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Medical Malpractice in Wuhan, China

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Medical disputes in China are historically poorly documented. In particular, autopsy-based evaluation and its impact on medical malpractice claims remain largely unstudied. This study aims to document autopsy findings and medical malpractice in one of the largest cities of China, Wuhan, located in Hubei Province. A total of 519 autopsies were performed by the Department of Forensic Medicine, Wuhan University School of Medicine, Wuhan, China, over a 10-year period between 2004 and 2013. Of these cases, 190 (36.6%) were associated with medical malpractice claims. Joint evaluation by forensic pathologists and clinicians confirmed that 97 (51.1%) of the 190 claims were approved medical malpractice cases. The percentage of approved malpractice cases increased with patient age and varied according to medical setting, physician specialty, and organ system. The clinico-pathological diagnostic discrepancy was significantly different among various physician specialties (P = 0.031) and organ systems (P = 0.000). Of those cases involved in malpractice claims, aortic dissection, coronary heart disease, and acute respiratory infection were most common. Association between incorrect diagnosis and malpractice was significant (P = 0.001). This is the first report on China's medical malpractice and findings at autopsy which reflects the current state of health care services in one of the biggest cities in China.
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Comparison of Clinical and Radiological Improvement
Between the Modified Trephine and High-speed
Drill as Main Osteotomy Instrument in
Pedicle Subtraction Osteotomy
Hui Wang, MD, Lei Ma, MD, Dalong Yang, MD, Di Zhang, MD,
Yong Shen, MD, and Wenyuan Ding, MD
Abstract: High-speed drill is the main osteotomy instrument in
pedicle subtraction osteotomy (PSO) currently. Considering the long
duration of surgery, the large amount of blood loss, and the high
incidence of neurovascular injury, the osteotomy procedure is challen-
ging. Use of trephine for the osteotomy displays high efficiency by
shortening surgery time and reducing blood loss in anterior cervical
corpectomy and fusion. However, the potential risk of neurological
injury is high. We modified the trephine by adding locking instrument,
when the serrated top of the trephine reaches the tip of the probe; the
locking instrument on the probe restricts the trephine and improves
security during the osteotomy procedure.
The aim of this study was to compare the clinical and radiological
improvement between the modified trephine and high-speed drill as
main osteotomy instrument in PSO.
From February 2009 to 2013, 50 patients with severe thoracolumbar
kyphotic deformity caused by old compressive vertebrae were prospec-
tively reviewed. All patients were randomly assigned to the experimen-
tal group (27 patients received PSO with modified trephine) and the
control group (23 patients received PSO with high-speed drill). The
clinical records were reviewed and compared for surgical time, oper-
ative blood loss, functional improvement (Oswestry Disability Index),
and pain relief (visual analog scale). The radiological records were
reviewed and compared for correction of kyphotic deformity post-
operatively and correction loss at 2-year follow-up.
All patients successfully finished the PSO procedure, and got
satisfactory kyphotic deformity correction and overall function
improvement. The surgery time was shorter in the experimental group
than that in the control group (132.7 12.6 vs 141.7 16.7 min;
P¼0.03). No significant difference was found in blood loss
(882.9 98.9 mL vs 902.2 84.9 mL; P¼0.47) or correction of the
kyphotic angle (33.4 3.48vs 32.1 2.58,P¼0.13) postoperatively
between the 2 groups. At 24-month follow-up, no difference was
discovered in loss of the correction (4.9 1.68vs 4.5 1.68;
P¼0.42), change of Oswestry Disability Index (49.4 6.2% vs
48.2 4.2%; P¼0.44), or in back pain relief (6.2 1.4 vs
6.4 1.2 min; P¼0.51) between the 2 groups. No internal fixation
related complication occurred and bony fusion was detected in lateral X-
ray in all patients. In the control group, 2 patients had transient nerve
root deficit, 14 patients at 3-month follow-up and 3 patients at 2-year
follow-up experienced graft donor site morbidity, and pain killer
medicine was always required.
In conclusion, the modified trephine obviously shortens surgery
time, and prevents graft donor site morbidity when compared to a high-
speed drill. The learning curve for using the modified trephine in PSO
procedure is short.
(Medicine 94(45):e2027)
Abbreviations: ACCF = anterior cervical corpectomy and fusion,
ODI = Oswestry Disability Index, PSO = pedicle subtraction
osteotomy, VAS = visual analog scale.
INTRODUCTION
Severe thoracolumbar kyphosis may develop secondary to
fracture, healed tuberculous infection, and congenital mal-
formation.
1–5
Irrespective of the etiology, the rigid kyphotic
deformity requires surgical intervention to prevent progressive
deterioration in sagittal imbalance and in neurologic function.
