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CRANIOMAXILLOFACIAL TRAUMA

Does Integration of Technology and


Customization of Implants Produce
Better Outcomes in Post-Traumatic
Orbital Reconstruction? A Systematic
Review and Meta-Analysis
Varad Rajendra Saptarshi, MDS,* Srivalli Natarajan, MDS,y
Padmakar Sudhakar Baviskar, MDS,z
Suraj Arjun Ahuja, MDS,x and Aditya Dinesh Dhirawani, MDS*
Purpose: This review aims to compare and evaluate the outcomes achieved by integrating techno-
logical aids and the influence of different implant designs in the reconstruction of post-traumatic
orbital defects.
Methods: Electronic searches of the MEDLINE, Embase, Cochrane Library, and Google Scholar databases
until March 2023 were conducted. Clinical controlled trials, observational studies, cohort studies, and
retrospective studies were identified and included. The predictor variables were the integration of tech-
nological aids namely, computer-assisted surgical planning, mirror image overlay, and intraoperative nav-
igation with the utilization of different orbital implant designs (standard orbital meshes, preformed
implants, prebent implants, and patient-specific implant [PSI]) during post-traumatic orbital reconstruc-
tion. The primary outcome variables were orbital volume, diplopia, and enophthalmos. Weighted or
mean difference and risk ratios at 95% confidence intervals were calculated, where P < .05 was consid-
ered significant and a random effects model was adopted.
Results: This review included 7 studies with 560 participants. The results indicate that the difference in
postoperative orbital volume between affected and nonaffected eye showed no statistically significant dif-
ference between PSI and prebent group (mean difference, 0.41 P = .28, I2 = 46%). PSI group resulted in
diplopia 0.71-fold less than that of the standard orbital mesh group but was not statistically significant
(P = .15). Standard orbital mesh group is 0.30 times at higher risk of developing enophthalmos as
compared to PSI group (P = .010). The literature suggests PSIs are preferred for patients with large defects
(Jaquiery’s III-IV), whereas prebent implants are equally effective as PSIs in patients with preserved infraor-
bital buttress and retrobulbar bulge.
Conclusion: PSIs are associated with improved outcomes, especially for correcting enophthalmos. The
data suggests the potential efficacy of prebent implants and PSIs in orbital volume corrections. There is a

