Review Article
Design Rationale for Total Ankle
Christopher E. Gross, MD
Ariel A. Palanca, MD
James K. DeOrio, MD
From the the Department of
Orthopaedics, Medical University of
South Carolina, Charleston, SC
(Dr. Gross), the Department of
Orthopaedic Surgery, Stanford
University, Stanford, CA
(Dr. Palanca), and the Department of
Orthopaedic Surgery, Duke University
Medical Center, Durham, NC
(Dr. DeOrio).
Dr. Palanca or an immediate family
member serves as a paid consultant
to Stryker. Dr. DeOrio or an immediate
family member has received royalties
from BioPro, Exactech, Merete, and
Stryker; is a member of a speakers’
bureau or has made paid
presentations on behalf of Acumed,
Exactech, Sanofi-Aventis, Stryker,
and Wright Medical Group; serves as
a paid consultant to Acumed,
DataTrace, Exactech, Integra
LifeSciences, Sanofi-Aventis, Small
Bone Innovation, Stryker, and Wright
Medical Group; serves as an unpaid
consultant to BioPro; has stock or
stock options held in Wright Medical
Group; and has received research or
institutional support from Integra
LifeSciences and Wright Medical
Group. Neither Dr. Gross nor any
immediate family member has
received anything of value from or has
stock or stock options held in a
commercial company or institution
related directly or indirectly to the
subject of this article.
J Am Acad Orthop Surg 2018;0:1-7
DOI: 10.5435/JAAOS-D-16-00715
Copyright 2018 by the American
Academy of Orthopaedic Surgeons.
Month 2018, Vol 0, No 0
Copyright Ó the American Academy of Orthopaedic Surgeons. Unauthorized reproduction of this article is prohibited.
Arthroplasty Systems: An Update
Abstract
The design of total ankle arthroplasty systems is evolving as a result of
findings from longer-term studies. Our understanding of modes of
failure has increased, and surgical techniques have become more
refined. Currently, five total ankle arthroplasty systems are used in the
United States. The landscape has changed considerably in the decade
since the latest article reviewing total ankle design was published.
Some implants with acceptable intermediate results had much poorer
outcomes at 7- to 10-year follow-up. As more research showing mid- to
long-term outcomes is published, the design rationale and current
outcomes data for each of these implants must be considered.
T he design of total ankle arthro-
plasty (TAA) systems is evolving.
With longer term follow-up, our
First-generation ankle arthroplasty
designs were associated with high
rates of osteolysis, implant loosening,
understanding of modes of failure has tibial and talar bone loss, and wound
increased and surgical techniques complications.4-7 The second-generation
have been refined. Currently, five designs improved on the first-generation
TAA systems are commonly used in devices, with porous metal-backed
the United States: INBONE (Wright surfaces to improve osseous integra-
Medical Group), INFINITY (Wright
tion; replacement of the tibiotalar,
Medical Group), Salto Talaris (In- talofibular, and medial-malleolar ta-
tegra Lifesciences), Scandinavian lar articulations; and/or improved
Total Ankle Replacement (STAR
stability with the fusion of the syn-
[Stryker]), and Trabecular Metal
desmosis. However, these designs had
Total Ankle (Zimmer Biomet). Two
complications related to syndesmotic
systems have recently entered the US
nonunion, polyethylene wear, im-
market: the VANTAGE (Exactech)
plant migration, and impingement.8
and the Cadence (Integra Life-
Improvements in the design of third-
Sciences). During the 10 years since
and fourth-generation TAA systems
the publication of the latest total
include minimal bone resection,
ankle design review article,1 the
landscape has changed substantially; superior bony ingrowth, retention of
some implants with adequate inter- ligamentous support, and anatomic
balancing. In fact, several companies
mediate results had much poorer
outcomes at 7- to 10-year follow- have also begun to invest in lines of
up.2,3 As more research regarding revision ankle replacements. Further-
mid- to long-term outcomes becomes more, refined implantation instru-
available, it is important to consider mentation has allowed for superior
the design rationale and current repeatability and a more compre-
outcome data for each of these hensive surgical technique compared
implants. with earlier systems.