6–
9
Pedicle subtraction osteotomy (PSO), first described by
Thomson, is an effective method for correcting the kyphotic
deformity, and about 308correction can be achieved by osteot-
omy at 1 level.
10– 13
Both the curette and osteotome are
traditional osteotomy instruments, and are used in PSO to make
a wedge osteotomy space within the target vertebrae.
14
The
volume of bone harvested by curette and osteotome is small,
repetitive manipulation is required, making the osteotomy
procedure sophisticated.
15– 17
Currently, high-speed drill is
the primary osteotomy instrument in the osteotomy procedure;
it allows easy manipulation, controls bleeding effectively, and
has been proven to be safer than curette.
18
However, the high
incidence of neurological complications, the large amount of
blood loss, and the long duration of surgery make the PSO a
demanding procedure.
19– 21
Trephine, a smooth cannular instrument with annular wavy
serrated top, smooth cylindrical wall, and cross handle, is
Editor: Liu Miao.
Received: May 26, 2015; revised: October 11, 2015; accepted: October 14,
2015.
From the Department of Spine Surgery, The Third Hospital of HeBei
Medical University, Shijiazhuang, China.
Correspondence: Wenyuan Ding, Department of Spine Surgery, The Third
Hospital of HeBei Medical University, 139 Ziqiang Road, Shijiazhuang
050051, China (e-mail: dingwenyuan2012@126.com).
Funding: No funds were received in support of this work. No benefits in any
form have been or will be received from a commercial party related
directly or indirectly to the subject of this manuscript.
Ethical statement: The study was approved by Ethics Committee of The
Third Hospital of HeBei Medical University, all patients provided
written informed consent to participate in this study before
the enrollment.
HW, LM, and DY contributed equally.
Copyright #2015 Wolters Kluwer Health, Inc. All rights reserved.
This is an open access article distributed under the Creative Commons
Attribution License 4.0, which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
ISSN: 0025-7974
DOI: 10.1097/MD.0000000000002027
Medicine®
OBSERVATIONAL STUDY
Medicine Volume 94, Number 45, November 2015 www.md-journal.com |1
usually used in anterior cervical corpectomy and fusion
(ACCF). The majority of cervical vertebrae can be harvested
by trephine at 1 manipulation, displaying high osteotomy
efficiency (Fig. 1). However, if the serrated top of the trephine
touches the spinal cord, the neurological injury is terrible. When
the top reaches the posterior cortical bone, stopping screwing
the trephine is proper, but requires experience and skill. For the
safety consideration, we added locking instruments on both the
trephine and the probe (Fig. 2). The length of the trephine is
10 cm, and there are different inner diameters of trephine,
ranging from 0.6 cm to 1 cm (Fig. 3). The modified trephine
and probe have been registered in China (the Patent number: ZL
2012 2 0001559.2). When the top of the modified trephine
reaches the tip of the probe, the locking instrument on the
probe can lock the trephine to avoid the neurovascular injury
(Fig. 4).
To the best of our knowledge, no study focuses on the
application of trephine in the osteotomy procedure for thora-
columbar kyphotic deformity correction. In this study, we
applied the modified trephine in PSO, and aimed to explore
the advantage of the modified trephine over high-speed drill as
osteotomy instrument.
MATERIALS AND METHODS
Patients
The study was approved by Ethics Committee of The Third
Hospital of HeBei Medical University from the very beginning.
The inclusion criteria were as follows: diagnosis of severe
FIGURE 1. The majority of cervical vertebrae can be harvested by
1 manipulation of trephine in ACCF. ACCF ¼anterior cervical
corpectomy and fusion.
FIGURE 2. The modified probe and trephine, with restricted
instruments on both of them.
FIGURE 3. The length of the trephine isabout 10 cm, and there are
different inner diameters of trephine, ranging from 0.6cm to 1 cm.
FIGURE 4. When the serrated top of the modified trephine
reaches the tip of the probe, the locking instrument on the probe
would restrict the trephine.
Wang et al Medicine Volume 94, Number 45, November 2015
2|www.md-journal.com Copyright #2015 Wolters Kluwer Health, Inc. All rights reserved.
thoracolumbar kyphosis caused by old compressive vertebrae
fracture (duration from fracture to surgery for more than 3
years); severe pain at the thoracolumbar region; and conserva-
tive treatment for more than 3 months which did not work (bed
rest, oral pain medication, physical therapy, etc.). Exclusion
criteria were s follows: serious underlying disease (myocardial
infarction, cerebral hemorrhage, and cerebral embolism); spinal
tumor, tuberculosis, metabolic diseases, and osteoporosis; and
multisegmental spinal fracture. All patients were provided
written informed consent to participate in this study before
the enrollment.
