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Surgical results of cranioplasty with a polymethylmethacrylate customized cranial implant in pediatric patients: A single-center experience

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OBJECTIVE Cranioplasty is a reconstructive procedure used to restore skull anatomy and repair skull defects. Optimal skull reconstruction is a challenge for neurosurgeons, and the strategy used to achieve the best result remains a topic of debate, especially in pediatric patients for whom the continuing skull growth makes the choice of material more difficult. When the native bone flap, which is universally accepted as the preferred option in pediatric patients, is unavailable, the authors' choice of prosthetic material is a polymethylmethacrylate (PMMA) implant designed using a custom-made technique. In this paper the authors present the results of their clinical series of 12 custom-made PMMA implants in pediatric patients. METHODS A retrospective study of the patients who had undergone cranioplasty at Gaslini Children's Hospital between 2006 and 2013 was conducted. A total of 12 consecutive cranioplasties in 12 patients was reviewed, in which a patient-specific PMMA implant was manufactured using a virtual 3D model and then transformed into a physical model using selective laser sintering or 3D printing. All patients or parents were administered a questionnaire to assess how the patient/parent judged the aesthetic result. RESULTS Patient age at craniectomy ranged from 5 months to 12.5 years, with a mean age of 84.33 months at cranioplasty. The mean extension of the custom-made plastic was 56.83 cm ² . The mean time between craniectomy and cranioplasty was 9.25 months. The mean follow-up duration was 55.7 months. No major complications were recorded; 3 patients experienced minor/moderate complications (prosthesis dislocation, granuloma formation, and fluid collection). CONCLUSIONS In this patient series, PMMA resulted in an extremely low complication rate and the custom-made technique was associated with an excellent grade of patient or parent satisfaction on long-term follow up.
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TECHNICAL NOTE
Cranioplasty is well established as a reconstructive
procedure in restoring skull anatomy and repairing
skull defects. The causes of skull defects are well
known and may be acquired or congenital. Skull defects
may produce disturbing deformity, lack of brain protec-
tion, and a variety of symptoms such as chronic headaches
and mild developmental delay in young children. In ad-
dition, the repair of cranial defects could provide relief
to psychological drawbacks and increase social perfor-
mance. Most commonly, cranioplasty in children younger
than 3 years of age is performed to correct growing skull
fractures and congenital anomalies, while in all age groups
tumor removal and previous decompressive craniectomies
are the most frequent reason for the defect.1
ABBREVIATIONS PMMA = polymethylmethacrylate.
SUBMITTED August 18, 2015. ACCEPTED October 23, 2015.
INCLUDE WHEN CITING Published online January 29, 2016; DOI: 10.3171/2015.10.PEDS15489.
* Drs. Fiaschi and Pavanello contributed equally to this work.
Surgical results of cranioplasty with a
polymethylmethacrylate customized cranial implant in
pediatric patients: a single-center experience
*Pietro Fiaschi, MD,2,5 Marco Pavanello, MD,1 Alessia Imperato, MD,1 Villiam Dallolio, MD,3
Andrea Accogli, MD,1,4 Valeria Capra, MD,1 Alessandro Consales, MD,1 Armando Cama, MD,1 and
Gianluca Piatelli, MD1
1Department of Pediatric Neurosurgery, Istituto Giannina Gaslini, Genoa; 2Department of Neurosurgery, San Martino - IST
University Hospital (IRCCS), Genoa; 3Department of Neurosurgery, ICCS Hospital, Milan; 4University of Genoa; and 5Department
of Neuroscience, University of Turin, Italy
OBJECTIVE Cranioplasty is a reconstructive procedure used to restore skull anatomy and repair skull defects. Optimal
skull reconstruction is a challenge for neurosurgeons, and the strategy used to achieve the best result remains a topic of
debate, especially in pediatric patients for whom the continuing skull growth makes the choice of material more difcult.
When the native bone ap, which is universally accepted as the preferred option in pediatric patients, is unavailable, the
authors’ choice of prosthetic material is a polymethylmethacrylate (PMMA) implant designed using a custom-made tech-
nique. In this paper the authors present the results of their clinical series of 12 custom-made PMMA implants in pediatric
patients.
METHODS A retrospective study of the patients who had undergone cranioplasty at Gaslini Children’s Hospital between
2006 and 2013 was conducted. A total of 12 consecutive cranioplasties in 12 patients was reviewed, in which a patient-
specic PMMA implant was manufactured using a virtual 3D model and then transformed into a physical model using
selective laser sintering or 3D printing. All patients or parents were administered a questionnaire to assess how the pa-
tient/parent judged the aesthetic result.
RESULTS Patient age at craniectomy ranged from 5 months to 12.5 years, with a mean age of 84.33 months at cra-
nioplasty. The mean extension of the custom-made plastic was 56.83 cm2. The mean time between craniectomy and
cranioplasty was 9.25 months. The mean follow-up duration was 55.7 months. No major complications were recorded; 3
patients experienced minor/moderate complications (prosthesis dislocation, granuloma formation, and uid collection).