1
Design Rationale for Total Ankle Arthroplasty Systems: An Update
Figure 1
Photograph of the INBONE II ankle
replacement. (Image courtesy of
Wright Medical Group, Memphis, TN.)
FDA-Approved Implants
Currently in Use
INBONE Total Ankle System
The INBONE I total ankle was cre-
ated by Mark Reiley, MD, and design
engineer Garret Mauldin in 2005.9
Originally called Topaz, then briefly
the Berkeley, and then the INBONE
total ankle system, it was purchased by
Wright Medical (now Wright Medical
Group) in 2008. The system was cre-
ated with advances in total knee ar-
throplasty in mind. Thus, it was
developed with an intramedullary stem
for the tibial component and a mini-
mally constrained matching talar
component with a saddle shape. The
2 Journal of the American Academy of Orthopaedic Surgeons
Copyright Ó the American Academy of Orthopaedic Surgeons. Unauthorized reproduction of this article is prohibited.
surgical leg is secured in an external
holder and, after proper alignment is
obtained with use of fluoroscopy, the
surgeon performs intramedullary
reaming through the calcaneus,
talus, and tibia. The stem is assembled
from multiple cylindrical segments
that screw into one another and are
placed individually through an
anterior opening in the ankle and
then attached to a base plate with a
Morse taper. The saddle-shaped talar
component has a 10- or 14-mm stem,
which is impacted into the implant
before insertion. Both the tibial and
talar components are made of cobalt-
chromium with a titanium plasma
spray coating.
The earliest literature on the
INBONE system addressed its use as
a revision prosthesis,10,11 because it
provided surgeons with a way to
replace large defects with metal and
to gain stability with the stem in the
case of loosening. The first early
review of primary ankles was pub-
lished in 2014 and involved 194
INBONE implants at a mean follow-
up of 3.7 years.12 The typical eval-
uation scores were significantly
higher than the preoperative values
(P , 0.003), but the survival rate
was only 89%. A second retrospec-
tive study showed a lower survival
rate of 77% at 2-year follow-up.13
One theory regarding the somewhat
lower survival rate was the poten-
tially deleterious effect of reaming
through the talus, sometimes pene-
trating the sinus tarsi and the artery
of the tarsal canal, leading to os-
teonecrosis of the talus. An anatomic
study demonstrated that the artery of
the tarsal canal, which is the main
blood supply of the talus, was in-
terrupted by the drill in three of four
cadaver specimens during INBONE
implantation.14 In a combination of
INBONE ankle replacement and a
subtalar arthrodesis, the talar blood
supply is at even greater risk because
some surgeons place subtalar ar-
throdesis screws from anterior to the
prosthesis into the calcaneus through
the sinus tarsi.
In 2010, the INBONE prosthesis
was revised as INBONE II to help
address some of the early failures.
This iteration was an improvement in
several ways. It provided a longer
anterior-posterior length for the tibial
component, added two anterior pegs
to the talar component, and changed
the saddle-shaped talus to a V-shaped
sulcus design with increased stabil-
ity15 (Figure 1). A review of 59
INBONE I and II prostheses showed
that the combined survival rate was
an estimated 96.6% at a follow-up
of 2 years. There were 5 revisions
(8%) in INBONE I prostheses (4/5)
and INBONE II prostheses, all for
talar subsidence.16 A more recent
study found that the reoperation
rates for 193 INBONE I and 56
INBONE II ankles were 18.5% and
15.9%, respectively, with failure
rates of 6.0% and 2.6%, respec-
tively, at 2 years postoperatively.17
The INBONE II is still used for both
primary and revision ankle replace-
ments. It is typically used for more
severe deformities, however, such as a
flat talus or major tibial bone loss,
although some surgeons reserve it for
revision only. Using this implant as a
revision system is technically chal-
lenging, as demonstrated by the 31.4%
complication rate in 35 Agility (DePuy
Synthes) to INBONE revisions.2
Future reporting of midterm data
and results on the INBONE II is ex-
pected to aid surgeons in making
informed decisions about the system.
