Single-Step Resection and Reconstruction Using Patient ... · and orbital protection. Restoration...
Transcript of Single-Step Resection and Reconstruction Using Patient ... · and orbital protection. Restoration...
SURGICAL ONCOLOGY AND RECONSTRUCTION
Rec
Tur
of H
Sch
De
and
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Single-Step Resection and ReconstructionUsing Patient-Specific Implants in the
Treatment of Benign Cranio-Orbital Tumors
eived
in, Italy
*Assista
ead an
yPhDP
ool in
partmen
zResideNeck
xAssistauroscie
Giovanni Gerbino, MD, DDS,* Francesca Antonella Bianchi, MD,yEmanuele Zavattero, MD,z Fulvio Tartara, MD,x Diego Garbossa, MD, PhD,k
and Alessandro Ducati, MD{
Purpose: The aim of this study was to evaluate surgical outcomes using patient-specific prostheses pro-duced by computer-aided design and manufacturing for primary reconstruction in patients with benign
cranio-orbital tumors. Polyetheretherketone was used to manufacture the implants.
Materials andMethods: The present study included 3 patients who underwent fronto-orbito-pterional
craniotomy using individual custom-made surgical guides. Patient-specific polyetheretherketone prosthe-
ses were used for reconstruction during the same surgery. All patients underwent esthetic examination
(facial and orbital symmetry, globe projection and position), ophthalmologic examination (diplopia
with the Hess-Lancaster test, visual field and acuity), and radiologic evaluations (computed tomography
and magnetic resonance imaging) during the preoperative and follow-up periods. Operating time andshort- and long-term complications were recorded.
Results: The immediate and long-term morphologic results were satisfactory; in particular, ocular globe
position and projection were correct. After 25 to 31 months, none of the patients developed implant-related complications, such as infection, extrusion, or malposition. Two-year postoperative computed
tomograms and magnetic resonance images showed no recurrences.
Conclusion: Single-step resection and reconstruction with computer-aided designed and manufactured
implants is a challenging new technique that decreases operative time and morbidity. The implants ade-
quately restore an anatomically complex area with satisfactory cosmetic results.
� 2013 American Association of Oral and Maxillofacial Surgeons
J Oral Maxillofac Surg -:1-14, 2013
Benign lesions of the cranio-orbital region require
resection followed by reconstruction for cerebral
and orbital protection. Restoration of anatomic and
functional cranial and orbital contouring representsa challenge for the surgical team when attempting an
appropriate cosmetic repair. The natural curvature of
the orbital rims and frontal convexity are difficult to
re-create precisely.
from San Giovanni Battista Hospital, University of Turin,
.
nt Professor, Division of Maxillofacial Surgery, Department
d Neck Surgery.
rogramme in Experimental Medicine andTherapy; Doctoral
Life and Health Sciences, Division of Maxillofacial Surgery,
t of Head and Neck Surgery.
nt, Division of Maxillofacial Surgery, Department of Head
Surgery.
nt Professor, Division of Neurosurgery, Department of
nce.
1
An appropriate reconstruction of orbital walls is
needed to restore correct globe position and prevent
postoperative restriction of extraocular muscles.1-4
Several materials and different techniques have beenused to reconstruct the cranio-orbital bone defect in
a cosmetically sufficient manner, including autograft
bone, allograft bone, xenograft bone, and bone
substitutes.5-20 Each material has advantages and
kDivision of Neurosurgery, Department of Neuroscience.
{Head, Division of Neurosurgery, Department of Neuroscience.
Address correspondence and reprint requests to Dr Bianchi:
Corso A.M. Dogliotti 14, 10126, Torino, Italy; e-mail: p_f_bianchi@
libero.it
� 2013 American Association of Oral and Maxillofacial Surgeons
0278-2391/13/00311-X$36.00/0
http://dx.doi.org/10.1016/j.joms.2013.03.021
2 TREATMENT OF CRANIO-ORBITAL TUMOR
disadvantages, and the search for an ideal calvarial
replacement continues.
