|Year : 2020 | Volume
| Issue : 3 | Page : 101-108
Comparison of an intravertebral reduction device and percutaneous vertebroplasty for anatomical reduction with single-level vertebral compression fractures
Chi-Chen Huang, Shih-Huang Tai, Chao-Han Lai, E-Jian Lee
Department of Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan
|Date of Submission||14-Jan-2020|
|Date of Decision||06-Feb-2020|
|Date of Acceptance||08-Apr-2020|
|Date of Web Publication||30-May-2020|
Prof. E-Jian Lee
Department of Surgery, College of Medicine, National Cheng Kung University Hospital, National Cheng Kung University, 138 Sheng-Li Road, Tainan 70428
Source of Support: None, Conflict of Interest: None
Background: The SpineJack, a third-generation percutaneous augmentation system, is designed to be left in the vertebral body to maintain the recovery of body height following treatment for vertebral compression fractures (VCFs). This study retrospectively compared SpineJack implantation with traditional percutaneous vertebroplasty (PVP) in terms of anatomic restoration in patients with single-level VCFs.
Materials and Methods: Between January 2015 and December 2017, 74 patients with single-level VCFs underwent SpineJack implantations or PVP. The degree of pain relief was measured by a Visual Analog Scale score, and the vertebral kyphotic angle, Cobb's angle, the vertebral body height, and the vertebral body compression ratio (VBCR) were recorded preoperatively as well as immediately, 1 month, 3 months, and 1 year after surgery to evaluate anatomical restoration.
Results: There were 42 patients in the SpineJack group and 32 patients in the PVP group. No significant difference in pain relief was observed between the two groups. The SpineJack group had better kyphotic angle (6.67° ± 4.38° vs. 9.86° ± 6.73°,P < 0.01) and Cobb's angle (12.28° ± 10.13° vs. 18.03° ± 9.66°,P < 0.01) corrections than the PVP group. The postoperative VBCR was also higher in the SpineJack group than in the PVP group (78.21% ± 19% vs. 67.05% ± 18.85%, P = 0.02). The complication rates did not differ between the groups.
Conclusion: SpineJack implantation achieved better kyphosis correction and vertebral body height restoration than PVP. SpineJack implantation is safe and may not increase the risk of subsequent VCFs.
Keywords: Kyphoplasty, low back pain, spinal fractures, vertebroplasty
|How to cite this article:|
Huang CC, Tai SH, Lai CH, Lee EJ. Comparison of an intravertebral reduction device and percutaneous vertebroplasty for anatomical reduction with single-level vertebral compression fractures. Formos J Surg 2020;53:101-8
|How to cite this URL:|
Huang CC, Tai SH, Lai CH, Lee EJ. Comparison of an intravertebral reduction device and percutaneous vertebroplasty for anatomical reduction with single-level vertebral compression fractures. Formos J Surg [serial online] 2020 [cited 2020 Sep 24];53:101-8. Available from: http://www.e-fjs.org/text.asp?2020/53/3/101/285399
| Introduction|| |
Vertebral compression fracture (VCF) is a common comorbidity of patients with osteoporosis, accounting for almost as many fractures as hip and distal radius fractures combined. In Taiwan, the prevalence of osteoporosis for the population aged 50 years or older was 23.9% in males and 38.3% in females. A high prevalence of VCF was also reported for the population aged 65 years and older: 12.5% in males and 19.8% in females. The average medical costs associated with acute fractures are over US$ 3,300 per case plus the subsequent indirect costs to society. VCF has already become a major public health problem that imposes a heavy socioeconomic burden in developed countries.
