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micromachines

Review
Ankle and Foot Arthroplasty and Prosthesis: A Review on the
Current and Upcoming State of Designs and Manufacturing
Richa Gupta 1 , Kyra Grove 1 , Alice Wei 1 , Jennifer Lee 1 and Adil Akkouch 2, *

1 Western Michigan University Homer Stryker M.D. School of Medicine, Kalamazoo, MI 49008, USA;
richa.gupta@wmed.edu (R.G.); kyra.grove@wmed.edu (K.G.); alice.wei@wmed.edu (A.W.);
jennifer.lee@wmed.edu (J.L.)
2 Department of Orthopaedic Surgery and Medical Engineering Program, Western Michigan University Homer
Stryker M.D. School of Medicine, Kalamazoo, MI 49008, USA
* Correspondence: adil.akkouch@wmed.edu

Abstract: The foot and ankle serve vital roles in weight bearing, balance, and flexibility but are
susceptible to many diverse ailments, making treatment difficult. More commonly, Total Ankle
Arthroplasty (TAA) and Total Talus Replacement (TTR) are used for patients with ankle degeneration
and avascular necrosis of the talus, respectively. Ankle prosthesis and orthosis are also indicated
for use with lower limb extremity amputations or locomotor disability, leading to the development
of powered exoskeletons. However, patient outcomes remain suboptimal, commonly due to the
misfitting of implants to the patient-specific anatomy. Additive manufacturing (AM) is being used to
create customized, patient-specific implants and porous implant cages that provide structural support
while allowing for increased bony ingrowth and to develop customized, lightweight exoskeletons
with multifunctional actuators. AM implants and devices have shown success in preserving stability
and mobility of the joint and achieving fast recovery, as well as significant improvements in gait
rehabilitation, gait assistance, and strength for patients. This review of the literature highlights
various devices and technologies currently used for foot and ankle prosthesis and orthosis with
deep insight into improvements from historical technologies, manufacturing methods, and future
developments in the biomedical space.

Citation: Gupta, R.; Grove, K.; Wei,


Keywords: additive manufacturing; 3D printing; total ankle arthroplasty; total talus arthroplasty;
A.; Lee, J.; Akkouch, A. Ankle and
ankle prosthesis; powered exoskeleton
Foot Arthroplasty and Prosthesis: A
Review on the Current and
Upcoming State of Designs and
Manufacturing. Micromachines 2023,
14, 2081. https://doi.org/10.3390/ 1. Introduction
mi14112081 The foot and ankle form a complex system of 28 bones and 33 joints and are involved
Academic Editor: Daeha Joung
in a wide variety of vital functions, including weight bearing, balance, shock absorption,
and flexibility to ground terrain. The foot and ankle are common sites of emergent injury;
Received: 22 August 2023 for instance, ankle fractures account for over 20% of visits to the emergency room due
Revised: 31 October 2023 to lower extremity fractures [1]. Injuries and ailments that affect the foot and ankle have
Accepted: 8 November 2023 been attributed to a wide variety of causes, ranging from high-energy trauma to end-stage
Published: 10 November 2023
osteoarthritis, making treatment of the injury difficult. Damage to the foot and ankle can
be debilitating, causing pain and loss of function in bearing weight and walking for the
patient. In recent years, it has been reported that the direct cost of managing ankle/foot
Copyright: © 2023 by the authors.
fracture can reach up to almost USD 22,000/patient, while treatment of soft tissue injury
Licensee MDPI, Basel, Switzerland. averages around USD 2700/patient [2]. Long-term recovery prognosis is also reported as
This article is an open access article variable and suboptimal in the literature [3].
distributed under the terms and Prosthetic components have become increasingly popular, ranging from single bone/joint
conditions of the Creative Commons components to functional limb prosthetics. Accordingly, attention in the scientific community
Attribution (CC BY) license (https:// has been paid to improving foot and ankle prosthetic options. With discomfort due to
creativecommons.org/licenses/by/ improper fit being the most common cause of rejection of prosthetic devices [4], it is vital to
4.0/). produce dependable prosthetic devices for patients [5]. Additive manufacturing (AM), or

Micromachines 2023, 14, 2081. https://doi.org/10.3390/mi14112081 https://www.mdpi.com/journal/micromachines


pared to traditional methods, AM methods had decreased costs, improved design and
fabrication efficiency, and had better or similar functionality and patient satisfaction. AM
prosthetics are typically lighter in weight than traditional prosthetics [7], which can be of
benefit to patients with limited mobility. Furthermore, traditional manufacturing results
in excess material and unnecessarily increased costs, and it produces inconsistent results
Micromachines 2023, 14, 2081 [8]. This is due to a more time-consuming process involving taking anthropometric meas- 2 of 18
urements, creating molds, constructing the prosthetic device using thermoplastic materi-
als, and subsequently, making further adjustments to the device post-construction to im-
prove comfort
the industrial and functionality.
process Instead, with
for three-dimensional (3D)AM, optimal
printing, hascustomization
become increasinglyis possible us-
prevalent
ing patient data scanning technology and 3D printing techniques [9].
in the development of custom prosthetic devices for individual patients, thereby improving Still, the structural
and material
patient integrity of AM prosthetics remain the main concerns of physicians [6].
satisfaction.
AM of implants is a multistep process [10,11], outlined in Figure 1. The first step en-
A previously published review on the use of polymer-based AM [6] found that com-
tails medical image acquisition, commonly obtained using computerized tomography
pared to traditional methods, AM methods had decreased costs, improved design and
(CT) or magnetic resonance imaging (MRI) of the patient [10,12]. Next, a digital 3D recon-
fabrication efficiency, and had better or similar functionality and patient satisfaction. AM
struction is generated and undergoes processing. During this stage, the internal and ex-
prosthetics are typically lighter in weight than traditional prosthetics [7], which can be
ternal geometries of the model can be modified, allowing for the inclusion of porous sur-
of benefit to patients with limited mobility. Furthermore, traditional manufacturing re-
faces and for significant control over the weight and mechanical properties of the implant
sults in excess material and unnecessarily increased costs, and it produces inconsistent
[10]. The model is then 3D printed into a physical product. There are several methods of
results [8]. This is due to a more time-consuming process involving taking anthropometric
3D printing available for use, of which the most common include powder bed fusion
measurements, creating molds,
(PBF), stereolithography (SLA), andconstructing the prosthetic
fused deposition modelingdevice
(FDM).using thermoplastic
materials, and subsequently, making further adjustments
PBF methods include Selective Laser Sintering (SLS), Direct to the device
Metal post-construction
Laser Sintering to
improve
(DMLS), Selective Laser Melting (SLM), and Electron Beam Melting (EBM), all ofiswhich
comfort and functionality. Instead, with AM, optimal customization possible
using patient
utilize datalaser
a focused scanning technology
or electron beam to and 3Ddeposited
fuse printing techniques [9]. Still, the[13–15].
particles layer-by-layer structural
and
SLSmaterial integrity
uses polymer andofceramic
AM prosthetics
powders,remain the main
while DMLS, concerns
SLM, and EBMof physicians [6].
use metal/alloy
AM ofSLA
materials. implants is the
utilizes a multistep
layering of process [10,11],resin
a liquid-base outlined
that isinsequentially
Figure 1. The first
cured, andstep
entails medical
FDM uses the image
extrusionacquisition,
of meltedcommonly
thermoplastic obtained
beads.using
SLS andcomputerized
EBM methods tomography
do not
(CT) or magnetic
require resonance
the use of supports imaging
during (MRI) of the
manufacturing andpatient [10,12].recognized
are, therefore, Next, a for digital
their3D
reconstruction
ability to construct complex geometries, beneficial in addressing patient-specific anatomyand
is generated and undergoes processing. During this stage, the internal
external geometries
and pathologies. of the model
Furthermore, canare
metals be more
modified, allowing
commonly for the
utilized inclusion ofappli-
in load-bearing porous
surfaces
cations such as within the foot and ankle compared to polymer materials [10,16]. The of
and for significant control over the weight and mechanical properties ad-the
implant
vantage[10]. ThePBF
of using model is then 3D
technologies printed
such as SLM into a physical
is that they can product.
result inThere
lower are several
wear-re-
methods of 3D printingscaffolds
sistant titanium-based availablewhenfor use, of which
compared the most common
to specimens fabricated include
by EBM powder
or cast-bed
ing methods
fusion [17].
(PBF), stereolithography (SLA), and fused deposition modeling (FDM).