INFINITY Ankle Replacement
Recognizing the need for a less-
invasive ankle without the use of a
leg holder, Wright Medical devel-
oped a new prosthesis in 2013—the
INFINITY Total Ankle System. The
tibial component was modified to
have ingrowth capability on three
sides of the rectangular implant, with
three spikes to impact into the cut

tibial surface. The longer-stemmed
tibia is still available for complex or
revision cases. The talar component
has two anterior spikes and an
anterior and posterior chamfer with
open sides, so it is possible to see
under the prosthesis all the way
across with fluoroscopy (Figure 2).
The INBONE II talar component can
also be used with the INFINITY
tibial component in patients with a
flat-topped talus, for which the
chamfers would take out too much
bone from the talar neck. The
implant is too new on the market for
outcomes data.
Salto Talaris and Salto
Talaris XT
The Salto Talaris and Salto Talaris
XT implants were acquired by In-
tegra in October 2015 with the
option to purchase the worldwide
rights in 2017. The Salto Talaris
fixed-bearing prosthesis has been
available in the United States since
2006. This prosthesis was designed
on the basis of its mobile-bearing
counterpart in Europe—the Salto
Total Ankle—first used in 1997. The
fixed-bearing design came about
after a radiographic study showed
no anterior-to-posterior motion be-
tween the inferior surface of the
tibial component and the superior
surface of the polyethylene, showing
that the implant was not functioning
as a mobile-bearing system.18
These cobalt-chromium implants
are single-coated with 200 mm
plasma-sprayed titanium. The tibial
component uses a central keel for
fixation. During implantation, the
trial tibial component is allowed to
rotate to find the proper axis of
rotation. However, the component is
usually wedged between the malleoli,
decreasing its rotation and under-
mining its ability to find its “home.”
The talar component has a conical
shape with two different radii of
curvature to match the morphology
Month 2018, Vol 0, No 0
Copyright Ó the American Academy of Orthopaedic Surgeons. Unauthorized reproduction of this article is prohibited.
Figure 2
Photograph of the INFINITY ankle
replacement. (Image courtesy of
Wright Medical Group, Memphis,
TN.)
of the talus (ie, medial smaller than
lateral). Although the lateral facet of
the talus is resurfaced, the medial
facet is not. The talar component
also has a sagittal curved groove
that, in theory, forces the foot into
external rotation with dorsiflexion
and allows internal rotation during
plantar flexion. Four degrees of ro-
tation around the center of talar
curvature allows motion of the sub-
talar joint. A central peg is also
present for stabilization.
The Salto Talaris XT consists of a
flat cut talar component and a range
of thicker polyethylene inserts aimed
at revision and more complex pri-
mary applications (Figure 3). The XT
implant uses the same articulation as
the standard talar component, thus
making it compatible with all Salto
Talaris tibial and talar components.
In a systematic review of 212 Salto
Talaris ankles with a weighted follow-
up of 34.9 months, only five prosthe-
ses (2.4%) needed revision (ie, three
metallic component exchanges and
two ankle arthrodeses).19 There was
no significant difference in revision
rates between the design team/con-
sultants and independent groups. The
revisions were attributed to aseptic
implant loosening, talar subsidence,
tibial component subsidence, talar
osteonecrosis, and tibial component
aseptic loosening.
Christopher E. Gross, MD, et al
Figure 3
Photograph of the Salto Talaris XT
with thickened polyethylene and flat
cut talar component. (Image
courtesy of Integra LifeSciences,
Plainsboro, NJ.)