When intractable back pain from VCFs persists after conservative therapy, percutaneous vertebral augmentation, such as vertebroplasty or kyphoplasty with a balloon tamp, is recommended. Both procedures have been found to be effective in the treatment of painful osteoporotic VCFs., In both procedures, polymethylmethacrylate (PMMA) bone cement infusion simplifies the stabilization of the fracture and has a thermal effect on nerve endings in surrounding tissues, resulting in a more satisfactory degree of pain relief than conservative treatment. However, the effect of vertebroplasty on height restoration of the vertebral body is limited. Thus, balloon kyphoplasty (BKP) was developed. The concept of BKP is a combination of vertebroplasty and balloon angioplasty, where an inflatable bone tamp is inserted into the vertebral body with a transpedicular approach and inflated to expand the compressed vertebral body. The bone cement is infused into the vertebral body after the balloon is deflated and removed from the body., However, the restoration of body height by BKP may be lost after the balloon deflates., The collapsed, wedge-shaped body leads to increased pressure on the facet joint and may be related to chronic back pain and further degenerative changes. The SpineJack (Vexim, Balma, France), a third-generation percutaneous vertebral augmentation system (PVAS), is a titanium implant that has been designed to apply a force in the craniocaudal direction to achieve fracture reduction in situ. Then, PMMA bone cement is injected into the expanded space to stabilize the restored vertebral body. Following the procedure, the device is placed in the vertebral body to maintain body height during recovery.
Several studies have reported the clinical efficacy and safety of SpineJack devices.,,, However, comparisons of the therapeutic effects between the SpineJack and previous interventions for VCF remain limited in the literature. In this study, we reported our experiences with the SpineJack device versus traditional percutaneous vertebroplasty (PVP) for the restoration of body height and correction of kyphotic deformity in patients with single-level VCFs.
| Materials and Methods|| |
This retrospective, monocentric, comparative study was approved by the Institutional Review Board of the National Cheng Kung University Hospital (IRB number: B-ER-106-100). We retrospectively reviewed our neurosurgical database for cases between January 2015 and December 2017. We performed vertebral augmentation procedures for 115 patients with VCFs in this period. The inclusion criteria of this study selected patients who had (1) single-level management during the operation, (2) a preoperative Visual Analog Scale (VAS) pain score of 4 or above, and (3) evidence of a fractured vertebra on magnetic resonance imaging (MRI). The exclusion criteria eliminated patients who had (1) severe spinal cord compression or neurological deficit, (2) multiple-level management during the operation, (3) implant insertion at the fractured vertebra or adjacent levels, or (4) intolerance to surgery due to severe underlying comorbidities. Under these conditions, we included 42 patients in the SpineJack (SJ) group and 32 patients in the PVP group to make comparisons.
Because kyphoplasty requires a longer operation time than vertebroplasty, all patients in the SJ group received surgery under general anesthesia, whereas the patients in the PVP group underwent the procedure under local anesthesia. In all 74 patients, the fractured vertebral bodies were accessed by a posterior transpedicular approach. In the SJ group, after inserting the guidewire transpedicularly, we reamed the vertebral body to obtain a space and inserted the template into the body. Then, the template was replaced by the implants. We opened the implants in the craniocaudal direction until a satisfactory reduction was achieved or until we encountered high resistance. Finally, the bone cement was injected inside the space created by the implants. All procedures were performed under fluoroscopic guidance.
All patients underwent preoperative, 1-day postoperative, 3-month postoperative, and 1-year postoperative plain radiography [Figure 1]. We used VAS scores to evaluate the clinical outcomes of the procedures. The degree of kyphosis was assessed by the vertebral kyphotic angle (VKA) and Cobb's angle, which is the angle formed between a line that extends from the superior endplates of the upper vertebra above the fracture and a line that extends from the inferior endplates of the lower vertebrae below the fracture., We measured the extent of vertebral body collapse by anterior vertebral body height (AVH), posterior vertebral body height (PVH), and vertebral body compression ratio (VBCR), which is the ratio of anterior vertebral height to posterior vertebral height.
|Figure 1: A 78-year-old female complained of severe back pain. (a and b) Preoperative radiography revealed a wedge-shaped compression fracture of L2. After kyphoplasty with the SpineJack device, (c and d) postoperative imaging demonstrated increased vertebral body height and reduced kyphotic deformity|
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Data are presented as the mean ± standard deviation. The categorical variables were analyzed by Chi-squared tests or Fisher's exact tests. A paired t-test was used to evaluate each difference between preoperative and postoperative conditions. The intergroup comparisons were measured by unpaired t-tests. Statistical analysis was performed using Prism Windows 6.0 (GraphPad Software, Inc., La Jolla, California, USA). The level of statistical significance was set at P < 0.05.
