design features are key elements in the
Vanguard PS system:
Cam and Post Engagement
The cam on the PS femoral
component is designed
to engage the spine on the
tibial component at 45
degrees of fl exion. Gait
analysis demonstrates that
weight bearing phase occurs
from 0 to 45 degrees. 5 After
stance phase (weight bearing),
the cam engages the spine
to provide stability and
45 Degrees Cam and Spine
increase quadriceps effi ciency,
Engagement
specifi cally during activities
such as ascending and descending stairs.
Low Cam Engagement/High Dislocation Height
The cam engages relatively low on the tibial post and
remains low throughout full range of motion. This decreases
the forces at the tibial-bone interface and at the locking
mechanism while maintaining a high dislocation height. The
dislocation height of the Vanguard PS is never less than
17.3mm at 90 degrees of fl exion or greater. The Vanguard
PS component allows for 10 degrees of hyperextension
before anterior post impingement.
45°
60°
75°
90°
Cam Contact Points
3

Post Geometry Designed for Stability,
Reduced Wear
The PS post geometry is rounded to minimize forces on
the post due to rotation of the femur and resultant rotation
of the PS box. According to mechanical wear test
simulation, the Vanguard PS bearing had a 71 percent
reduction in gravimetric wear at 5.5 million cycles as
compared to a standard square post design geometry. 3
PS Box Resection Options
The Vanguard knee offers
several options for PS box
resection. The choices of
standard bone conserving or
closed box cuts are available
for the open box femoral
component. The standard cut
allows for a parallel cut to be
made relative to the distal
resection, whereas the bone
conserving cut produces an
angled cut, conserving bone
near the anterior chamfer area.
Closed
Open
Bone
Conserving
Two PS Box Resection Options
Rounded PS Post
PS Plus—An Additional Constraint Option
The Vanguard PS femoral component will accept the
standard PS bearing as well as the PS plus, a more
constrained bearing. The PS plus bearing is indicated for
use in a primary situation when more stability is desired to
resist rotation and varus/valgus lift-off.
The standard PS post does not constrain the femur in
rotation or varus/valgus lift-off.
The Premier instrumentation also provides the option of
milling the PS box resection. The mill conserves bone at the
corners of the box, resulting in a fi ve percent reduction in
box volume as well as reducing the stress risers created by
square corners.
Premier PS Femoral Mill Box Resection
Note: The PS plus bearing does not articulate with the
Vanguard SSK femoral component and is not indicated
for use as a revision bearing.
Square Corner
PS Bearing
4
PS Plus Bearing
Round Corner
Finite Element Analysis Demonstrating Lower Concentration of Stress at
Corner of Box

Specific Cruciate Retaining
Design Features
The Vanguard CR femoral component incorporates
all design and articulation features of the posterior
stabilized design as well as key features specifi c to the
CR femoral component.
Removable Femoral Lugs
The femoral lugs on the Vanguard CR are removable.
This feature allows for augmentation if required in
primary total knee arthroplasty or in the revision of a
failed unicompartmental knee arthroplasty.
Two Fixation Options
The Vanguard CR and PS femoral components are
available in two fi xation options: Interlok ® roughened fi nish
for cement fi xation or PPS ® Porous Plasma Spray Coating
for cementless fi xation.
The Vanguard CR and PS porous options have been
cleared by the FDA for cementless fi xation.
Cruciate Retaining Bearing Options
The options for tibial bearings include standard (with three
degrees posterior slope built into the articulating surface),
posterior lipped and anterior stabilized.
Standard CR (Three-Degrees Posterior Slope)
Removable CR Lugs
CR Lipped (No Slope)
Anterior Stabilized Bearing (No Slope)
These options provide a multitude of choices to meet
patient needs and surgeon preferences.
Augment Attached to CR Knee
5