Figure 1. Schematic of the process of Additive Manufacturing of medical implants, outlining the
Figure 1. Schematic of the process of Additive Manufacturing of medical implants, outlining the
process of acquisition of medical imaging data, creation and processing of a digital model, and cre-
process
ation ofofa acquisition of medical
3D-printed physical imaging
product [11]. data, creation and processing of a digital model, and
creation of a 3D-printed physical product [11].

PBF methods include Selective Laser Sintering (SLS), Direct Metal Laser Sintering
(DMLS), Selective Laser Melting (SLM), and Electron Beam Melting (EBM), all of which uti-
lize a focused laser or electron beam to fuse deposited particles layer-by-layer [13–15]. SLS
uses polymer and ceramic powders, while DMLS, SLM, and EBM use metal/alloy materials.
SLA utilizes the layering of a liquid-base resin that is sequentially cured, and FDM uses the
extrusion of melted thermoplastic beads. SLS and EBM methods do not require the use of
supports during manufacturing and are, therefore, recognized for their ability to construct
complex geometries, beneficial in addressing patient-specific anatomy and pathologies.
Furthermore, metals are more commonly utilized in load-bearing applications such as
within the foot and ankle compared to polymer materials [10,16]. The advantage of using
PBF technologies such as SLM is that they can result in lower wear-resistant titanium-based
scaffolds when compared to specimens fabricated by EBM or casting methods [17].
The objective of this review is to outline the historical development and current state of
treatments and fabrication technologies specifically available in foot and ankle prosthetics,
with a focus on AM methods.
Micromachines 2023, 14, x FOR PEER REVIEW 3 of 19

Micromachines 2023, 14, 2081 3 of 18


The objective of this review is to outline the historical development and current state
of treatments and fabrication technologies specifically available in foot and ankle pros-
thetics, with a focus on AM methods.
2. Total Ankle Replacement
2. Total Ankle
Total Replacement
Ankle Arthroplasty (TAA) is an orthopedic procedure used as an increasingly
Totaltreatment
popular Ankle Arthroplasty (TAA)
for patients is an
with orthopedic
end-stage procedure
arthritis used
in the as anjoint.
ankle increasingly
The ankle joint,
popular treatment for patients with end-stage arthritis in the
also known as the tibiotalar joint, is formed from the meeting of the ankle joint. The ankle joint,
tibia, fibula, and
also known as the tibiotalar joint, is formed from the meeting of the tibia,
talus bone [18], shown and labeled in Figure 2. Wearing of the cartilage within fibula, and talus the joint
bone [18], shown and labeled in Figure 2. Wearing of the cartilage within the joint can lead
can lead to the bone ends rubbing against each other, causing bone spurs, inflammation,
to the bone ends rubbing against each other, causing bone spurs, inflammation, stiffness,
stiffness, osteophyte formation, and pain in the joint, overall resulting in severely decreased
osteophyte formation, and pain in the joint, overall resulting in severely decreased func-
function
tion [18,19].
[18,19].

Figure 2. Graphic of bones in ankle joint, including talus, fibula, tibia, calcaneus, and surrounding
Figure 2. Graphic of bones in ankle joint, including talus, fibula, tibia, calcaneus, and surrounding
bones[20].
bones [20].

2.1. The Evolution of Total Ankle Arthroplasty Implants


2.1. The Evolution of Total Ankle Arthroplasty Implants
Previously,ankle
Previously, anklearthrodesis
arthrodesis(AA),
(AA),which
which consists
consists of of fusing
fusing two
two oror more
more bones within
bones
the joint
within thetogether, was considered
joint together, the standard
was considered the standardtreatment
treatment forfor
end-stage
end-stageankle
anklearthritis
ar- [21].
While[21].
thritis studies
While have reported
studies patient patient
have reported satisfaction following
satisfaction AA as
following AAvery high,
as very assessment
high,
of functional
assessment outcomesoutcomes
of functional has shown has reduced mobility
shown reduced of theofjoint
mobility during
the joint activities
during activ- of daily
living
ities as well
of daily as post-surgical
living degeneration
as well as post-surgical of the neighboring
degeneration subtalar
of the neighboring jointjoint
subtalar [21–25].
[21–25].TAA was developed as a method of reducing pain while also preserving the mobility
of theTAA wasEarly
joint. developed as a methodTAA
first-generation of reducing
implantspain(Figure
while also preservingofthe
3) consisted mobility
two components: a
of the joint.
concave Early
tibial first-generation
component TAA of
composed implants (Figureand
polyethylene 3) consisted
a convexoftalar
two component
components:composed
a concave tibial component composed of polyethylene and a convex talar component com-
of metal alloy, both fixated with bone cement. However, early TAA implants are still associated
posed of metal alloy, both fixated with bone cement. However, early TAA implants are
with a high rate of failure, which has been attributed to permanent deformation of the
still
Micromachines associated
2023, withREVIEW
14, x FOR PEER a high rate of failure, which has been attributed to permanent defor- 4 of 19
polyethylene component, large bone resection to allow for cement fixation and loosening of
mation of the polyethylene component, large bone resection to allow for cement fixation
the talar component due
and loosening of the talar componentto the highdue
strength
to theof the strength
high talus bone [21,23–25].
of the talus bone [21,23–
25].

Figure 3. Labeled X-ray of (A) preoperative and (B) TAA implant performed on a patient, consisting
Figure 3. Labeled X-ray of (A) preoperative and (B) TAA implant performed on a patient, consisting
of a polyethylene tibial component and metallic talar component [26].
of a polyethylene tibial component and metallic talar component [26].
2.2. Current Total Ankle Arthroplasty Implants
Second through fourth-generation TAA implants consist of three components: a
metal component attached to the tibia, a metal component attached to the talus, and a
mobile plastic implant between the two [27,28], as shown in Figure 4. Advancements in
this design provided almost normal kinematic function of the joint in plantarflexion/dor-
Figure 3. Labeled X-ray of (A) preoperative and (B) TAA implant performed on a patient, c
of a polyethylene tibial component and metallic talar component [26].

Micromachines 2023, 14, 2081 4 of 18


2.2. Current Total Ankle Arthroplasty Implants
Second through fourth-generation TAA implants consist of three compo
metal
2.2. component
Current attached to
Total Ankle Arthroplasty the tibia, a metal component attached to the talu
Implants
mobile
Second plastic
throughimplant betweenTAA
fourth-generation the implants
two [27,28],
consistas shown
of three in Figurea metal
components: 4. Advance
this design
component provided
attached to thealmost normal
tibia, a metal kinematic
component function
attached to theoftalus,
the and
jointa in plantarflex
mobile
plastic implant between the two [27,28], as shown in Figure 4. Advancements
siflexion, inversion/eversion, and tibial rotation, resulting in overall improved ga in this design
provided almost normal kinematic function of the joint in plantarflexion/dorsiflexion,
mance as well as increased pain relief compared to AA outcomes [26,28]. Existing
inversion/eversion, and tibial rotation, resulting in overall improved gait performance
ashave
well concluded that relief
as increased pain complication
compared to rates in patients
AA outcomes withExisting
[26,28]. TAA (19.7%)
reviews in recent ye
have
also beenthat
concluded lower than in rates
complication patients with AA
in patients with (26.9%)
TAA (19.7%)[29].inHowever,
recent yearscomplication
have also an
rates
been remain
lower higher
than in than
patients withthose for knee
AA (26.9%) [29].and hip arthroplasties,
However, complication andstill making
failure rates TAA
remain higher than those for knee and hip arthroplasties, still making
versial technique in clinical use. Revision rates following TAA have also been repTAA a controversial
technique in clinical use. Revision rates following TAA have also been reported as high as
high as 7.9%, compared to 5.4% for AA [29], which has been largely attributed to
7.9%, compared to 5.4% for AA [29], which has been largely attributed to the loosening of
ening
the of the implant.
implant.