| Results|| |
The patient characteristics of both the groups are summarized in [Table 1]. All patients in our series underwent 3 months of follow-up postoperatively. Thirty patients (71.4%) in the SJ group and 20 patients (62.5%) in the PVP group achieved a 1-year follow-up at outpatient clinics. There were no significant differences between the two groups with respect to age, gender, preoperative T-score, or fracture level. The mean age of the patients in the SJ group was 71.62 ± 9.30 years, and the mean age of the patients in the PVP group was 73.59 ± 9.14 years. Both the groups were predominantly female (73.8% in the SJ group and 68.7% in the PVP group). The most commonly involved level of fracture in each group was the thoracolumbar junctions, and 57.1% of the patients in the SJ group and 65.6% of the patients in the PVP group had fractured vertebral bodies within the T11–L1 interval. In total, 14 patients (33.3%) in the SJ group and 12 patients (37.5%) in the PVP group had previous VCFs. The chief complaint in each group was back pain, and a fraction of patients had referred pain in the lower limb.
The preoperative VAS scores were 7.88 ± 1.15 in the SJ group and 7.43 ± 0.76 in the PVP group. After the operation, the VAS scores decreased significantly in both the groups (3.49 ± 2.20 in the SJ group and 4.82 ± 1.83 in the PVP group). The VAS scores 1 month after the operation were 3.18 ± 1.93 in the SJ group and 3.11 ± 2.20 in the PVP group. The VAS scores 3 months after the operation were 2.10 ± 2.11 in the SJ group and 1.91 ± 0.94 in the PVP group. There were no statistically significant differences between the two groups at any time point [Table 2].
|Table 2: Comparison of Visual Analog Scale scores between the SpineJack and percutaneous vertebroplasty groups|
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In the SJ group, the 1-day postoperative (6.67° ± 4.38°) and 3-month postoperative (9.05° ± 4.94°) VKA values were significantly improved as compared to the preoperative value (11.45° ± 6.89°). The 1-year postoperative VKA value was also lower than the preoperative value, although there was no statistical significance. In the PVP group, the 1-day postoperative VKA value (9.86° ± 6.73°) was also lower than the preoperative value (10.17° ± 5.20°), but the difference was not statistically significant. The 3-month postoperative (11.74° ± 6.12°) and 1-year postoperative values (11.76° ± 6.45°) were not significantly different from the preoperative value. The Cobb's angle at postoperative 1 day in the SJ group (12.28° ± 10.13°) was significantly lower than the preoperative value (16.77° ± 10.34°); however, there was no statistical significance in the difference between the preoperative value and 3-month postoperative as well as 1-year postoperative values. In the PVP group, the Cobb's angle values at postoperative 1 day (18.03° ± 9.66), 3 months (20.45° ± 8.43°), and 1 year (20.87° ± 8.05°) were slightly higher than the preoperative value (17.00° ± 8.37°) despite no statistical difference. Notably, both 1-day postoperative VKA and Cobb's angle were significantly lower in the SJ group than in the PVP group [Table 3].
|Table 3: Comparison of radiological outcomes between the SpineJack and percutaneous vertebroplasty groups|
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Regarding vertebral body collapse, the AVH values at postoperative 1 day (20.90 mm ± 5.99 mm), 3 months (18.87 mm ± 6.12 mm), and 1 year (16.78 mm ± 5.18 mm) in the SJ group increased significantly compared to the preoperative value (16.35 mm ± 6.69 mm). In the PVP group, the 1-day postoperative value was only slightly higher than the preoperative value (18.40 mm ± 5.33 mm vs. 17.89 mm ± 5.88 mm, P = 0.312). However, the AVH values at postoperative 3 months (17.45 mm ± 5.03 mm) and 1 year (16.31 mm ± 4.60 mm) were lower than the preoperative value. The PVH did not significantly increase after intervention in the SJ group or the PVP group. In the SJ group, the vertebral compression ratio at postoperative 1 day (78.21% ±19.74%), 3 months (69.27% ±18.76%), and 1 year (66.16% ±18.78%) also increased significantly as compared to the preoperative value (62.97% ±21.33%). However, no postoperative improvement was observed in the vertebral compression ratio compared to its preoperative value in the PVP group (67.05% ±18.85% vs. 65.40% ±17.31%, P = 0.49). No statistical difference was observed between the preoperative AVH and vertebral compression ratio in both the groups, but the 1-day postoperative vertebral compression ratio was significantly higher in the SJ group than in the PVP group [Table 3].
