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Application of piezosurgery osteotomy in cervical laminoplasty: prospective, randomized, single-blind, clinical comparison study
*Corresponding author: Yongxiong He
Mailing address: Department of spinal surgery, Inner Mongolia
people's hospital, Hohhot 010017, China.
Email: spinedoctor@sina.com
Received: 23 February 2020 Accepted: 27 May 2020
DOI: 10.31491/CSRC.2020.06.053
Abstract
Objective: To compare and analyze the clinical efficacy of piezosurgery osteotomy and high-speed drilling
respectively in cervical laminoplasty, so as to explore the operability, safety and clinical application value of
piezosurgery osteotomy in cervical laminoplasty.
Methods: A total of 60 patients with multilevel cervical stenosis from the Inner Mongolia Autonomous Region
People's Hospital were randomly divided into two groups (piezosurgery osteotomy group and high-speed
drill group) with 30 patients in each group. Operation time, intraoperative blood loss, postoperative drainage,
complication rate, Japanese orthopaedic association (JOA) score and JOA improvement rate were compared
and analyzed.
Results:The operation time in piezosurgery osteotomy group and high-speed drill group was (87±22 min) and
(96±35 min), respectively, and the difference between two groups was not statistically significant (P > 0.05).
The intraoperative blood loss in the piezosurgery osteotomy group was (121 ± 86 mL) lower than that (172
± 93 mL) in the high-speed drill group (P < 0.05). The postoperative drainage in the piezosurgery osteotomy
group was (155±87 mL) lower than that (246 ± 95 mL) in the high-speed drill group (P < 0.05). Postoperative
JOA scores in both groups were better than those before surgery, but there were no significant differences in
the postoperative JOA scores, improvement rates, and excellent rates between the two groups (P> 0.05). Dural
injury developed 1 patient in high-speed drill group and cerebrospinal fluid leakage occurred after surgery. No
serious complications such as spinal cord injury occurred in either group.
Conclusions: Piezosurgery osteotomy in cervical laminoplasty is safe and effective, and is superior in operation
time, intraoperative blood, and postoperative drainage. Its safety and efficacy are similar to high-speed drill in
cervical laminoplasty.
Keywords
Cervical laminoplasty; piezosurgery osteotomy; high-speed drill; cervical spondylotic myelopathy; safety; efficacy
Introduction
Cervical spondylotic myelopathy (CSM) is the most major etiology of cervical spinal cord dysfunction. It is a cervical spondylosis with clinical dysfunction of the spinal
cord based on the intervertebral disc degeneration, and
usually caused by degeneration of spinal vertebral connection structures such as ossification of the posterior longitudinal ligament (OPLL), which induces the compression of the spinal cord or the spinal pathway [1, 2]. It is
estimated that the incidence of CSM-related hospitalizations is 4.04 per 100,000 person-years, and the number
of patients undergoing surgical treatment increases by 7
times each year [3]. With the further aggravation of population aging and more and more people bending over
theirs desk working for a long time, multilevel cervical
spondylotic myelopathy occurring in elderly patients
is no longer rare and tends to be younger. Early surgical intervention is recommended to relieve spinal cord
compression, prevent aggravation of spinal cord injury,
restore the function of spinal cord, and provide favorable
conditions for the recovery of spinal cord function [4].
Posterior cervical expansive laminoplasty uses the "bowstring principle," in which the spinal cord moves in
a direction with less tension, avoiding the compression
in front and achieving decompression [5]. In traditional
treatments, bone rongeur and high-speed drill are used
for decompression, but it is difficult to control the bone
drill. In addition, the cervical anatomical is complicated
and congenital mutation is common, which bring great
difficulties to the operation. Furthermore, these posterior decompression techniques are associated with
improvements in the nervous system and visible complications, which pose a great challenge for surgeons
[6]. Piezosurgery osteotomy is a new type of osteotomy
technique, which has advantages of favorable tissue
selectivity, osteotomy accuracy, good hemostasis, cold
cutting, and easy operation. It has been widely used in
the surgical field [7,8,9].
In terms of posterior cervical expansive laminoplasty
alone, whether the safety and effectiveness of piezosurgery osteotomy is superior to traditional high-speed
drills has also appeared in related clinical reports [10].
However, most are retrospective studies and there is
less evidence of high-quality evidence-based medicine.
In this study, a 3-year randomized controlled study was
conducted to compare the long-term clinical effects of
cervical laminoplasty with piezosurgery osteotomy and
high-speed drill, in order to provide evidence-based
medical evidence to for the long-term clinical safety and
efficacy of these two treatments.