Specific Vanguard SSK Revision
Femoral Design Features
While the Vanguard SSK femoral component integrates all
the primary femoral component design features, there are a
few differentiating design features specifi c to the Vanguard
SSK revision femoral component.
Stability
The SSK constrained bearing offers a large swept back
tibial post that provides stability and continued constraint in
deep fl exion. The large tibial post also maintains increased
post/box contact. At 90 degrees of fl exion, 17mm of the
post remains in the box.
SSK Femoral Component
SSK Bearing Options
The Vanguard SSK revision system offers two bearing
options: the SSK PS tibial bearing and the SSK constrained
tibial bearing. This feature allows the surgeon intraoperative
fl exibility in the case of collateral defi ciencies.
The SSK PS bearing provides only posterior stabilization
with the Vanguard SSK revision femur.
SSK Tibial Post in Box
SSK Femoral Component Extended Cam
The Vanguard SSK
femoral component
adds an additional
3mm of material on
the cam. This provides
for a higher dislocation
height, up to 23mm,
prior to dislocation.
Stem Boss Angle
Extended Cam
The Vanguard SSK femur has a fi ve-degree stem valgus
angle which will accept multiple stem lengths in straight and
curved profi les to match the patient’s anatomy.
SSK PS Bearing and SSK Constrained Bearing
The SSK constrained bearing is designed to allow
for +/-1 degree of varus/valgus lift-off and +/-0.5 degree
of rotational freedom.
Stem Boss Angle
6

Femoral Augmentation
Individual distal (5mm, 10mm and 15mm thicknesses) and
posterior (5mm and 10mm thicknesses) augmentation
blocks are available for patients with inadequate bone stock.
5mm
10mm
15mm
Oxidation may negatively impact the fatigue characteristics
of the polyethylene, causing delamination.
Biomet was the fi rst company to use an inert gas, argon,
to replace oxygen during the sterilization and packaging
processes. The use of argon reduces the degradative effects
of oxygen present in polyethylene-bearing designs.
Furthermore, gamma sterilization in an argon atmosphere
has been shown to decrease wear over EtO sterilized
polyethylene by 44 percent. 15 ArCom ® polyethylene has
been clinically proven to be more resistant to wear,
delamination and oxidation. 16–19
5mm
10mm
Augments
CLINICAL HERITAGE
ArCom ® Polyethylene
Biomet has made the commitment to Direct Compression
Mold all tibial bearings* within the Vanguard system to
minimize the potential for wear and oxidative breakdown.
Biomet’s ability to combine clinically proven polyethylene 6–10
with the Vanguard knee system punctuates Biomet’s
engineering-driven approach. Knee wear is thought to
predominately be a fatigue mechanism, which may lead to
delamination and pitting of the bearing surface. Traditional
machining of tibial articulations has been shown to be
detrimental to the long-term performance of knee
replacements. 11–14 The cutting tools used in machining
shear the polyethylene and pull the material apart, creating
regions of residual stress. This residual stress may sensitize
the material to localized breakdown and oxidation.
Wear Testing
Polyethylene Thickness/Locking
Mechanism Design
Meding, et al. demonstrated excellent long-term results
with 4.4mm minimum thickness Direct Compression
Molded tibial bearings. 7 The Vanguard knee system provides
a minimum of 6mm of polyethylene thickness in its primary,
posterior stabilized and revision components. Thicknesses
for all polyethylene sizes are listed in the polyethylene size/
thickness chart.
+
=
Size
Thickness
10 12 14 16 18 20 22 24
Extruded Bar Stock Machining Oxidized Cross-Section
Polyethylene
Articulating 6 8 10 12 14 16 18 20
Thickness(mm)
+
=
Polyethylene Size/Thickness
Resin Direct Molding Non-Oxidized Cross-Section
*May not be applicable to custom products.
7

Effective polyethylene thickness is determined by evaluating
not only thickness at the center of the tibial condyle but
also by measuring the periphery of the polyethylene insert.
Many currently manufactured components provide adequate
thickness at the center but compromise thickness around
the edges due to the design of the locking mechanism. Feng,
et al. have found that the most severe polyethylene wear
occurs at the periphery, where the component had a raised
metal edge. 20 These concerns have been addressed in the
Biomet modular tibial trays. The peripheral polyethylene
thickness is maintained by locating the locking mechanism
anteriorly and within the intercondylar area. Concerns have
been raised about modularity and bearing micromotion as
a contributor to osteolysis and early failure. 21–26 Biomet’s
locking mechanism compresses the polyethylene bearing
against the tray, thereby reducing micromotion. Published
literature has also shown the Biomet ® locking mechanism to
be the most stable overall. 22,23
Micro Macro Macro
M/L 59 63 67 71 75 79 83 87 91
A/P 38 41 43 46 48 51 53 56 58
Biomet Tibial Plate Sizing
Mensch and Amstutz Tibial Sizing 27
Achieving Optimal Bone Coverage
The Vanguard femoral components are based on extensive
cadaver studies. Mensch and Amstutz 27 reviewed 200
cadaver knees which served as the basis of AGC, ® Maxim ®
and Vanguard femoral component sizing. Four additional
sizes are offered with the Vanguard system, reducing the
interval between sizes in the center of the usage distribution.
Anterior Compressive Locking Mechanism
Tibial Tray Sizing
Many knee systems offer a variety of tibial tray sizes.
However, few systems offer consistent, close sizing. The
Vanguard knee system offers nine tibial sizes that change
in consistent 4mm M/L intervals, based on the work of
Mensch and Amstutz. 27 A scientifi c study was conducted
that examined eight tibial tray designs, six symmetrical and
two asymmetrical. 28 Incavo, et al. showed that the sizing
rationale for the AGC ® Total Knee System, which is closely
paralleled by the Vanguard system, offers optimal coverage
as compared to competitive asymmetrical designs. Of all the
tibial trays tested, the AGC ® knee was ranked as the best in
total coverage, covering 80.8 percent of the tibial surface. 28
Bell Curve of Femoral Coverage with Additional Intermediate Sizes
8