CONCLUSIONS In this patient series, PMMA resulted in an extremely low complication rate and the custom-made
technique was associated with an excellent grade of patient or parent satisfaction on long-term follow up.
http://thejns.org/doi/abs/10.3171/2015.10.PEDS15489
KEY WORDS cranioplasty; polymethylmethacrylate; custom-made technique; pediatric reconstructive surgery
©AANS, 2016 J Neurosurg Pediatr January 29, 2016 1
P. Fiaschi et al.
J Neurosurg Pediatr January 29, 20162
The optimal skull reconstruction remains a challenge
for neurosurgeons, especially in pediatric patients, in
whom the strategy choice, commonly based on the fac-
tors of biocompatibility and cosmetic result, is made even
more difcult by the continuing skull growth with age. Re-
garding biocompatibility, many autograft, xenograft, and
allograft materials have now been used for cranioplasty.
Many characteristics have been suggested to describe the
ideal material for cranioplasty: biocompatibility features
such as tissue tolerance, simplicity of manufacture, ease of
sterilization, low thermal conductivity, radiolucency, light
weight and biomechanical reliability, resistance to infec-
tions, no dilatability with heat, low cost, ready to use, etc.,
but there is no perfect material that ts all of these criteria.
The various implant materials in use today are either au-
tografts or allografts.
Autologous bone grafts offer superior resistance to in-
fection and a decreased likelihood of extrusion but suffer
from variable resorption, difculties in reshaping, and do-
nor-site morbidities.3,9,10,20 While autologous bone is widely
used and favored in reconstructive procedures, synthetic
alternatives are indicated in select cases, such those with
severe bone graft resorption, bone comminution, infection,
and limited donor site options. Over time, metals, ceram-
ics, plastics, and recently, resorbable polymers and bioma-
terials have been used in craniofacial reconstructions.
Polymethylmethacrylate (PMMA) is a thermoplastic
and transparent plastic and is the most frequently used
material for allogenic cranial reconstructions with long-
term results. Zander, in 1940, was the rst physician to
implant a methylmethacrylate prosthetic into a patient.17
Chemically, PMMA is commonly called acrylic glass or
plexiglass. Methylmethacrylate proved to be superior to
metals because of its light weight, low cost, malleability,
radiolucency, and lack of thermoconduction. A disadvan-
tage of PMMA is that it behaves in a brittle manner when
loaded, especially under a strong impact force. Another
disadvantage of this cement is that during polymerization
it heats up to approximately 70°C, therefore it is manda-
tory to remove the modeled PMMA cranioplastic in a de-
formable status with a small but residual risk of modifying
the exact tting of the implant. If the polymerization pro-
cess takes place in situ, the surrounding tissue (dura mater
or cortex) could be severely damaged due to the heat.2 The
major advantage of PMMA is the exible intraoperative
application and the unlimited possibilities of adaptation
to individual anatomy. In the majority of all cases PMMA
cranioplasties are performed freehand. Solid PMMA is
nonporous and does not allow for the ingrowth of native
tissue; consequently, the integration with the surrounding
tissue often necessitates the use of hardware to immobi-
lize the implant. Porous PMMA is a modication of tra-
ditional PMMA that improved this aspect. It is composed
of acrylic bone cement and an aqueous carboxymethyl
cellulose gel. Histological analysis demonstrated that both
hard and soft tissues are able to “grow” into the pores of
the cement, thereby anchoring the implant to native struc-
tures, with evidence of bone ingrowth up to 4.5 mm into
the prosthesis.5 In addition, porous PMMA, despite having
30%–40% less material than nonporous PMMA, offered
no less impact resistance.7
Methods
A retrospective study was conducted of the hospital re-
cords of patients who had undergone cranioplasty at Gasli-
ni Children’s Hospital between 2006 and 2013 (Table 1).
A total of 12 consecutive cranioplasties using nonporous
PMMA (SIAD Healthcare Tecres Cranos) in 12 patients
were reviewed. The custom-made implants cost approxi-
mately 5 times as much as a noncustomized implant with
PMMA. With the purpose of manufacturing a PMMA
prosthesis using computer-aided design/computer-aided
manufacturing, a digital subtraction mirror image tech-
nique with 1-mm-thick spiral CT scan data (using infor-
mation from the contralateral side of the defect) was used.
We considered the following contraindications for cra-
nioplasty: the presence of hydrocephalus, infection, and
brain swelling. The DICOM data were then downloaded
to medical imaging visualization software for editing and
3D reconstruction to obtain a virtual 3D model of the skull.
Starting from a segmentation process, data on cranial
curvature are obtained. With information about the curves
of the shape of the affected side and the contralateral side
of the skull, a model of closure of the defect is proposed.
The curves obtained are then used as a framework on
which the virtual solid model is produced. The virtual
solid model is fused with the virtual model of the skull, to
verify the correct coupling.
The virtual model is then read from a prototyping ma-
chine that builds the solid model section by section. This
model is used to create the mold for the nal step of the
process. The PMMA is injected into the mold to obtain
(after the polymerization) the nal result ready to be ster-
ilized (Figs. 1–3). All patients or parents provided written
informed consent for this study.
The surgical procedure consists of reopening and fol-
lowing the previous incision and separating the epicranial
tissues to the dura mater and to the osseous contour. In
cases in which the prosthesis does not t perfectly on the
skull defect, it can be modied by drilling. The xation is
performed with mini plates or silk thread. To avoid epi-
dural uid collection the rm suspension of the dura mater
is crucial. All patients were strictly followed-up with se-
rial clinical evaluations at 7, 14, 21, and 28 days, a CT scan
at 6 months after the surgery, and clinical evaluation 12
months later. All families were administered a question-
naire (proposed by Fischer et al.)8 to assess how the pa-
tient (or parent in very young patients) judged the aesthetic
result (Table 2). The study was performed with approval
from the Giannina Gaslini Institutional Review Board.