In a study of 300 patients who
underwent 321 TAAs with Salto Ta-
laris prostheses, 83.8% of patients
experienced very good to excellent
pain relief and 77.9% reported
improved function at a mean follow-
up of 38.9 months.20 Interestingly,
patients demonstrated improvement
between postoperative months 12
and 24. At a mean follow-up of 20.1
months, eight patients required re-
vision arthrodesis and two required
revision TAA (2.3% and 0.6%,
respectively).
A recent study of 78 patients who
underwent 81 TAAs demonstrated a
97.5% survival rate at a mean follow-
up of 5.2 years.21 Seventeen patients
(21.8%) underwent additional pro-
cedures after the arthroplasty, most
commonly gutter débridement. Of
those who had .2-year radiographic
follow-up, 31% displayed evidence
of lucency around either the tibial or
the talar component.
3
Design Rationale for Total Ankle Arthroplasty Systems: An Update
Figure 4
Photograph of the Scandinavian
Total Ankle Replacement. (Image
courtesy of Stryker, Kalamazoo, MI.)
Scandinavian Total Ankle
Replacement
The STAR was designed by Hakon
Kofoed, MD, in collaboration with
LINK AG, a German orthopaedic
implant manufacturer, in 1978. The
system was acquired by Small Bone
Innovations (SBI) in 2009 and, ulti-
mately, by Stryker in 2014. In total,
five different versions of the STAR
ankle have been implanted worldwide
since 1981. Only the fourth-generation
prosthesis has ever been available in
the US market. Unlike the previous
generations, the fourth-generation sys-
tem is distinguished by the addition of
a rough titanium plasma spray as a
base coat to improve ongrowth. This
design was used in the prospective
clinical trials conducted in the United
States under the investigational device
exemption 8-year trial and ultimately
received approval for widespread use
in the country in 2009.
All the surgical instruments used in
this system have been completely re-
designed under the guidance of sur-
geons who participated in the clinical
studies under the investigational device
exemption. The goal in redesigning the
instruments was to increase accuracy
and reproducibility by changing the
cuts from open blocks to captured
cutting guides.
4 Journal of the American Academy of Orthopaedic Surgeons
Copyright Ó the American Academy of Orthopaedic Surgeons. Unauthorized reproduction of this article is prohibited.
Figure 5
Photograph of the Trabecular Metal
Total Ankle. (Image courtesy of
Zimmer Biomet, Warsaw, IN.)
The STAR ankle is the only three-
piece mobile-bearing design ap-
proved and available in the United
States, although many mobile-
bearing devices are available world-
wide (Figure 4). The tibial tray has
two 6.5-mm cylindrical bars for
ongrowth, which allows for only
5 mm of distal tibial resection. The
distal face of the tibial component is
a flat, polished surface to allow
unconstrained movement of the
polyethylene component. The tibial
component is wider anteriorly than
posteriorly to mimic native anatomy.
The talar component is symmetri-
cally cylindrical, with medial and
lateral wings to support the medial
and lateral facets of the talus. A crest
on the talar dome corresponds to a
groove in the polyethylene compo-
nent. The polyethylene insert has a
meniscus that is congruent with
both metal components. A recent
study showed that there was pre-
served axial and sagittal motion at
the tibial-polyethylene interface at
a minimum follow-up of 1 year
postoperatively.22
To date, the fourth-generation
STAR ankle has the longest follow-
up data in the United States. In 2011,
Mann et al23 reported 91% metal
component survivorship at 9.1-year
follow-up. In 2015, Jastifer and
Coughlin24 reported 94.4% metal
survivorship at a follow-up of 10.2
to 14.6 years. In 2012, Nunley et al25
demonstrated 93.9% total implant
survivorship rate at a mean of 60.1
months postoperatively.