Figure
Figure 4. 4. Photograph
Photograph of 3-part
of 3-part TAA TAA implant
implant composed
composed of tibial
of a metal a metal tibial component,
component, a mobile a mo
ethylene insert,
polyethylene insert, and
and aametal
metal talar
talar component
component [30]. [30].

2.3. Advancements in Total Ankle Arthroplasty Design and Manufacturing


2.3. Advancements in Total Ankle Arthroplasty Design and Manufacturing
Loosening of TAA implants has been attributed to the mal-positioning of the implant,
leadingLoosening of TAA
to altered motion implants
and pressureshas been
at the attributed
contact surfaceto the Furthermore,
[24]. mal-positioning end- of the
stage osteoarthritis (OA) can lead to significant degradation of the articular
leading to altered motion and pressures at the contact surface [24]. Furthermore, surface of e
the tibia and talus, which may lead to deformity of the underlying osteochondral bone
osteoarthritis (OA) can lead to significant degradation of the articular surface of
and properties of the supporting soft tissue. Thus, mass-produced implants limited to
and talus,
mimicking thewhich
anatomy may
of alead to deformity
healthy of theunstable
joint can be highly underlying osteochondral
and unsupported in an bone a
OA joint. However, AM permits the fabrication of personalized TAA implants and reduces to m
erties of the supporting soft tissue. Thus, mass-produced implants limited
the
therisk of implant
anatomy offailure and patient
a healthy jointdiscomfort.
can be highly unstable and unsupported in an O
Attention has been paid to the bone–implant
However, AM permits the fabrication of personalized interface of TAATAA implants. In addition
implants and reduces
to hydroxyapatite and porous surface coating technologies commonly used in other joint
of implant failure
replacements, a recentandcase patient discomfort.
study reported the use of a third-generation TAA implant,
Attention
comprised has been
of a titanium paidcomponent
alloy tibial to the bone–implant interface
and cobalt–chromium of TAA
(CoCr) implants. In
talar compo-
to hydroxyapatite
nent, and porous
both coated with porous tantalum surface coating
(P-Ta) (80% technologies
porosity) [31]. Threecommonly used in ot
years following
implantation, the authors performed a histological analysis of the
replacements, a recent case study reported the use of a third-generation intact implant (Figure 5). TAA
Results showed significantly increased bone ingrowth into the P-Ta layer of 9.4% to 13.6%
(previously reported as 1–5%), allowing for increased initial bone stability and symmetric
loading [32].
comprised of a titanium alloy tibial component and cobalt–chromium (CoCr) talar com-
ponent, both coated with porous tantalum (P-Ta) (80% porosity) [31]. Three years follow-
ing implantation, the authors performed a histological analysis of the intact implant (Fig-
Micromachines 2023, 14, 2081 ure 5). Results showed significantly increased bone ingrowth into the P-Ta layer5 of of
18 9.4%
to 13.6% (previously reported as 1–5%), allowing for increased initial bone stability and
symmetric loading [32].

Figure 5. Light Figure 5. Light


microscopy microscopy
images images of the
of the talar/bone talar/bonestained
component componentwithstained with Sanderson’s
Sanderson’s rapid bone rapid
bone stain (SRBS) 3.5 years post-operation. Mineralized bone was stained pink, osteoid and non-
stain (SRBS) 3.5 mineralized
years post-operation. Mineralized
soft tissue were boneand
stained blue, wasthestained pink,isosteoid
color black and non-mineralized
for tantalum. (a) Low-magnification
soft tissue wereimage
stained
of explants showing bony ingrowth into the porous tantalum implant, with image
blue, and the color black is for tantalum. (a) Low-magnification healthyofremod-
explants showing eling.
bony(b)ingrowth
Higher-magnification view
into the porous of the green
tantalum dotted
implant, boxhealthy
with in image (a) showing(b)
remodeling. osseointegration
Higher-
to the
magnification view of porous tantalum
the green dottedwith
box the patientʹs
in image (a) newly
showingformed bone. Ta: tantalum,
osseointegration O: osteoid,
to the porous OI: osseoin-
tantalum
tegration [32].
with the patient’s newly formed bone. Ta: tantalum, O: osteoid, OI: osseointegration [32].
Given the instability of TAA implants in cases of malalignment, advancements have
Given the instability of TAA implants in cases of malalignment, advancements have
also been made in surgical planning technologies consisting of patient-specific CT scans
also been made andin3D-printed
surgical planning technologies
bone models. Studies haveconsisting of patient-specific
shown that planning using CT scans
patient-specific
and 3D-printed bone models. Studies have shown that planning using patient-specific
bone models allows for increased reliability and reproducibility in the surgical placement
bone models allows
of TAA for increased
implants reliability and reproducibility in the surgical placement
[33,34].
of TAA implants [33,34].
A group recently outlined their use of AM and testing of patient-specific TAA im-
A group plants
recently
[35].outlined
CT scans their
of theuse
tibia,offibula,
AM andtalus,testing of patient-specific
and calcaneus TAA im-
bones of anatomical cadaver
plants [35]. CTspecimens
scans of were used fibula,
the tibia, to design computer
talus, models of bones
and calcaneus the implant with matched
of anatomical curvature
cadaver
specimens were radius
usedand
toexternal
design contouring of the bones
computer models (Figure
of the 6). Selective
implant Laser Melting
with matched (SLM) us-
curvature
radius and external contouring of the bones (Figure 6). Selective Laser Melting (SLM) usingto cre-
ing cobalt–chromium–molybdenum powder (spherical, 15–45 µm) was then used
ate near-full density implants
cobalt–chromium–molybdenum powder for(spherical,
the two metal components
15–45 µm) was of then
the implant.
used toIn vitro
createtesting
of the components implanted on corresponding cadaveric specimens was performed by
near-full density implants for the two metal components of the implant. In vitro testing
applying loading/unloading cycles in three dimensions. Joint mobility and stability were
of the components implanted on corresponding cadaveric specimens was performed by
tested through manipulation in dorsiflexion/plantarflexion.
applying
Micromachines 2023, 14, x FOR loading/unloading cycles in three dimensions. Joint mobility and
PEER REVIEW 6 of stability
19 were
tested through manipulation in dorsiflexion/plantarflexion.