From February 2009 to 2013, 50 patients with severe
thoracolumbar kyphotic deformity were prospectively
reviewed. All of the patients were randomly assigned to the
experimental group (patients received PSO with the modified
trephine) and the control group (patients received PSO with
high-speed drill), according to random number table method.
First, a random number table was created in the computer
(Fig. 5). Second, every patient, enrolled in this study, was asked
to choose a number within the table, in a way of row (1 to 10)
and column (1 to 10); then they were assigned the corresponding
numbers. For example, if a patient chose row 6 and column 6,
then the corresponding number was 62. Third, if the selected
number was odd, the patient was enrolled into the experimental
group. If the patient selected an even number, he/she was
enrolled into the control group.
There were 27 patients who received PSO with modified
trephine and were enrolled in the experimental group (17 male
and 10 female), and the mean age at the time of surgery was
43.8 3.6 years (range 38–52 y). The distribution of vertebral
compression fracture was as follows: 2 patients with T
12
,8
patients with L
1
, 12 patients with L
2
, and 5 patients with L
3
.
There were 23 patients who received PSO with high-speed drill
and who were enrolled in the control group (15 male and 8
female), and the mean age of the patients was 45.2 5.4 years
(range 36–57 y). The distribution of vertebral compression
fracture was as follows: 1 patient with T
12
, 6 patients with
L
1
, 11 patients with L
2
, and 5 patients with L
3
(Fig. 6a). The 2
groups were compatible in age, sex composition, preoperative
FIGURE 5. The random number table.
FIGURE 6. A, The distribution of compressive vertebrae in the experimental group and the control group. B, Comparison of age and
surgery time between the experimental group and the control group. C, Preop and 24-month follow-up ODI. D, Preop and 24-month
follow-up VAS. ODI ¼Oswestry Disability Index, VAS ¼visual analog scale.
Medicine Volume 94, Number 45, November 2015 Application of the Modified Trephine in PSO
Copyright #2015 Wolters Kluwer Health, Inc. All rights reserved. www.md-journal.com |3
kyphotic angle, Oswestry Disability Index (ODI), and visual
analog scale (VAS) (Table 1, Figure 6B– D, and Fig. 7).
Surgery Technique
All surgeries were performed by the same combined
surgical and anesthesia team. The patient was placed in a prone
position; both the motor and somatosensory-evoked potentials
(MEPs and SSEPs) were used in all the patients. A standard
posterior exposure of the spine was provided and pedicle screws
were inserted 2 levels above and below the target vertebrae
under C-arm guidance. A laminectomy was performed before
the resection of the anterior column. The screws were connected
on 1 side with a temporary stabilizing rod, which was contoured
to the shape of the deformity. Careful subperiosteal dissection
was carried out on the contralateral side (opposite to the
stabilizing rod), following the lateral wall of the vertebral body,
until the anterior aspect was reached.
Experimental Group
The PSO procedure was performed with the modified
trephine. Firstly, the pedicle probe was inserted into the com-
pressed vertebrae under C-arm guidance; then a modified hand-
held trephine was introduced into the vertebrae through the
probe. Osteotomy could be easily done by twisting the handle of
trephine slowly into the vertebrae (Figs. 8 10). When the
serrated top of the trephine reached the tip of the probe, the
restricted instrument on the probe would block the trephine and
prevent the potential injury to the major or radicular vessels
ahead. A cylindrical cancellous bone could be harvested after
the trephine and probe were taken out together (Fig. 11), with a
round space left within the vertebrae (Fig. 12). This procedure
could be performed repeatedly, as trephine was inserted into the
vertebrae from different directions (Fig. 13). The pedicle of the
compressed vertebrae and its lateral wall were removed by
curette. An osteotomy procedure on opposite side could be
performed in the same manner, to create a wedge osteotomy
space. A thin shell of the posterior wall bone anterior to the
dural sac was left, and was removed with a rongeur (for a typical
case see Fig. 14).
Control Group
The PSO procedure was performed with high-speed drill.
For the compressed vertebrae, a probe was used to determine the
entry point and depth. After enlarging the entry with a curette, a
5-mm drill was used to perform regular ‘‘egg shell’’ technique
with icy water flush. During this procedure, the inner wall of the
pedicle was kept as intact as possible; the cancellous bone from
pedicle and vertebral body was cleared thoroughly, till the
residual bony cortex and the shell of endplates remain. The
TABLE 1. Comparison of General Data and Surgery Data Between Experimental and Control Group
Group Age (y) Sex (M/F) Preoperative Kyphosis (8) Blood Loss (mL) Surgery Time (min)
Experimental 43.8 3.6 17/10 48.9 5.2 882.9 98.9 132.7 12.6
Control 45.2 5.4 15/8 46.84.2 902.2 84.9 141.7 16.7
Statistics t¼1.12 x
2
¼0.03 t¼1.58 t¼0.73 t¼2.16
Pvalue 0.26 0.87 0.12 0.47 0.03
FIGURE 7. Comparison of preoperative, 2 weeks postoperative,
and 24 months postoperative kyphotic angle between the 2
groups.
