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SRM Orbital recon
SRM Orbital recon
*Resident, Department of Oral & Maxillofacial Surgery, MGM Address correspondence and reprint requests to Dr Natarajan:
Dental College & Hospital, Navi Mumbai, Maharashtra, India. Department of Oral & Maxillofacial Surgery, MGM Dental College
yDean, Professor and Head, Department of Oral & Maxillofacial & Hospital, Sector – 1 Kamothe, Navi Mumbai, Maharashtra, India
Surgery, MGM Dental College & Hospital, Navi Mumbai, 410209; e-mail: srivalli.shrikanth@gmail.com
Maharashtra, India. Received October 16 2023
zAssistant Professor, Department of Oral & Maxillofacial Surgery, Accepted March 26 2024
MGM Dental College & Hospital, Navi Mumbai, Maharashtra, India. Ó 2024 American Association of Oral and Maxillofacial Surgeons
xAssociate Professor, Department of Oral & Maxillofacial Surgery, 0278-2391/24/00213-1
MGM Dental College & Hospital, Navi Mumbai, Maharashtra, India. https://doi.org/10.1016/j.joms.2024.03.031
Conflict of Interest Disclosures: None of the authors have any
relevant financial relationship(s) with a commercial interest.
1
2 DO TECHNOLOGICAL AIDS PRODUCE BETTER OUTCOMES IN ORBITAL RECONSTRUCTION?
lack of randomized studies. This review should serve as a recommendation for further studies to contribute
to the existing literature.
Ó 2024 American Association of Oral and Maxillofacial Surgeons
J Oral Maxillofac Surg -:1-14, 2024
The orbit is one of the most complex and intricate traumatic orbital defects. Additionally, the review also
structures in the human skeleton. Orbital fractures assesses the outcomes associated with various orbital
occur due to a sudden rise in intraorbital pressure, implant designs, such as standard orbital mesh, pre-
causing fractures of these frail and delicate orbital formed implants, prebent implants, and PSIs.
walls.1 The normal position of the globe within the
orbit is maintained by a balance between the orbital Materials and Methods
volume and intraorbital soft tissue.2 Reconstructing
post-traumatic orbital defects is complex and requires Protocol and Registration: The protocol was regis-
precise techniques and sound knowledge. Due to the tered in the International Prospective Register of Sys-
narrow operating field, the surgery is heavily reliant on tematic Reviews under registration number
skill, knowledge, and experience of the surgeon.1 CRD42023415564. The systematic review was con-
Complex cases involving the orbit still pose a signifi- ducted in accordance with the Preferred Reporting
cant challenge due to the complex anatomy and diffi- Items for Systematic Reviews and Meta-Analyses
culty in replicating the geometry, dimensions, and statement.12
volume, which have a very narrow margin for error
from an esthetic and functional stand point.3 Focus Question and Population,
Conventional reconstruction methods afford the ad-
Intervention, Comparison, and Outcome
vantages of availability and ease of intraoperative
Criteria
manipulation while also being cost-effective.4 Howev-
er, these lack the personalized approach that is desired The focus question was developed according to the
while reconstructing an anatomically challenging area population, intervention, comparison, and outcome
like the orbit. This particular lacuna is filled by the study design: ‘‘In patients requiring post-traumatic
incorporation of various technological aids in the sur- orbital reconstruction, does the integration of techno-
gical management of orbital fractures. logical aids (CASP, MIO, ION) and different orbital
The advent and widespread use of computer-assisted implant designs (prebent, PSI) contribute to improved
surgical planning (CASP) and computer-aided design outcomes in terms of orbital volume, diplopia, and
and computer-aided manufacturing (CAD-CAM) has enophthalmos?’’
paved the way for personalized solutions for orbital Population (P): Patients requiring post-traumatic
reconstruction.4 This may include either of the two: orbital reconstruction. Intervention (I): Open reduc-
1. Computed tomography (CT) scan-derived mirror im- tion and internal fixation with integration of techno-
age overlay (MIO) from the contralateral, uninjured logical aids (CASP, MIO, ION) and different orbital
orbit to obtain a stereolithographic three-dimensional implant designs (prebent, PSI). Comparison (C):
model serving as a template onto which an orbital Open reduction and internal fixation without integra-
implant can be prebent preoperatively. 2. Fabrication tion of technological aids and use of standard orbital
of a patient-specific implant (PSI), which involves a mesh/preformed implant. Outcomes (O): Primary out-
CT scan-derived MIO followed by virtual design and is comes (orbital volume, enophthalmos, diplopia) and
usually manufactured externally, thus not requiring secondary outcomes (intraoperative time, postopera-
the step of precontouring.5-8 One of the first orbital tive implant position, restricted ocular motility).