*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

reconstruction; and 3) at least one of the following PREBENT IMPLANTS


outcome measures was assessed and recorded: orbital Implants that are bent preoperatively to the desired
volume, diplopia, and enophthalmos. The exclusion contour on a three-dimensional printed model of the
criteria were: 1) Studies with # 10 patients; 2) no out- ideal orbit form by using MIO and CAD-CAM.
comes of interest; 3) published in a language other
than English; and 4) inappropriate study design (ie, re- PATIENT-SPECIFIC IMPLANTS (PSIs)
view, protocol, animal trial, and conference article).
Customized implants, manufactured to fit a specific
orbit using CAD-CAM technology.
Screening and Data Extraction After thoroughly reviewing the included studies, an
Two reviewers (V.R.S. and S.N.) independently re- understanding was reached as to which of the four
viewed the titles and abstracts, excluding those that above-mentioned categories of implants were used in
did not meet inclusion criteria. In case of any doubt, the respective study. Table 1 summarizes the technol-
the study was included for further screening in the ogy employed and the type of implants used in the
next stage. The abstracts were then independently included studies.
screened. Disagreements were resolved by discussion.
A third reviewer (P.S.B.) was involved in the final deci- Risk of Bias
sion if any disagreement persisted. The following data
Two independent reviewers appraised the risk of
were extracted from the included studies: author, year
bias in the studies included in the review using the
of publication, study design, country, demographics of
Risk Of Bias In Non-randomised Studies - of Interven-
participants (age range, site of fracture), sample size,
tion (ROBINS-I) tool.13 Every domain was assessed
mechanism of injury, technology employed and type
for the risk of bias. The categories for risk of bias judg-
of implants used, outcomes (orbital volume, diplopia,
ments are low risk, moderate risk, and high risk of bias.
enophthalmos, intraoperative time, postoperative
For quality assessment of observational studies, the
implant position, restricted ocular motility.)
Newcastle-Ottawa Scale (NOS) tool14 was used. The
NOS evaluates three quality parameters (selection,
Variables comparability, and outcome) divided across eight spe-
Predictor variables: integration of technological aids cific items, which slightly differ when scoring cross-
namely, CASP, MIO, ION, and utilization of different sectional and cohort studies. Each item on the scale
orbital implant designs (standard orbital meshes, pre- was scored at one point, except for comparability,
formed implants, prebent implants, PSI) during open which was adapted to the specific topic of interest
reduction and internal fixation of orbital fractures. to score up to two points. Thus, the maximum for
Primary outcome variables: orbital volume, enoph- each study was 9, with studies having less than 5
thalmos, diplopia. points being identified as having a high risk of bias.
Secondary outcome variables: intraoperative time,
postoperative implant position, restricted ocular motility. Data Synthesis
Review Manager (RevMan) 5.3 was applied for sta-
Standardization of Terms tistical analysis. Mean difference (MD) and relative
It became apparent to the authors that the nonuni- risks were adopted as effect size measures for contin-
form utilization of terminology to describe implant uous variables and dichotomous variables, respec-
types introduced a state of ambiguity, making it chal- tively. 95% confidence intervals (CIs) were used, and
lenging to discern interstudy associations. Therefore, P < .05 was considered to indicate statistical signifi-
with the aim of simplifying and standardizing, this sys- cance. c2 and Tau-square were used to assess whether
tematic review categorizes implant types into four cat- the observed difference was homogeneous or hetero-
egories, namely: geneous among the studies. Statistical heterogeneity
was assessed by the I2 test at a = 0.10. For I2>50%,
STANDARD (CONVENTIONAL) ORBITAL MESHES the random effects model was applied. Also, the statis-
tical significance was set at P value (two-tailed) <.05.
Standard, noncustomized implants require freehand Summary Measures: The primary objective of this
intraoperative shaping and bending. systematic review was twofold. First, to evaluate the
impact of integrating technological aids (CASP, MIO,
PREFORMED (STOCK) IMPLANTS and ION) in the reconstruction of post-traumatic
Standardized implants are manufactured with pre- orbital defects. Second, to assess the outcomes
determined shapes that closely resemble generic achieved with the use of different implant designs
anatomical features. (standard orbital meshes, preformed implants,
4 DO TECHNOLOGICAL AIDS PRODUCE BETTER OUTCOMES IN ORBITAL RECONSTRUCTION?

Table 1. SUMMARY OF TECHNOLOGY EMPLOYED AND TYPES OF IMPLANTS USED

Study Technology Employed Types of Implants Used

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

Risk of Bias Enophthalmos


All four included CCTs (nonrandomized studies) Four studies evaluated enophthalmos as one of the
showed a low risk of bias (Table 4). All the retrospec- parameters. The pooled outcomes from 2 studies15,17
tive and cohort studies evaluated by the NOS tool using a random effects model for assessing the risk of
showed high study quality, ie, low risk of bias developing enophthalmos in PSI group as compared
(Table 5,6). Because quality assessment was, to the standard orbital mesh group was conducted.
however, an ordered variable, a weighted kappa was As in the study conducted by Zimmerer et al,15 there
also carried out to establish relative concordance were 0 reported cases of enophthalmos in both the
between reviewers. It was assumed that the PSI and standard orbital mesh group, the risk ratio
differences between individual quality scores were for that study was not estimated. In the study conduct-
equal. The inter-rater agreement (kappa with linear ed by Chepurnyi et al,17 it was observed that the stan-
weighting) was 0.89 (95% CI, 0.76 to 0.94) indicating dard orbital mesh group is 0.30 times at higher risk of
substantial to perfect agreement. developing enophthalmos as compared to PSI group.
The test of overall effect was z = 2.58 and P value = .010
(Fig 3), but the overall heterogeneity was not esti-
Synthesis of Results
mated. Fan et al1 reported a statistically significant dif-
A total of 4 studies10,15-17 fulfilled the inclusion ference between the affected and unaffected orbits
criteria for quantitative analysis. Subsequently, 3 with the use of prebent implants compared to
6 DO TECHNOLOGICAL AIDS PRODUCE BETTER OUTCOMES IN ORBITAL RECONSTRUCTION?

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

Author and Country Age Range Sample


Year of Study Study Design of Study in Years Site of Fracture Size Mechanism of Injury

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

Abbreviation: RTA, road traffic accident.