Figure 6. Fabrication of cobalt–chromium–molybdenum 3D implants using SLM technology for


6. Fabrication
FigureTAA replacement. of
(a) cobalt–chromium–molybdenum
Computer model of talar component of 3D implants
cadaveric using
specimen and SLM technology
rendering of for TAA
replacement. (a) Computer
talar component model
with matching of talar
curvature componenttheofprocess
to demonstrate cadaveric
of bonespecimen
modeling andandcustom
rendering of talar
prosthesis design. (b) 3D-printed talar components polished with a mirror finish. (c) Mechanical
component with matching curvature to demonstrate the process of bone modeling and custom prosthesis
testing of implanted custom 3D-printed implants using a cadaver specimen on a testing rig. Modi-
design.fied
(b)from
3D-printed
[35]. talar components polished with a mirror finish. (c) Mechanical testing of implanted
custom 3D-printed implants using a cadaver specimen on a testing rig. Modified from [35].
More recently, a group released a case report of the use of a patient-specific AM TAA
implant in a patient when standard, modular TAA implants were found to be too small
for the patient’s anatomy. A CT scan of the mid-tibia to the whole foot was obtained and
analyzed to model the morphology of the joint as well as existing bone resections (Figure
7). The metal components were created using AM with cobalt–chromium–molybdenum.
Following implantation, the patient was shown to regain activities of daily living and ex-
perience no pain after 4 months. Gait analysis at this time point also revealed a quasi-
Figure 6. Fabrication of cobalt–chromium–molybdenum 3D implants using SLM technology for
TAA replacement. (a) Computer model of talar component of cadaveric specimen and rendering of
talar component with matching curvature to demonstrate the process of bone modeling and custom
prosthesis design. (b) 3D-printed talar components polished with a mirror finish. (c) Mechanical
Micromachines 2023, 14, 2081 6 of 18
testing of implanted custom 3D-printed implants using a cadaver specimen on a testing rig. Modi-
fied from [35].

More
Morerecently,
recently,a agroup
groupreleased
releaseda acase
casereport
reportofofthe
theuse
useofofa apatient-specific
patient-specificAMAM TAA
TAA
implant in a patient when standard, modular TAA implants were found
implant in a patient when standard, modular TAA implants were found to be too small for to be too small
for the
the patient’s
patient’s anatomy.
anatomy. AACTCT scan
scan of of
thethe mid-tibia
mid-tibia to to
thethe whole
whole foot
foot was was obtained
obtained andand
ana-
analyzed to model the morphology of the joint as well as existing bone resections
lyzed to model the morphology of the joint as well as existing bone resections (Figure 7). The (Figure
7).metal
The metal components
components were created
were created using AMusing AMcobalt–chromium–molybdenum.
with with cobalt–chromium–molybdenum. Follow-
Following implantation,
ing implantation, the patient
the patient was shown
was shown to regain
to regain activities
activities of dailyof living
daily living and ex-
and experience
perience
no pain no
afterpain after 4 Gait
4 months. months. Gait at
analysis analysis
this timeat point
this time point also
also revealed revealed a quasi-
a quasi-physiological
physiological
pattern revealing limited deficits in the joint with normal muscle activation activation
pattern revealing limited deficits in the joint with normal muscle aside from
aside from prolonged
prolonged activationactivation in the gastrocnemius
in the gastrocnemius [36]. [36].

Figure 7. 7.
Figure (a)(a)
Computer model
Computer modelof of
custom-designed
custom-designedimplant onon
implant patient CTCT
patient scan rendered
scan bone
rendered model
bone model
and (b) anterior–posterior and lateral X-rays of implanted AM TAA implant [36].
and (b) anterior–posterior and lateral X-rays of implanted AM TAA implant [36].

3. Total Talus Replacement


The talus articulates with the fibula and tibia to form the ankle joint, allowing dorsi-
flexion and plantarflexion of the foot, and with the calcaneus to make the subtalar joint,
allowing inversion and eversion of the foot (for anatomical pictural representation, refer-
ence Figure 2: Graphic of bones in the ankle joint, including talus, fibula, tibia, calcaneus,
and surrounding bones). It is responsible for the transmission of weight and pressure forces
from the lower leg to the foot and is covered by articular cartilage for smooth movement
against its neighboring bones [37].
Total talus arthroplasty (TTA) is an alternative orthopedic procedure that was devel-
oped as a treatment in cases of total talar compromise due to avascular necrosis, trauma,
osteonecrosis, tumor-induced bone defects, or talar body collapse due to complications of
TAA [18,38–44].

3.1. The Evolution of Total Talus Arthroplasty Implants


Prior to the advent of TTA, the recommended treatment for trauma or avascular necro-
sis of the talus was either arthrodesis or talectomy paired with simultaneous tibiocalcaneal
arthrodesis; however, both options often resulted in the loss of ankle and foot function, as
well as hindfoot instability in the former and discrepant leg shortening in the latter. TTA
was designed to replace the talus while preserving the motion and work of the ankle and
foot [38].
The bone consists of three parts: head, neck, and body. In first-generation TTA
implants (Figure 8), the prosthesis consisted of two components: the talar body and a peg
for attachment into the talar neck. Only the talar body was replaced, and the talar neck
was fixated on the prosthetic stem with bone cement. Satisfactory results were reported
in post-operative evaluations, with preserved joint stability and increased mobility of
the ankle and foot. However, there were noted issues with prosthesis congruence and
prosthesis failure where the prosthesis stem had sunken into the talar neck [38,39].
In second-generation TTA implants (Figure 8), the peg was removed to address th
previously reported sinkage and subvert the concentration of stress in the talar neck. Th
talus body was surgically placed without fixation. While radiological appearances wer
more satisfactory, second-generation implants could not be recommended as a treatmen
Micromachines 2023, 14, 2081 7 of 18
for avascular necrosis due to the high degree of loosening seen between the prosthesis an
talar neck [40].

Figure8.8.(a,b)
Figure (a,b)First-generation
First-generation talar
talar body
body prosthesis
prosthesis with
with an attachment
an attachment peg peg
and and
(c,d) (c,d) second-gen
second-
eration prosthesis [38,40].
generation prosthesis [38,40].

In second-generation TTA implants (Figure 8), the peg was removed to address the
previously reported sinkage and subvert the concentration of stress in the talar neck. The
talus body was surgically placed without fixation. While radiological appearances were
more satisfactory, second-generation implants could not be recommended as a treatment
for avascular necrosis due to the high degree of loosening seen between the prosthesis and
talar neck [40].

3.2. Current Total Talus Arthroplasty Implants


Since the talus is not stabilized by any muscular attachments, its positioning primarily
depends upon the support of the surrounding bones and ligaments, and thus, the most
important factor for prosthesis survival is implant congruence with articular surfaces [45].
Recently introduced third-generation TTA implants (Figure 9) are described as custom
total talar prostheses, which circumvents the earlier concerns of loosening and sinking
between the talar neck and prosthesis. Many groups have designed TTA implants using the
patient’s healthy contralateral talus as a model for AM, which can be made into forms that
may not have been possible to achieve using the current production method [46]. Custom
third-generation TTA implants have been manufactured primarily by SLS, using materials
including cobalt–chrome, nickel-plated cobalt, titanium alloy, and alumina ceramics. These
implants have demonstrated retention of mobility, rapid pain relief, and preserved joint
height, as well as a shorter duration of restricted weight bearing [42–44,47,48]. A case series
evaluating the outcomes of patients who underwent TTA with AM titanium or cobalt–
chromium talus implant reported no complications at a mean follow-up of 36 months
with preserved range of motion in the ankle and improved pain scores [49]. To date, there
have been no issues of prosthesis size incongruence, but long-term follow-up is needed
to evaluate the longitudinal durability of custom-made TTA implants and their effects on
ankle and foot function. Potential complications of concern with third-generation TTA may
involve displacement of the implant.
44,47,48]. A case series evaluating the outcomes of patients who underwent TTA with AM
titanium or cobalt–chromium talus implant reported no complications at a mean follow-
up of 36 months with preserved range of motion in the ankle and improved pain scores
[49]. To date, there have been no issues of prosthesis size incongruence, but long-term
Micromachines 2023, 14, 2081
follow-up is needed to evaluate the longitudinal durability of custom-made TTA implants
8 of 18
and their effects on ankle and foot function. Potential complications of concern with third-
generation TTA may involve displacement of the implant.