reconstructions with a PSI was reported in 2010.9 Addi- Search Strategy: Electronic searches of MEDLINE,
tionally, intraoperative imaging techniques such as in- Embase, Cochrane Library, and Google Scholar data-
traoperative CT and intraoperative navigation (ION) bases until March 2023 were conducted using key
can provide real-time visualization and guidance during words such as orbital floor fracture, blowout fracture,
surgery, enabling the surgeon to make informed deci- orbital injury, orbital trauma, orbital reconstruction,
sions and adjustments as needed. Finally, the use of PSI, prebent, computer-assisted surgery planning,
augmented reality and virtual reality technologies may ION, and orbital implants.
have potential for intraoperative visualization and guid- Selection Criteria: The inclusion criteria were: 1)
ance in the future.10,11 randomized controlled trials (RCTs), controlled clin-
This systematic review aims to compare and evaluate ical trials (CCTs), clinical studies, case-control studies,
the outcomes of different technological aids, namely, cohort studies, and retrospective studies; 2) studies
CASP, MIO, and ION, in the reconstruction of post- integrating technological aids for post-traumatic
SAPTARSHI ET AL 3
Without Navigation Fan et al1 2017 MIO + 3D Printing Prebent vs Standard orbital
3D planning software: MIMICS mesh
software (V17, Materialize,
China), 3D model: RL200 A,
Myriwell, China
Chepurnyi et al17 2020 MIO + 3D Printing vs PSI PSI vs Standard orbital mesh
3D planning software: Disior
Bonelogic CMF Orbital
Analysis Software (Helsinki,
Finland), 3D model: N/A*, PSI:
N/A*
Beder et al16 2022 MIO + 3D Printing vs PSI PSI vs Prebent implants
Orbital volume analysis:
BONELOGIC CMF ORBITAL
version 2.1.18-research
software, 3D planning
software: 3Diagnosys, version
4.1; 3diemme, Como, Italy), 3D
model: (Upbox, Tiertime,
Korea) PEEK PSI milling:
Mimics 10.01 (Materialise,
Leuven, Belgium)
With Navigation Rana et al10 2015 MIO + 3D Printing vs ION + PSI PSI vs Prebent implants
3D planning software: iPlan CMF
3.0.5 (Brainlab, Feldkirchen,
Germany), 3D model: Phacon
(Lepizig, Germany), PSI:
Freeform Plus (Geomagic,
Morrisville, NC), Navigation
system: Kick, Brainlab
Zimmerer et al15 2016 MIO + 3D Printing + ION vs PSI (n = 3) vs Prebent (n = 47)
PSI + ION vs Preformed implants
3D planning software: iPlan CMF (n = 100)y
(Version 3.0.5, Brainlab,
Feldkirchen, Germany), 3D
model: Phacon GmbH, Leipzig,
Germany, Navigation system:
N/A*
Cai et al3 2012 MIO + ION N/A*,z
3D planning software: iPlan
Cranial version 2.6; Brainlab,
Feldkirchen, Germany,
Navigation system: Kolibri
(BrainLab, Munich, Germany)
Zavattero et al18 2017 MIO + ION a. Isolated single-wall and Floor
Navigation system: Brainlab, fractures: standard orbital
Munich, Germany, 3D mesh (n = 43)
planning software: N/A*, 3D b. Fractures involving medial wall
model: N/A* and orbital floor: preformed
implants (n = 12)
Abbreviations: 3D, three-dimensional; ION, intraoperative navigation; MIO, mirror image overlay; PSI, patient-specific implants.
* Not available.
y Non-CAD (n = 45)-based orbital implants were used in addition to the above-mentioned implants in the study group.
z Assisted and control groups were matched for implants used.
Saptarshi et al. Do Technological Aids Produce Better Outcomes in Orbital Reconstruction? J Oral Maxillofac Surg 2024.