Patellar Articulation
Ritter, Lombardi, Insall, Ranawat and others have
shown excellent long-term results with domed patellar
designs. 6,8,29–31 The domed patella is more forgiving in
placement than other designs and can more reliably
provide congruent contact.
Component Fixation
The Vanguard knee system incorporates two types
of fi xation fi nishes. The Interlok ® fi nish allows for proper
cement interdigitation into the surface for a more
secure bond.
Interlok ® Finish
Domed Patella
Series A Patellas
The Vanguard total knee system offers multiple patella
options. Patellas are available in one and three peg options
in standard thicknesses and in a thinner version which is on
average 1.5mm thinner than the standard patella.
Since its introduction in 1981, Biomet’s PPS ® Porous Plasma
Spray Coating has been used by surgeons throughout the
world to achieve better fi xation on a multitude of products
including the AGC ® knee, Maxim ® knee, Ascent knee,
Taperloc ® hip, and Bio-Modular ® total shoulder. At follow-up,
surgeons are observing extremely low rates of osteolysis
and nearly 100 percent survivorship at over 10 years with
PPS ® coating prostheses. 32–35
Series A Standard One and Three Peg Patellas
PPS ® Coating
9

Additionally, it has been clinically proven that titanium
porous surfaces facilitate increased ingrowth as compared
to similar cobalt chrome surfaces. 36
Biomet’s proprietary PPS ® Porous Plasma Spray application
is unique in comparison to competitors’ techniques in that
only the titanium alloy powder is heated, not the substrate
of the implant. The sintering process (used to apply beads
and wire mesh coatings) compromises the substrate’s
strength and results in a greatly decreased ability to withstand
in-vivo stresses. 37–46 Biomet’s plasma spray process maintains
the implant’s inherent fatigue strength. 37–46
Tibial Tray Options
Tibial Augments
Fatigue Strength
Offset Tibial Tray
The Biomet ® offset tibia offers offset immediately from the
bottom of the tibial tray and can be positioned 360 degrees
for exact offset placement. The offset is available in neutral,
2.5mm and 5.0mm.
Tibial Baseplate Options
Biomet’s tibial tray options are the most comprehensive
on the market today. Primary tibial trays are made from
both titanium and cobalt chrome alloys. Titanium baseplates
come either with an Interlok ® fi nish or a PPS ® coating to
enhance bone ingrowth. PPS ® coated baseplates accept
up to four 6.5mm cancellous bone screws for enhanced
fi xation when a cementless tibial component is desired. The
porous, stemmed and offset tibial plates can be used with
block or wedge augments. All augments are fi xed to the
baseplates via bolts, allowing a mechanical lock between
the tray and augments. Cobalt chrome baseplate options
come in either fi xed I-beam or fi xed cruciate fi n with an
Interlok ® fi nish.
Neutral
5.0mm Offset
2.5mm Offset
Offset Trays and Adaptors
10

Stem Options
The modular primary tray provides for the intraoperative
selection of the stem to match the specifi c needs of the
patient. The combination of a Morse-type taper and screw
fi xation helps maintain a solid connection between the stem
and plate. When more fi xation is desired, the stemmed tray
or offset tray will accept stem extensions.
Modular Tibial Tray Stems
Stem Extensions
11

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*Bench test results are not necessarily indicative of clinical performance.
12

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