FIGURE 8. Intraoperative view of the modified trephine being
introduced into the vertebrae through the probe.
Wang et al Medicine Volume 94, Number 45, November 2015
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lateral wall of the vertebrae and the remaining posterior
vertebral wall attached to the posterior longitudinal ligament
(PLL) were removed with rongeur on both sides, decompressing
the cord circumferentially.
Contoured rods were placed bilaterally, sequential com-
pression of the rods was performed to close the osteotomy site
posteriorly, till the bone elements touched each other. The
closure of the osteotomy should be performed gradually, and
under close visualization of the dura, to prevent dural buckling.
After closure of the osteotomy space, bone grafts were placed in
the laminae (Fig. 15). In the experimental group, the graft was
collected from the vertebral bone that harvested by trephine.
Whereas in the control group, the high-speed drill ground the
cancellous bone to debris, little bone was left for grafting, and
autologous bone harvested from ilium was required. Adequate
hemostasis was ensured and the wound was thoroughly irrigated
with saline. Closed suction drains were inserted at the resection
sites and the surgical wound was closed layer-by-layer. Hypo-
tensive anesthesia and perioperative auto transfusion by means
of cell-saver were used in all cases to reduce the need for
homologous bank blood. Antibiotics were used for all patients
on the first postoperative day. Analgesics were used based on
patient requirement. The loss through the drains was measured
and recorded everyday, the drain was removed when the blood
loss through drain was less than 50 mL per 24-hour period.
FIGURE 11. A cylindrical cancellous bone is harvested after the
trephine and probe are taken out.
FIGURE 9. Intraoperative X-ray of the modified trephine being
introduced into the vertebrae through the probe.
FIGURE 10. Diagram illustration of the modified hand-held tre-
phine being introduced into the vertebrae.
FIGURE 12. A round osteotomy space is left within the vertebrae
after taking out the trephine.
Medicine Volume 94, Number 45, November 2015 Application of the Modified Trephine in PSO
Copyright #2015 Wolters Kluwer Health, Inc. All rights reserved. www.md-journal.com |5
Patients were allowed out of bed at the second postoperative
week, with a custom-made plastic thoracolumbosacral orthosis
(TLSO), and the TLSO was kept for at least 3 months.
Effect Evaluation
The clinical records were reviewed for surgery time, blood
loss, pain relief, and functional improvement. Preoperative and
postoperative pain assessments at the thoracolumbar region
were conducted using the (pain scores of 0 10). The ODI
was used to make a comprehensive and systematic evaluation
of the overall physical condition of the patient at 1 day pre-
operation and at 24 months postoperation.
Imaging Evaluation
Standard radiographic measurement was made from standing
posterior –anterior and lateral radiographs. The angle of the deform-
ity was measured using lines projected from the upper border of the
vertebra above and lower border of the vertebra below the com-
pressed vertebrae. Preoperative and postoperative (2 weeks and 24
months) lateral views were preparedtoassessdeformitycorrection
(preoperative kyphotic angle-kyphotic angle at 2 wks postopera-
tive) and loss of correction (kyphotic angle at 24 mos postopera-
tive– kyphotic angle at 2 wks postoperative). Radiographic fusion
was determined to be solid if there was bone bridging at the
osteotomy site in posterior–anterior and in lateral projections.
Statistical Analysis
Data were analyzed using Statistical Product and Service
Solutions software (version 13; SPSS, Chicago, IL). The inde-
pendent ttest was used to evaluate numeric variables (age,
preoperative kyphotic angle, surgery time, blood loss, correc-
tion of kyphotic angle, loss of correction, decrease of ODI, and
decrease of VAS), and chi-square test was used to evaluate
countable variable (sex composition). Statistical significance
was accepted at the 0.05 alpha level.
RESULTS
The surgery time was shorter in the experimentalgroup than
that in the control group (132.7 12.6 vs 141.7 16.7 min;
FIGURE 13. The osteotomy procedure by trephine can be per-
formed from different directions.
FIGURE 14. The preoperative kyphotic angle was 398, the kyphotic angle was 98at 2 weeks postoperative, 118at 1-year follow-up, and
128at 2 years follow-up.
