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Received, September 29, 2022; Accepted, November 24, 2022; Published Online, February 7, 2023.
BACKGROUND: Epidural cement leakage (CL) is a common complication in cement-augmented fenestrated pedicle
screw fixation (CAFPSF) with the potential for neural injury. However, there are no reports discussing basivertebral vein
morphology and pedicle screw placement, which are critical in the analysis of the risk of epidural CL after CAFPSF.
OBJECTIVE: To identify the incidence and risk factors of epidural CL in osteoporotic patients during CAFPSF.
METHODS: Two hundred and eighty-two osteoporotic patients using 1404 cement-augmented fenestrated screws
were included. Preoperative computed tomography (CT) was used to characterize the morphology of posterior cortical
basivertebral foramen. After CAFPSF, the severity of epidural CL, the implantation position of the screw tip, and cement
extension within the vertebral body were determined by postoperative CT scans. In this study, significant risk factors for
epidural CL were identified through logistic regression analysis.
RESULTS: In total, 28 patients (18.8%) and 108 screws (7.7%) had epidural CL and 7 patients (13 screws) experienced
neurological symptoms. Although local epidural CL was generally not clinically significant, extensive epidural leakage
posed a higher risk of neurological symptoms. Significant predictors for extensive epidural CL were a magistral type of
basivertebral foramen and the smaller distance between the tip of the screw and the posterior wall of the vertebral body.
CONCLUSION: In osteoporotic patients receiving CAFPSF, epidural CL is relatively common. The morphology of ba-
sivertebral foramen should be taken into account when planning a CAFPSF procedure. It is important to try and achieve a
deeper screw implantation, especially when a magistral type of basivertebral foramen is present.
KEY WORDS: Cement-augmented fenestrated pedicle screw fixation, Osteoporotic patients, Epidural cement leakage
ince the introduction of pedicle screw fixation for the for those with osteoporosis, have become well-known problems.1,2
In pedicle screw augmentation, Hu et al6 divided CL into 3 technique described by Mueller et al7 and Ulusoy et al.8 Besides eval-
areas: anterior–lateral (involving the anterior and/or anterior– uating the patients’ BMD, the experienced surgeons decided whether to
lateral to anterior half of the vertebral body), posterior–lateral perform augmentation when manual findings during tapping indicated
(involving the posterior–lateral to posterior half of the vertebral that mechanical strength of implanted screws might be insufficient. A
freehand placement of fenestrated screws (DTPSTM, Dream STS) was
body), and epidural leakage (involving the spinal canal). Although
performed on the osteoporotic spine. The pedicle screws (6.5 or 7.5 mm
anterior–lateral and posterior–lateral leakages were generally not
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CL have been identified including lower bone mineral density were injected under lateral fluoroscopic guidance. The injection of bone
(BMD) and cement distribution morphology.6 Nonetheless, that cement would be stopped if bone cement reached the posterior vertebral
study did not investigate the association between leakage and body line or if apparent CL was noted below the endplates or anterior
other possible risk factors, such as cement injection volume per cortex of the vertebral body. In all 3 medical centers, PMMA preparation
screw and the position of pedicle screw in the vertebral body. To and application followed a standardized protocol provided by the
our knowledge, the incidence, the severity, and risk factors of company. Consequently, 30 seconds were required to mix powder and
epidural CL in osteoporotic patients treated with cement- liquid, 30 seconds were needed to fill the application device, and 300
seconds must elapse before using cement. The mean amounts of cement
augmented fenestrated pedicle screw fixation (CAFPSF) have
injected in each pedicle screw were 2.15 mL (range, 0.6-5 mL). Three
not been reported in the previous literature. more than 13 years experienced spinal surgeons performed the opera-
tions. The technique does not require a steep learning curve.
FIGURE 1. The morphology of basivertebral foramen in the posterior vertebral cortex in coronal and axial
computed tomography images. A and B, A magistral type of basivertebral foramen (a large, single centrally located
foramen with a width/height of ≥5 mm). C and D, A disperse type of basivertebral foramen (multiple small
nutrient foramina).
Statistical Analysis The levels treated were from T10 to S1, and Figure 4 illustrates
All the statistical analyses in this study were performed using SPSS the distribution of pedicle screws and epidural CL.