SAPTARSHI ET AL 5
prebent implants, and PSIs) for post-traumatic orbital meta-analyses were conducted, out of which 2 forest
reconstruction. plots compared the results of enophthalmos and
diplopia at 3 months between the PSI and standard
Results orbital mesh and one forest plot compared the results
of difference in orbital volume between affected and
Results of Literature Screening: A pool of 702 arti- nonaffected eyes between the PSI and prebent group.
cles was initially retrieved. 551 remained after
removing duplicates. After screening the titles and ab-
stracts, the full texts of 32 articles were left. These 32 Orbital Volume
articles underwent a comprehensive full-text assess- Orbital volume, a key factor in orbital reconstruc-
ment, resulting in a final set of 7 articles included in tion, was assessed in five of the seven studies. Table 7
the review. A descriptive summary of data selection summarizes comparative orbital volume data. The
is presented in Figure 1 as a Preferred Reporting Items meta-analysis of two studies10,16 (Fig 2) assessing the
for Systematic Reviews and Meta-Analyses flowchart. MD for difference in orbital volume between affected
Characteristics of the Included Studies: Four studies and nonaffected eyes comparing PSI and prebent
were demarcated as CCTs,3,15-17 1 cohort study18 and groups was carried out using a random effects model.
2 retrospective studies.1,10 No RCTs were identified. The MD for difference in orbital volume between
One of these studies was a multicentric study. affected and nonaffected eyes PSI group showed no sta-
Table 2 summarizes the demographics of the included tistically significant difference between PSI and preb-
studies. Table 3 summarizes outcomes of the included ent group (MD, 0.41, 95% CI = 1.16 to 0.34,
studies. The review comprised a total of 560 patients P = .28, I2 = 46%). The orbital volume data reported
across 7 studies. From an epidemiological perspective, by Zimmerer et al15 included only the range of orbital
the demographic domain of age (mean age 43.19 years) volume differences and variances with no mention of
was found to be consistent with the data found in the central tendency. However, it is worth noting that
literature.19 In relation to the etiology of orbital frac- this study reported statistically significant results with
tures, assault was found to be the most prevalent the use of PSI in correcting orbital volume (P < .001).
cause, followed by road traffic accidents and sports- The results reported by Chepurnyi et al17 indicate
related incidents. Assault and road traffic accidents ac- that PSI group (0.137 0.8 cm3) exhibited a lower
counted for more of all etiologies, aligning with the mean orbital shape difference between damaged and
existing body of scientific literature.20 The fracture intact orbits when compared with the standard orbital
site most commonly observed was the floor of the mesh (1.05 1.9 cm3) group, indicating that the orbits
orbit, followed by fractures involving both the floor reconstructed with PSI were more similar to unaf-
(one of the weakest parts of the orbit) and medial fected orbits. Zavattero et al18 analyzed the influence
wall. This anatomical relationship can be explained of ION. Volume reductions were 3.066 cm3
by the inherent vulnerability of these regions to frac- (1.304 cm3) in the navigation group and 2.064 cm3
ture, which can be attributed to their thin bony (1.372 cm3) in the non-navigation group.
structure.21
FIGURE 1. PRISMA flowchart of the search process. PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses.
Saptarshi et al. Do Technological Aids Produce Better Outcomes in Orbital Reconstruction? J Oral Maxillofac Surg 2024.
standard orbital mesh (P < .05). Beder et al16 reported PSI and standard orbital mesh groups, respectively,
results in favor of PSI group compared to prebent using a random effects model showed that PSI group
group. Cai et al3 reported no statistically significant dif- resulted in diplopia 0.71-fold less than that of the stan-
ferences in enophthalmos in the ION group at dard orbital mesh group with 0% heterogeneity (I2)
different time points. (risk ratio, 0.71; 95% CI: 0.45 to 1.13; P = .15), but
the difference was not statistically significant (Fig 4).