Figure9.9.(a)
Figure (a)3D-printed
3D-printed third-generation
third-generation total
total talustalus prosthesis
prosthesis and post-operative
and post-operative X-raysX-rays of im-
of implanted
planted 3D-printed
3D-printed third-generation
third-generation TTA prosthesis,
TTA prosthesis, (b) anterior–posterior,
(b) anterior–posterior, andviews
and (c) lateral (c) lateral views
[46,49].
[46,49].
3.3. Advancements in Total Talus Arthroplasty Design and Manufacturing
3.3. Advancements in Total
Third-generation TTATalus
withArthroplasty Design and
complete, custom Manufacturing
talus implants has shown promising
resultsThird-generation
for post-operative TTA
painwith complete,
relief custom
and mobility; talus implants
however, the currenthasproduction
shown promising
method
isresults
costly for
andpost-operative
slow. In a 55-patient case study
pain relief examininghowever,
and mobility; the use oftheceramic
current TTAproduction
implants,
CT imaging
method was used
is costly to generate
and slow. a wire model,
In a 55-patient from which
case study examininga stereolithographic
the use of ceramic model
TTA
was generated.
implants, From the
CT imaging wasmodel,
used an alumina-ceramic
to generate prosthesis
a wire model, fromwas
whichcreated, with the entire
a stereolithographic
manufacturing process taking
model was generated. approximately
From the 4 weeks [43]. As AM
model, an alumina-ceramic becomes
prosthesis wasancreated,
increasingly
with
popular
the entiremethod for TTA implant
manufacturing processmanufacturing, attention4isweeks
taking approximately being[43].
paidAsto faster prosthesis
AM becomes an
design, resulting in optimized anatomical fit within a shorter timeline.
increasingly popular method for TTA implant manufacturing, attention is being paid to
Furthermore,
faster the useresulting
prosthesis design, of metal Additive Manufacturing
in optimized anatomicalallows for a more
fit within flexible
shorter pros-
timeline.
thesisFurthermore,
design, wherethe a broader
use of range
metalofAdditive
metals can be utilized to allows
Manufacturing devise anforoptimal
a morefit. With
flexible
topology
prosthesis optimization,
design, where unnecessary
a broaderweight
range from materials
of metals within
can be the inner
utilized spacesanofoptimal
to devise the im-
plant can be eliminated for a lightweight design that improves comfort [46,50]. To address
the development of osteosclerosis due to incongruent elastic modulus between prosthesis
materials and bone, the use of ultra-high-molecular-weight polyethylene (UHMWP) on the
articulation of the prosthesis with the tibia has been promoted as a potential substitute for
wear reduction [51].

4. Ankle Prosthetics
Ankle prosthetic devices are indicated for patients with various lower extremity im-
pairments, including lower limb amputations resulting from trauma or underlying disease,
as well as neurological deficits due to spinal cord injuries or strokes. In patients with lower
extremity amputations, recent developments in ankle prosthetic devices aim to decrease
metabolic costs and improve mobility and gait while simultaneously increasing comfort for
the patient. Additionally, in patients with lower extremity neurological deficits, ankle pros-
thetics have the potential to alleviate many negative health consequences, including obesity
syndrome, various chronic diseases, decreased bone health, and pressure injuries [52].
Ankle prosthetics can be divided into three main categories, including passive, quasi-
passive, and active prosthetic devices, with studies providing evidence for the superiority
of quasi-passive and active devices [53]. Passive prosthetics do not contain an external
energy source, while active prosthetic devices, otherwise known as powered exoskeletons,
have demonstrated significant improvements in functionality, including improved accom-
including obesity syndrome, various chronic diseases, decreased bone health, and pres-
sure injuries [52].
Ankle prosthetics can be divided into three main categories, including passive, quasi-
passive, and active prosthetic devices, with studies providing evidence for the superiority
Micromachines 2023, 14, 2081 of quasi-passive and active devices [53]. Passive prosthetics do not contain an external 9 of 18
energy source, while active prosthetic devices, otherwise known as powered exoskele-
tons, have demonstrated significant improvements in functionality, including improved
accommodation
modation forfor terrain
terrain andand faster
faster walking
walking speedspeed
[54]. [54]. Different
Different prosthetic
prosthetic typestypes are
are indicated
indicated based on varying lifestyles and activity levels
based on varying lifestyles and activity levels [55]. [55].

4.1. Evolution of Ankle


4.1. Evolution Prosthetics
of Ankle Prosthetics
Conventional,
Conventional, passive prosthetic
passive feet feet
prosthetic include the Solid
include Ankle
the Solid Cushion
Ankle HeelHeel
Cushion (SACH)(SACH)
foot and Energy Storage and Return (ESAR) prosthetics. After its introduction in 1980, the the
foot and Energy Storage and Return (ESAR) prosthetics. After its introduction in 1980,
SACH SACHfootfoot became
became thethe standard
standard due
due to to
itsitsavailability,
availability,inexpensiveness,
inexpensiveness, and and durability.
durability. The
The SACH
SACH foot
foot isisaabasic
basicdesign
designconsisting
consistingof ofwood,
wood,rubber,
rubber,andandcompressible
compressiblefoam foammaterials
ma-
(Figure
terials 10).10).
(Figure TheTheSACH SACHfootfoot
design has been
design shown
has been to provide
shown flexibility
to provide based based
flexibility on the on height
and weight
the height of the patient
and weight and provide
of the patient some degree
and provide of mobility
some degree in dorsiflexion
of mobility only [56].
in dorsiflexion
onlyHowever, it is not
[56]. However, appropriate
it is for active
not appropriate amputees
for active due todue
amputees its lack
to itsoflack
functionality compared
of functionality
with other ankle–feet prosthetics. Passive ankle prosthetic devices,
compared with other ankle–feet prosthetics. Passive ankle prosthetic devices, such as the such as the SACH
foot, have been shown to produce less, approximately one-eighth
SACH foot, have been shown to produce less, approximately one-eighth of the power of of the power of intact
gastrocnemius
intact gastrocnemius andandsoleus
soleusmuscles
muscles[57].
[57].ItItisisnow
now more
more commonly
commonly used used asas aa tempo-
temporary
raryprosthetic
prostheticdevice
devicewhile
whilepatients
patientsdecide
decideon onaalong-term
long-termprosthetic
prostheticoption
option[58].
[58].

(a) (c)

(b)

Figure 10. (a) Labeled drawing of a SACH foot cross-section, including wood, rubber, and com-
Figure 10. (a) Labeled drawing of a SACH foot cross-section, including wood, rubber, and compress-
pressible
Micromachines 2023, 14, x FOR PEER REVIEWfoam materials, and (b,c) photograph of SACH foot prosthetic including a cosmetic shell
10 of 19
ible foam materials, and (b,c) photograph of SACH foot prosthetic including a cosmetic shell [59,60].
[59,60].
ESAR feet are designed to store elastic energy during midstance and subsequently
ESAR feet are designed to store elastic energy during midstance and subsequently
release
design energy during
consisting push-off.
of multiple Multiple
flexible variations
blades attachedoftothe
an ESAR
adaptorfoot exist,
with with the basic
a mechanical link
release energy
design duringof
consisting push-off.
multipleMultiple
flexible variations
blades of thetoESAR
attached an foot exist,
adaptor with with
a the basic link
mechanical
(Figure 11). ESAR implants are typically composed of carbon fiber or carbon fiber-rein-
(Figure 11). ESAR implants
forced polymers, are have
and groups typically
alsocomposed
employedofAM carbon
usingfiber
SLSortocarbon fiber-reinforced
manufacture patient-
polymers, and groups have also employed AM using SLS
specific implants with desired stiffnesses to improve gait [61]. to manufacture patient-specific
implants with desired stiffnesses to improve gait [61].

