Comparison of the curative effect of vertebroplasty with spiral and traditional pushrod injector in the treatment of osteoporotic vertebral fractures

doi:10.21203/rs.3.rs-2601104/v1

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Research Article

Comparison of the curative effect of vertebroplasty with spiral and traditional pushrod injector in the treatment of osteoporotic vertebral fractures

https://doi.org/10.21203/rs.3.rs-2601104/v1

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Background

Cement diffusion and cement leakage are key and contradictory problems in the vertebroplasty, so vertebroplasty instruments constantly develop to explore the optimal treatment. The purpose of this study was to evaluate and compare the clinical efficacy of percutaneous vertebroplasty (PVP) with spiral bone cement injector and traditional push-rod injector in the treatment of osteoporotic vertebral compression fractures (OVCF).

Methods

A retrospective study was conducted on 86 patients with OVCF who respectively received PVP surgeries with spiral injector (Observation group) and traditional pushrod injector (Control group) from February 2017 to February 2019. The preoperative baseline data, postoperative clinical efficacy, complications and imaging data between the two groups were analyzed.

Results

Follow-up period was two years. The baseline data of the two groups were comparable (all P > 0.05).The anterior edge height and kyphosis angle of the injured vertebrae were significantly improved in both groups after surgery (all P < 0.05). The VAS and ODI in both groups were significantly lower on 3rd day and 2nd year after surgery than those before surgery, and decreased gradually with time (all P < 0.05). The number of fluoroscopy and operation time in the observation group were significantly lower than those in the control group (all P < 0.05). The kyphosis angle and the recovery rates of kyphosis angle, anterior edge height, and posterior edge height in the observation group were significantly improved compared with the control group (all P < 0.05). The rate of bone cement leakage and the diffusion coefficient of bone cement in the observation group were significantly higher than those of the control group (all P < 0.05). The VAS and ODI in the observation group were significantly lower than those in the control group at 3rd day after surgery (P < 0.05), but there was no statistical difference between the two groups at 2nd year after surgery (P > 0.05).

Conclusions

PVP surgery both with spiral injector and traditional pushrod injector can achieve satisfactory outcomes, which could effectively relieve pain of lower back, improve motor function, obviously restore vertebral height and correct kyphosis. However, the spiral injector can remarkably reduce the number of fluoroscopy, operation time, and the radiation exposure dose of patients and operators. In addition, spiral injector is better than pushrod injector in restoring vertebral height, correcting kyphosis, alleviating pain immediately and improving function. But its rate of bone cement leakage is significantly higher than that of traditional pushrod injector, which requires the surgeons to pay close attention to.

Percutaneous vertebroplasty

Osteoporotic vertebral compression fracture

Lower back pain

Lumbar vertebrae

Thoracic vertebrae

Percutaneous vertebroplasty (PVP) can rapidly relieve the pain caused by osteoporotic vertebral compression fractures (OVCF), improve patients' motor function and quality of life, so PVP has been widely used in the treatment of OVCF (1, 2). However, patients with OVCF, especially those with cortical bone injury to the posterior vertebral wall, have an increased risk of bone cement leakage to spinal canal (3–5). At present, the rate of bone cement leakage is significantly less in percutaneous kyphoplasty (PKP) than PVP in the treatment of OVCF, but it still cannot avoid bone cement leakage (6, 7). PKP use balloon to expand the compressed vertebral body and squeeze the cancellous bone around the balloon. After the balloon is withdrawn, a cavity is formed, resulting in the clumpy distribution of bone cement during later injection, which is not conducive to the diffusion of bone cement(8). Considering the cost and clinical efficacy of PVP and PKP, PVP is superior to PKP in clinical selection (9).

At present, PVP usually adopts traditional push-rod bone cement injector (3). With the continuous development of PVP technology, more and more techniques are applied in clinical practice. Frequent fluoroscopy is needed in PVP surgery. Excessive X-ray fluoroscopy will increase the radiation exposure of patients and surgeons, which is harmful to their health (3). More and more PVP devices are used in clinical practice in order to reduce the number of intraoperative fluoroscopy, increase the diffusion of bone cement, and effectively restore the height of the vertebral body and correct kyphosis (10).

