593079

research-articleXXXX
FASXXX10.1177/1938640015593079Foot & Ankle SpecialistFoot & Ankle Specialist

vol. XX / no. X Foot & Ankle Specialist 1

〈 Evolving
Techniques 〉
Patient-Specific
3-Dimensional Printed
Titanium Truss Cage
With Tibiotalocalcaneal Andrew R. Hsu, MD, and
J. Kent Ellington, MD

Arthrodesis for Salvage

of Persistent Distal Tibia
Nonunion
S
Abstract: Management of large successfully treated using a patient- alvage of large bony defects of the
structural defects of the ankle specific 3-dimensional printed ankle is challenging with modest
and hindfoot is challenging with titanium truss cage in combination outcomes in the literature.1
modest outcomes in the literature. with a retrograde TTC nail. At most Tibiotalocalcaneal (TTC) arthrodesis
Tibiotalocalcaneal (TTC) arthrodesis recent 1-year follow-up, the patient using a retrograde intramedullary nail
using a retrograde intramedullary had minimal pain, no wound has been used in combination with
nail has been used for the treatment of complications, and was able to biologic adjuvants and/or femoral head
talar avascular necrosis, severe tibial ambulate and work independently allografts for the treatment of talar
plafond fractures, ankle and hindfoot without an assistive device for the avascular necrosis, severe tibial plafond
nonunions, Charcot arthropathy, first time in 2 years since his original fractures, ankle and hindfoot nonunions,
and failed total ankle arthroplasty. injury. The case presented here serves Charcot arthropathy, and failed total
External fixators and spatial frames as a proof of principle that requires ankle arthroplasty (TAA).1-4 However,
provide robust multiplanar correction future research to determine its complication rates are high with
of deformity, but little is known in long-term clinical benefits, cost- subsequent amputation rates up to 19%,
the literature regarding the salvage effectiveness, and complications. particularly in patients with diabetes and
treatment of persistent nonunion revision surgery.1,5 TTC nails used with
Levels of Evidence: Level V: Expert
refractory to frame treatment. In commercially available Trabecular Metal
Opinion
this report, we present the case of (Zimmer, Warsaw, IN) interpositional
an open tibial plafond fracture with Keywords: patient-specific implants; spacers have been described to address
nonunion despite 1 year of fixator custom cage; 3D printing; truss design; bone loss of the ankle with limited
and frame management that was roughened titanium preliminary results.6-8 These spacers can

DOI: 10.1177/1938640015593079. From the OrthoCarolina Foot & Ankle Institute, Charlotte, North Carolina. Address correspondence to: Andrew R. Hsu, MD,
OrthoCarolina Foot & Ankle Institute, 2001 Vail Avenue, Suite 200B, Charlotte, NC 28207; e-mail: andyhsu1@gmail.com.
For reprints and permissions queries, please visit SAGE’s Web site at http://www.sagepub.com/journalsPermissions.nav.
Copyright © 2015 The Author(s)