Wang et al Medicine Volume 94, Number 45, November 2015
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P¼0.03) (Table 1 and Figure 6B). No significant difference was
found in blood loss (882.9 98.9 mL vs 902.2 84.9 mL;
P¼0.47) or correction of the kyphotic angle (33.43.48vs
32.1 2.58;P¼0.13) postoperatively between the 2 groups
(Tables 1 and 2, Fig. 16). At 24-month follow-up, no difference
was discovered in loss of the correction (4.91.68vs 4.5 1.68;
P¼0.42), change of ODI (49.4 6.2% vs 48.2 4.2%;
P¼0.44), or in back pain relief (6.2 1.4 vs 6.4 1.2 min;
P¼0.51) between the 2 groups (Tables 2 and 3, Figure 16).
There was no implant related complication in this study;
bony fusion was detected on lateral X-ray in all patients at 24-
month follow-up. In the control group, 2 patients had transient
nerve root deficits, but had recovered completely 6 weeks after
having undergone the operation, without any intervention. Four-
teen patients at 3-month follow-up and 3 patients at 24-month
follow-up experienced graft donor site morbidity, and treatment
with pain killer medicine was always required (Table 4).
DISCUSSION
The key steps of PSO procedure by the modified trephine is
summarized as follows:
(1) The pedicle probe is inserted into the compressed
vertebrae through pedicle, then the modified hand-held
trephine is introduced into the vertebrae through the probe
without a need for nerve root traction, because the smooth
cylindrical wall of the modified trephine presents no threat
to the dural sac and the nerve root and the pedicle probe
plays the guiding role in this procedure.
(2) Osteotomy could be easily performed by twisting the
handle of the trephine slowly into the vertebrae. The
restricted instrument on the probe can block the trephine
when the serrated top of the trephine reaches the tip of the
probe, the pedicle probe plays the restrictive/locking role
in this procedure.
(3) A cylindrical cancellous bone can be harvested after the
trephine and the probe are taken out together, and the
osteotomy procedure mentioned above can be performed
repeatedly as trephine is inserted into vertebrae from
different directions.
(4) The pedicle of the compressed vertebrae and its lateral
wall are removed by curette; a thin shell of the posterior
wall bone anterior to the dural sac is removed with a
rongeur. After closure of the osteotomy site, bone grafts
collected from the harvested vertebral bone by the
modified trephine are placed in the laminae.
High-speed drill is commonly used in spinal osteotomy
procedure due to its advantages of security and convenience.
22–
25
However, there are two principal defects of using a high-
speed drill in PSO. First, after closure of the osteotomy space,
bone grafts need to be placed in the laminae to achieve fusion.
High-speed drill grinds the cancellous bone within the pedicle
and vertebrae to debris, which may lead to heterotopic ossifica-
tion. Even worse, no harvested bone from the vertebrae is left
for grafting. Autologous bone harvested from ilium is required,
and the graft donor site morbidity is inevitable. In the
control group, 14 patients at 3-month follow-up and 3 patients
FIGURE 15. After closure of the osteotomy, bone grafts are placed in the laminae.
FIGURE 16. Comparison of VAS improvement, ODI improvement,
correction loss, and kyphotic correction between the 2 groups.
ODI ¼Oswestry Disability Index, VAS ¼visual analog scale.
TABLE 2. Comparison of Kyphotic Correction and Correction Loss Between the Two Groups (8)
2 Wks Postoperative 24 Mos Follow-up
Group Preoperative Kyphosis Kyphosis Correction Kyphosis Correction Loss
Experimental 48.9 5.2 14.9 3.1 33.4 3.4 19.7 3.3 4.9 1.6
Control 46.8 4.2 14.6 2.9 32.1 2.5 19.1 3.1 4.5 1.6
Statistics t¼1.58 t¼0.18 t¼1.55 t¼0.57 t¼0.82
Pvalue 0.12 0.86 0.13 0.57 0.42
Medicine Volume 94, Number 45, November 2015 Application of the Modified Trephine in PSO
Copyright #2015 Wolters Kluwer Health, Inc. All rights reserved. www.md-journal.com |7
at 24-month follow-up complained of pain around the graft
donor site, and pain killer medicine was always required for
these patients. Second, a large amount of heat may be produced
when the drill works within the vertebrae, resulting in a thermal
burn threat to the spinal cord and nerve root through bone
conduction. Icy water flush is required in the procedure to create
the wedge osteotomy space with the use of a high-speed drill.
The relative fuzzy surgical field, mixed with bone debris, blood,
and icy water, may increase the risk of neurovascular
injury unintentionally.