Figure 11. (a) Appearance of constructed functional ESAR prosthetic and (b) labeled graphic of the
Figure 11. (a) Appearance of constructed functional ESAR prosthetic and (b) labeled graphic of the
ESAR foot design with the top blade, middle blade, sole blade, mechanical link, and main body [62].
ESAR foot design with the top blade, middle blade, sole blade, mechanical link, and main body [62].
ESAR prosthetic feet generate greater energy, reduce metabolic costs, and increase
ESAR prosthetic
self-selected feet generate
walking speeds greater energy,
when compared reduce metabolic
to the conventional SACHcosts, and A
foot [63]. increase
study
self-selected
comparing thewalking speeds
ESAR foot whenfeet
to SACH compared to the conventional
demonstrated that the ESARSACH foot [63].
foot allowed forAhigher
study
comparing the ESAR foot to SACH feet demonstrated that the ESAR foot allowed
push-off power and increased intact step length without decreasing backward stability [64] for
higher push-off
(Figure 12). power and increased intact step length without decreasing backward sta-
bility [64] (Figure 12).
ESAR foot design with the top blade, middle blade, sole blade, mechanical link, and main body [62].

ESAR prosthetic feet generate greater energy, reduce metabolic costs, and increase
self-selected walking speeds when compared to the conventional SACH foot [63]. A study
comparing the ESAR foot to SACH feet demonstrated that the ESAR foot allowed for
Micromachines 2023, 14, 2081 10 of 18
higher push-off power and increased intact step length without decreasing backward sta-
bility [64] (Figure 12).

Figure12.
Figure 12.Push-off
Push-offpower
powerof
ofthe
theprosthetic
prostheticfoot
footas
asaafunction
functionof
ofnormalized
normalizedstance
stancetime
time[64].
[64].

Recent
Recentdevelopments
developmentsin inpowered
poweredankle
ankleexoskeletons
exoskeletons(PAEs)
(PAEs)aim aimtotoreduce
reducethethe energy
energy
expenditure
expenditure of patients with lower extremity amputations and improve their quality
of patients with lower extremity amputations and improve their quality of
of
life
life [65].
[65]. PAEs
PAEs utilize
utilize microprocessors,
microprocessors, which
which areare internal
internal computers
computers withwith sensors
sensors that
that
relay
relay information
information between
between the thehuman
humanbodybodyandandthethedevice.
device.Microprocessor-controlled
Microprocessor-controlled
ankle–foot
ankle–foot(MPF)
(MPF)systems
systemswerewere commercially
commerciallyintroduced
introducedin in 2006
2006 with
with the
the goal
goal of improv-
ing
ing gait mechanics. The original MPF system, however, lacked the ability for
gait mechanics. The original MPF system, however, lacked the ability for powered
powered
plantarflexion.
plantarflexion. In more recent years, MPF prosthetic devices have been developedto
In more recent years, MPF prosthetic devices have been developed tomore
more
closely
Micromachines 2023, 14, x FOR PEER REVIEW mimic physiological ankle function (Figure 13) [66,67]. MPFs
closely mimic physiological ankle function (Figure 13) [66,67]. MPFs have shown have shown multiple
11 ofmultiple
19
advantages
advantages compared
compared to to non-microprocessor
non-microprocessor prosthetic
prosthetic feet,
feet, including
including improvement
improvement in in
biomechanical performance during
biomechanical performance duringclimb
climbofoframps
ramps andand stairs,
stairs, increased
increased toe clearance
toe clearance dur-
during swing,
ing swing, reduced
reduced pressuresagainst
pressures againstremaining
remaininglimblimbwithin
within the
the socket,
socket, and
and increased
increased
mobility of the
mobility ofprosthetic
the prosthetic[66].[66].
Additionally, significant
Additionally, improvements
significant improvements in in
physical
physicalfunc-
function
tion scores werefound
scores were foundininprosthesis
prosthesis users
users who who transitioned
transitioned fromfrom
usingusing non-MPFs
non-MPFs to MPFs to [66].
MPFsCommon
[66]. Common materials used in MPF ankle systems include carbon
materials used in MPF ankle systems include carbon fiber and titanium. fiber and tita-
nium.

Figure Figure
13. A 13. A commercially
commercially available
available modernmodern
MPF MPF advertised
advertised as an as an electronically
electronically controlled
controlled ankleankle
jointallows
joint that that allows adjustment
adjustment to user’s
to user’s walking
walking speedspeed and ground
and ground conditions
conditions [68]. [68].

Microprocessors
Microprocessors for powered
for powered exoskeletons
exoskeletons can becan be divided
divided intomain
into two two main categories:
categories:
those that utilize neural control versus those that utilize mechanically intrinsic control [69].
those that utilize neural control versus those that utilize mechanically intrinsic control
Neural control
[69]. Neural control relies
relieson
onbrain
brainorormuscle
muscleelectrical
electricalactivity,
activity, interpreting
interpreting these signals
these and co-
signals
ordinating actions of the device appropriately. In mechanical control,
and coordinating actions of the device appropriately. In mechanical control, the device the device combines
information
combines on gait
information on events, joint joint
gait events, angles, and forces
angles, to predict
and forces human
to predict humanintention. A direct
intention.
comparison study found that plantar flexor muscle recruitment was
A direct comparison study found that plantar flexor muscle recruitment was less in par- less in participants
using
ticipants time-based
using controllers
time-based compared
controllers to myoelectric
compared control
to myoelectric [69]. No
control [69].metabolic work rate
No metabolic
work rate differences were noted between myoelectric-controlled prosthetics compared to
mechanically intrinsic control. Further research is needed to determine the superiority of
neural versus mechanical control.
Micromachines 2023, 14, 2081 11 of 18

differences were noted between myoelectric-controlled prosthetics compared to mechani-


cally intrinsic control. Further research is needed to determine the superiority of neural
versus mechanical control.

4.2. Early Powered Exoskeletons in Gait Rehabilitation


Early robot-assisted gait training was first initiated in a clinical therapeutic setting,
often attached to training devices such as treadmills. These initial models were designed
as orthotic devices with body-weight support. For instance, the Lokomat (Figure 14) is
composed of a motorized exoskeleton that provides guidance forces onto the knee and hip
joints and has been shown to increase the range of motion about the ankle joint. Briefly,
the motorized exoskeleton consists of a DC motor with helical gears to direct the trajectory
of the joints [70]. The Lokomat device has been used successfully in gait rehabilitation
for patients with brain or spinal cord injuries that exhibit muscle weakness, spasticity,
or abnormal muscular activation patterns. Previous forms of therapy used body weight
support with assistance from physical therapists, but recent advancements have allowed
for motorized exoskeletons to provide these additional forces. This allows therapy sessions
Micromachines 2023, 14, x FOR PEER REVIEW 12 of 19
for patients to increase in both intensity and duration while also maintaining physiological
gait patterns.

Figure14.
Figure 14. Lokomat
Lokomat device
device used for gait rehabilitation following lower-limb disability, brain injury,
or spinal
or spinal cord
cord injury.
injury. The
The device
device consists
consists of
of aa treadmill,
treadmill, body
body weight
weight support,
support, and
and powered
powered legleg
orthosis [70].
orthosis [70].