Since 1995, improvements in medical imaging and
computationalmodelinghave allowed thedevelopment
of various computer-aided prefabricated patient-
specific implants (PSIs).21-33 In delayed (secondary)
reconstruction procedures, PSIs enable excellent
functional and cosmetic results with a shorteroperating time.21,31 In single-step (primary) resection
and reconstruction procedures, the transfer of a treat-
mentplan to an intraoperative site depends on the expe-
rience of the individual surgeon.30
Computer-designed prostheses have been made of
titanium,21-24,27,30methylmethacrylate,21,27,31,32 hydroxy-
apatites,34porouspolyethylene, hard tissue replacement
polymethylmethacrylate-polyhydroxyethyl-calciumhydroxide-coated patient-matched implants,1,2 and
polyetheretherketone (PEEK).33,35-37
In this report, the authors describe the surgical
planning and technique and esthetic and functional
Table 1. DETAILSOF PATIENTSWHOUNDERWENTSINGLE-STEWITH PREFABRICATED COMPUTER-AIDED DESIGNED ANDMAN
Patient
Age (yr)/
Gender Signs/Symptoms Diagnosis
1 54/F exophthalmos,
dystopia
meningioma
(WHO grade I)
right
mid
bas
late
orb
sph
win
tem
bon
bon
2 56/M exophthalmos,
proptosis,
diplopia,
slight visual
impairment
(40/100)
meningioma
(WHO grade I)
right
sku
roo
wal
ant
clin
sph
win
tem
bon
bon
3 46/F dystopia, right
roof orbit
swelling
hemangioma right:
orb
bon
Abbreviations: F, female; M, male; PEEK, polyetheretherketone; W* Three-dimensional models based on data from computed tomy Three-dimensional models based on data from computed tom
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillofac Sur
outcomes of custom-made prefabricated PEEK PSIs
(Synthes Maxillofacial, Oberdorf, Switzerland) using
computer-aided design and computer-aided man-
ufacturing for primary reconstruction in patients with
cranio-orbital tumors.
Materials and Methods
From June through December 2010, 3 patients with
benign cranio-orbital tumors underwent combined
maxillofacial and neurosurgical treatment at the Divi-
sion of Maxillofacial Surgery and Division of Neurosur-
gery, San Giovanni Battista Hospital, University of
Turin (Turin, Italy; Table 1). In all cases, PEEK implants
were used successfully for cranio-orbital reconstruc-tion during the same surgical procedure.
All patients gave their written informed consent.
This study was performed in agreement with the local
institutional review board. This study followed the
Declaration of Helsinki guidelines.
PRESECTIONANDCRANIO-ORBITAL RECONSTRUCTIONUFACTURED PEEK IMPLANTS
Site
PEEK Implant
and Cutting
Guide: Site
and Shape*
PEEK Implant:
Site and ShapeyFollow-Up
(mo)
anterior-
dle skull
e: roof/
ral walls of
it, great
enoid
g,
poral
e, frontal
e
31
anterior
ll base:
f/lateral
ls of orbit,
erior
oid, lesser
enoid
g,
poral
e, frontal
e
29
roof wall
it, frontal
e
25
HO, World Health Organization.ograms (green, cutting guide; red, custom-made implant).ograms (red, custom-made implant).
g 2013.
FIGURE 1. Patient 2. A-D, Preoperative views show swelling involving the right eye and proptosis, but without signs of restricted gaze in theright eye. (Fig 1 continued on next page.)
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillofac Surg 2013.
GERBINO ET AL 3
All patients underwent clinical examinations during
the preoperative period. Facial and orbital symmetry,
globeprojection andposition, visual acuity, anddiplopia
were recorded. Results of the Hess-Lancaster test
and digital visual field were obtained. Preoperative ra-
diologic evaluations included computed tomography
(CT) and magnetic resonance (MR) imaging with and
without gadolinium enhancement. Operating time andshort- and long-term complications were recorded.