There was no significant difference between the groups in the amount of bone cement infused during surgery between the two groups (SJ: 3.87 ml ± 1.47 ml vs. PVP: 3.30 ml ± 1.47 ml, P = 0.11). Nine patients (21.4%) in the SJ group experienced cement leakage during the procedure; however, all of the leakage incidents were asymptomatic. In the PVP group, 12 patients (37.5%) had cement leakage, which were all asymptomatic. One patient (2.3%) in the SJ group had a new-onset compression fracture at the adjacent level after 4 months of follow-up at the outpatient clinic. In the PVP group, five patients (15.6%) had new-onset compression fractures. Four fractures occurred at adjacent levels; two of four occurred after 3 months, one occurred after 4 months, and one occurred after 6 months postoperatively. One fracture occurred at a nonadjacent level 1 month later after an accidental fall [Table 4].
|Table 4: Adverse effects after the use of vertebral augmentation systems|
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| Discussion|| |
Osteoporosis and associated fragility fractures are common but serious problems in developed countries. The prevalence of osteoporosis is higher in Taiwan than in America for both men and women., Thus, osteoporosis-related VCFs have become more serious public health concern and caused increasing ripple effects on society. Severe, intractable back pain is the chief complaint of patients with VCFs. The first-generation PVAS, PVP, was first introduced by Galibert et al. for treating vertebral angiomas and is widely used due to its minimally invasive nature., In a large randomized controlled trial for cases of painful VCFs, Klazen et al. reported that vertebroplasty had a better pain-relieving effect than conservative treatment at an acceptable cost. However, once a vertebral wedge-shaped fracture occurs, the pressure load on the neural arch may increase. Thus, the pressure on the facet joints also increases, which leads to hypertrophic changes in these joints and subsequent back pain or radiculopathy., The anatomical restoration of the fractured body may interrupt this domino effect. However, PVP has a limited effect on height restoration of the vertebral body and cannot correct the altered biomechanics., Therefore, second- and third-generation PVASs, including BKP and the SpineJack, were developed.
The SpineJack is a third-generation PVAS that is applied to the fractured vertebral bodies transpedicularly with fluoroscopic guidance. Subsequently, the operator can expand the device along the craniocaudal axis of the vertebral body. The device is detached and left in situ after the reduction is achieved. Finally, highly viscous PMMA is injected into the body to maintain the reduction. Several studies have reported the clinical performance of the SpineJack. A 77-patient case series showed a significant decrease in Visual Analog Scale (VAS) pain scores (from 7.9 to 1.8) postoperatively. Noriega et al. collected multicenter data from 103 patients throughout Europe and reported an 81.5% decrease in pain intensity postoperatively; this effect could be sustained for 12 months. Our results also showed significant pain relief after SpineJack implantation. There was no statistically significant difference in pain relief between the SpineJack group and the PVP group at any time point. This result may be explained by the mechanisms of pain relief by these augmentation systems. One of the mechanisms consists of the local chemical and thermal effects of PMMA on the surrounding nerve endings. There is no correlation between the augmentation device or the injected cement volume and the degree of pain relief.
However, in terms of biomechanical correction, including kyphosis reduction and vertebral body height restoration, the SpineJack system showed more potential than PVP in our series. The restoration effect to AVH could even last for 1 year in the SJ group. Both AVH and PVH in the PVP group were decreased significantly after 1 year in comparison with that of the SJ group. The improved anatomical reduction could be explained by the additional direct force applied not only by PMMA but also by the jack-like device that supports the endplates and stabilizes the fractured body. The ligamentotaxis on the anterior longitudinal ligament occurred after fracture reduction by the device, which also helps maintain the AVH. The limited effect of PVH restoration in both the groups may be because most of our cases were wedge-shaped, and the posterior part of vertebral bodies had less potential to be reduced. A few studies available on PubMed have compared the SpineJack system with first- or second-generation percutaneous augmentation systems [Table 5]. The results of a retrospective comparative study by Lin et al. were consistent with ours. Those investigators evaluated 36 SJ implantation cases and 39 vertebroplasty cases, and the SJ group had more favorable reductions of the kyphotic angle, anterior body height, and middle body height than the vertebroplasty group. However, the degree of pain relief was similar between the two groups in that study.