Varoquietetal.
Varoqui al.utilized
utilizeda a4-week
4-week Lokomat
Lokomat training
training program
program on patients
on patients withwith incom-
incomplete
plete spinal
spinal cord injuries
cord injuries due todue
traumato trauma and impaired
and impaired voluntary
voluntary ankle movements
ankle movements [71].
[71]. Their
Their outcomes
outcomes showedshowed significant
significant improvement
improvement in theofrange
in the range of of
motion motion of the
the ankle. ankle.and
Kinetic Ki-
netic and measurements
kinematic kinematic measurements also demonstrated
also demonstrated voluntary of
voluntary movements movements of thefarther
the ankle were ankle
werefaster
and farther and
after faster after
training. training. Additionally,
Additionally, patients demonstrated
patients demonstrated an increase inan increase in
dorsiflexion
strength, which
dorsiflexion is significant
strength, which isassignificant
patients with spinal cord
as patients with injuries often
spinal cord have gait
injuries oftenissues
have
from foot drop
gait issues fromsyndrome.
foot drop syndrome.

4.3.
4.3. Battery-Powered
Battery-Powered Exoskeletons
Exoskeletons in
in Congenital
Congenital Disorder
Disorder Gait
Gait Rehabilitation
Rehabilitation
As
As powered
powered exoskeletons
exoskeletons advance
advance toto more
more mobile
mobileforms
forms that
that allow
allow patients
patientsto
to move
move
overground in an unrestricted area, applications are being explored in congenital
overground in an unrestricted area, applications are being explored in congenital neuro- neurologi-
cal disorders
logical like cerebral
disorders palsypalsy
like cerebral (CP). (CP).
Previous therapies
Previous for these
therapies for patients with pathological
these patients with patho-
gaits that ultimately progressed to reduced walking ability in adolescence
logical gaits that ultimately progressed to reduced walking ability in adolescence included phys-
included
ical therapy, orthotics, muscle injections, and surgeries, which did not necessarily
physical therapy, orthotics, muscle injections, and surgeries, which did not necessarily show
show improvement in gait. The possibility of using wearable battery-powered exoskele-
tons is being explored to reinforce more favorable walking patterns in CP patients [72].
These exoskeletons (Figure 15) are composed of an onboard battery that powers high-
performance DC motors. This structure is actuated onto a pulley aligned with each ankle
joint via a Bowden cable transmission that helps to mount the heaviest components of the
Micromachines 2023, 14, 2081 12 of 18

improvement in gait. The possibility of using wearable battery-powered exoskeletons is


being explored to reinforce more favorable walking patterns in CP patients [72].
These exoskeletons (Figure 15) are composed of an onboard battery that powers high-
performance DC motors. This structure is actuated onto a pulley aligned with each ankle
joint via a Bowden cable transmission that helps to mount the heaviest components of the
exoskeleton onto the patient’s torso. In addition, torque sensors are mounted in line with
the exoskeleton’s ankle joint, allowing for feedback-based motor control. Under the ball of
each foot, additional foot sensors allow for the implementation of the plantar flexion assist
Micromachines 2023, 14, x FOR PEER REVIEW 13 of 19
on the mode of the exoskeleton, adding torque to the ankle joint to mimic the shape and
timing of normal physiological ankle movement.

Figure 15. (a) Photograph of exoskeleton Ekso 1 equiped with 4 powered motors at the hips and
Figure 15. (a) Photograph of exoskeleton Ekso 1 equiped with 4 powered motors at the hips and
knees, 2 powered joints at the hip and knee, and a semi-rigid unpowered ankle joint; (b,c) patient
knees, 2 powered joints at the hip and knee, and a semi-rigid unpowered ankle joint; (b,c) patient
utilizing mobile ankle exoskeleton with the aid of crutches to maintain balancing. The system was
utilizing mobile
equiped with ankleanalysis
motion exoskeleton with(red
markers thedots)
aid ofand
crutches to maintain balancing.
electromyographs (blue dots)The system
for gait was
analyis;
equiped with motion analysis markers (red dots) and electromyographs
(d) kinematic data resulting from the motion capture system [72]. (blue dots) for gait analyis;
(d) kinematic data resulting from the motion capture system [72].
4.4. Powered Exoskeletons in Stroke Rehabilitation
Patients of varying ages and severity of gait pathologies due to CP disease progression
showedStroke patientslower
improved commonly sufferposture,
extremity from foot drop syndrome,
increased which
propulsive equates
ankle to a higher
joint point, and
falling risk, making effective gait rehabilitation essential to improve patients’
reduced plantar flexion activity, which was shown to be a contributing factor toward qualitygait
of
life and independence. Prior gait training systems generally confined patients
abnormalities. Augmentation with the powered exoskeleton also showed more efficient to a tread-
mill-likepatterns,
walking setting and may not
meaning the contribute to theassistance
additional ankle ultimate goal of independent
provided walkingwas
by the exoskeleton on
real-world surfaces. Passive ankle–foot orthotics have also been used in conjunction
reducing the use of additional muscles at the hip joint for walking and, therefore, improved with
conventional seen
contractures physical therapy,
in these but they
patients. also limit
Overall, the patient’s
the wearable range of was
exoskeleton motion about
shown tothe
be
ankle joint.
well-tolerated by patients and has the potential for long-term gait improvements in CP
Powered exoskeletons are being applied in the gait rehabilitation of both chronic and
patients.
sub-acute stroke patients [73,74]. One such model being used is a modified form of an
4.4. Poweredorthotic
ankle–foot Exoskeletons in Stroke
coupled Rehabilitation
to a rotatory servomotor and torque amplifier that provides
powered assistance in plantarflexion and dorsiflexion
Stroke patients commonly suffer from foot drop syndrome, (Figure 16). The powered
which equates toexoskele-
a higher
ton also contained force-sensitive resistors that could identify changes
falling risk, making effective gait rehabilitation essential to improve patients’ in gait phase
quality ofand
life
foot loading.
and independence. Prior gait training systems generally confined patients to a treadmill-like
setting and may not contribute to the ultimate goal of independent walking on real-world
surfaces. Passive ankle–foot orthotics have also been used in conjunction with conventional
physical therapy, but they also limit the patient’s range of motion about the ankle joint.
Powered exoskeletons are being applied in the gait rehabilitation of both chronic and
sub-acute stroke patients [73,74]. One such model being used is a modified form of an ankle–
foot orthotic coupled to a rotatory servomotor and torque amplifier that provides powered
real-world surfaces. Passive ankle–foot orthotics have also been used in conjunction with
conventional physical therapy, but they also limit the patient’s range of motion about the
ankle joint.
Powered exoskeletons are being applied in the gait rehabilitation of both chronic and
Micromachines 2023, 14, 2081 sub-acute stroke patients [73,74]. One such model being used is a modified form of an18
13 of
ankle–foot orthotic coupled to a rotatory servomotor and torque amplifier that provides
powered assistance in plantarflexion and dorsiflexion (Figure 16). The powered exoskele-
ton also contained force-sensitive resistors that could identify changes in gait phase and
assistance in plantarflexion and dorsiflexion (Figure 16). The powered exoskeleton also
foot loading.
contained force-sensitive resistors that could identify changes in gait phase and foot loading.