Saptarshi et al. Do Technological Aids Produce Better Outcomes in Orbital Reconstruction? J Oral Maxillofac Surg 2024.

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

DO TECHNOLOGICAL AIDS PRODUCE BETTER OUTCOMES IN ORBITAL RECONSTRUCTION?


2015 orbit (in degrees):
Angle anterior Angle medial Angle posterior
Prebent 11.3 11.6 10.8
PSI 4.1 8.2 8.2
Zimmerer et al15 Performed  Preformed implants: 25 (29.8%)  Preformed implants: 0 Mean Duration of Standard: Not available  Preformed implants: 1 (1.2%)
2016  PSI/Prebent implants: 15 (24.6%)  PSI/Prebent implants: 0  PSI/Prebent implants:  PSI/Prebent implants: 2 (3.3%)
60 minutes
 Preformed implants:
71 minutes
Zavattero et al18 Performed Navigation Non- Not available Not available Not available Not available
2017 navig
ation
Grade III 05 03
Grade II 15 13
Grade I 07 03
Fan et al1 2017 Performed Not available Absolute difference of  Prebent: Standard orbital mesh Prebent Not available
postoperative enophthalmos: 75.34  15.68 minutes
 Prebent: 1.0  0.5 mm  Standard orbital mesh:
 Standard orbital mesh: 95.37  22.19 minutes
2.5  1.0 mm
DMW 5.60  0.90 mm 2.51  0.53 mm
DMD 4.61  0.89 mm 2.58  0.46 mm
DAR 84.05  20.89 mm2 43.59  9.53 mm2
DAG 12.58  5.04o 2.82  0.44o
Chepurnyi Performed  PSI: 7  PSI: 5 Not available Implant malposition: Not available
et al17 2020  Standard orbital mesh: 13  Standard orbital mesh: 16  PSI: 3
 Standard orbital mesh: 10
Beder et al16 Performed  PSI: 0 2 wk 1 mo 3 mo 6 mo Not available Not available 2 wk 1 mo 3 mo 6 mo
2022  Prebent: 1
PSI 3 3 3 3 PSI 1 1 1 1
Prebent 4 4 4 4 Prebent 2 2 2 2

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

findings suggest a positive impact of the ION. Zavat-

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

implants. Fan et al,1 reported a statistically significant


Moderate risk
of Outcomes

difference with the use of prebent implants


No risk

No risk
No risk

(75.34  15.68 minutes) compared to standard orbital


meshes (95.37  22.19 minutes) (P < .05).

Postoperative Implant Position


Saptarshi et al. Do Technological Aids Produce Better Outcomes in Orbital Reconstruction? J Oral Maxillofac Surg 2024.

Assessed by four studies. Cai et al3 reported that the


Missing Data
Bias Due to

No risk
No risk
No risk
No risk

vertical distance measured from the boundaries of the


floor defects for patients in the navigation group was
3.24 mm lower in the non-navigation group, this was
highly significant P = .001. Rana et al10 showed a signif-
icant difference for the anterior angle favoring PSI
Interventions
Bias Due to
Deviation

(mean 4.1) over prebent implants (11.3), P = .001.


Intended

No risk
No risk
No risk
No risk
From

Fan et al1 reported that the reconstructed angle of


the medial and inferior wall corners was more similar
between the affected and unaffected eyes in the preb-
ent group compared to standard orbital mesh group,
P < .05. Chepurnyi et al17 reported that implant malpo-
Misclassification

sition occurred in 3 cases with PSI (6.4%) and 10 cases


No risk
No risk
No risk
No risk

with standard orbital mesh (22.2%) (P = .033).


Bias
Table 4. RISK OF BIAS OF CCTS (NONRANDOMIZED TRIALS)

Restricted Ocular Motility


Assessed by three studies. No statistical differences
Selection

were found in restricted ocular motility in navigation


No risk
No risk
No risk
No risk
Bias

and non-navigation groups at different time points,


as reported by Cai et al.3 A similar finding was reported
Abbreviation: CCTs, controlled clinical trials.

by Zimmerer et al.15 Results reported by Beder et al,16


showed improvement in the limitation of ocular
Confounding

No risk
No risk
No risk
No risk

motility of the affected eye in comparison to preoper-


Bias

ative status favoring the use of PSI. These results were


not statistically significant.