The earlier generations of the STAR
system have different prosthetic
coatings. From 1989 through 1999,
the prosthesis had a brushite and
hydroxyapatite coating over smooth
cobalt-chromium. In 1999, the coat-
ing was changed to a titanium plasma
spray with a top layer of calcium
phosphate, referred to as a double
coat. These versions are available in
Europe and are included in the
European registry data but have
never been available for use in the
United States. Results with these
prostheses are inferior to the results
with the fourth-generation prosthesis
in the United States. In 2013, Brunner
et al26 published results from the
European registry with the first-
generation STAR system, showing
70.7% survivorship at 10 years
and 45.6% at 14 years. In 2016,
Kerkhoff et al27 showed a 10-year
survivorship rate of 78% with the
second-generation STAR system.
Trabecular Metal Total Ankle
The Trabecular Metal Total Ankle is
a fixed-bearing prosthesis with char-
acteristics that differentiate it from
other TAA devices. One notable fea-
ture of the system is that it uses a
lateral transfibular approach, which
requires a fibular osteotomy and
transection of the anterior talofibular
ligament, both of which necessitate
postoperative repair.
The aim of the transfibular approach
is to maintain the integrity of the blood
supply to the skin and to spare the
deltoid ligament and minimize wound
healing complications. In addition, the
implant is designed to anatomically
mimic the natural curvature of the
tibia and talus. This results in less
bone removal and more surface area
contact. It also optimizes the per-
pendicular orientation between the

prosthesis and the underlying bony
trabeculae, which in turn resists
subsidence (Figure 5).
The system relies on an external
alignment system to hold the tibial
plafond and talus in place while a
burr removes articular cartilage and
subchondral bone. The external
alignment system also can be used for
deformity correction.
The system is available in six sizes.
The talar component is convex and
is a cobalt-chromium-molybdenum
alloy with a trabecular metal surface
and a thin interlayer of titanium. It is
available in separate right and left
configurations. Its bicondylar artic-
ular geometry has a larger sagittal
radius of curvature laterally than
medially. The distal surface includes
two fixation rails to facilitate stabil-
ity. The articulating surface is on an
8° conical axis to replicate the ge-
ometry of the ankle. The tibial
component is concave and symmet-
ric. The tibial base is made from a
Ti-6AL-4V alloy diffusion bonded to
a trabecular metal surface. The
proximal surface includes two fixa-
tion rails that are oriented perpen-
dicular to the flexion-extension axis
in the coronal plane to facilitate
stability. The articular geometry of
the implants is semiconforming in
both the sagittal and coronal planes
to allow semiconstrained motion.
The polyethylene insert is highly
cross-linked to achieve lower wear
than conventional polyethylene.
In a study of 20 TAAs with a mean
follow-up of 18 months, no fibular
nonunion or delayed union was
observed with the transfibular
approach.28 No implant failure was
seen at 12 months postoperatively.
Future Directions
VANTAGE Total Ankle
System
The Vantage Total Ankle System
(Exactech) is a new prosthesis that
Month 2018, Vol 0, No 0
Copyright Ó the American Academy of Orthopaedic Surgeons. Unauthorized reproduction of this article is prohibited.
Figure 6
Photograph of the Vantage ankle
replacement. (Image courtesy of
Exactech, Gainesville, FL.)
was approved by the FDA in 2016.
The ankle, which has a two-piece
fixed-bearing design, is inserted
through a standard anterior ap-
proach. It has four tibial and five talar
sizes, each with right and left orien-
tations (Figure 6). The polyethylene
comes in thicknesses of 6 mm to
12 mm.
The design is unique in that it was
created from CT scans of normal
and arthritic ankles29 to provide
maximum coverage in the anterior-
posterior direction of the standard
cut surface of the tibia. It has a fib-
ular notch region that allows increased
coverage without impinging on the
fibula. It has a fenestrated cage
design on the superior aspect of the
tibial component, along with three
spikes to help ensure bony ingrowth.
The talar component has a rounding
device that allows the surgeon to
match the surface area of the talus to
the implant rather than set the talar
component on a flat surface. An an-
terior flange also helps prevent sub-
sidence. The polyethylene component
is inserted and fixed in place with a
locking clip to allow easier removal
and replacement in revision cases.