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2 Foot & Ankle Specialist
fill in large bony defects, but do not
dynamically interact with native bone,
have structural support only around the
periphery of the implant, and allow for
bony fusion only through the central
opening of the spacer.
External fixators and spatial frames are
good alternatives to intramedullary TTC
nails and can provide robust multiplanar
correction of deformity.9-12 In addition,
distraction osteogenesis using the
Ilizarov method for the treatment of
bone loss (average 5.1 cm) and salvage
arthrodesis has been shown in small
series to have good functional outcomes
and fusion rates.13,14 Little is known
regarding the limb-salvage treatment of
persistent nonunion refractory to
external fixator and circular spatial frame
treatment. In this report, we present the
case of an open tibial plafond fracture
with nonunion despite 1 year of fixator
and frame management that was
successfully treated using a patient-
specific 3-dimensional (3D) printed
titanium cage in combination with a
retrograde TTC nail.
Case Report
A 63-year-old male self-employed as a
trucker sustained right open tibial
plafond and fibula fractures during a
motorcycle versus auto collision. The
patient was provisionally treated at an
outside facility with a spanning ankle
external fixator in combination with
intravenous and oral antibiotics and a
wound vac for an open medial distal
tibia wound. He was then transferred to
our clinic 3 weeks after his initial injury
for further management. On presentation
the patient had a positive smoking
history, a body mass index of 24, and a 4
× 6 cm open wound over the medial
aspect of his ankle with exposed distal
tibia covered by a wound vac.
Given the complexity of the patient’s
bony and soft-tissue injuries, the initial
plan was for continued external fixator
treatment with wound vac, oral
antibiotics, bone stimulator, and plastic
surgery intervention for distal tibia free
flap for soft-tissue coverage. Serial
exams, radiographs, and computed
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Figure 1.
(A) Preoperative standing anteroposterior (AP) and (B) lateral radiographs of the
patient’s right lower extremity after 6 months of treatment in a Taylor Spatial
Frame (Smith&Nephew, Cordova, TN) for distraction osteogenesis and deformity
correction.
tomography (CT) scans over the course
of the following 4 months showed
minimal callus formation with good
soft-tissue healing and no evidence of
pin site infections. Laboratory values of
C-reactive protein, erythrocyte
sedimentation rate, and vitamin D were
ordered and all found to be within
normal range. At that time, a lengthy
discussion was had with the patient
regarding limb salvage versus below the
knee amputation, and the patient
consented to move forward with external
fixator removal, incision and
debridement of devitalized bone and soft
tissue, distal tibia and fibula osteotomies,
ankle arthrodesis, and placement of a
Taylor Spatial Frame (Smith & Nephew,
Cordova, TN) for distraction
osteogenesis. At the time of surgery,
biologic adjuvants were used to aid with
ankle arthrodesis including allograft with
viable osteogenic and osteoprogenitor
cells within the matrix and a
demineralized cortical bone component
(TRINITY Evolution, OrthoFix, Lewisville,
TX) along with bone-morphogenic
protein (BMP-2; Infuse, Medtronic,
Minneapolis, MN).
Mon XXXX
Over the following month, 14° of
anterior translation with 5° of varus
deformity were noted on serial
radiographs with increased motion at the
distal tibia nonunion site. Therefore, 4
weeks after initial frame placement the
spatial frame was revised with
application of a multiplane ring and
exchange of 6 struts. The frame was
maintained for 5 months during which
pin sites were clean and serial
radiographs showed stable alignment
with bridging bone posteriorly at the
distal tibia (Figure 1). Six months after
initial frame application, the frame was
removed in the operating room.
Examination under live fluoroscopy
showed stable ankle fusion with
persistent motion at the distal tibia
nonunion. A short leg cast was applied
and serial radiographs confirmed
nonunion at the previous fracture site
(Figure 2).
After 1 month of casting, the patient
had progressively worsening pain and
deformity with gross motion at the
nonunion site. Given the patient’s
extensive treatment over the past 1 year
combined with his stated desire to
vol. XX / no. X
Figure 2.
(A) Preoperative standing AP and (B) lateral radiographs of the right ankle after
frame removal show persistent nonunion and deformity at the distal tibia fracture
site.
pursue limb salvage, informed consent
and institutional review board (IRB)
approval for single-patient use was
obtained for a patient-specific 3D printed
titanium truss cage (4WEB, Frisco, TX) in
conjunction with a TTC arthrodesis using
a retrograde nail. The 3D printed cage
was created using a preoperative CT
scan of the patient’s ankle and hindfoot
with surgeon input and editing to
produce a computer model surgical plan,
intraoperative trials, and final implant
matched to the patient’s anatomy made
of roughened titanium in a truss design
allowing for graft insertion (Figure 3).
The patient was taken to the operating
room and placed in the prone position
with a thigh tourniquet. A midline
posterior approach to the distal tibia was
performed with Z-lengthening of the
Achilles tendon (Figure 3). Dissection
was then taken down through significant
scar tissue and hypertrophic nonunion to
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the tibia. Tissues were carefully
mobilized and posterior fasciotomy was
performed followed by release of the
flexor hallucis longus and flexor
digitorum longus. Fluoroscopy was used
to identify the area of nonunion and
perform a distal tibia osteotomy with a
½” osteotome and saw (Figure 4).
Meticulous debridement was performed
of the nonunion site until healthy,
bleeding bone was obtained on both
sides of osteotomy.
Trial implant spacers for the cage
were inserted into the bony defect
following the preoperative surgical
plan and adjusted in order to obtain
proper alignment and positioning. With
the trial in place, the guidewire for a
retrograde TTC arthrodesis nail
(VALOR, Wright Medical Technology,
Inc, Memphis, TN) was inserted
followed by reaming. Posterior iliac
crest autograft was obtained using an
Foot & Ankle Specialist 3
incision over the posterior superior
iliac spine and a trap door technique.
The trap door and wound was closed
after obtaining 40 cc of autograft to fill
the titanium cage. Autograft was mixed
with 5 cc of TRINITY and 1 g of
vancomycin powder for infection
prophylaxis and then packed into the
cage. A centralizer was use to prevent
graft from entering the central canal of
the cage.
The filled cage was then inserted into
the final distal tibia defect and confirmed
to be in the correct position using
fluoroscopy. The retrograde TTC nail was
inserted in a standard fashion and
washers were used for the interlocking
screws due to severe diffuse osteopenia.
The nail was compressed and an endcap
was placed to create a fixed angle
device. The thigh tourniquet was inflated
for a total of 2 hours during the 4-hour
procedure to reduce the overall burden
of lower extremity ischemia. The Achilles
tendon and sheath were closed using 2-0
polyester sutures (PDS, Ethicon,
Somerville, NJ) and the subcutaneous
tissues and skin were closed in a layered
fashion. A well-padded splint was placed
in neutral alignment.
The incision was well healed 3 weeks
after surgery and sutures were removed
followed by application of a non-
weight-bearing short leg cast. At
2-month follow-up the patient was
ambulating independently with 50%
weight-bearing in a walking cast with
good maintenance of hardware
alignment and positioning. The patient
was able to bear full weight in a tall
CAM boot 3 months after surgery with
use of a cane for ambulation. Standing
radiographs and CT scan at 5 months
demonstrated good consolidation of the
fusion site in and around the titanium
cage with stable alignment (Figure 5).
The patient is currently 1 year
postoperative doing well with minimal
pain, no wound complications, and
ambulating and working independently
without assistive device for the first time
in 2 years since his original injury.
Standing ankle radiographs show
continued fusion consolidation with the
4 Foot & Ankle Specialist Mon XXXX