The results reported by Cai et al,3 favor the use of
Diplopia
ION. The ION group consistently had a lower percent-
Assessed by five studies. The pooled outcomes from age of patients with diplopia at different time points,
2 studies15,17 with a total sample size of 108 and 129 in which were statistically significant (0 = 0.039). These
SAPTARSHI ET AL
Table 2. SUMMARY OF DEMOGRAPHICS
Cai et al3 2012 Controlled Singapore 19 - 61 Site Non-navigation Navigation 58 Mechanism Non-navigation Navigation
Clinical group group group group
Trial
Floor 29 29 RTA 14 11
Roof 04 05 Fall 04 06
Medial Wall 13 16 Assault 09 06
Lateral Wall 13 16 Others 02 06
Rana et al10 Retrospective Germany 17 - 70 Not mentioned 92 Not mentioned
2015 study
Zimmerer Controlled Germany, 18 - 80 Orbital floor and/or medial wall 195 RTA, assault, sports injury, fall, other
et al15 2016 Clinical Spain,
Trial United
States of
America,
Singapore,
Austria
Zavattero Prospective Italy 26 - 62 Isolated orbital floor: 39 55 Assault: 26, RTA: 04, fall: 14, sports: 11
et al18 2017 Cohort Isolated medial wall: 04
with Medial and orbital floor: 12
Historical
Controls
Fan et al1 Retrospective China Mean age: Medial wall: 22 56 Assault: 32, sport injury: 10, fall: 09, RTA: 03,
2017 study Standard orbital Inferior wall: 13 others: 02
mesh group: Medial and inferior wall: 21
34.07
Prebent
implant
group: 39.03
Chepurnyi Controlled Ukraine 17 - 70 Orbital floor and/or medial wall 92 Not mentioned
et al17 2020 Clinical
Trial
Beder et al16 Controlled Egypt 14 - 55 Orbital floor 11 RTA: 58.3%, fall 25.3%, assault 16.7%
2022 Clinical
Trial
7
8
Table 3. SUMMARY OF OUTCOMES OF INCLUDED STUDIES
Postoperative Postoperative
Postoperative Postoperative Position of Restricted
Study CT Scan Postoperative Diplopia Enophthalmos Intraoperative Time Implant Ocular Motility
Cai et al3 2012 Performed 1 mo 3 mo 6 mo 12 mo Navigation group 3 vs 10% in non- Not available Vertical distance measured from the boundaries of the floor defects 1 mo 3 mo 6 mo 12 mo
navigation group over for patients in the navigation group was 3.24 m
12 months. lower than the vertical distance measured for patients i
n the non-navigation group.
Navigation 24% 14% 14% 02% Navigation 14% 10% 07% 03%
Non-navigation 59% 55% 45% 10% Non- 17% 07% 03% 03%
Navigation
Rana et al10 Performed Not available Not available Not available Postoperative mean angular deviation from unaffected Not available
Abbreviations: DAG, difference in the angle of the medial and inferior wall corner in the same coronal plane between the surgical eye and the healthy eye; DAR, difference in the area
between the fracture zone and implant; DMD, difference in the maximum depth between the fracture zone and implant; DMW, difference in the maximum width between the fracture
zone and implant; PSI, patient-specific implants.
Saptarshi et al. Do Technological Aids Produce Better Outcomes in Orbital Reconstruction? J Oral Maxillofac Surg 2024.
SAPTARSHI ET AL 9
Risk of Bias
tero et al18 also reported similar results in favor of
Low
Low
Low
Low
ION. Diplopia was assessed using the diplopia severity
scoring described by Bly et al22 Beder et al16 reported
improvement in diplopia with the use of PSI, but these
results were not statistically significant.
Bias Due to Selective
Reporting of Results
Moderate risk
No risk Intraoperative Time
No risk
No risk Assessed by two studies. Zimmerer et al,15 reported
a median intraoperative time of 71 minutes in pre-
formed group versus 60 minutes in PSI/prebent group
(P = .017). The study also shows that 90% of pre-
formed implants require intraoperative adjustments
and take more time to implant than PSI/Prebent
Bias in Measurement
No risk
No risk
No risk
No risk
No risk
No risk
No risk
No risk
No risk
No risk
From
No risk
No risk
No risk
No risk
Discussion
Chepurnyi et al 2020
Zimmerer et al 2016
Zavattero et al * * * * * - * * - 7 High
2017
No score assigned.
* Score assigned.
Saptarshi et al. Do Technological Aids Produce Better Outcomes in Orbital Reconstruction? J Oral Maxillofac Surg 2024.
SAPTARSHI ET AL
Table 7. COMPARATIVE ORBITAL VOLUME DATA
Study Mean Orbital Shape Difference Preoperative Orbital Volume Postoperative Orbital Volume Volume Difference
11
12 DO TECHNOLOGICAL AIDS PRODUCE BETTER OUTCOMES IN ORBITAL RECONSTRUCTION?
preoperative CT scan is necessary for accurate diag- rim posteromedially, the orbital floor inclines superi-
nosis and CASP, whereas a postoperative CT scan is orly to meet the medial wall, creating a distinct bony
necessary to assess the effectiveness of the interven- convergence profile. This bulge is an important struc-
tions, volume measurement, and implant positioning, ture supporting the globe in an anteroposterior posi-
thereby reiterating it as a need in orbital fractures tion, making the reconstruction of this anatomic
where there is minimal margin of error.24 landmark along with the medial wall critical for cor-
Five studies employed the transconjunctival/trans- recting enophthalmos.31,32 The meta-analysis suggests
caruncular approach when dealing with orbital the effectiveness of PSIs in correcting enophthalmos
fractures. Despite the potential complications of and diplopia.