POSTOPERATIVE FOLLOW-UP PERIOD
All patients were followed with standardized serialclinical and radiologic examinations (mean, 28.3
months; range, 25 to 31 months). Follow-up appoint-
ments were scheduled every week in the first postop-
erative month, every month in the first year, and then
every 3 months.
Standardized clinical evaluation consisted of
esthetic evaluation (facial and orbital symmetry, globe
projection and position) and ophthalmologic evalua-tion (diplopia with the Hess-Lancaster test, visual field
and acuity). The esthetic results were listed as poor
(major defects were present, evident to the patient
and the surgeon, requiring new operation), fair (minor
defects were present, evident to the surgeon but not
to the patient, no operation required), or satisfactory
(almost no defects present, the patient and the sur-
geon satisfied with the result).
Axial, coronal, and 3-dimensional (3D) CT scans
were taken immediately postoperatively; 1 and 2 years
later, CTand MR imaging with and without gadolinium
enhancement were repeated.
SURGICAL PLANNING
Spiral CT datasets (Somatom Sensation 16 scanner,
Siemens, Erlangen, Germany), with 16 � 0.75 collima-tion, 0.55-pitch increment, 1-mm slice thickness, and
0� gantry tilt, were acquired for preoperative planning
and surgery on a computer.
Images in Digital Imaging and Communications in
Medicine format were sent by compact disk to the
manufacturer (Synthes Maxillofacial) for processing.
The 3D CT images were returned by the Web to the
surgeon with software that allowed rotation, crop-ping, and manipulation of the images.
In a Web conference with the engineer, the surgeon
simulated on the computer screen the osteotomies for
planned tumor resection.
FIGURE 1 (cont’d).
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillofac Surg 2013.
4 TREATMENT OF CRANIO-ORBITAL TUMOR
A custom-made implant was designed, taking intoaccount the individual anatomy of the patient. Once
the virtual planning was completed, custom-made sur-
gical guides for the planned resection were designed.
These patient-specific surgical guides aided the trans-
fer of the virtual planned craniotomy to the operating
field, allowing reconstruction with a perfectly match-
ing custom-made implant for shape and size. The sur-
geon reviewed and approved the guides.Surgical guides and implants for reconstruction
were produced using rapid prototyping technologies.
Then, the custom-made prefabricated PEEK im-
plants and surgical guides were returned to the sur-
geon for further approval or additional editing. If
satisfactory, a nonsterile prefabricated PEEK implant
and cutting guides were delivered and sterilized by
heat at the authors’ hospital facility.
Results
The patients’ demographic and pathologic features
are presented in Table 1.
All patients underwent a coronal flap procedure.Fronto-orbito-pterional craniotomy was performed
by the maxillofacial and neurosurgical teams using
the individual custom-made surgical guides as a tem-
plate for the bone flap.
In patients 1 and 2, temporary orbito-zygomatic
osteotomies were performed to allow greater reflec-
tion of the temporalis muscle. The zygoma was left
pedicled to the masseter muscle. This was useful forimproving access for the pterional craniotomy and
for orbital lateral wall osteotomy, according to the sur-
gical guides. After completion of the neurosurgical
procedure and fixation of the implants, the osteotom-
ized zygoma was fixed with miniplates.
In each patient, the scalp was elevated carefully; the
tumor and dysplastic bone were removed, taking great
care to avoid injury to the orbital contents, and weresent for histologic analysis. An intraoperative naviga-
tion system (VectorVision Cranial 7.8, BrainLAB AG,
Heimstetten, Germany) was used during the operation
to check for deep tumor resection margins and to pre-
serve vital structures.
FIGURE 2. Patient 2. A, Intraoperative use of cutting guide.
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillofac Surg 2013.
GERBINO ET AL 5
In patient 2, the skull base approach allowed extra-
dural optic canal unroofing and optic nerve decom-
pression, without any morbidity.
