Single-Step Resection and Reconstruction Using Patient ... · and orbital protection. Restoration of anatomic and functional cranial and orbital contouring represents a challenge

SURGICAL ONCOLOGY AND RECONSTRUCTION

Rec

Tur

of H

Sch

De

and

Ne

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

Delta:1_given name

Delta:1_given name

Delta:1_given name

Delta:1_surname

Delta:1_given name

Delta:1_given name

Delta:1_given name

Delta:1_surname

Delta:1_given name

Delta:1_given name

Delta:1_given name

Delta:1_surname

Delta:1_given name

Delta:1_given name

Delta:1_given name

Delta:1_surname

Delta:1_given name

Delta:1_given name

mailto:[email protected]

mailto:[email protected]

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).



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 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.



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


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 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).



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).


FIGURE 5. Patient 1. A, B, Preoperative facial views of right exophthalmos and dystopia. (Fig 5 continued on next page.)


GERBINO ET AL 9

FIGURE 5 (cont’d). Patient 1.C, Preoperative coronal computed tomogram displays hyperostotic bone owing to an intraosseous meningioma.



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


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.


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 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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