Results
Patient age at craniectomy ranged from 5 months to
12.5 years (mean 75.08 months) with a mean age of 84.33
months at cranioplasty. The mean time between craniecto-
my and cranioplasty was 9.25 months. There were 6 boys
and 6 girls. All data concerning sex, age, etiology, and de-
fect dimension were recorded (Table 1). The mean follow-
up time was 55.7 months, ranging between 24 months (in
one of the oldest patients of the series, almost 11 years old)
and 96 months (in one of our youngest patients, 14 months
old). Two patients were previously treated elsewhere with
Cranioplasty with PMMA customized cranial implant
J Neurosurg Pediatr January 29, 2016 3
2 different techniques to cover the bone defect: 1 patient
(Case 8) had parietal bone splitting that underwent resorp-
tion after 8 months, and the other patient (Case 9) had an
initial acrylic resin cranioplasty that cracked after minor
head trauma. All complications are reported in Table 1; all
but 2 patients were treated conservatively.
One patient incurred prosthesis dislocation after a head
trauma (Case 6). He underwent a new surgical procedure
to replace the prosthesis. He was 39 months old at the time
of the trauma, and only 5 months had passed since the cra-
nioplasty, thus remanufacturing on the preexisting model
was performed.
In another case (Case 9) the prosthesis underwent spon-
taneous dislocation; in the previous procedure, the pros-
thesis was xed with absorbable sutures. At the second
intervention, the same prosthesis was used and xed with
resorbable plates and screws. The same patient experi-
enced a cutaneous foreign body granuloma, as a reaction
to intradermal absorbable suture. He consequently under-
went a cutaneous granuloma removal procedure and skin
closure with silk sutures. Case 4 showed an extradural and
subcutaneous uid collection (probably due to the lack of
surgical drain) with spontaneous recovery after a period
of compressive bandaging.
The mean extension of the custom-made plastic was
56.83 cm2, with the smallest extension only 6 cm2 and the
largest reaching 98 cm2. The aesthetic results, assessed
through the questionnaire noted above, were judged as
satisfying to very satisfying by all but 1 patient (Case 9,
wound revision due to a granuloma), with the implant size
estimated as medium in 7 cases, small in 4 cases, and
large in 1 case; the grade of satisfaction did not change
over time except for Cases 6 and 9, whose implants were
removed and replaced after dislocation. Medical compli-
cations related to cranioplasty are reported in Table 1.
Discussion
Cranioplasty is a reconstructive procedure used to
restore skull anatomy and repair skull defects. Optimal
skull reconstruction is a challenge for neurosurgeons and
the strategy to achieve the best result remains a topic of
debate. There are 3 main determinants that inuence the
choice. The rst is biocompatibility: many features should
be evaluated, such as tissue tolerance, allergic reaction,
early vascularization, possibility of intraoperative ther-
mic damage, thermal conductivity, and resistance to in-
fections. The second determinant is the cosmetic result.
Regarding the aesthetic outcome, an important innovation
in the cranioplasty technique had been achieved with the
novel method of rapid prototyping, developed in the past
few decades. This method offers the possibility of pre-
operatively forming various materials into custom-made
implants to precisely t each individual’s cranial defect.
This procedure has been demonstrated to not signi-
cantly increase the overall treatment cost, together with
TABLE 1. Patients who underwent cranioplasty at Gaslini Children’s Hospital (2006–2013)
Case
No. Sex Diagnosis Location
Age at
Craniectomy
(mos)
Age at
Cranioplasty
(mos) Other
Cranioplasty
Defect
Dimension
(cm2)Complications FU
(mos)
1 F Meningioma Frontoparietal
(bilat) 140 148 82 None 84
2 F Osteoma Lt parietooccipital 14 34 48 None 96
3 F TBI Lt parietal 10 20 49 None 80
4 F Plagiocephaly Lt frontoparietal 70 75 35 Intracranial hypotension,
uid collections
73
5 M TBI Rt parietal 100 109 55 None 55
6 M Trigonocephaly Frontal (bilat) 534 Later acrylic resin 80 After 6 mos: head injury,
prosthesis dislocation,
re moval & new acrylic
implant
58
7 F Fibrous dysplasia Lt parietal 150 155 61 None 53
8 M TBI Lt frontotemporal 68 79 Previous parietal
bone splitting
(resorption)
87 EEG alterations, anticonvul-
sant therapy, no crisis 47
9 M Temporal AVM
+ aneurysm
(intracerebral
hematoma)
Lt frontotemporo-
occipital 54 58 Previous acrylic
resin (rupture) 50 After 2 mos prothesis
dislocation, xation w/
resorbable plates &
screws; after 23 mos
granuloma formation,
wound revision
45
10 MFibrous dysplasia Lt occipital 59 62 31 None 28
11 FFibrous dysplasia Rt hemispheric 130 130 98 None 24
12 MHistiocytosis Rt pterional 101 108 6 None 25
AVM = arteriovenous malformation; EEG = electroencephalography; FU = follow-up; TBI = traumatic brain injury.