In patient 3, the resection included the lateral
aspect of the frontal sinus, which was preserved
FIGURE2 (cont’d). Patient 2. B, Intraoperative view of bone defect. t, tepage.)
and sealed with a pericranial flap. On postopera-
tive day 7, a cerebrospinal fluid leak was noted
and the patient underwent a second surgical inter-
vention. Abdominal fat was harvested and used
directly on the dura, over the pericranial flap.
mporal muscle; b, brain;Or, right orbit. (Fig 2 continuedonnext
FIGURE 2 (cont’d). Patient 2. C, Reconstruction with polyetheretherketone patient-specific implant perfectly fits the bone defect. t, temporalmuscle.
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillofac Surg 2013.
6 TREATMENT OF CRANIO-ORBITAL TUMOR
The frontal sinus was preserved. The cerebrospinal
fluid leak ceased and no other complications were
registered.
The implant was checked for fit and then fixed
with 2.0-mm titanium miniplates and screws. If nec-
essary, contouring was performed using a high-
speed drill with a cutting burr. The pericranialflap was used as a watertight seal to protect the
dura and the implant. The dura was secured to
the implant, which had premade holes, to prevent
FIGURE 2 (cont’d). Patient 2. D, Postoperative 3-dimensi
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillofac Sur
epidural hematoma formation. One drainage
tube was placed and the skin was closed in a 2-layer
fashion.
During the immediate postoperative period, all
patients complained of some degree of diplopia. This
resolved spontaneously within 1 month. The vision
of patient 2 recovered from 40/100 to 70/100. Thepostoperative course was uneventful from a recon-
structive standpoint, with no implants requiring
removal because of infection.
onal computed tomogram shows good reconstruction.
g 2013.
FIGURE 3. Patient 2. A-D, Postoperative views show good functional globe position, satisfactory extraocular muscle function, and excellentpostoperative cosmetic appearance. (Fig 3 continued on next page.)
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillofac Surg 2013.
GERBINO ET AL 7
The immediate and long-term morphologic and
esthetic results were satisfactory in all 3 patients. Inparticular, ocular globe position and projection were
correct. Postoperative CT scans showed that PEEK
PSIs re-established correct orbital rim and wall mor-
phology (Figs 1 through 3).
Postoperative CT scans and MR images showed no
recurrences 2 years later.
Discussion
Cranio-orbital reconstruction after tumor resection
can prove challenging from technical and esthetic
standpoints. Reconstruction of the bone defect during
the same surgical procedure is a complex procedure,
especially for large defects or defects involving the
fronto-orbito-temporal region.13,20,30 However, pri-
mary reconstruction has been suggested to provide
biomechanical stability, cerebral protection, optimalcosmetic results, and landmarks for postoperative
imaging.32,38
The problem of finding the ideal material and
technique for craniofacial reconstruction has been
addressed in several publications and numerous solu-
tions have been proposed, with acceptable results.4,39
In patients with defects involving esthetically rele-
vant regions, such as the convexity of the frontal
bone and the orbital rims, the use of autogenous tissue
for primary reconstruction is particularly complex
because of the amount of donor tissue needed and
the increased difficulty and time required for shaping
bone or alloplastic grafts.1,2,19,20,33
Computer-designed alloplastic implants have revo-lutionized the conceptualization and approach to
complex cranioplasty and have become a reliable alter-
native. These implants have the advantage of being
preoperatively tailored to the exact size of the cranial
defect, thus allowing a shorter operating time, im-
proved postoperative stability, and incomparable cos-
metic results.21-33
If a primary reconstruction procedure is planned,determining the tailoring of the approach and the
exact size of the craniotomy is the main difficulty. It
is of the utmost importance to ensure that the planned
defect corresponds to the true defect, so that the cus-
tom implant correctly fits into the defect.
FIGURE 3 (cont’d).
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillofac Surg 2013.