Spiral bone cement injector is a type of PVP device that simplifies the surgical procedure and, in theory, can reduce the number of fluoroscopy and radiation exposure. Moreover, when bone cement is injected with the spiral injector, the pressure is higher and more uniform than that of push-rod injector, which is conducive to the diffusion of bone cement and the reduction of the compressed vertebral body. The diffusion filling of bone cement for the compressed vertebral body is conducive to maintaining the reduction state, which theoretically produce better pain relief. Therefore, in order to verify these hypothesis, this study was designed to retrospectively evaluate and compare the clinical efficacy of PVP with spiral injector and traditional push-rod injector in the treatment of OVCF, with a view to guiding clinical practice and related studies.

Selection criteria

This study is a retrospective study. Inclusion criteria were as follows : (1) Patients with a single-level OVCF; (2) Magnetic resonance imaging (MRI) confirmed fresh vertebral fractures; (3) The site of percussion pain found by physical examination was consistent with the segment confirmed by imaging; (4) T value of Dual energy X-ray examination < − 2.5; (5) The follow-up time was more than two years; (6) No recurrence of injury. Exclusion criteria were as follows : (1) Patients received non-surgical treatment for surgical contraindications such as severe coagulation dysfunction and local or systemic infection etc.; (2) Patients had these symptoms of nerve root and spinal cord compression; (3) Patients suffered fresh OVCF in other vertebral bodies. (4) The obvious compression and flattening of adjacent vertebral bodies affected the stability of the spine.

General Information

This study was approved by the institutional review boards/Ethics Committees of our Hospitals. Informed consent was obtained from all subjects or their family members. A total of 43 OVCF patients treated with PVP surgery with spiral injector in CR & WISCO General Hospital from February 2017 to February 2019 were selected as the observation group. A total of 43 OVCF patients treated with PVP with traditional pushrod injector during the same period were randomly selected as the control group. The main clinical symptoms of the patients were lumbar and back pain, which worsened when changing in the patient's position such as sitting up or getting up. Percussion pain of the vertebral body could be found on physical examination. Some patients developed kyphosis. Oral analgesics and anti-osteoporosis drugs showed poor efficacy. All patients received routine preoperative thoracolumbar anteroposterior and lateral radiographs and thoracolumbar MRI examinations. CT scans were performed when necessary to evaluate the integrity of the posterior wall of the vertebral body and exclude spinal cord and nerve root compression. Visual analogy score (VAS) and Oswestry disability index (ODI) were routinely assessed.

Surgical Techniques

The prone position was taken for the posterior extension position of spine. After routine disinfection and covering, 1% lidocaine was used for local anesthesia at the puncture point. Under C-arm fluoroscopy, puncture was performed through bilateral pedicles. In the observation group, the tip of the puncture needle should reach the front-middle 1/3 of the vertebral body on the lateral view and be close to the middle of the vertebral body on the anteroposterior view. The spiral bone cement injector (Fig. 1A) (Shandong Guanlong Medical Products Co., Ltd., Jinan, China) was filled with 10 ml of the prepared bone cement (Osteopalplus, Heraeus Medical Co., Ltd., Germany). When the bone cement was in the condition of toothpaste-like state, the spiral injector was directly connected to the puncture needle and the bone cement was injected slowly and evenly (Fig. 2). In the control group, the puncture needle was stopped when the tip of the puncture needle reached the posterior third of the vertebral body in the lateral view. The guide wire was inserted through the puncture needle and the working channel was used to replace the puncture needle through the guide wire. Then a pushrod bone cement injector (Fig. 1B) (Shandong Guanlong Medical Products Co., Ltd., Jinan, China) was placed to the anterior and middle 1/3 of the vertebral body through the working channel. Bone cement was injected slowly in the early stage of bone cement wiredrawing. The injector depth was adjusted according to the orientation of the diffusion of bone cement. The pushrod injector often need to be replaced during the surgery to meet the dosage requirements. Intraoperative C-arm fluoroscopy was performed to observe the diffusion of bone cement in both groups. When the bone cement diffused to the posterior wall of the vertebral body or the paraspinal venous plexus, the injection of bone cement was suspended. If the bone cement was close to the upper and lower end plates of the vertebral body on the lateral view or bone cement was fused in the midline with each other on both sides on the anteroposterior view, the injection was ended. (Fig. 3)