|Table 5: Literature review of SpineJack compared with first- or second-generation vertebral augmentation systems|
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A large prospective randomized controlled study was performed by Vanni et al. to compare the SpineJack system with BKP; in that study, 150 SpineJack cases and 150 BKP cases were evaluated. The results showed that 85% of the patients in the SpineJack group achieved more than 50% height restoration, whereas only 58% of the patients in the BKP group achieved similar height restoration. There was no significant difference in the VAS score or Oswestry Disability Index. Noriega et al. also obtained similar results. Some studies have reported reduction height loss after balloon deflation., In contrast to BKP, which requires deflation and removal of the balloon before the PMMA injection, the SpineJack device can be left in the vertebral body to maintain the reduction force. In addition, the inflated balloon may touch the lateral wall of the fractured body first before achieving enough reduction in the sagittal plane. These features may explain why SpineJack implantation achieved better anatomical restoration results than BKP.
Our postoperative bone cement leakage rates were 21.4% in the SpineJack group and 37.5% in the PVP group. All leakage incidents in this series were asymptomatic. The previously reported leakage rates of the SpineJack procedure are 0%–39.8%, and only one symptomatic case is reported in these studies.,,,,, The leakage rate associated with PVP was as high as 72% due to the nature of the fractured, osteoporotic body and the low viscosity of the injected cement.,, Fortunately, clinically significant leakage following vertebroplasty is rare under cautious fluoroscopic guidance and with skilled techniques. In contrast to vertebroplasty, the use of the SpineJack device can create a cavity in the fractured body before cement injection; thus, high-viscosity cement can be injected under relatively low pressure. Anin vitro study by Rotter et al. demonstrated that strength and stiffness will be restored if the amount of cement filling reaches 10% of the vertebral body volume when a SpineJack device is used. In PVP, the amount of cement filling was required to be 16%–30% of the body volume to restore strength. The reduced amount of cement required in the SpineJack procedure also decreases the leakage rate.
Another potential adverse effect of PVASs is the possibility of an increased risk of subsequent vertebral fractures, especially at the adjacent level. In our series, there was no statistically significant difference in subsequent adjacent fracture rates between the two groups. The reported adjacent fracture rate after SpineJack implantation was 2.2%–13.13%.,,,, A meta-analysis from Han et al. reported adjacent fractures in 155 of 1133 patients (13.7%) who underwent vertebroplasty. Lindsay et al. reported that once an osteoporotic VCF occurs, the incidence of a new fracture in the subsequent year may be as high as 19.2%. A subsequent compression fracture is a cumulative effect of osteoporosis and the vertebral augmentation systems, but the most important risk factor may be the low baseline bone density rather than the interventions.
The limitations of our study include its retrospective nature, small patient population, and limited follow-up period. However, our report, along with previous relevant studies, demonstrated that the SpineJack is effective in the management of painful VCFs without raising the complication rate. However, considering the high cost of the SpineJack device compared to other options, larger randomized controlled studies with long-term follow-up are required to demonstrate the enduring pain relief or anatomical restoration effects and to determine whether select subgroups of patients will receive maximum benefits from the SpineJack over PVP.
| Conclusion|| |
This retrospective study demonstrated that the SpineJack device is safe to use and that it has a sufficient pain-relieving effect for painful VCFs. In addition, the SpineJack procedure leads to better kyphosis correction and vertebral body height restoration with a lower bone cement leakage rate than traditional PVP. The SpineJack procedure does not increase the risk of remote- or adjacent-level fractures compared with the natural history of osteoporosis. However, large prospective randomized controlled studies are required to determine the long-term effects and patient subgroup selection criteria for the different augmentation systems.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form the patients have given their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]