Materials and Methods
Patients
After examined and approved by the hospital ethics committee and signed the informed consent by the patient
.A total of 60 patients with multilevel cervical stenosis
who met the criteria for case selection were included
in this study, and they were randomly divided into two
groups (piezosurgery osteotomy group and high-speed
drill group) with 30 patients in each group. Posterior
cervical expansive laminoplasty with a titanium plate
(C3-7) was performed on the surgical segments in both
groups.
Inclusion criteria: (1) the diagnosis is multilevel cervical spondylotic myelopathy (Figure 1); (2) Conservative
treatment is ineffective or not suitable for non-surgical
treatment; (3) Two patients were operated segments
perform C3-7.
Exclusion criteria: (1) secondary cervical spine surgery;
(2) Cervical instability; (3) Cervical Kyphosis ≥ 10º; (4)
Osteoporosis; (5) Cervical spine tumor, tuberculosis,
infection; (6) Combined with other serious systemic
diseases.
Surgical method
General anesthesia was performed, the neck in the prone position was flexed and the head was fixed to the Mafield head frame. Through the longitudinal incision in the posterior center, the skin, subcutaneous tissue, and deep fascia was cut layer by layer to reach the spinous process along the “white line”. The paraspinal muscles on both sides are peeled off under the periosteum to fully expose the lamina. The left side is the hinge side, and the right side is the opening side. According to the preoperative lottery results, the appropriate grinding head of piezosurgery osteotomy (piezosurgery osteotomy group) or spherical drill (high-speed drill group) were selected. Slots were made on the lamina of the inner edge of the left articular process, and the outer cortex of the lamina and part of the cancellous bone were ground away, exposing the inner cortical bone as a hinge (Figure 2). The vertebral lamina was grinded to the inner cortex by using grinding head of piezosurgery osteotomy and spherical drill on the medial border of right articular process (Figure 3). Replace with a spatula blade (piezosurgery osteotomy group) or Kerrison rongeur (high-speed drill group), remove the remaining bone in the lamina slot and pry the vertebral lamina one by one, and carefully separate sticky tissue between the dural sac and the lamina. Finally, lift the lamina about 2cm from the opening side to the hinge side to enlarge the spinal canal and relieve the compression of the spinal cord. Centerpiece micro-plate with appropriate length was selected to be fixed on the open side lamina and the side mass to maintain lamina openning (Figure 4). The removed spinous process cancellous bone was trimmed into broken bone particles and planted at the hinge. Clean, close the incision and place the drainage tube. After surgery, 20% mannitol, methylprednisolone and neurotrophic drugs were routinely given for 3 days. After 3 days, patients can get out of bed under the protection of the cervical brace (Figure 5).
Therapeutic evaluation
The operation time, intraoperative blood loss, postoperative drainage volume, and complication rate were recorded. Japanese orthopaedic association (JOA) scoring system was used to evaluate the neurological recovery of patients [11]. The JOA improvement rate was calculated based on the JOA score of the patient before and 7 days after the operation to determine the surgical effect. Excellent: improvement rate ≥ 75%; good: improvement rate was from 50% to 74%; medium: improvement rate was from 25% to 49%; poor: improvement rate <25%.
Statistical analysis
SPSS 22.0 statistical software was used for analysis. Measurement data conforming to the normal distribution are expressed as mean ± standard deviation (x±s). Two groups were compared using two independent samples t-test or paired t-test. Fisher's exact probability method was used to compare the counting data. P < 0.05 was considered statistically significant.
Results
Comparison of general preoperative data
There were no statistically significant differences in the gender (p=0.706), age (61 vs 59, p=0.689), and JOA score (10.0 vs 11.0, p=0.184) among patients who underwent the two surgical treaments (Table 1).
Comparison of postoperative outcomes
Table 2 compares clinical outcomes between patients who underwent piezosurgery osteotomy and those who underwent high-speed drill. There were no significant difference between the two groups for operative time (piezosurgery osteotomy 87 vs high-speed drill 96, p=0.107) and intraoperative blood loss (piezosurgery osteotomy 121 vs high-speed drill 172, p=0.542). Postoperative drainage flow in piezosurgery osteotomy group was lower than that in high-speed drill group (p<0.05). The neurological function in piezosurgery osteotomy group and high-speed drill group was significantly improved, and the JOA score 7 days after the operation was significantly better than that before the operation (t=9.6727, 9.571, P= 0.000, 0.000). However, there were no significant differences in postoperative JOA score, JOA improvement rate, and JOA excellent rate between the two groups (P> 0.05).