Micromachines 2023, 14, x FOR PEER REVIEW 14 of 19

Figure
Figure16.
16.(a)(a)
Graphic
Graphicof of
powered ankle
powered exoskeleton
ankle usedused
exoskeleton in gait training
in gait of stroke
training survivors,
of stroke in-
survivors,
cluding labels of rotatory servomotor and torque amplifier and (b,c) photographs of a manufactured
including labels of rotatory servomotor and torque amplifier and (b,c) photographs of a manufactured
powered
Afterankle exoskeleton
multiple usedof
sessions ongait
stroke patients [73,74].
rehabilitation, including walking over-ground and
powered ankle exoskeleton used on stroke patients [73,74].
stair training, stroke patients were able to walk with greater speed and higher cadence
compared
Aftertomultiple
those just undergoing
sessions of gait conventional
rehabilitation,physical
includingtherapy.
walkingThis finding was
over-ground andalso
stair
true once robotic
training, assistance
stroke patients was
were removed
able to walk in clinical
with assessments,
greater suggesting
speed and higher further
cadence im-
compared
plications for gait-relearning
to those just applications
undergoing conventional in the future.
physical therapy.It This
was finding
also shown
was that patients
also true once
had improved
robotic gaitwas
assistance patterns,
removedmore independence
in clinical with suggesting
assessments, walking, and increased
further walking
implications for
gait-relearning
speed, which hasapplications in the
been associated withfuture.
lowerItfall
wasrisk.
also shown that patients had improved
gait patterns, more independence with walking, and increased walking speed, which has
4.5. Powered
been Exoskeletons
associated in Lower
with lower Extremity Trauma Patients
fall risk.
More and more are lower extremity trauma patients opting for limb reconstruction
4.5. Powered Exoskeletons in Lower Extremity Trauma Patients
surgeries over amputations, making them candidates for wearable foot and ankle exoskel-
etons, More
termed and more are orthotics
ankle–foot lower extremity
(AFOs).trauma patients opting
More traditional formsfor of limb
AFOsreconstruction
are passive
surgeries over amputations, making them candidates for wearable
(Figure 17). Although they can function to improve walking abilities in lower foot and ankle
limb exoskele-
muscle
tons, termed
weakness, theyankle–foot
cannot fullyorthotics (AFOs). Morepush-off,
restore plantarflexion traditional
stillforms of AFOs
limiting gait asare
thepassive
ankle
(Figure
can 17). Although
only return theyposition
to a neutral can function to improve
instead walking
of producing moreabilities in lower
peak power limb
as in muscle
an intact
weakness,
ankle. they cannot fully
The introduction restore plantarflexion
of powered AFOs provides push-off,
assistivestill limiting
torque thatgait as the
their ankle
passive
can only return
counterparts to aable
are not neutral positionThis
to provide. instead of producing
allows for greatermore
anklepeakrangepower as in an
of motion, intact
active
ankle. The introduction of powered AFOs provides assistive torque that their passive
dampening when the heel strikes the ground, and powered push-off during plantarflex-
counterparts are not able to provide. This allows for greater ankle range of motion, active
ion.
dampening when the heel strikes the ground, and powered push-off during plantarflexion.

Figure 17. (a) Photographs of traditional, passive AFOs and (b,c) a graphic and photograph of a
Figure 17. (a) Photographs of traditional, passive AFOs and (b,c) a graphic and photograph of a
powered PFO, including labels of elastic actuator and ankle/foot sensors [75].
powered PFO, including labels of elastic actuator and ankle/foot sensors [75].
In a study involving three male Service Members who had sustained lower extremity
In a study involving three male Service Members who had sustained lower extremity
injuries requiring surgical interventions [75], the use of their current passive AFOs was
injuries
comparedrequiring surgical
with the interventions
PowerFoot [75], the
Orthosis (PFO), use of their
a powered currentAFO.
advanced passive
The AFOs was
PFO, which
compared with the PowerFoot Orthosis (PFO), a powered advanced AFO. The PFO, which
was powered by a lithium polymer battery, was formed by a carbon fiber scaffold struc-
ture that was customized to each Service Member. It contains a series-elastic actuator that
generates net positive work about the ankle joint. This provides assistance by increasing
dorsiflexion to allow for toe clearance and preparation for foot strike and for powered
Micromachines 2023, 14, 2081 14 of 18

was powered by a lithium polymer battery, was formed by a carbon fiber scaffold structure
that was customized to each Service Member. It contains a series-elastic actuator that
generates net positive work about the ankle joint. This provides assistance by increasing
dorsiflexion to allow for toe clearance and preparation for foot strike and for powered
plantarflexion during push-off. Angular sensors, spring systems, and state controllers are
used to vary torque and joint position in response to each Service Member’s step-to-step
variations and walking phase.
Overall, the range of motion of the ankle joint and peak power generation at push-off
was greater in the PFO compared to each Service Member’s previous passive AFO. It was
found that the PFO has the potential to restore a more biomimetic gait by providing power
torque with plantar flexion and assisting with dorsiflexion during swing. When asked
about preference among the devices, all three Service Members still preferred their previous
passive AFO. Their major concern was difficulty or discomfort with lateral movements and
walking backward. However, their comments did reflect that they may have preferred the
PFO had the construct been less bulky and lighter in weight.

5. Conclusions and Future Perspectives


In this review, we focused on a variety of implants used for foot and ankle prostheses
and the evolution of material/fabrication processes. Broadly, trends in the field are moving
towards personalized prostheses to overcome limitations related to patient discomfort
or implant failure attributed to traditional designs. Furthermore, the potential of AM
to manufacture prostheses with complex geometries at a high speed has attracted the
interest of the scientific community. AM is currently being employed to fabricate implant
components using materials, including ceramics, metals, or plastics. AM is also being used
to manufacture customized sensors and actuators that can be assembled in a manner to
improve patient mobility and rehabilitation. Attention is now being turned to combining
advances in AM, imaging technologies, and robot-assisted surgery to manufacture custom-
made guides for osteotomies that not only take into consideration the patient’s anatomy
but also will allow a perfect fit between the native tissues and the prosthesis.
However, there are still challenges in substituting conventional technologies for AM
technologies. Among them is the cost of the 3D printers, manufacturing, and assembly
of the prosthesis, calling into consideration factors such as in-house printing versus local
or global fabrication and shipping. At the current stage, many implants are developed
by individual academic or industry groups using different AM technologies, materials,
electronics, and post-treatment processes, making a cost analysis study between AM and
traditionally manufactured implants hard to perform. Furthermore, despite the outstand-
ing advancements in metals and polymers used in AM, more specific and oriented research
needs to be conducted and applied to the prosthesis manufacturing field, including the
development of multi-material printers and automation of multiple 3D printing technolo-
gies and processes. For example, stereolithography (SLA), digital light processing (DLP),
and liquid-crystal display (LCD) printers use resin-based materials that need extensive
washings and curing. Metal and ceramics printing involves extra steps for debinding and
sintering, and sometimes, a polishing or plasma spray treatment is needed.
One step further than the personalization of prosthetic devices is the development of
personalized exoskeletons in combination with human-in-the-loop optimization. Tradition-
ally, collecting data on individual performance can be a time-consuming and expensive
process. However, recent progress in developing wearable sensors and rapid methods of
analysis [76] can measure and analyze the patient as well as the prosthetic performance
data in real time. With the aid of artificial intelligence, the system energy storage and
motor torque continuously change, overall enhancing performance with the ultimate goal
of improving the patient’s quality of life and satisfaction. As AM technology continues
to evolve, it plays an increasingly significant role in medicine. In addition to the direct
manufacturing of foot and ankle implants and devices, AM patient-specific models can aid
in surgical planning in complex cases and visualization of anatomy in medical education,
Micromachines 2023, 14, 2081 15 of 18

further contributing to bettering the quality of patient care [77,78]. The AM of personalized
implants used for ankle and foot prostheses and orthosis is an advanced interdisciplinary
research area requiring cross-talk and collaborations from multiple research fields.

Author Contributions: Conceptualization, A.A. and R.G.; methodology, R.G., K.G., A.W. and J.L.;
investigation, R.G., K.G., A.W. and J.L.; data curation, R.G., K.G., A.W. and J.L.; writing—original
draft preparation, R.G., K.G., A.W. and J.L.; writing—review and editing, A.A., R.G., K.G., A.W. and
J.L.; supervision, A.A.; project administration, A.A. All authors have read and agreed to the published
version of the manuscript.
Funding: This research received no external funding.
Data Availability Statement: Not applicable.
Conflicts of Interest: The authors declare no conflict of interest.

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