One advantage of the modified trephine over high-speed
drill is the decrease of surgery time. To complete the wedge
shape osteotomy, manipulation of trephine was often needed to
be performed 3 or 4 times, with half a minute per time. In other
words, less than 5 minutes is enough to finish the osteotomy
procedure within the target vertebrae. Whereas in the control
group, the relatively complicated manipulation of high-speed
drill (icy water flush, fuzzy surgical field) and the extra surgical
procedure of autologous bone grafts from ilium increase the
overall surgery duration. Another advantage is that the cylind-
rical vertebral bone harvested by trephine is an ideal graft, and
there is no need for autologous bone grafts from ilium, which
effectively shortens the duration of surgery, decreases blood
loss, and prevents graft-donor site morbidity. The size of
harvested bone differs from 0.6 cm 0.6 cm 2cm to
1cm1cm2cm, depending on the diameter of trephine in
use and the depth of trephine being screwed into the vertebral
body. Considering the safety of the probe and trephine we
modified is solid, risk of nervous impingement and vascular
injury in osteotomy procedure is much lower than the use of
traditional trephine, and the learning curve for use of the
modified trephine is short.
Although it has some advantages, the modified trephine
alone is not enough to finish the osteotomy procedure. First, the
trephine has the power to harvest vertebral cancellous bone, but
is unable to remove cortical bone; this is particularly true
regarding the posterior cortical bone anterior to the dural sac.
During the osteotomy procedure, the pedicle and lateral wall of
the compressed vertebrae are removed by curette, and the
posterior wall bone is removed by rongeur. Second, the trephine
is a cylindrical instrument, the osteotomy interface created by
trephine within the compressed vertebrae is irregular, and
further procedure to smoothen its surface before closing the
osteotomy space is necessary to achieve bony fusion. In con-
clusion, the modified trephine and high-speed drill used in the
PSO procedure demonstrate comparable radiographic and
clinical results. Application of the modified trephine obviously
shortens surgery time when compared to the high-speed drill.
The cylindrical vertebral bone harvested by trephine is an ideal
graft, without the need of autologous bone grafts from ilium,
effectively preventing the graft donor site morbidity.
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TABLE 3. Comparison of ODI and VAS Improvement Between the 2 Groups
ODI (%) VAS
Group Preop 24 Mos Postop Change Preop 24 Mos Postop Change
Experimental 69.6 5.0 22.7 6.1 49.4 6.2 7.3 1.1 1.1 0.9 6.2 1.4
Control 68.3 4.7 20.2 3.6 48.2 4.2 7.2 1.3 0.8 0.7 6.4 1.2
Statistics t¼0.89 t¼1.75 t¼0.79 t¼0.22 t¼1.26 t¼0.67
Pvalue 0.38 0.08 0.44 0.83 0.21 0.51
ODI ¼Oswestry Disability Index, Postop ¼postoperation, Preop ¼preoperation, VAS ¼visual analog scale.
TABLE 4. Surgery-associated Complications in the Exper-
imental and Control Group
Surgery-associated
Complications
Experimental
Group
Control
Group
Transient nerve root deficit 0 2
Superior posterior infection 1 1
Internal fixation failure 0 0
Deep venous thrombosis 1 0
Graft donor site morbidity
(3-mo postop)
014
Use of analgesics (3-mo postop) 0 10
Graft donor site morbidity
(2-year postop)
03
Use of analgesics
(2-year postop)
03
Postop ¼postoperation.
Wang et al Medicine Volume 94, Number 45, November 2015
8|www.md-journal.com Copyright #2015 Wolters Kluwer Health, Inc. All rights reserved.
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Medicine Volume 94, Number 45, November 2015 Application of the Modified Trephine in PSO
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... These practices pose a significant risk of patient injury, disease, disability, or death. Subsequently, it may give rise to criminal and financial liabilities on hospitals and healthcare institutions (He et al., 2015;Ramanathan, 2014). Medical negligence lawsuits are focused on the medical professional's damage, injury, or failure to the patient. ...
... A study in Wuhan city in China performed 519 autopsies between 2004 and 2013 to evaluate medical negligence. The study showed that 36.6% of the death cases were due to medical malpractice (He et al., 2015). Every year, thousands of cases are filed in the courts against healthcare professionals due to tort cases (Sohn, 2013). ...