P. Fiaschi et al.
J Neurosurg Pediatr January 29, 20164
a signicant patient benet, compared with those patients
who underwent autologous bone cranioplasty11 and con-
sequently can be reasonably considered the gold standard
cranial defect repair method when the native bone ap
is unavailable. To produce a custom-made prefabricated
PMMA prosthesis (such as in our patients) manufactured
using CAD/CAM, a preoperative, transversal, 1-mm spiral
CT scan with 3D reconstruction of the cranium has to be
performed before surgery. Each implant then undergoes
a sterilization process.16 In addition to the signicant ad-
vantage of improving the cosmetic result (mostly in large
skull defects), custom-made cranioplasty implantation im-
plies a shorter operative time, a positive effect on the heal-
ing process, less invasiveness and low bleeding risk, fewer
infectious complications, no donor site morbidity from the
use of allografts, and faster recuperation compared with
intraoperatively molded cranioplasty surgery. In addition,
in the case of infection or early trauma, the customized
implant may be easily remanufactured on the preexisting
model.6,15,18,19,21 Application of the custom-made technique
does, however, have a few disadvantages. First, it is rela-
tively expensive: it costs approximately 5 times more than
a noncustomized implant with the same material. Second,
the problem of temporal muscle atrophy after a crani-
ectomy also persists using a custom-made cranioplasty
implant, which causes some asymmetry in the temporal
regions. Third, custom manufacturing of a prefabricated
PMMA prosthesis is very time consuming.12 While in
adult patients the main determinants of material choice
are biocompatibility and cosmetic results, in pediatric pa-
tients a third concern is the continuing skull growth with
age, especially in young children. The major skull growth
occurs in the rst 2 years, achieving about 84% of the
adult size, with a strong deceleration after that age. Even
FIG. 1. Case 1. Preoperative CT (upper row) and MR images (lower row) of a 140-month-old patient affected by a falcine menin-
gioma with hyperostotic deformation of the skull.
TABLE 2. Five questions asked to assess how the patient (or parent, in very young patients) judged the aesthetic result of the procedure*
1. Please estimate the size of your implant (small/medium/large)†
2. Choose one of the following statements, which best describes your satisfaction with the aesthetic result of cranioplasty:
a. I do not accept the aesthetic result after cranioplasty & would like to improve the appearance with another surgical intervention
b. I am not satised with the aesthetic result
c. I am satised with the aesthetic result
d. I am very satised with the aesthetic result & think that the cranioplasty does not impair my appearance at all
3. If you are dissatised, please indicate the reason for your dissatisfaction: e.g., dents, bulges, scars, or bulging of bone edges
4. Did your grade of satisfaction change over time after cranioplasty?
5. Did you have any medical complications after cranioplasty?
* As proposed by Fischer et al.8
† Implant size was assessed objectively from radiological images and postoperative treatment from patient records. The slice of greatest cross-sectional area of the
defect was chosen for size analysis: small, medium, and large defects were dened as ≤ 50 cm2, 50–100 cm2, and ≥ 100 cm2, respectively.
Cranioplasty with PMMA customized cranial implant
J Neurosurg Pediatr January 29, 2016 5
in the youngest patients we did not encounter a lack of
ability of the prosthesis (made of nonporous PMMA) to
become integrated over time, consistent with the growth
of the pediatric skeleton. Porous PMMA is a modication
of traditional PMMA that further improves this aspect,
with its particular architecture allowing ingrowth of na-
tive tissue, resulting in a better xation of the prosthesis.
The 3D pore structure serves as an effective “scaffold”
for the attachment of osteoprogenitor cells, and as a sub-
strate for deposition of new extracellular matrix material.13
Acrylic cranioplasty is generally well tolerated in the adult
population, despite an overall complication rate ranging
between 5% and 25% and an infection rate of 5%–20%
in different series.4,5,14 Conversely, hydroxyapatite cranio-
plasty was found to have the highest complication rate,
mostly due to infection and material exposure.
When the native bone ap (universally accepted as the
preferred option in pediatric patients) is unavailable, our
choice of prosthetic material is PMMA; in addition to the
above-mentioned explanation, we prefer it for many other
reasons: it is one of the most biocompatible alloplastic ma-
terials currently available, with a low rate of foreign body
reaction, and provides adequate protection for the under-
lying neural tissues, comparable to that of native osseous
tissue. Furthermore, the custom-made technique offers
important advantages, such as an implant that perfectly
ts to the bone defect, the avoidance of exposing intra-
cranial tissue to the heat of polymerization, the absence
of monomer residue and dust produced during intraopera-
tive molding, and easy remanufacturing on the preexisting
model in cases of infection or early trauma. In addition,
we determined the already mentioned shorter operative
time to be of particular importance in children due to de-
creased intraoperative blood loss.
In our patient series the choice of implant material was
evaluated on a case-by-case basis and discussed with the
parents, who were informed about the features, benets,
and risks of the available materials. None of the proce-
dures we performed caused symptomatic foreign body
reactions, nor an infection rate. In addition to the intrinsic
porus architecture of PMMA, we believe that the surgical
lling of the prosthesis with periosteal tissue may help fu-
ture bone growth as a “scaffold” for the osseous margins
of the cranial gap. The mean follow-up duration time was
55.7 months, with two of the longest follow-up durations in
the second- and third-youngest patients (10 and 14 months
old, respectively). As reported in the questionnaire, these
2 patients did not experience any complications or residual
skull defects, with a high level of cosmetic satisfaction.