developing entropion with transconjunctival Two of the included studies3,18 reported results in
approach,25 it indicates a gradual yet conscious shift favor of ION while assessing diplopia; however, due
toward utilizing the hidden scar approach in the man- to missing data, they were not amenable to a meta-
agement of orbital fractures. analysis. ION is thought to be beneficial as it provides
Orbital volume correction is one of the primary aims a real-time feedback on implant position, minimizes
of performing orbital reconstruction in traumatic the necessity of extensive dissection, and helps trans-
cases. The results of this review indicate that integra- fer the virtually planned surgery into patient
tion of technological aids has a positive impact on outcomes.33,34
orbital volume correction. Although the meta- The study by Schreurs et al35 confirms the findings
analysis yielded nonsignificant results while equating of this review, reiterating that PSIs are suitable for pa-
PSI with prebent implant, it is clear that some element tients with large orbital defects. Chepurnyi et al17
of customization (PSI/prebent implants) is associated through their study concluded that prebent implants
with improved orbital volume results. Results by are equally effective as PSIs in patients with preserved
Zimmerer et al15 and Zavattero et al underscore infraorbital buttress and retrobulbar bulge; however,
advantages of combining two different technologies they are not the choice when reconstructing large de-
(MIO-PSI + ION) for superior outcomes. This has fects. The existing literature suggests that the primary
found support in the literature as well.26,27 problem with using standard orbital meshes is restora-
Post-traumatic enophthalmos is caused by orbital tion of the deep areas of the inferior and medial orbital
volume expansion rather than changes in the fat con- walls. Standard orbital meshes have demonstrated a
tent;2,28,29 hence, correcting the orbital volume is weakness in cases that require cantilevered recon-
paramount. Globe position is the result of a complex struction (Jaquiery’s category36 III and IV).17 This is
interplay between the bony orbital anatomy and the where the customized approaches in the form of
soft tissue envelope.30 A key restoration landmark is either prebent implants or PSIs have yielded bet-
the retrobulbar bulge. As one moves from the orbital ter results.
A statistically significant reduction in intraoperative This is evidenced by only one study17 utilizing
time was reported by Zimmerer et al15 when different Jaquiery’s categories to describe the orbital defect.
technological aids (MIO + PSI + ION) were combined. This systematic review has several limitations. The
In the context of maxillofacial surgery, a reduced intra- absence of RCTs, while not uncommon, stands out
operative time contributes to reduced hospitalization as a significant limitation. Diverse case presentations
time and also lowers cost of hospitalization.37 As high- make standardization of treatment options and
lighted by Zimmerer et al,15 even in the hands of highly obtaining ethical clearances challenging, creating an
experienced surgeons, the overall precision of recon- inherent limitation at the selection and inclusion stage.
struction tends to be inferior with preformed implants There is a paucity of literature in the field, nonstandar-
compared to either prebent implants or PSIs, thus con- dized reporting, and the fact that most studies looked
tradicting the intended purpose of preformed implants. at very few outcomes, and patient-reported outcome
Utilization of PSI with ION produced fewer instances measures were rarely reported. This review does not
of implant malpositioning.10 The improved fit and comment on outcomes achieved by using different
reduced instances of malpositioning seen with PSI implant materials.
can be attributed to the fact that these implants are The outcomes of this review offer valuable insights
custom-made and ION provides real-time feedback. into the available evidence for the integration and uti-
None of the studies included in this review utilized lization of technological aids and various implant de-
autogenous materials for orbital reconstruction. Beder signs for post-traumatic orbital reconstruction.
et al,16 mentioned that the decision to use titanium Nevertheless, the reliability of these findings is con-
mesh was influenced by the results of Ellis and Tan,38 strained by the nature of the included studies. To
who reported that titanium meshes showed better re- affirm the conclusions derived from this review, it is
sults than bone grafts for orbital reconstruction. Tita- imperative to undertake well-designed randomized
nium mesh is preferred because of its malleability and studies. These studies should incorporate objective as-
adaptability to the shape of the defect, excellent sessments and comprehensive reporting of vital pa-
biocompatibility, and the ability for connective tissue rameters to establish a foundation for quantifiable
to grow around and through the implant, preventing and robust conclusions.
migration. This is seconded in the study by Gor-
don et al.32 References
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