Postoperative Management

These patients were strictly supine for 4–6 hours after the surgeries. After that, the patient could go to the toilet and get out of bed under the protection of lower back brace. Within 1st to 2nd month after the surgeries, these patients can get out of bed intermittently under the protection of lower back brace, and should avoid holding heavy objects and bending over. After the surgeries, patients were immediately given calcium supplements, and anti-osteoporosis drugs treatment. We advised the patient to prevent reinjury and instructed these patients to follow up regularly in the outpatient department or by telephone after discharge. These patients was generally reexamined in the outpatient department at the 1st week, 3rd months, sixth month, twelfth month and 2nd year after the surgeries.

Evaluation Indicators

Preoperative data were collected as follows: gender, age, course of disease, anterior edge height and posterior edge height of vertebral body, kyphosis angle of injured vertebral body, VAS and ODI (8, 11). Intraoperative data were collected as follows: fluoroscopy time, operative time and complications such as bone cement leakage. Postoperative data were collected as follows: VAS and ODI on 3rd day after the surgeries and at the 2nd year after the surgeries, and the rate of refracture of the adjacent vertebrae during 2 years after the surgeries (8, 11). Anterior edge height, posterior edge height and kyphosis angle of the injured vertebrae were measured on lateral radiographs using an image report view system (DJ HealthUnion Systems Corporation, Shanghai, China). According to the method of Xiao et al. (8, 9, 11), these recovery rates of the anterior and posterior edges height and the kyphosis angle of the injured vertebral body were calculated. The recovery rate of vertebral height = (postoperative vertebral height - preoperative vertebral height) / preoperative vertebral height × 100%. The Cobb angle of the injured vertebra is the kyphosis angle. So the intersection angle of the vertical lines of the upper and lower endplate of the injured vertebra measured on the lateral X-ray film is the kyphosis angle. The recovery rate of kyphosis angle = (preoperative kyphosis angle - postoperative kyphosis angle) / preoperative kyphosis angle × 100%. Image-Pro Plus Version 6.0 software (Media Cybernetics, Inc: Bethesda, MD, USA) was used to measure the diffusion coefficient of bone cement, that is, the sum of the diffusion area of bone cement on the lateral and anteroposterior radiographs divided by the sum of the vertebral body area on the lateral and anteroposterior radiographs, and then multiplied by 100% (Fig. 4).

Statistical analysis

Statistical analysis was performed using SPSS 19.0 software (IBM Corporation, New York, USA). Enumeration data were expressed by absolute numbers and percentages, and statistically analyzed by χ² test. Measurement data were expressed as mean ± standard deviation. The Levene test was used to detect homogeneity of variance of data. The independent sample t test was used for comparison between two groups. One-way analysis of variance was used for comparison at different time points within the group. P < 0.05 was considered statistically different.

The study was followed up for 2 years. Baseline data of patients in the two groups showed no statistical difference and were comparable (all P > 0.05, Table 1). The anterior edge height and kyphosis angle of the injured vertebrae were significantly improved in both groups after the surgeries (all P < 0.05). VAS and ODI in both groups were significantly lower on the 3rd day and 2nd year after the surgeries than before the surgeries, and decreased gradually with time (all P < 0.05). The number of fluoroscopy and operation time were significantly lower in the observation group than in the control group (P < 0.05). The kyphosis angle and these recovery rates of kyphosis angle, anterior edge height, posterior edge height after the surgeries in the observation group were significantly improved compared with the control group (all P < 0.05). The rate of bone cement leakage in the observation group was 55.8%, which was significantly higher than that of the control group 23.3%(P < 0.05). The VAS and ODI were significantly lower in the observation group than in the control group on the 3rd day after the surgeries (all P < 0.05), but there was no statistical difference between the two groups at the 2nd year after the surgeries (P > 0.05). The bone cement diffusion coefficient of 62.5% in the observation group was significantly higher than that of the control group 40.9% (P < 0.05). There was no significant difference between the two groups in the height of the anterior and posterior edges of the injured vertebrae after the surgeries and the refracture rate of the adjacent vertebrae (all P > 0.05). (Table 2).