Conclusions
A large skull defect mandates subsequent cranioplasty.
This procedure is full of possible complications. Our choice
of implanting a custom-made PMMA prosthesis was accu-
rately discussed with the parents when the native bone ap
was unavailable. In our series, use of PMMA resulted in
an extremely low complication rate and the custom-made
technique was associated with an excellent grade of patient
or parent satisfaction on long-term follow-up.
Acknowledgements
We are grateful to Dr. A. Rossi for his contribution and the
images provided.
FIG. 2. Case 1. Postoperative CT scan (A) with 3D reconstruction (B)
and MR images (C) 3 months after custom-made prosthesis implanta-
tion.
FIG. 3. Case 1. Intraoperative images at the age of 148 months, includ-
ing the custom-made prosthesis before implantation (right) and how it
perfectly ts to the skull defect (left). Figure is available in color online
only.
P. Fiaschi et al.
J Neurosurg Pediatr January 29, 20166
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Disclosures
The authors report no conflict of interest concerning the materi-
als or methods used in this study or the findings specified in this
paper.
Author Contributions
Conception and design: Fiaschi, Pavanello, Imperato, Dallolio,
Piatelli. Acquisition of data: Consales. Analysis and interpretation
of data: Consales. Drafting the article: Accogli, Capra, Cama.
Study supervision: Capra.
Correspondence
Pietro Fiaschi, Department of Neurosurgery, San Martino - IST
University Hospital (IRCCS), Largo Rosanna Benzi 10, Genoa
16132, Italy. email: pietro.fiaschi@alice.it.
... The limitations of this material include shrinkage of material and the absence of pores, especially if tissue repair is necessary. Fiaschi et al. [84] improved traditional nonporous PMMA by crosslinking with aqueous carboxymethyl cellulose resulting in hydrogel formation in 3D pre-printable mold acquired by virtual CAD model. Porous PMMA offered sufficient impact resistance and provided cell growth in prosthesis. ...
Preprint
Full-text available
Maxillofacial defects, arising from trauma, oncological disease or congenital differences, detrimentally affect everyday life. Prosthetic repair offers the aesthetic and functional reconstruction with the help of materials mimicking natural tissues, among which polymers take unprecedented role. The three-dimensional (3D) printing techniques based on the computer-aided design, where polymers are essential, provide a rapid and cost-effective workflow protocol to perfectly restore patient-specific anatomy for prosthetics. This review discusses the main 3D printing approaches to maxillofacial prostheses fabrication: extrusion and lithography, which are radically preferable to the traditional methods. The main assessment criteria, affording the polymer implementation in 3D printing of prostheses, as well as the characteristics of the key advanced polymers, are considered. The success of the prosthesis is shown to be largely dependent on the retention system, predominantly using polymers in the form of adhesives and osseointegrated implants as a support for the prosthesis. The approaches and technological prospects are also discussed in the context of specific aesthetic restoration on the example of the nasal, auricle and ocular prostheses. 3D printing techniques determine the development of personalized approaches to improve aesthetic and functional effect of prosthetics in patients with maxillofacial defects.
... It is possible to view, segment, and display objects from 2D DICOM pictures produced by CT scans in 3D by importing them into Mimics software, which includes interfaces for all main scanner formats. The Segmentation, Simulation, and Import/Export modules are all part of the Mimics program [35][36][37][38]. The slice pictures produced by the CT scan can be automatically imported into the Mimics software [39]. ...
... Titanium plates offer an excellent choice for cranioplasty based on their strength, low infection rate, biocompatibility, handling characteristics, and suitability for postoperative imaging techniques, but they are often avoided because of their high costs [4,5] . Polymethyl methacrylate bone 683 cement is another excellent choice for cranioplasty as it is easy to mold, less irritant to surrounding tissues, has a good cosmetic result, is affordable, and can be impregnated with antibiotics so the rate of infection can be lowered [5,6,7] . However, any synthetic material implanted may lead to infection or seroma that may lead to exposure of the construct and may need reoperation [3] . ...
... Titanium mesh, PEEK, polymethylmethacrylate, acellular bone autografts, and hydroxyapatite implants are being utilised to treat bony defects of the skull. 64,65 Currently, titanium mesh is the primary choice. However, the inherent disadvantages of titanium mesh, such as its high thermal conductivity, deformation in vivo, and artefact generation in medical imaging examinations, cause many difficulties. ...
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Polyether-ether-ketone (PEEK) is believed to be the next-generation biomedical material for orthopaedic implants that may replace metal materials because of its good biocompatibility, appropriate mechanical properties and radiolucency. Currently, some PEEK implants have been used successfully for many years. However, there is no customised PEEK orthopaedic implant made by additive manufacturing licensed for the market, although clinical trials have been increasingly reported. In this review article, design criteria, including geometric matching, functional restoration, strength safety, early fixation, long-term stability and manufacturing capability, are summarised, focusing on the clinical requirements. An integrated framework of design and manufacturing processes to create customised PEEK implants is presented, and several typical clinical applications such as cranioplasty patches, rib prostheses, mandibular prostheses, scapula prostheses and femoral prostheses are described. The main technical challenge faced by PEEK orthopaedic implants lies in the poor bonding with bone and soft tissue due to its biological inertness, which may be solved by adding bioactive fillers and manufacturing porous architecture. The lack of technical standards is also one of the major factors preventing additive-manufactured customised PEEK orthopaedic implants from clinical translation, and it is good to see that the abundance of standards in the field of additive-manufactured medical devices is helping them enter the clinical market.