Cadence Total Ankle System
The design rationale for the Cadence
Total Ankle System (Integra Life-
Christopher E. Gross, MD, et al
Figure 7
Photograph of the Cadence Total
Ankle System. (Image courtesy of
Integra LifeSciences, Plainsboro, NJ.)
Sciences) was to develop an ankle
replacement device that maintains
anatomic kinematics while also of-
fering the surgeon a multitude of fit
options. The system is a cobalt-
chromium alloy with a porous tita-
nium plasma spray coating. The tibial
component has two pegs and a pos-
terior fin for fixation that is not
prepped before insertion, allowing a
solid press fit. The tibial component is
available in standard and extra-long
sizes, as well as left- and right-sided
options to accommodate the patient’s
anatomy (Figure 7).
Similar to the Trabecular Metal
Total Ankle, the Cadence provides
complete coverage of the resected
tibia from the medial malleolus to the
lateral edge of the tibia, thus necessi-
tating left and right options. The talar
component requires minimal bone
resection and has two pegs for fixa-
tion. Articulation of the talar com-
ponent is based on an 8° conical axis
to replicate the natural kinematics of
the ankle, and it has a sulcus design
for rotational stability.
The polyethylene insert is made
of highly cross-linked, ultra-high‒
molecular-weight materials. The
inserts can be anterior or posterior
biased to help maintain the reduction
of the talus under the tibial axis in
5
Design Rationale for Total Ankle Arthroplasty Systems: An Update
Figure 8
Photograph of the anteriorly biased
polyethylene of the Cadence Total
Ankle System. (Image courtesy of
Integra LifeSciences, Plainsboro, NJ.)
Figure 9
Photograph of the Prophecy patient-
specific instrumentation. (Image
courtesy of Wright Medical Group,
Memphis, TN.)
cases of anterior or posterior sub-
luxation (Figure 8).
Patient-Specific
Instrumentation
The INFINITY ankle replacement is
unique in that it comes with an
6 Journal of the American Academy of Orthopaedic Surgeons
Copyright Ó the American Academy of Orthopaedic Surgeons. Unauthorized reproduction of this article is prohibited.
optional patient-specific guide tech-
nique called the Prophecy. A proto-
coled non‒weight-bearing CT scan
of the patient’s lower extremity is
obtained, including views of the knee
and ankle. The engineers then create
a three-dimensional computer sche-
matic that is approved by the surgeon
and used to create patient-specific
three-dimensional printed molds
(Figure 9).
The molds are placed on the
patient’s tibia and talus intra-
operatively, and after radiographic
verification that the alignment is
correct, pins are placed in the bone
through the molds. After that, the
molds are removed and replaced
with cutting guides. This technique
has been 100% predictive within 3°
of the preoperative alignment, 92%
predictive of the tibial component
size, and 36% predictive of the size
of the talus.30 The aberrancy in the
talar sizing is likely a result of
manual removal of bone from the
gutters, which necessitates a nar-
rower talar component. In addition,
the measurements and guides are
based on a non‒weight-bearing CT
scan. Increased availability of weight-
bearing CT scans may improve the
accuracy of patient-specific instru-
mentation. The Prophecy is also
available for the INBONE ankle
replacement.
Summary
Fourth-generation and emerging an-
kle replacement designs share many
factors: decreased distal tibial and
talar bone resection, minimized dis-
ruption of the anterior tibial cortex,
anatomically contoured distal tibial
trays, and talar components with
different curvatures of radii. Sur-
geons must balance the use of prom-
ising new designs with use of implants
on which mid- to long-term outcome
data are available. Informed conver-
sations with patients are necessary to
ensure that expectations are set and
concerns are addressed in this bur-
geoning field. Surgeons need more
complete and thorough data to help
patients make informed decisions.
Joint registries, research from high-
volume institutions, and collabora-
tion between institutions will be
needed in the future.
References
References printed in bold type are
those published within the past 5 years.
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