8 TREATMENT OF CRANIO-ORBITAL TUMOR
The implants in the present study were patient spe-
cific and custom generated by validated software that
allowed mirroring of the contralateral uninjuredfronto-orbital region. The advantages of an implant
generated with mirroring procedures, in terms of
esthetic reconstruction and shorter operating time,
are maintained only if minor intraoperative revision
of the implant is needed.
In the present series, the preoperative determina-
tion of the craniotomy and orbital resection size was
performed virtually using 3D CT images, whereas Epp-ley et al,1 Eppley,2 Vougioukas et al,27 and Pritz and
Burgett32 reported planning of the resection on stereo-
lithographic models. In accordance with Eppley,2 the
authors suggest that the estimation of the amount of
bone to be excised be generous to avoid a time-
consuming procedure of bridging gaps between the
implant and bone resection edges in case of underesti-
mated osseous infiltration. Transfer of the preopera-tive plan to the operative field is the key to success.
In this case series, the authors used computer-
generated cutting guides for the exact guidance of
craniotomy and orbital rim resection. These cutting
guides must be solid and must fit in a precise position
on the skull. To have a precise fit and stability of the
template, the authors planned cutting guides with
arms within the orbit for 1 cm around the bony rims(Fig 4). Other investigators have used different
methods, such as navigation-guided craniotomy,27 rub-
ber,2 or aluminum27 templates fixed to the skull with
bone and screws.
The deep resection margins for sphenoid wing
meningiomas near the orbital apex were determined
with the help of intraoperative navigation and by the
individual skills of the surgeon.In this series, the plannedmargins of the craniotomy
were adequate and only minor adjustments of the
implants and bone edges were necessary. In all cases,
fixation of the implant required less than 30 minutes.
A shorter operative time was achieved and morbidity
related to the reconstruction procedure was minimal.
The Web conference for planning required approx-
imately 1 hour and the entire planning process lasted20 to 35 days.
The use of PEEK implants for cranio-orbital recon-
struction after tumor resection has been documented
in the literature.33,35-37,40 Before the introduction of
PEEK implants for craniofacial reconstruction, the
FIGURE4. Cutting guides are built with arms around the orbital rims to fit in a precise position on the skull. Arms help to orient the position of thetemplate (green, cutting guide; red, custom-made implant; blue, tumor).
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillofac Surg 2013.
FIGURE 5. Patient 1. A, B, Preoperative facial views of right exophthalmos and dystopia. (Fig 5 continued on next page.)
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillofac Surg 2013.
GERBINO ET AL 9
FIGURE 5 (cont’d). Patient 1.C, Preoperative coronal computed tomogram displays hyperostotic bone owing to an intraosseous meningioma.
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillofac Surg 2013.
10 TREATMENT OF CRANIO-ORBITAL TUMOR
major medical use of PEEKwas in vertebral fusion cage
implants and hip replacement implants.41
PEEK is a semicrystalline thermoplastic biocompat-
ible material with numerous physical characteristics
that are favorable for use in calvarial reconstruction.
FIGURE 5 (cont’d). Patient 1. D, Intraoperative use of cutting guide totherketone implant. t, temporal muscle; m, meningioma; Or, right orbit. (F
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillofac Sur
PEEK polymers have ideal imaging properties (they
are translucent to x-rays and nonmagnetic so they do
not create artifacts on CT or MR images, facilitating
postoperative diagnostic monitoring), good stiffness,
durability, light weight, fatigue and chemical
outline the area of resection that matches the size of the polyethere-ig 5 continued on next page.)
g 2013.
FIGURE 5 (cont’d). Patient 1. E, Three-dimensional model basedon data from computed tomogram (green, cutting guide; red,custom-made implant).
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillo-
fac Surg 2013.
GERBINO ET AL 11
resistance, and can be repeatedly sterilized without
degradation of their mechanical properties. Further-
more, their modulus may be adapted to closely match
that of cortical bone, which is important to avoid
shielding and modulus mismatch against the cortical
bone. PEEK implants are also nonallergenic. PEEK is
easily contoured with high-speed burrs and easily
fixed with a conventional plate and screw system,
FIGURE5 (cont’d). Patient 1. F, Reconstruction of bone defect with a poland screws. t, temporal muscle.