... Nevertheless, titanium mesh may cause artefacts during CT or MRI (31). The PMMA family behaves in a brittle manner under strong impact forces, is exothermic during polymerisation, and may cause further damage to the surrounding tissues (32). A single-centre cohort study provided Level 3 evidence that custom-made hydroxyapatite bone flaps showed better osseointegration, lower reoperation rate, and higher patient satisfaction than PMMA materials (33). ...
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Cranioplasty with polyetheretherketone (PEEK) has recently shown better cerebral protection performance, improved brain function, and aesthetic contour compared with titanium mesh. However, whether patients undergoing PEEK cranioplasty tend to develop subgaleal effusions remains elusive. This retrospective study included patients who underwent cranioplasty with PEEK implants or titanium mesh after decompressive craniectomy between July 2017 and July 2020. Patient information, including general information, location, size of the defect, subgaleal depth, and brain midline shift was collected and statistically analyzed. There were 130 cases of cranioplasty, including 35 with PEEK implants and 95 with a titanium mesh. Patients who underwent cranioplasty with a PEEK implant had a higher subgaleal effusion rate than those who underwent cranioplasty with titanium mesh (85.71% vs. 53.68%, P < 0.001), while a midline shift >5 mm was more frequently observed in the PEEK group than in the titanium group (20% vs. 6.3%, P = 0.021). The PEEK material was the only factor associated with subgaleal effusion after cranioplasty (OR 5.589, P = 0.002). Logistic regression analysis further showed that age was a protective factor against midline shift in the PEEK cranioplasty group (OR 0.837, P = 0.029). Patients who underwent cranioplasty with PEEK implants were more likely to develop severe subgaleal effusion and significant brain midline shifts than those with titanium mesh implants.
... Titanium mesh, PEEK, polymethylmethacrylate, acellular bone autografts, and hydroxyapatite implants are being utilised to treat bony defects of the skull. 64,65 Currently, titanium mesh is the primary choice. However, the inherent disadvantages of titanium mesh, such as its high thermal conductivity, deformation in vivo, and artefact generation in medical imaging examinations, cause many difficulties. ...
Article
Maxillofacial defects, arising from trauma, oncological disease or congenital abnormalities, detrimentally affect daily life. Prosthetic repair offers the aesthetic and functional reconstruction with the help of materials mimicking natural tissues. 3D polymer printing enables the design of patient-specific prostheses with high structural complexity, as well as rapid and low-cost fabrication on-demand. However, 3D printing for prosthetics is still in the early stage of development and faces various challenges for widespread use. This is because the most suitable polymers for maxillofacial restoration are soft materials that do not have the required printability, mechanical strength of the printed parts, as well as functionality. This review focuses on the challenges and opportunities of 3D printing techniques for production of polymer maxillofacial prostheses using computer-aided design and modeling software. Review discusses the widely used polymers, as well as their blends and composites, which meet the most important assessment criteria, such as the physicochemical, biological, aesthetic properties and processability in 3D printing. In addition, strategies for improving the polymer properties, such as their printability, mechanical strength, and their ability to print multimaterial and architectural structures are highlighted. The current state of the prosthetic retention system is presented with a focus on actively used polymer adhesives and the recently implemented prosthesis-supporting osseointegrated implants, with an emphasis on their creation from 3D-printed polymers. The successful prosthetics is discussed in terms of the specificity of polymer materials at the restoration site. The approaches and technological prospects are also explored through the examples of the nasal, auricle and ocular prostheses, ranging from prototypes to end-use products.
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Background: Pediatric cranio-orbital tumors have several etiologies and given the broad spectrum of pathology, it is difficult to predict the extent of resection. Reconstruction in children and adolescents is particularly challenging due to potential craniofacial growth and the relatively limited availability of donor sites. In this review, we analyze 10 pediatric and adolescent cases from a single institution, discuss the existing literature, and propose a reconstruction algorithm for managing these complex defects. Methods: A retrospective chart review was performed to identify pediatric and adolescent patients with cranio-orbital tumors who underwent tumor resection and reconstruction at our institution between January 2012 and July 2022. Results: A total of 10 patients underwent oncoplastic reconstruction of defects of either the cranium alone or combination of cranium and orbit, with a mean age of 12.4 years (range: 2-20). The defects involved the parietal (n = 3, 30%), parietooccipital (n = 1; 10%), temporoparietal (n = 1; 10%), occipital (n = 1, 10%), and fronto-orbital (n = 4; 40%) regions. Cranioplasty was performed with split-thickness bone grafts, exchange cranioplasty, or alloplastic materials. A pericranial flap was used to isolate intracranial and extracranial contents in 2 cases. Free flaps were utilized for additional soft tissue coverage in 2 cases. Complications included free flap venous thrombosis, CSF leak, hardware exposure, sagittal sinus injury, superior sagittal sinus thrombosis, vertical diplopia, and hypertropia. Conclusion: The goals of oncoplastic reconstruction for cranio-orbital defects in pediatric and adolescent patients align with those in adults. However, reconstructive surgeons must consider age-specific differences, such as growth potential and limited donor sites. Effective reconstruction can be achieved through meticulous planning, clear communication, and a multidisciplinary approach.