Complications and treatment
Dural injury developed 1 patient in high-speed drill group, and duraplasty was performed. Cerebrospinal fluid leakage occurred after surgery, and the postoperative indwelling time of drainage tube was prolonged. We found no dural injury in piezosurgery osteotomy group, and no serious complications such as spinal cord injury occurred in either group.
Discussion
In recent years, with the gradual maturity of the titanium mini-plate technology reported by Brien [12] for the
first time and the improvement of surgical skills, posterior cervical expansive laminoplasty for the treatment
of multilevel cervical spondylotic myelopathy has been
widely used and achieved favorable clinical effect. Due to
the low tolerance of the cervical spinal cord to minor injuries, coupled with the older age of patients with CSM who
are prone to complicated those multiple basic diseases.
There are mutiple and sophisticated complications in
the perioperative period, and these factors have high
requirements for cervical decompression operation.
Traditional treatment equipment have large mechanical vibrations, long operation time, more intraoperative
hemorrhage and labor intensity. It is easy to damage the
dura mater and cause cerebrospinal fluid leakage after
surgery. In severe cases, it can damage the spinal cord,
increase the risk of surgery, and cause patients to recover slowly after surgery or even have severe sequelae. By
contrast, high-speed drills have a strong cutting force,
especially when cutting large bones with higher efficiency, which can quickly and precisely remove bone tissue,
significantly reduce the labor intensity of the operator,
improve surgical efficiency and reduce the risk of spinal cord injury [13]. However, high-speed drills also have
defects such as local high temperature, excessive bone
debris, and easy rolling of the surrounding soft tissue.
When the drill bit rotates at a high speed, the reaction
force to the handle is relatively large. In addition to the
influence of the carbonized bone mud in the groove, the
drill bit is prone to slippage. The operation is often interrupted by cooling operations such as irrigation and
imbibition, which requires high operator technical skills
[10]. In our study, there was 1 patient with dura injury
in the high-speed drill group. The reasons may be high
temperature and curving, combined with severe spinal
stenosis and obvious dura ossification adhesion, which
also indicates that the risk of high-speed drill is sometimes inevitable and new bone treatment tools are urgently needed.
As a new efficient treatment tool, the piezosurgery osteotomy plays a role in bone cutting through mechanical fragmentation effect and cavitation effect, which has
the advantages of its good hemostasis, tissue selectivity,
small neurovascular damage and easy operation. It was
first used in oral bone treatment, and has been widely
used in stomatology, plastic surgery, facial surgery, neurosurgery and orthopedics [7, 8]. Hidaka first applied piezosurgery osteotomy to spinal surgery in 1998, which
can reduce the incidence of nerve and dura mater injury
during double-door cervical expansive laminoplasty [14].
Matsuoka et al [15] analyzed 33 patients who underwent
unilateral laminoplasty, suggesting that the ultrasonic
bone knife is effective and safe for laminoplasty, and has
less damage to the posterior structures such as the interspinous ligament and the supraspinous ligament. It
demonstrated a postoperative spinal stability, reduced
the intractable back pain caused by spinal instability and
improved the postoperative satisfaction rate. Parker et
al [16] compared the traditional drill and piezosurgery
osteotomy for laminoplasty. The incidence of dura injury in the former was 4.3%, while that in the latter was
2.5%. The results showed that piezosurgery osteotomy
could reduce the risk of iatrogenic injury compared with
traditional tools.
In terms of safety, the most serious complication of cervical laminoplasty is spinal cord injury. Hu [17] found that
the piezosurgery osteotomy was safe and effective in the
field of spinal surgery. Some studies have shown that
compared with the traditional operation, the piezosurgery osteotomy can significantly shorten the operation
time [18]. Our results displayed that the operation time
and intraoperative blood loss in the piezosurgery osteotomy group were significantly shorter than those in the
traditional drill group (P <0.05). We believed that this
is related to the excellent efficiency of piezosurgery osteotomy in bone cutting and its characteristic of hemostasis of surrounding bone tissue during bone cutting.