Figure 3.
(A) Pre-operative computer model of the patient-specific 3-D printed titanium truss cage (4WEB, Frisco, TX) with retrograde
TTC nail in place. (B) Diagram of the implant geometry showing measurements and architecture with the open truss design.
(C) Intraoperative photo showing trial implants and different size cages created (small, medium, large volume). (D) View of the
posterior ankle after excision of nonviable scar tissue and bone with the trial spacer in place. (E) Cage with centralizer in place
packed full of iliac crest bone graft mixed with adjuvant biologic and vancomycin powder. (F) Final position of the packed cage
within the previous distal tibia bony defect.

titanium cage and TTC nail in
appropriate alignment (Figure 6).
Discussion
The current case is the first
demonstration in the literature of a
patient-specific 3D printed implant for
treatment of a large lower extremity
bony defect. The role of patient-specific
implants in orthopaedic surgery remains
highly controversial with lack of Food
and Drug Administration (FDA)
approval for routine use. In the present
case, a compassionate use proposal was
approved by our IRB for a single time
use of the patient-specific titanium cage.
Given the extensive surgical history of
our patient with persistent nonunion
despite 1 year of external fixator and
spatial frame use, we believed that use
of an investigational device was the last
option available before proceeding with
below the knee amputation. Given the
high rates of nonunion (50%) and
amputation (19%) associated with TTC
arthrodesis using bulk femoral head
allograft for large ankle defects,1 we did
not view this as a viable option given
the patient’s previous treatment failures.
It is important to note that our use of
this custom device was based on
theoretical benefits not previously tested
in a clinical scenario. This was
explained in detail to our patient who
demonstrated understanding of the
risks, benefits, and experimental nature
of the procedure.
The patient-specific cage used in the
present case follows the FDA’s custom
device guidelines and utilizes a truss-
based open architecture to guide bone
formation by dynamically interacting with
bone to theoretically increase fusion
rates. The fundamental premise of the
design is that the roughened titanium
surfaces on the individual trusses within
and around the implant provide adhesion

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vol. XX / no. X Foot & Ankle Specialist 5