Chapter
Maxillofacial surgery was among the first to understand the potential of rapid prototyping and three-dimensional printing as an aid in the preparation and execution of surgery. The reasons are to be found in the fact that, especially in the early years of the development of this technology, both the hardware and the software were more easily able to manage digital information regarding bones compared to soft tissues. Since the beginning of three-dimensional printing, it has been easier to prepare models for bones, materials such as ABS were rigid and robust, perfect for simulating bone, much less for reproducing cartilage or muscle.
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Acquired skull deformities are common and most likely treated surgically by cranioplasty. Since data on patient aesthetic outcome after cranioplasty are rare in literature, we aimed to assess patient satisfaction after polymethyl-methacrylate (PMMA) cranioplasty in this study using a questionnaire. A patient questionnaire was developed to evaluate the grade of satisfaction after surgery. After approval by the institutional ethical review board, we were allowed to send to all 115 patients, who received a cranioplasty from 2001 to 2008 at the University Hospital of Zurich, our questionnaire once to retrospectively analyze the patient response together with the patient hospital records. Out of 115 patients, 36 patients were lost to follow-up and our questionnaire was sent out once to 79 patients. Sixty-three of 79 patients replied to the questionnaire (79·7%) and 16 did not reply. Seventeen declined to participate in this study and out of the remaining 46 patients (58·2%, 18 women, mean age 54 years, range 20-83 years), who agreed to participate in this study, 22 (47·8%) judged their cranioplasty to be aesthetically 'excellent', 16 (34·8%) 'favorable' and 4 (8·7%) 'poor'. Another four patients (8·7%) were not satisfied, asking for a surgical revision. Patient age and gender was not related to the assessment of the aesthetic result. A higher satisfaction grade was found in patients with primary PMMA cranioplasty compared to PMMA cranioplasty implanted during a second surgery (Fisher's exact test, P = 0·031). A dent was strongly associated with absence of satisfaction (P<0·01, Fisher's exact test). Our questionnaire was suitable to assess patient satisfaction after cranioplasty. Localization of cranioplasty showed to be an important factor of aesthetic outcome, especially in the fronto-temporal region where a carefully planned reconstruction should be performed to guarantee an excellent grade of satisfaction after surgery.
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Cranioplasty is the surgical intervention to repair cranial defects. The aim of cranioplasty is not only a cosmetic issue; also, the repair of cranial defects gives relief to psychological drawbacks and increases the social performances. Many different types of materials were used throughout the history of cranioplasty. With the evolving biomedical technology, new materials are available to be used by the surgeons. Although many different materials and techniques had been described, there is still no consensus about the best material, and ongoing researches on both biologic and nonbiologic substitutions continue aiming to develop the ideal reconstruction materials. In this article, the principle materials and techniques of cranioplasty are reviewed.
Article
Cranioplasty can be performed either with gold-standard, autologous bone grafts and osteotomies or alloplastic materials in skeletally mature patients. Recently, custom computer-generated implants (CCGIs) have gained popularity with surgeons because of potential advantages, which include preoperatively planned contour, obviated donor-site morbidity, and operative time savings. A remaining concern is the cost of CCGI production. The purpose of the present study was to objectively compare the operative time and relative cost of cranioplasties performed with autologous versus CCGI techniques at our center. A review of all autologous and CCGI cranioplasties performed at our institution over the last 7 years was performed. The following operative variables and associated costs were tabulated: length of operating room, length of ward/intensive care unit (ICU) stay, hardware/implants utilized, and need for transfusion. Total average cost did not differ statistically between the autologous group (n = 15; $25,797.43) and the CCGI cohort (n = 12; $28,560.58). Operative time (P = 0.004), need for ICU admission (P < 0.001), and number of complications (P = 0.008) were all statistically significantly less in the CCGI group. The length of hospital stay and number of cases needing transfusion were fewer in the CCGI group but did not reach statistical significance. The results of the present study demonstrated no significant increase in overall treatment cost associated with the use of the CCGI cranioplasty technique. In addition, the latter was associated with a statistically significant decrease in operative time and need for ICU admission when compared with those patients who underwent autologous bone cranioplasty.Level of evidence: IV, therapeutic.
Article
The aim of this study was to assess quantitatively whether a symmetric reconstruction of the calvaria could be achieved using 3-dimensional (3D) custom-made implants and to examine any complications caused by the cranioplasty. Custom-made cranial implants were produced using data obtained from computed tomographic scanning of the defect using computer-aided design and rapid prototyping techniques. Polymethylmethacrylate was used as the reconstruction material and the implant was cast from a silicone rubber mold. These implants were used in 10 patients (9 men and 1 woman) who previously received a craniectomy. The symmetry gained after cranioplasty was quantified by volumetric analysis using 3D reconstructed postoperative computed tomographic imaging. Any complications after cranioplasty also were recorded. The average follow-up was 42.5 months (range, 7 to 85 mo). The esthetic appearance of all patients was much improved. When the volume of the reconstructed right calvaria was compared with the left calvaria, the difference was not statistically significant (P > .05). There were 2 cases of complications. One exhibited a transient seroma collection. Another had a wrinkle formation in the forehead. No infectious episodes or signs of plate rejection were encountered. The custom-made implants for cranioplasty showed a significant improvement in morphology. The implants may be very useful for repairing large and complex-shaped cranial defects. The technique may be useful for the bone reconstruction of other sites.