Table 1 Comparison of baseline data between the two groups before surgery

Parameters

Observation group

Control group

t/c²

Cases

Gender（Cases）

Male

Female

Age（Years）

Course of disease（Days）

Anterior edge height（cm）

Posterior edge height（cm）

Kyphosis angle（º）

VAS

ODI

77.3±6.5

8.7±13.7

2.1±0.38

2.8±0.42

13.4±4.93

7.9±1.27

69.7±9.20

77.2±8.3

8.4±13.4

2.3±0.41

2.9±0.31

13.0±5.18

8.1±1.04

71.9±9.48

0.567

0.419

8.905

-4.951

-1.771

1.336

-1.762

-1.726

0.451

0.675

0.266

0.293

0.078

0.182

0.078

0.086

Table 2 Comparison of clinical data between the two groups

Parameters

Observation group

Control group

t/c²

Anterior edge height postoperatively (cm)

Posterior edge height postoperatively (cm)

Kyphosis angle postoperatively (º)

Recovery rate of anterior edge height after surgery (%)

Recovery rate of posterior edge height after surgery (%)

Recovery rate of kyphosis angle after surgery (%)

The number of fluoroscopy

Operation time (min)

The refracture rate of the adjacent vertebrae (cases)

The rate of bone cement leakage (cases)

VAS

On 3rd day after surgery

At 2nd year after surgery

ODI

On 3rd day after surgery

At 2nd year after surgery

The bone cement diffusion coefficient (%)

2.7±0.38*

3.2±0.39

6.1±5.33*

20.2±14.53

8.4±8.79

62.4±25.15

15.1±3.45

44.1±5.88

9.3% (4)

55.8% (24)

2.8±1.17*

1.1±0.62*#

23.0±4.96*

20.3±4.71*#

62.5

2.5±0.33*

3.0±0.28

5.9±4.85*

16.5±17.95

7.6±7.85

48.5±27.08

18.7±3.68

49.5±5.78

11.6% (5)

23.3% (10)

3.2±1.52*

1.0±0.64*#

24.5±4.44*

20.4±3.96*#

40.9

-3.861

-1.261

2.054

5.564

7.737

12.119

-19.952

-18.492

0.124

9.534

-2.257

0.931

-2.296

-0.213

50.077

0.375

0.208

0.040

0.000

0.725

0.002

0.025

0.353

0.023

0.831

0.000

* Compared with pre-surgery, P<0.05

# Compared with 3rd day after surgery, P<0.05

Since the application of PVP in clinical practice in 1987, PVP has been widely used in the treatment of OVCF due to its significant advantages, including good efficacy, less trauma, faster recovery, and fewer complications. Bone cement leakage is the main complication of PVP. It is also the focus that the surgeon needs to pay close attention to during the operation (11). The decrease of the leakage rate of bone cement and the improvement of the operative safety have become a common concern of surgeons. In the early stage, the PVP surgery with traditional push-rod bone cement injector injected bone cement directly into the vertebral body through the push-rod, and the leakage rate of bone cement was as high as 11-73.8% (12, 13). The kyphosis could be partially corrected by balloon dilation, which is used to expand the vertebral body and compress cancellous bone to form a space. Bone cement is then injected at low pressure. Using this technique, the leakage rate of bone cement can be reduced to 1%-21.4% (14). However, the problem of bone cement leakage has not been completely solved. In addition, balloon dilators do not remain in the vertebral body and may result in a re-loss of vertebral height. After balloon removal, the cavity is filled with bone cement, which, unlike the stress in the surrounding cancellous bone, does not properly reconstruct the biomechanical properties of the vertebral body. Stress concentration increases the risk of secondary vertebral fractures. At the same time, balloon dilation compresses the trabeculae, which can impede the crosslinking between the cement and the trabeculae and result in reduced torsional locking and shear resistance. It leads to an increased risk of refracture and further collapse of the augmented vertebral body. In addition, after the balloon is removed, the injected bone cement can directly spread to the outside of the vertebral body through the dilated fracture fissures, causing serious consequences ⁽¹⁵⁾. Spontaneous vertebral reduction can occur in OVCF patients in the posterior extension position of spine, restoring the height of the fractured vertebral body and correcting kyphosis without further balloon expansion reduction (16, 17). Heo et al. (18) reported that excessive reduction of the injured vertebrae is easy to accelerate the process of ischemic necrosis in the vertebrae, leading to severe recollapse of the vertebral body. Considering the clinical cost and efficacy, PVP is superior to PKP in clinical selection (9). PVP stabilizes the fractured vertebral body in a minimally invasive way, alleviates the lumbar and back pain in the early stage, and can restore the partial height of the vertebral body and correct kyphosis (19). PVP surgery can reduce the risk of vertebral wedge change and nerve injury in OVCF patients, so early surgical treatment should be performed (4).