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Retrospective study. Short-segment pedicle instrumentation (SSPI) is widely used to treat thoracolumbar junction fracture. Implant failure is the most common complication of SSPI and often necessitates revision surgery. The stand-alone anterior technique for failed SSPI provides excellent decompression and anterior column reconstruction but it is incapable of restoring normal stability. High rate of complications is solely attributable to the anterior approach. Thus, the reconstruction of the anterior column with posterior compression instrumentation is the strategy of choice. In this study, we use a modified pedicle subtraction osteotomy (PSO) technique through a single posterior approach as the salvage method for the failed SSPI. Thirteen patients with failed SSPI after thoracolumbar fracture were included and followed up at regular intervals. Revision indications include intractable pain, deteriorating neurological deficits and progressive deformity. The modified pedicle subtraction osteotomy (PSO) was performed. After osteotomy, anterior cortex thinned and the anterior longitudinal ligament was also preserved to maintain stability during correction. Autograft inserted into osteotomy gap to increase stability and fusion rate. The correction has been achieved with closure. We evaluated the patients' clinical symptoms, Segmental kyphosis correction, Bony fusion time, and complications. Segmental kyphosis correction was from preoperative average 20.9°(range 9.5° to 38.5°) to 3.0° (range 1° to 5.5°) immediately after operation and 6.1° (range 3° to 8° at the last follow-up. Bony fusion was confirmed on radiographs in all patients at average 9.9 months (range 7.5-12 mo) after revision surgery. There was no implant failure in any of the 13 patients. Average preoperative VAS was 6.5 (range 5-9) and reduced to 3.7 (range 2-5) at the last follow-up. There was also a significant decrease in mean preoperative ODI from 55.2 (range38-76) to 32.8 (16-56). No patients suffered any neurological deterioration related to revision surgery. Complication was encountered in 6 patients (46.1%), including 4 with CSF leak and 2 with superficial wound infection. All these complications were managed conservatively and none of them underwent re-operation. We conclude that modified PSO possesses the advantages of excellent kyphosis correction safe and reliable salvage alternative for revision of SSPI failure.
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The purpose of this study was to evaluate the clinical and radiographic outcomes of modified pedicle subtraction osteotomy (mPSO) for thoracolumbar post-tubercular kyphosis in pediatric patients. From January 2008 to August 2012, 26 consecutive pediatric patients with thoracolumbar post-tubercular kyphosis underwent modified pedicle subtraction osteotomy (mPSO). The clinical and radiologic outcomes were analyzed preoperatively, postoperatively, and at the last follow-up. Twenty-six patients with thoracolumbar post-tubercular kyphosis underwent mPSO. The average operation time was 256 min (188~314 min). The mean follow-up was 41 months (18~56 months). The mean estimated blood loss was 870 ml (620 ~ 1020 ml). The thoracolumbar kyphotic angle ranged from 51° to 79° before operation, 60.6° in average. The mean thoracolumbar kyphotic Cobb angle was 19.7° after operation, with a mean correction of 40.9°. The C7 sagittal plumb line was 3.8 cm after operation, comparing to the 10.5 cm preoperative. The mean preoperative angle of thoracic kyphosis (TK) was 9.9° ± 1.2° and increased to 11.8° ± 1.4°, postoperatively. Lumbar lordosis (LL) improved from -22.8° ± 4.9° preoperative to -17.8° ± 2.1° postoperative. Visual analogue scale (VAS) was 8.7 ± 1.1 preoperative and 1.2 ± 0.4 postoperative, respectively. The mean Oswestry Disability Index (ODI) improved from 49.2 ± 5.3 before surgery to 10.8 ± 3.3 postoperative (P < 0.01). All patients received good bone healing, no significant loss of correction angle. Most patients (24/26) considered pain and exterior was significantly improved. Modified pedicle subtraction osteotomy (mPSO) is effective and reliable for thoracolumbar post-tubercular kyphosis in pediatric patients.
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To the authors' knowledge, this is the first article to present a pedicle subtraction osteotomy in the lumbar spine to correct and stabilize a high-grade isthmic spondylolisthesis, which poses many challenges with regard to treatment options and outcomes. The optimal surgical treatment for high-grade spondylolisthesis is controversial, but the goals of treatment are to stabilize the affected spinal levels and to decompress the neural elements. A pedicle subtraction osteotomy is a reconstructive procedure that addresses fixed sagittal imbalance by increasing lumbar lordosis through posterior spinal column shortening. The authors report a 46-year-old patient with chronic, progressively worsening back and leg radiculopathy accompanied by sagittal plane malalignment and for which a pedicle subtraction osteotomy was performed. The procedure yielded stabilization of the patient's lumbar spondylolisthesis and sagittal plane alignment was restoration. At 3 months postoperatively, the patient's pain had fully resolved and her motor and neurologic examination exhibited no deficits. At 24 months postoperatively, she was still symptom-free and ambulating without assistance. This report is the first documented successful pedicle subtraction osteotomy in the treatment of high-grade spondylolisthesis. This report indicates that certain patient populations may be amenable to pedicle subtraction osteotomy as a treatment option for pathology involving high-grade isthmic spondylolisthesis [Orthopedics. 2015; 38(4):e347-e351.]. Copyright 2015, SLACK Incorporated.