Article
Primary autologous particulate bone grafting has been demonstrated to heal osseous defects after fronto-orbital advancement. We sought to determine if this technique was equally effective for larger defects resulting from major cranial expansion procedures. We studied children who underwent cranial expansion (other than fronto-orbital advancement) between 1989 and 2008. Defects either were left to heal spontaneously (group 1) or had autologous cranial particulate bone graft placed over dura at the time of cranial expansion (group 2). Particulate bone graft was harvested from the endocortical or ectocortical surface using a hand-driven brace and bit. Outcome variables were ossification and need for revision cranioplasty. The study included 53 children. Mean (SD) age at procedure was 12.2 (8.1) months (range, 1.0-36.0 months) for group 1 (n = 15) and 20.2 (15.1) months (range, 3.3-78.6 months) for group 2 (n = 38) (P = 0.06). There were palpable bony defects in 33.0% (n = 5) of group 1 patients versus 7.9% (n = 3) of group 2 patients (P = 0.03). Corrective cranioplasty was needed in 26.7% of group 1 patients and only 5.3% of those in group 2 (P = 0.04). Primary cranial particulate bone grafting significantly reduced the frequency of osseous defects and secondary cranioplasty following cranial remodeling.
Article
After studying this article, the participant should: 1. Be able to define indications and timing for secondary cranioplasty. 2. Understand the surgical options for reconstructing the cranium and overlying soft-tissue defect including their advantages and disadvantages. 3. Be able to apply this knowledge to the clinical setting of an infectious bone flap loss. Infection after craniotomy occurs in approximately 1.1 to 8.1 percent of cases and often necessitates bone flap removal. For a secondary cranioplasty, there is an increased risk of recurrent infection, which influences the reconstructive plan. The soft tissue/scalp is frequently compromised by infection, sequelae of prior surgery, and/or adjuvant radiation therapy. A literature review was conducted to compile and summarize the indications for secondary cranioplasty after infectious bone flap loss, the timing of the procedure, and the surgical options for bone and soft-tissue reconstruction. In coordination with soft-tissue coverage, cranioplasty options include alloplastic reconstruction, allogeneic or autogenous bone grafts, and free tissue transfer. The literature review identified the following factors that must be considered in the treatment plan for secondary cranioplasty after postneurosurgical bone flap loss: indications, timing of reconstruction, soft-tissue status and the need for soft-tissue reconstruction, and method of cranioplasty. Treatment recommendations for cranioplasty in the clinical setting of infectious postneurosurgical bone flap loss are presented. These guidelines consider the risk factors for a recurrent infection, the condition of the soft-tissue coverage, and the concavity of the preoperative cranial deformity.
Article
In this retrospective study we attempted to assess the clinical performance of prefabricated polymethyl methacrylate (PMMA) prostheses and to determine whether they outperform intra-operatively moulded PMMA prostheses in reducing operating time, blood loss and surgical complications in elective delayed cranioplasty operations, after decompressive craniectomy, to repair large (> 100 cm2) cranial defects. Patients (n=131) were divided into three groups according to the cranioplasty technique used. Group 1 patients received fresh frozen autograft bone that had been removed at the craniectomy and refrigerated at -80 degrees C. Group 2 included patients whose PMMA prosthesis was moulded intra-operatively. Group 3 patients received a custom-made prefabricated PMMA prosthesis manufactured using computer-aided design/computer-aided manufacturing (CAD/CAM). Group 2 patients required significantly more operating time than both group 1 (p<0.001) and group 3 (p<0.001) patients, but operating time did not differ significantly between groups 1 and 3 (p>0.05). Mean intra-operative blood loss was significantly higher in group 2 than in group 1 (p=0.015) but did not differ significantly between group 1 and group 3 (p>0.05). The infection rate associated with prefabricated PMMA prostheses was lower than that for intra-operatively moulded PMMA prostheses and was comparable to that for autograft bone flaps. A CAD/CAM PMMA prosthesis is an excellent alternative when no autogenous bone graft harvested during craniectomy is available.
Article
Cranioplasty is a surgical repair of a structural or morphological deformity of the skull, involving the resection, remolding and displacement of the bones of the head. As it pertains to abnormal head shape, cranioplasty is an operative procedure aimed to fill a gap in the cranial theca or to replace bone removed either as a result of trauma or infection, by means of a biocompatible artificial bony substitute. In the present paper authors report a case of custom-made cranioplasty for the reconstruction of a large bilateral skull defect, based on advanced computerized tomography data processing and rapid prototyping (stereolithography) techniques.
Article
The complexity of cranioplasty increases with increased defect size. It is difficult to produce a symmetric, accurate implant presurgically or at the time of surgery when the defect is greater than 50 cm2. The procedure is also more difficult to perform when the defect is located in the temporal, infratemporal, or frontal areas. A new procedure generates a three-dimensional cast of the skull through computed tomography and computer-aided design reformation. This article describes the process of model generation and the production of a preprocessed cranial implant. To date, six cranial implants have been made with this technique. The whole head models are accurate and help the neurosurgeon-prosthodontist team in the creation of a symmetric, anatomically correct restoration. It is the technique of choice for large implants or where the cranial bones are thin. It is not necessary to augment or alter the implant during surgery. The technique reduces surgical time, and postsurgical complications have been minimal.