In order to reduce the dose of radiation exposure and improve the diffusion state of bone cement, more and more PVP devices have been applied in clinical practice to find the optimal PVP program (4). The spiral bone cement injector has a simpler operative process than the traditional push rod injector. After pulling out the needle core, the puncture needle was directly connected to the spiral injector for bone cement perfusion surgery. There isn’t need to replace the needle with cannula and the bone cement injector during the operation. In the process of bone cement injection, a traditional push rod injector is often not enough for the dose requirements of the cement, so the push rod injector needs to be replaced to meet the dose requirements of the bone cement for vertebral augmentation. After the replacement of the push rod injector is inserted, fluoroscopy is needed to confirm the insertion depth and adjust the depth. While the spiral injector does not need to be replaced, so one-time injection can meet the needs of the injection. Therefore, our study found that the operation time and number of fluoroscopy in the observation group were significantly reduced compared with the control group, so the radiation exposure dose of patients and surgeons was obviously reduced. In the process of injection, the spiral injector can be used for spiral propulsion, and its pressure is large. Theoretically, the risk of bone cement leakage is greater than that of the traditional push rod injector. Our study also found that the bone cement leakage rate of 55.8% in the observation group was significantly higher than 23.3% in the control group. Previous studies found that the leakage rate of bone cement after PVP and PKP could be as high as 54.7% and 18.4%, respectively (20). Our study found that in the observation group, the leakage was mainly lateral leakage, accounting for 16 cases (37.2%), followed by 6 cases (14.0%) of disc leakage, 1 case (2.3%) of anterior leakage, and 1 case (2.3%) of lateral and anterior leakage. The lateral and anterior leakage in 1 patient of the observation group was large-dose leakage. Leakage in the control group was also mainly lateral leakage, accounting for 6 cases (14.0%), followed by disc leakage in 2 cases (4.7%) and anterior leakage in 2 cases (4.7%). Overall, the volume of bone cement leakage in this study was small. Bone cement leakage did not cause clinical discomfort in both groups.

Both groups significantly recovered the height of injured vertebral body and improved kyphosis angle, which was consistent with previous studies (8, 9, 11). However, kyphosis angle after surgery and these recovery rates of kyphosis angle, anterior edge height, and posterior edge height of the injured vertebra in the observation group was significantly higher than those in the control group. This may be due to the larger injection pressure during the injection of bone cement by spiral injector, which has the effect of extended reduction on the compressed cancellous bone, thus contributing to partial recovery of the height of injured vertebra and correction of kyphosis. In addition, good cement diffusion is beneficial to maintain vertebral height after reduction during and after the surgery. Due to the high injection pressure, the diffusion of bone cement is advantageous. Therefore, the bone cement diffusion coefficient of 62.5% in the observation group was significantly higher than that of 40.9% in the control group.

Previous studies have reported that PVP surgery is superior to conservative treatment in pain relief (4). Therefore, surgical treatment is more suitable for the elderly patients who can't be kept in bed for a long time, or suffer obvious pain after conservative treatment. PVP surgery is widely accepted for filling the injured vertebrae with bone cement to achieve mechanical stability, which could not only facilitate early walking but also reduce lower back pain. Although the mechanism of pain relief after bone cement strengthening is still unclear, most scholars believe that the heat and toxic substances released during the polymerization of bone cement will cause the degeneration and necrosis of nerve endings in the adjacent tissues of bone cement, thus alleviating pain to a certain extent. In addition, PVP surgery enhances the mechanical stability of the vertebral body, which is also conducive to pain relief (21). In this study, VAS and ODI scores at each time point after surgery were significantly lower than those before the surgeries in both groups, which showed that PVP surgeries with the spiral injector and traditional pushrod injector could achieve satisfactory results, effectively relieve pain and improve motor function. However, the VAS and ODI in the observation group were significantly lower than those in the control group on the 3rd day after the surgeries. This may be related to the degree of the diffusion of bone cement. Diffusion degree of bone cement in the observation group was more diffuse than that in the control group. Bone cement fully permeates most of the vertebral tissue, so that the force around the bone cement is uniform. Instant solidification of the vertebral body restores the stability of the vertebral body, which is conducive to the relief of pain. However, over time, the fracture healed gradually and the pain was gradually relieved. So there wasn’t statistical difference of the VAS and ODI between the two groups at the 2nd year after surgery.