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillofac Sur
which are important features for single-step resection
and reconstruction procedures.
Lethaus et al33 reported that, unlike titanium, the
absence of a bioactive potential is the major disadvan-
tage of pure PEEK. A common disadvantage, as for all
alloplastic materials, is related to the potential for post-
operative infection.35-37,41 In the 3 present cases, no
infection of the implant was observed. PEEK implantuse after infection has been reported in the
literature.33,36,37
An important consideration in cranial reconstruc-
tion is the frontal sinus. Eppley2 reported that any
sinus exposure to the defect site likely will result in
eventual implant infection. Cranialization of the sinus
and exclusion of the frontonasal ducts is strongly advo-
cated.1,2 This statement is appropriate in cases inwhich porous implants, such as methylmethacrylate,
hard tissue replacement patient-matched implants,
and MEDPOR (Stryker, Kalamazoo, MI), are used.
For titanium implants and meshes and PEEK
implants that have no porous structure and are resis-
tant to infections, the authors believe that the interpo-
sition of vascularized tissue between the implant and
a physiologically aerated sinus system is adequate. Foran infected sinus, cranialization and obliteration of
the nasofrontal recess is mandatory. In patient 3, the
implant was in contact with a pedicled pericranial
flap interposed between the implant and the lateral
recess of a physiologically pneumatized frontal
sinus. No infection has been reported in 2 years of
follow-up.
yetheretherketone patient-specific implant fixed in position with plate
g 2013.
FIGURE 6. Patient 1.A, B, Postoperative facial views show good functional globe position and excellent postoperative cosmetic appearance.C, One-year postoperative coronal computed tomogram shows good reconstruction and no signs of recurrence.
Gerbino et al. Treatment of Cranio-Orbital Tumor. J Oral Maxillofac Surg 2013.
12 TREATMENT OF CRANIO-ORBITAL TUMOR
GERBINO ET AL 13
Diplopia occurred in all patients but resolved spon-
taneously. Diplopia was considered to be caused by
a minor imbalance of the extraocular muscles rather
than by paralysis of the muscles, which is thought to
be caused by tumor displacement, surgical resection,
or nerve displacement. The extraocular muscles in
the present patients were intact postoperatively.
Patient 2, who had slight visual impairment at presen-tation, recovered his visual loss, as documented by
ophthalmologic evaluation. No signs of restricted
gaze in the right eye were observed postoperatively.
The esthetic results were satisfactory, with no
asymmetries of the orbital rim and cranial convexity.
Preoperative exophthalmos was corrected in all
patients. In patients 1 and 2, the implants were
designed with incomplete reconstruction of the lat-eral wall, thus simulating a 1-wall orbital decompres-
sion (Figs 2C, 5, 6).
In conclusion, there are several advantages of the
present technique: 1) the preoperative model allows
the surgeon to plan the resection and reconstruction
before surgery; 2) single-step resection and recon-
struction shortens operative time and decreases
morbidity; and 3) the implant accurately restoresthe complex 3D structure of the resected bone
and minimal or no additional adjustments are needed
to position it. The use of custom-made implants
and cutting guides results in adequate reconstruction
of an anatomically complex area, with good func-
tional globe position, satisfactory extraocular muscle
function, and excellent postoperative cosmetic
appearance. Therefore, this method is indicated inselected cases in which complex reconstruction is
required. Conventional methods might be preferable
for cost-related reasons when the resected area is
small and does not involve a large portion of the
orbital rims and walls. Furthermore, the PEEK
implants were well tolerated; neither infections of
the implant material nor failures were observed in
the 3 present cases.The main limitation of this study is the small sample.
More experience and further long-term follow-up
studies are needed to evaluate a much larger patient
population with better control over the variables.
Nevertheless, this specific technique appears to be
a promising option for primary reconstruction of
cranio-orbital defects after benign tumor resection.
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