High-speed drill has accessory injury to soft tissue, and
the cut bone surface has no hemostatic effect. The operator should be careful to hold to prevent skidding. In
this study, no spinal cord injury occurred in any of the
30 patients in the piezosurgery osteotomy group, which
on the one hand indicates that the design of the surgical
method assisted by piezosurgery osteotomy for cervical
laminoplasty is safe, and on the other hand indicates that
the application of piezosurgery osteotomy for laminectomy and decompression is safe for the spinal cord. The
most common complications of decompression surgery
for CSM are dural injury and cerebrospinal fluid leakage,
the main cause of which is dura ossification or the dense
adhesion between the dura and the ossified mass, as well
as intraoperative instrument injury [18]. Studies on the
use of piezosurgery osteotomy in other spinal surgeries have found that piezosurgery osteotomy can reduce
the incidence of dura injuries compared with high-speed
drilling, but no statistical difference has been found [19,
20]. In this study, there was no dura mater injury or cerebrospinal fluid leakage due to instrument damage in the
piezosurgery osteotomy group. The reason is considered
that the piezosurgery osteotomy has the following two
significant advantages: high tissue selectivity, no cutting
effect on dura; the bone cutting mode is vibration mode,
without scraping the surrounding tissue. 1 patient in the
high-speed drill group suffered from cerebrospinal fluid leakage due to severe spinal canal stenosis and dural
ossification. At this time, no matter whether the highspeed drill or piezosurgery osteotomy was used, dura
mater injury could not be avoided. At the same time, we
should also pay attention to the influence of the curve
effect of the piezosurgery osteotomy learning. For those
who have performed a large number of operations with
high-speed drills, the application of piezosurgery osteotomy will be more handy and the learning curve will
be more stable.
In terms of work efficiency, from previous studies, we can
see that the piezosurgery osteotomy can shorten the operation time [21]. Nakase et al [22] pointed out that piezosurgery osteotomy was less efficient in cutting bones than
electric drills, but piezosurgery osteotomy was more
efficient in cutting bones when delicate operation was
carried out close to important tissue structures. Sanborn
et al [18] compared the surgical effects of piezosurgery
osteotomy and high-speed drill in animal experiments
of laminectomy, and piezosurgery osteotomy has advantages in terms of operation time and intraoperative blood
loss. Our results indicate that the piezosurgery osteotomy can significantly shorten the average operation time
of the hinged side and the open side, and better reflected
its efficiency advantage when used for more segment operations. Previous studies have shown that in terms of
blood loss, cancellous bone tends to continuously bleed
when bone cutting is performed with a high-speed drill,
and piezosurgery osteotomy is synchronized with hemostasis [23]. The bleeding tendency of the bone section was
significantly reduced, which was more advantageous in
intraoperative blood loss and postoperative drainage. It
also indirectly reduces the occurrence of perioperative
complications in a sense, and provides a guarantee for
the rapid recovery of postoperative patients.
In the operation of cervical laminoplasty with piezosurgery osteotomy, the technique of the surgeon has higher
requirements. In the "forming process", first of all, you
need to be familiar with the anatomical characteristics
of the cervical spine and the pathological characteristics
of CSM, and also to be able to skillfully and accurately
determine the position of the hinge side and the open
side. Secondly, during the grooving process, both hands
need to hold the piezosurgery osteotomy, and both hands
cooperate to control the cutting depth and advance layer by layer. Press gently with one hand, and antagonize gently with the other to prevent cutting too deep. Hold the
piezosurgery osteotomy with both hands on the opening
side [24]. The operation was carried out from the spinal
canal to the outside at the lateral mass joint using the
ladle head to minimize intraoperative stimulation of the
spinal cord. When severe spinal canal stenosis causes
nerve root or dura mating between tissues to make
buffer space disappear, attention should be paid to the
control of cutting depth to avoid direct damage of piezosurgery osteotomy to the dura and nerve roots. Nakase
et al recommend the use of electric drills in combination
with piezosurgery osteotomy. High-speed drills are used
for slotting the outer cortex and cancellous bone of the
lamina, and it may be safer to cut the inner cortex with
a piezosurgery osteotomy in a relatively large area provided by the grinding drill. Our experience is that with
the use of various spoon-shaped blades, you can first use
a relatively wide spoon-shaped blade to make a groove,
which can also provide a relatively large area, and can
predict whether the position of the groove and the door
is appropriate and accurate. Incision of the inner cortex
with a relatively narrow spoon-shaped knife head minimizes interference with the spinal cord and nerve roots.
However, the number of cases in this study is small, and
the operation time of the piezosurgery osteotomy is not
recorded in real time during the operation. Prospective
studies of large samples are needed in the future to further confirm the value of piezosurgery osteotomy in
spine surgery.
Conclusion
This study has initially confirmed that the use of piezosurgery osteotomy can safely and effectively complete the operation of cervical laminoplasty, and has the advantages of less intraoperative blood, less postoperative drainage and relatively high efficiency.
Declaration
Conflicts of interest
All authors declared that there are no conflicts of interest.
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