25.0 (SPSS, Inc) and R Software version 3.6.2. Significant differences Extensive epidural CL was observed in 13 patients (involving
were identified when the P value was < .05. Means and SD were used 23 screws), 6 patients (10 screws) of whom were asymptomatic.
to express qualitative characteristics of groups. The differences be- However, 7 patients (13 screws) of those 13 patients presented
tween the groups were assessed using univariate analysis for variables with neurological symptoms because of nerve compression caused
with symmetrical distributions and the nonparametric Wilcoxon test by CL, 4 of whom experienced mild postoperative sciatica and
for variables with other distributions. Fisher’s exact test was used to
recovered after conservative treatment; 2 of whom received excess
assess the statistical significance of dichotomous variables. We used
binary logistic regression analysis and receiver operating characteristic cement removal during the same surgical procedure without
curves to determine independent risk factors and critical values, severe neurological sequelae of paralysis, but did experience
respectively. sensory complaints such as burning, tingling, and numbness in
the distal lower extremities and got complete disappearance after
conservative treatment within 3 months after the operation; and
RESULTS only 1 of whom had neurological injury and required a revised
surgery for total laminectomy at the L1/L2 level on the second
There were 53/282 (18.8%) patients who developed epidural postoperative day (Figure 5), but continued to complain of
CL, whereas 108/1404 (7.7%) augmented screws were involved. weakness and numbness in his right leg within a 1-year follow-up.
FIGURE 2. A, The location of pedicle screw implantation in the mediolateral (red line) and anterior-posterior
(green line) directions of the vertebral body on axial CT scan. B, Cement distribution within the vertebral body
was divided into 4 zones on CT axial view. CT, computed tomography.
Local epidural CL was observed in 40 patients (involving 85 The independent risk factors for patients with epidural CL were
screws) although all patients were asymptomatic. In addition, no decreased BMD (odds ratio [OR] = 0.56, P = .019) and more
patient observed in our study suffered from pulmonary cement number of augmented screws (OR = 1.59, P = .002). Based on a
embolisms. logistic regression analysis, screws with epidural CL were asso-
A magistral type of basivertebral foramen was observed in 622 ciated with 5 independent factors, including a magistral type of
(44.3%) of the 1404 augmented screws, and of these, 17 (2.7%) basivertebral foramen (OR = 2.27, P = .002), more volume of
demonstrated extensive epidural CL. A disperse type of basi- cement injected (OR = 2.40, P < .001), the smaller distance
vertebral foramen was observed in 782 (55.7%) of the 1404 between the screw tip and the midline of the vertebral body (OR =
augmented screws; of these, 6 (0.8%) demonstrated extensive 0.64, P < .001), the smaller distance between the tip of the screw
epidural leakage. These differences were analyzed using Fisher’s and the posterior wall of the vertebral body (OR = 0.64, P < .001),
exact test and found to be statistically significant with a P value and cement extension into the pedicle area (OR = 4.08, P < .001)
of .002. (Table 1).
FIGURE 3. A, Local epidural CL on the axial CT image (cement meniscus only at the nutrition foramen).
B, Extensive epidural CL on the axial CT image (cement mass exceeding the range of the nutrition foramen in
the posterior wall of the vertebral body or canal leakage measuring more than a thickness of 2 mm). CL,
cement leakage; CT, computed tomography.
DISCUSSION
Interpretation
CL into the spinal canal is a common complication with
CAFPSF and has a higher risk of developing neurological defi-
cits.1-5 Unfortunately, most cases of epidural CL cannot be
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FIGURE 5. In the presence of magistral basivertebral foramen, A and B, postoperative computed tomography
scans demonstrate C and D, that the screw is inserted relatively shallowly and close to the midline of the
vertebral body, resulting in extensive epidural cement leakage with neurological injury.