Article
Object: The purpose of this study was to determine the efficacy of a modified vertebral column resection for the treatment of thoracolumbar angular kyphosis. Methods: A total of 13 patients (8 male, 5 female) with thoracolumbar kyphosis (kyphotic angle > 60°) were included in this study (Group A). There were 3 patients with failure of spinal formation (Type 1 deformity), 6 patients with old thoracic or lumbar compression fracture, and 4 patients with old spinal tuberculosis (including 1 case of T3-5 vertebral malunion). The average preoperative kyphotic angle was 67.3° (range 62°-75°). Each patient underwent an expanded eggshell procedure combined with the closing-opening technique for the treatment of thoracolumbar angular kyphosis. Sixteen patients who were previously treated with a closing-opening wedge osteotomy in the same spine classification group (kyphotic angle > 60°) were used as a control group (Group B). Results: In Group A, the average (± SD) operative time was 400 ± 60 minutes, and the average blood loss was 960 ± 120 ml. There were no surgery-related complications observed during or after the operations. The average local kyphotic angle was 20.3° (range 18°-24.5°), and the average correction rate was 68.7%. In Group B, the average operative time was 470 ± 90 minutes, and the average blood loss was 2600 ± 1600 ml (range 1200-8200 ml). There were segmental vessels and spinal canal venous plexus injury in 1 case, spinal cord injury in 1 case, dural tearing in 2 cases, pleural rupture in 2 cases, and hemothorax and pneumothorax in 1 case. Each patient had more than 2 years of follow-up. At the latest follow-up examination, the average regional kyphotic angle was 19.9° ± 9.1° (range 19°-34°), and there was no significant loss of correction (p > 0.05). There was greater blood loss and a higher complication rate in Group B than in Group A (p < 0.05). Conclusions: An expanded eggshell procedure combined with the closing-opening technique for the treatment of thoracolumbar angular kyphosis resulted in significant reduction of the kyphotic angle, few complications, and good follow-up results. However, a larger series of patients and long-term follow-up results is still required to verify the effectiveness and safety of this method.
Article
A systematic review and meta-analysis. To compare the efficacy and safety outcomes of Smith-Petersen osteotomy (SPO) and pedicle subtraction osteotomy (PSO) for patients with ankylosing spondylitis (AS) with thoracolumbar kyphotic deformity. Both SPO and PSO are used to correct thoracolumbar kyphotic deformity due to AS. Evidence is insufficient to determine which has better efficacy and safety outcomes. A systematic literature search was performed. Studies concentrating on treating thoracolumbar kyphotic deformity due to AS with SPO and/or PSO were included. Efficacy was determined with radiographical outcomes, including sagittal vertical axis and lumbar lordosis. Safety was determined with complication rates. The data were analyzed with Review Manager and R software. Twenty-three studies were included. Among them, 5 were comparative studies and were used for a meta-analysis. All 23 studies were pooled to evaluate the radiographical correction and incidence of complications. The meta-analysis of the 5 comparative studies showed no significant difference between groups in either correction of sagittal vertical axis and lumbar lordosis or incidence of complications. The pooled data also showed similar radiological correction and complication rates between SPO and PSO. SPO was found to have potential risk of aortic rupture and slightly higher risk of permanent neurological deficit without statistical significance, whereas PSO was shown longer operative time and more blood loss. This systematic review and meta-analysis demonstrates that both SPO and PSO are effective in correcting thoracolumbar kyphotic deformity in AS and have similar risk of most complications. Aortic rupture and related death during correction is reported in SPO and should be taken into consideration for decision making. 4.
Article
Study Design. Outcomes of transpedicular decompression and/or osteotomy were analyzed retrospectively. Objectives. To determine the effectiveness of decompression and correction, fusion stability, procedural safety, neurologic outcome, complication rates, and overall patient outcomes. Summary of Background Information. The “eggshell” procedure is reserved for complex reconstructive problems in the treatment of acute trauma, deformity, tumor, or infection. The technique encompasses a range of procedures from simple transpedicular decompression and posterior fusion to more complex procedures, including transpedicular vertebrectomy and strut-grafting or pedicle subtraction (closing wedge) osteotomy with posterolateral fusion. These procedures are completed through a single posterior midline incision, with anterior spinal canal decompression via a transpedicular approach, accompanied by a posterior or posterolateral fusion and internal fixation. Methods. From 1990 to 1998, 59 “eggshell” procedures were performed for 37 deformity cases and 22 tumor or infection cases. Forty-two patients had a minimum 2-year follow-up, averaging 4.5 ± 2.5 years. Thirty-six patients were available for patient interview, physical examination, and radiographic analysis. Outcome data were collected using SF-36 and SRS instruments. Results. No patients worsened neurologically, and all incomplete spinal cord injuries improved. All patients achieved solid fusion radiographically. Correction with osteotomy averaged 26°. Systemic complication rates were low with a pulmonary complication rate of 5%. Blood loss averaged 2342 mL. Overall patient outcomes were below population norms, but patient satisfaction was very high. Conclusion. Overall, the results suggest that the “eggshell” procedure is a reliable and safe technique to achieve anterior decompression of the spinal canal and posterior stabilization through a single approach.