setting.16 However, patient-specific 3D

Figure 4. printed implants represent a new frontier
(A) Intraoperative AP radiograph marking out the site of the distal tibia nonunion of exploration in surgery and medicine
before and (B) after excision of nonviable scar tissue and bone. (C) AP and (D) in general.17-19 Three-dimensional
lateral radiographs of trial implant in place showing good fit and alignment following printing is a type of manufacturing
the pre-surgical plan. (E) Intramedullary reaming with the trial in place followed process that uses a digital model to
by (F) final cage placement and insertion of retrograde TTC nail (VALOR, Wright create a 3D object out of a variety of
Medical Technology, Inc., Memphis, TN). (G) Final lateral radiographs of the distal materials. This process is distinct from
and (H) proximal aspects of the fixed angle construct with interlocking screws in traditional manufacturing techniques in
place and (I) final AP radiograph. that it is an additive rather than a
subtractive process, thus allowing for the
production of complex shapes that
cannot be produced with conventional
techniques. Additive processes build
objects using layering techniques while
subtractive processes carve them out of
larger blocks of material. Additively
manufactured porous tantalum implants
created using selective laser melting have
been shown to have excellent
osteoconductive properties with high
fatigue strength and plastic deformation
due to increased ductility.19 Recent
advances in 3D printing have also
enabled the manufacturing of
biocompatible materials, cells, and
supporting components into complex 3D
functional living tissues.17
While the potential for rapid
prototyping of 3D printed implants may
seem limitless, there are distinct concerns
surrounding their use in the future.
Implant-related cost is a major limitation
of current patient-specific implants as
significant time and resources are
required to complete the manufacturing
process. A preoperative CT scan is
required followed by computer model
design, editing, IRB approval on a
case-by-case basis, and 3D printing of
implant trials and final implant sizes. In
addition to the cost involved with the
trials and implants themselves (~$8400),
in our case over 12 hours were spent
sites for osteoblasts. Adherent osteoblasts combination with additional hardware outside of surgery editing the computer-
then release BMP to drive “through- required. In the current case, a cage was generated surgical plan and petitioning
growth” of bone in and around the cage customized to accommodate 30.5 mm of for IRB approval. The overall cost of the
as shown in the manufacturer’s (4WEB) distal tibia resection and a central canal procedure was significant and pursued
preliminary animal studies in sheep. An 14 mm in diameter to allow passage of a only after receiving approval from a
important aspect of the manufacturing retrograde TTC nail. panel of physicians confirming that no
process of the patient-specific cage is the Patient-specific navigation and other treatment modalities were available
preoperative surgical plan based on CT instrumentation in foot and ankle surgery other than amputation.
scan. The computer models can be edited has been previously demonstrated using Another concern regarding the implant
and adjusted by the surgeon to match the TAA with good preliminary results in a used in the present case is its long-term
exact bony resection desired in cadaveric model15 and in a clinical stability as it is unknown whether the

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6 Foot & Ankle Specialist Mon XXXX

cage functions more as a true fusion

Figure 5. device or biologic spacer with increased
(A) Postoperative weight-bearing AP and (B) lateral radiographs 5 months after surgery capacity for bone growth through the
showing good maintenance of hardware alignment and positioning. (C) Mortise implant due to the truss design.6-8 Our
radiograph of the ankle shows robust bone formation in and around the titanium cage patient is currently 1 year postoperative
confirmed on (D) coronal CT cuts adjacent and (E) through the intramedullary nail. (F) ambulating and working independently
Sagittal CT cuts adjacent and (G) through the nail also show successful fusion of the with good clinical alignment and
distal tibia with bone formation through and around the cage. CT-confirmed evidence of fusion across
the titanium cage. However, it is
important to note that the subtalar joint
was prepared only using the reamer for
the retrograde TTC nail to create a spot
weld fusion around the nail. It is possible
in the future that repetitive torque on the
nail through an unfused subtalar joint
may potentially create distal loosening
and a windshield wiper effect at the level
of the calcaneus with secondary stress at
the fusion site or cage-bone interface.
While we have not observed this yet at
1-year follow-up, it is a theoretical
mechanical disadvantage that could have
been reduced by taking down the
subtalar joint and formally preparing it.
This was not done in the current case
due to the already extensive nature of the
surgery and the belief that a spot weld at
the subtalar joint would be sufficient for a
stable construct. Close analysis of our
5-month and 1 year postoperative
standing radiographs also shows subtle
anterior translation of the foot on the
tibia, which may disrupt the long-term
load distribution of the foot and ankle.
Figure 6. Overall, the case presented here of a
A) Postoperative weight-bearing AP, (B) mortise, and (C) lateral ankle patient-specific 3D printed titanium truss
radiographs 1 year after surgery demonstrate continued fusion consolidation cage with retrograde TTC nail for limb
with the titanium cage and TTC nail in appropriate alignment. salvage in a complex patient serves as a
proof of principle that requires future
research to determine its long-term
clinical benefits, cost-effectiveness, and
complications.

Conclusions
The future of patient-specific 3D printed
implants in orthopaedic surgery is
uncertain, with numerous potential
benefits and limitations. While the cost,
resources, and surgical time required can
be extensive, there are potential limb-
saving scenarios such as the current case
that may warrant use of these implants
moving forward. There are a myriad of
arguments surrounding the present case
that could be made regarding if the FDA

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vol. XX / no. X
should approve patient-specific implants,
the regulatory issues that need to be
addressed, and the implications of future
structural cage use as the number of
revision TAAs increases over time. While
these topics are beyond the scope of the
current article, they merit future
discussion and investigation as 3D printed
implants will likely be further explored in
medicine in upcoming years.
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