balance biomechanical strength with spinal canal leakage risk screw tip was smaller or the screw tip was closer to the midline,
perfectly. epidural CL was more likely to occur. Furthermore, we
In addition, our analysis data also showed that there was a identified risk factors associated with extensive epidural CL,
positive correlation between the applied cement volume and the and an analysis of binary logistic regression showed that only
likelihood of epidural leakage. According to previous studies, it is the smaller distance between the screw tip and the posterior
also a risk factor for epidural leakage in percutaneous vertebral wall of the vertebral body was significantly associated with
augmentation when there is a large amount of bone cement, extensive epidural CL. Besides, the morphology of posterior
resulting in an increase in injection pressure, a possibility of cortical basivertebral foramen has been added as another
secondary venous wall rupture, and pressed cement into the clinically significant factor, with a magistral type of basi-
basivertebral vein.14 Based on literature, the amount of cement vertebral foramen being significantly associated with a much
used per screw varies between 1.8 and 3.0 mL,5,7 similar to the higher risk of extensive epidural CL. We believe that anatomic
amount used in this study. The purchasing strength is not in- characteristics of the basivertebral vein might play a major role
creased by injecting more cement than 2.8 mL per screw, ac- in the cause. It originates in the ventral third of the vertebral
cording to biomechanical studies.15 To reduce the risk of epidural body and converges posteriorly to drain into the ventral part of
leakage, we believe that 1.5 to 2 mL per pedicle screw is a good the internal venous plexus. When screws are inserted too
amount to use.7 shallowly and a magistral type of basivertebral foramen is
In our study, pedicle screw placement also had a significant present, more volume of cement injected may easily enter the
association with epidural CL, and in cases where the depth of the magistral basivertebral system and be transferred to the ventral
TABLE 1. Using Binary Logistic Regression Analysis to Judge Independent Risk Factors for Epidural CL
Operative time (min)a 273.17 ± 57.93 257.28 ± 62.35 1.00 (0.99-1.01) .349
No. of augmented screws 5.49 ± 0.91 4.85 ± 1.65 1.59 (1.18-2.15) .002b
Blood loss (mL)a 623.01 ± 428.31 745.76 ± 611.14 1.00 (0.99-1.01) .169
Volume of cement injected (mL)a 2.59 ± 1.06 2.12 ± 0.74 2.40 (1.81-3.18) <.001b
Distance between the screw tip and the midline of the vertebral body (mm)a 3.89 ± 1.71 5.72 ± 2.28 0.64 (0.57-0.73) <.001b
Screw depth in the AP direction of the vertebral body (mm)a 20.85 ± 3.07 24.77 ± 3.13 0.64 (0.59-0.70) <.001b
Cement extension into the pedicle area (yes/no) 19/89 70/1226 4.08 (1.97-8.47) <.001b
AP, anterior-posterior; BMD, bone mineral density; BMI, body mass index; CL, cement leakage; OR, odd ratio.
a
Quantitative variables are expressed as mean ± SD.
b
P<0.05.
epidural space through these veins, compromising the neural further prospective study is needed. Second, in our study, most of
elements in the spinal canal.5,16,17 the pedicle screw tip’s position could be identified either directly
or by adjusting the window level and width on postoperative CT
Limitations scans. However, a small proportion of screw tip’s position was still
There are still some limitations in this study. First, we adopted a invisible, and we determined the position of the screw tip based on
multicenter retrospective study, but selection bias and technical the lengths of intraoperatively implanted screws. Although it
and interpretational bias among surgeons are inevitable, and might lead to some potential bias in comparison with direct
TABLE 2. Using Binary Logistic Regression Analysis to Judge Independent Risk Factors for Extensive Epidural Leakage
95% CI of OR
Cement extension into the pedicle area (yes/no) 0.181 1.199 0.312 4.598 .792
Disclosures
The authors have no personal, financial, or institutional interest in any of the
drugs, materials, or devices described in this article. COMMENTS
Epidural leakage was identified in 18.8% (53) of patients and 7.7% (108) of authors’ observations support these previous findings and have identified
screws. Extensive leakage was identified in 13 patients (23 screws), with 7 2 additional risk factors, the configuration of the basivertebral foramen
thought to develop neurological sequelae. Based on their analysis, the authors and proximity of the screw type to the posterior cortical wall, as inde-
identified a “magistral type” basivertebral foramen (single large foramen) and pendent risk factors that may lead to concerning epidural cement leakage.
decreased distance between the screw tip and the posterior cortical wall as The presence of a large basivertebral foramen may exacerbate the in-
independent risk factors for extensive epidural leakage. The authors conclude creased risk associated with decreased BMD, as a point of least resistance
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that when utilizing fenestrated pedicle screws supplement with cement in for cement to escape into the epidural space.
osteoporotic patients, the configuration of the basivertebral foramen is Although this manuscript suffers from several limitations, for instance,
considered and an attempt to maximize screw length is attempted. the retrospective study design and subjective surgeon interpretation to
CywCX1AWnYQp/IlQrHD3i3D0OdRyi7TvSFl4Cf3VC4/OAVpDDa8K2+Ya6H515kE= on 10/04/2023
The authors are to be commended for exploring a difficult clinical determine necessity of cement augmentation, it provides novel infor-
scenario that can be problematic under the best of circumstances. Uti- mation to stimulate further research. At the very least, these additional
lization of cement can prove to be an effective adjunct, which, however, is risk factors should be taken into account when considering cement
associated with the potential complication of cement leakage into the augmentation in the osteoporotic patient.
epidural space with possible neurological compromise. To date, several
criteria, such as decreased BMD and an increased number of screws, have Michael G. Kaiser
been identified as potential risk factors for epidural dement leakage. The Ridgewood, New Jersey, USA