In a study, 10.69%-12.16% of vertebral augmentation of OVCF patients were suffered new vertebral compression fractures within the 2 years follow-up period (22). In another study, 1255 patients (13.39%) suffered re-fracture after PVP/PKP surgery (23). Adjacent vertebral fracture is another complication after PVP treatment (10, 24). In another study, 11 patients (14.1%) in the early PVP group (n = 78) and 18 patients (39.1%) in the late PVP group (n = 46) had an adjacent vertebral fracture in the first year after PVP (25). Compared with the control group, the bone cement in the observation group was evenly and diffusely distributed, which could reduce the stress concentration and thus reduce the influence on the spinal stress conduction. Our study found that the rate of refracture in the observation group was 9.3% less than 11.6% in the control group, but there wasn’t statistical difference between the two groups. In this study, the incidence of refracture both in the two groups was lower than that in the previous study, which may be related to the restriction of premature activity, thoracolumbar protection, prevention of re-injury and continuous anti-osteoporosis treatment after the surgeries.

Limitations

The deficiencies of this study are as follows: Firstly, the nature of retrospective study cannot be avoided; Secondly, there was not randomization, and researchers and patients were not blinded, which may lead to subjective bias. Thirdly, this surgery was performed by several senior surgeons in our department, not just by one surgeon, which may lead to bias. Finally, the sample size of this study is relatively small, and the data are from a single hospital, so the included cases may be biased. Therefore, the results of this study need to be confirmed by further large clinical randomized, controlled, multicenter studies.

Both spiral injector and traditional pushrod injector PVP can achieve satisfactory outcomes, which could effectively relieve pain of lower back and improve motor function, obviously restore vertebral height and correct kyphosis. However, the spiral injector can remarkably reduce the number of fluoroscopy, operation time, and the radiation exposure dose of patients and surgeons. In addition, spiral injector is better than pushrod injector in restoring vertebral height, correcting kyphosis, alleviating pain immediately and improving function. But the rate of bone cement leakage of spiral injector is significantly higher than that of traditional pushrod injector, which requires the surgeons to pay close attention to.

PVP

Percutaneous vertebroplasty

PKP

Percutaneous kyphoplasty

OVCF

Osteoporotic vertebral compression fractures

ODI

Oswestry disability index

VAS

Visual analogue scale. BMD:Bone mineral density

Ethics approval and consent to participate

This study was approved by the institutional review boards/Ethics Committees of CR & WISCO General Hospital (HRWGZYY20210006) and Tongren Hospital of Wuhan University, and was conducted in compliance with the ethical principles of the Helsinki Declaration of 1975. Informed consent was obtained from all subjects or their family members.

Consent for publication

Not applicable.

Availability of data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests

No potential conflict of interest relevant to this article was reported.

Fundings

Ya-Ping Xiao was funded by the Wuhan Medical Scientific Research Project (WX20Z07) during the implementation of the research.

Authors’ contributions

All authors made substantive intellectual contributions in this study to qualify as authors. X YP and L ZH designed this study. X YP and C JZ participated in collecting and analyzing raw materials. B MJ and L YQ played an important role in statistical analysis and language editing. An initial draft of the manuscript was written by X YP and L YQ. L ZH re-drafted parts of the manuscript and provided helpful advice on the final revision. All authors were involved in writing the manuscript. All authors read and approved the final manuscript.

Acknowledgements

We are very grateful for the help and cooperation given during this study by medical personnel from radiology department, rehabilitation department, and other medical staff and nursing staff of orthopedic department.

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No competing interests reported.

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Comparison of the curative effect of vertebroplasty with spiral and traditional pushrod injector in the treatment of osteoporotic vertebral fractures

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Abstract

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Background

Methods

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Surgical Techniques

Postoperative Management

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