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The Journal of Craniofacial Surgery Volume 34, Number 2, March/April 2023 551
Copyright © 2022 Mutaz B. Habal, MD. All rights reserved.
Zhang et al The Journal of Craniofacial Surgery Volume 34, Number 2, March/April 2023
reconstruction and new bone formation around the sutures, 4.34 ± 0.79 kg, and the duration of the traction period ranged
which can effectively adjust the shape and position of the cra- from 24 to 60 days, with a mean of 40.7 ± 8.1 days.
niomaxillofacial skeleton to a certain extent without osteotomy.
Trans-sutural distraction osteogenesis avoids the risks of enor- Distraction Device
mous trauma, heavy bleeding, and other complications caused The distraction device consisted of a RED (Cibei Medical
by osteotomy. It is particularly suitable for pediatric patients Treatment Appliance Co.), nickel-titanium springs (GEE Co.),
during the growth period;3,23 accordingly, children can undergo and traction hooks (GEE Co.). The traction spring can produce
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surgery at an early age without carrying a deformed appearance a stable and continuous traction force of 250 g per 1 mm stretch
and dysfunction into older age or adulthood. within the deformation range.
Many studies have conducted cephalometric analysis on
2-dimensional (2D) or 3-dimensional (3D) images to describe Surgical Procedure
the craniomaxillofacial skeleton after distraction osteogenesis While the patient was under general anesthesia, an incision
therapy.24–33 However, few reports have investigated the was made in the mucosa at the top of the oral vestibular sulcus
changes in the cranial base, which may play an essential role in in the position of the maxillary cuspid on each side and sepa-
midfacial skeleton growth. The cranial base is the bony con- rated to reveal the piriform aperture margins. A bone hole was
nection between the cranial and facial bones. It consists of the dilated obliquely, ~10 mm outside the lateral pyriform rim and
ethmoid, sphenoid, and occipital bones. Three growth plate-like 5 mm above the root of the cusp, to connect with the nasal
structures are located between these bones, which are called the cavity. A traction hook was installed through the perforation,
cranial base synchondroses (CBS); these are the growth centers with the caudal end passing through the base of the corre-
of the cranial base.34 The CBS consists of 3 cartilage unions sponding nostril. The RED was fixed to the skull with titanium
called spheno-ethmoidal synchondrosis (SES), intersphenoid nails 4 to 5 cm above the superior point of the auricle. Care was
synchondrosis, and spheno-occipital synchondrosis (SOS). The taken to prevent the titanium nail from entering the skull. Then,
anterior cranial base is closely related to the maxilla below it, traction hooks on both sides were attached to the RED through
and together, they form the ethmoid-maxilla complex.35 This nickel-titanium springs. Finally, the traction force direction was
demonstrates that the cranial base is closely related to midfacial adjusted to ~20 to 30 degrees downward and horizontally
growth and development. (Fig. 1).
To reveal the morphological changes of the cranial base after Distraction Procedure
TSDO, we built and analyzed 3D models based on computed The starting traction force at the end of the surgery was 750
tomography (CT) images of 29 children with midfacial hypo- g per side, which was maintained for 3 to 5 days to allow the
plasia due to CLP who have undergone bone-borne TSDO patient to adapt. Then, the length of the spring was adjusted at a
therapy. rate of 1 to 2 mm every 2 to 3 days to gradually increase the
traction force until the desired maxillary advancement was
achieved. This was followed by a maintenance and con-
METHODS solidation period of 1 to 3 months. Subsequently, the traction
force was gradually decreased, and the whole distraction device
was removed.
Participants
This study is a retrospective analysis of pediatric cases with Three-Dimensional Measurement and
skeletal midfacial hypoplasia secondary to CLP who underwent Statistical Analysis
TSDO performed by our medical team at the Plastic Surgery Computed tomography images of the whole skull were col-
Hospital, Chinese Academy of Medical Science, and the De- lected at T0 and T1. The CT images were stored in the digital
partment of Plastic and Cosmetic Surgery, Peking University imaging and communications in medicine (DICOM) file format,
Third Hospital, from January 2005 to June 2020. and 3D models were created and measured using Mimics Re-
The inclusion criteria were as follows: (1) Children (under 18 search software (version 20.0; Materialize). Craniometric anal-
y of age) with midfacial hypoplasia due to CLP; (2) complete yses were performed after segmentation. The definition of
medical records of the traction procedure; (3) complete cranial landmarks is listed in Supplemental Table 1 (Supplemental
computed tomography (CT) imaging data collected pre- Digital Content 1, http://links.lww.com/SCS/E661). The defi-
operatively (T0) and within 1 week after the removal of rigid nition of distances, angles, and volume are listed in Supple-
external distractor (RED) (T1); and (4) the TSDO procedure mental Table 2 (Supplemental Digital Content 2, http://links.
must be performed by the same surgeon. lww.com/SCS/E662). Two physicians independently calibrated
The exclusion criteria were as follows: (1) severe complica- the measurement points and the results were averaged from the
tions during traction, including titanium nail fixation site in- 2 measurements.
fection, severe titanium nail maladjustment, loosening of the We used a 2-tailed t test in the Statistical Package for the
RED, and traction hook dislodgement; (2) early withdrawal of Social Sciences software (SPSS version 23.0; IBM Corp) to
the traction device for any reason; and (3) incomplete data re- perform the statistical analysis (P ≤ 0.05, level of significance).
cords.
According to our surgical data, 85 consecutive children with
midfacial hypoplasia due to CLP underwent TSDO. Eight of RESULTS
the 85 children were excluded because of complications and 48
lacked complete clinical records. Finally, 29 children met the Morphological Analysis of the Cranial Base
inclusion criteria, including 25 males (86.2%) and 4 females We performed linear and angular measurements of the cra-
(13.8%). Before traction, the mean age was 11.1 ± 2.3 years old nial base on a 3D model at T0 and T1, and the data is shown in
(5–15 y old). Nine children had bilateral CLP, and 20 had Supplemental Table 3 (Supplemental Digital Content 3, http://
unilateral CLP (8 on the right and 12 on the left). The maximum links.lww.com/SCS/E663). The length of the cranial base in the
unilateral traction force ranged from 3 to 6 kg, with a mean of anteroposterior direction increased significantly after TSDO,
TSDO. The main limitation of this study was the lack of normal
controls, and the difficulty of excluding the effect of normal
growth and development on the cranial base, which will be
explored in our subsequent studies. Further studies analyzing
the impact of different CLP repair methods, orthodontic sur-
geries, time of CLP repair surgery, and other related factors on
the growth and development of the cranial base are needed to
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unilateral transpalatal distraction in cleft patients. J Craniofac Surg Bone- and dentoalveolar-anchored dentofacial orthopedics for class
2003;14:786–790 iii malocclusion: new approaches, similar objectives?: a systematic
15. Zheng Y, Tong H, Yin N, et al. Rigid external distraction with review. Angle Orthod 2013;83:540–552
intranasal bone-borne traction hooks for midfacial hypoplasia. Sci 31. Tong H, Gao F, Yin J, et al. Three-dimensional quantitative
Rep 2018;8:9948 evaluation of midfacial skeletal changes after trans-sutural
16. Neelapu BC, Kharbanda OP, Sardana HK, et al. Craniofacial and distraction osteogenesis for midfacial hypoplasia in growing
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upper airway morphology in adult obstructive sleep apnea patients: patients with cleft lip and palate. J Craniomaxillofac Surg 2015;43:
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