Discussion
Chepurnyi et al 2020

Zimmerer et al 2016

By identifying gaps in the literature, this review aims


Beder et al 2022
Cai et al 2012

to improve clinical decision-making and patient out-


comes in post-traumatic orbital reconstruction. All
studies necessitated the inclusion of preoperative
Study

and postoperative CT scans. Operative planning of


complex fractures depends on optimal imaging.23 A
10
Table 5. RISK OF BIAS OF RETROSPECTIVE STUDIES

Selection Comparability Outcome Total


Score Quality
Representativeness Sample Ascertainment Main Additional Assessment Statistical
Study of Sample Size Nonresponders of Exposure Factor Factor of Outcome Test

Fan et al 2017 * - * * * - * * 6 High


Rana et al * - * * * - * * 6 High
2015

DO TECHNOLOGICAL AIDS PRODUCE BETTER OUTCOMES IN ORBITAL RECONSTRUCTION?


No score assigned.
* Score assigned.
Saptarshi et al. Do Technological Aids Produce Better Outcomes in Orbital Reconstruction? J Oral Maxillofac Surg 2024.

Table 6. RISK OF BIAS OF COHORT STUDY

Selection Comparability Outcome Total


Score Quality
Outcome of
interest Was
Selection of present follow- Loss to
Representativeness nonexposed Ascertainment at start of Main Additional Assessment up follow-
Study of cohort cohort of exposure study factor factor of outcome enough up

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

Chepurnyi et al17 PSI: Not mentioned Not mentioned Not mentioned


0.137  0.8 cm3 (1.7 cm3 to
2.3 cm3)
Standard orbital mesh:
1.05  1.9 cm3 (1.8 cm3 to
8.3 cm3)
Beder et al16 2022 Not mentioned PSI: PSI: PSI: 0.50  0.72 cm3
Affected eye: 28.89  3.28 cm3 Affected: 25.82  3.44 cm3 Prebent: 1.35  0.86 cm3
Nonaffected eye: 24.98  2.34 cm3 Nonaffected: 25.32  2.72 cm3
Prebent: Prebent:
Affected eye: 28.87  3.42 cm3 Affected: 26.91  3.3 cm3
Nonaffected eye: 25.23  2.13 cm3 Nonaffected: 25.56  2.44 cm3
Rana et al10 Not mentioned Not mentioned Not mentioned Volume between unaffected and
affected eye:
PSI: 0.4 cm3
Prebent: 0.6 cm3
Zimmerer et al15 Not mentioned Not mentioned Not mentioned Differences in volume between the
reconstructed and the unaffected
orbit:
PSI/Prebent + Navigation:
3.5 to 1.4 ml Variance: 0.6 ml2
Standard preformed + Navigation:
4.3 to 2.7 ml Variance: 1.8 ml2
Zavattero et al18 Not mentioned Volumes of affected orbits: Not mentioned Navigation group:
Navigation group: 3.066 cm3 (1.304 cm3)
31.945 cm3 (2.035 cm3), Non-navigation group:
Non-navigation group: 2.064 cm3 (1.372 cm3)
31.415 cm3 (3.520 cm3).

Abbreviation: PSI, patient-specific implants.


Saptarshi et al. Do Technological Aids Produce Better Outcomes in Orbital Reconstruction? J Oral Maxillofac Surg 2024.

11
12 DO TECHNOLOGICAL AIDS PRODUCE BETTER OUTCOMES IN ORBITAL RECONSTRUCTION?

FIGURE 2. Forest plot of comparative orbital volume data.


Saptarshi et al. Do Technological Aids Produce Better Outcomes in Orbital Reconstruction? J Oral Maxillofac Surg 2024.

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.

FIGURE 3. Forest plot of the risk of developing enophthalmos.


Saptarshi et al. Do Technological Aids Produce Better Outcomes in Orbital Reconstruction? J Oral Maxillofac Surg 2024.
SAPTARSHI ET AL 13

FIGURE 4. Forest plot of the risk of developing diplopia at 3 months.


Saptarshi et al. Do Technological Aids Produce Better Outcomes in Orbital Reconstruction? J Oral Maxillofac Surg 2024.

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-
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