A clinical study of improved percutaneous vertebroplasty for treatment of Kummell’s disease without neurological symptoms

doi:10.21203/rs.3.rs-5297833/v1

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A clinical study of improved percutaneous vertebroplasty for treatment of Kummell’s disease without neurological symptoms

https://doi.org/10.21203/rs.3.rs-5297833/v1

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[Objective] To investigate the clinical effect of improved percutaneous vertebroplasty (PVP) for the treatment of Kummell’s disease without neurological symptoms.

[Methods] Thirty-nine Kummell’s disease patients without neurological symptoms, including 7 males and 32 females aged between 59 and 89, who received surgery on their T8-L5 vertebrae at our hospital from November 2022 to February 2024 were included in this study. Of them, 18 received the improved PVP surgery and 21 underwent the traditional bilateral PVP surgery. Both groups of patients had complete follow-up data for 6-15 months, averaging (9.28±1.99) months. Outcome measures included intraoperative bone cement leakage, bone cement injection volume, C-arm fluoroscopic frequency, operation time, visual analog scale (VAS) and Oswestry disability index (ODI) before operation, 1d after operation, and at the last follow-up. The two surgical operations were approved by the Ethics Committee of Loudi Central Hospital in Hunan Province.

[Results] All the 39 patients were successfully operated and had complete follow-up data. ① The bone cement injection volume in the improved PVP group was significantly higher than that in the traditional PVP group (P＜0.01). ② The operation time and intraoperative C-arm fluoroscopic frequency of the improved PVP group were significantly less than those of the traditional PVP group (P＜0.05). ③ Both groups did not suffer nerve injury and other severe complications during operation. Bone cement leakage occurred in 12 patients (66.67%) of the improved PVP group and 16 patients (76.19%) of the traditional PVP group. The difference in bone cement leakage between the two groups was not significant (P＞0.05). ④ The VAS and ODI scores of both groups were significantly improved after surgery (P＜0.05). There was no significant difference in VAS and ODI scores 1d after operation and at the last follow-up between the two groups (P＞0.05).

[Conclusion] Both improved and traditional PVP have good effects and high safety in the treatment of Kummell’s disease without neurological symptoms. However, the former has advantages of shorter operation time, a lower C-arm fluoroscopic frequency, and higher bone cement injection volume.

Kummell’s disease

percutaneous vertebroplasty

bone cement

Oswestry disability index

visual analog scale

surgical complications

Kummell’s disease is a serious complication of osteoporotic vertebral compression fractures (OVCFs) ^[1], and it usually affects the thoracic and lumbar regions of the spine ^{[2, 3]}. Lesions are often detected in a single segment ^[4]. Kummell’s disease was found and defined by Hermann Kummell in 1895. Due to a history of minor spinal injury, the patients present progressively aggravated lower back pain and motor function impairment accompanied by kyphotic deformity and even neurological dysfunction ^[6] after several weeks to years of asymptomatic stage ^[5]. The main manifestations include vertebral osteonecrosis, nonunion, and pseudoarthrosis ^[7]. Kummell’s disease typically features intravertebral vacuum cleft (IVC) on images ^[8]. The study by Libicher Martin et al. shows that the sensitivity and specificity of IVC for the diagnosis of Kummell’s disease are 85% and 99%, respectively. However, IVC may also be detected in primary or metastatic tumors of the spine ^[9], so it cannot be used as an image feature specific to Kummell’s disease ^[5]. Li divides Kummell’s disease into three stages according to the loss of height of the affected vertebra and associated symptoms. As research on Kummell’s disease deepens, most scholars believe patients with stage-Ⅲ Kummell’s disease should receive surgery as soon as possible ^{[10, 11]}. PVP and percutaneous kyphoplasty (PKP) are preferred treatment methods for stage-I and -II Kummell’s disease at present ^[12–14]. Since most Kummell’s disease patients were of advanced age or have postmenopausal osteoporosis, and they do not have a good financial state, PVP with economic advantages was studied in this paper. By combining connectors with traditional PVP, a connector-like working channel featuring “inlet-IVC-outlet” was constructed for PVP. The PVP with such channel is different from traditional bilateral PVP. The inlet of this channel was connected to the ventral side of IVC while the outlet was connected to the back side of IVC. To compare the clinical effect between improved and traditional bilateral PVP, data on the treatment of stage-I and -II Kummell's disease without neurological symptoms using the said two PVP methods in the Department of Spine Surgery at our hospital from November 2022 to February 2024 were collected and analyzed. Details are shown below.

1.1 Study object

Thirty-nine patients with Kummell's disease who underwent surgery in the Department of Spine Surgery at Loudi Central Hospital, Hunan province from November 2022 to February 2024 were included in the study. Among them, 18 patients underwent improved PVP and 21 patients received traditional bilateral PVP.

1.2 Inclusion and exclusion criteria

Inclusion criteria: ① Patients confirmed as Kummell's disease according to the medical history, physical and imaging examinations; ② Patients classified as stages Ⅰ and Ⅱ based on Li’s staging criteria; ③ Patients showing no or poor response to 3-month conservative treatment; ④ Patients receiving regular anti-osteoporosis treatment after surgery; ⑤ Patients followed-up for at least 6 months with complete follow-up data.

Exclusion criteria: ① Patients with other spinal diseases, such as congenital spinal deformity, primary or metastatic spinal tumor; ② Patients with other systemic diseases, such as neurogenic and muscular diseases; ③ Patients classified as stage Ⅲ based on Li’s staging criteria; ④ Patients who did not take regular anti-osteoporosis treatment under medical supervision after surgery; ⑤ Patients who were not followed-up or followed-up for less than 6 months with incomplete follow-up data.

1.3 Bone cement material

Information of the bone cement kit

Basic information	Bone cement kit
Manufacturer	Tecres S.P.A
Batch number	AC2425
Registration certificate number	Imported medical device registration number 20173137165
Material and composition	It consists of bone cement, an injection tool and a cooling sleeve. Bone cement contains powder and liquid components. Powder includes methyl methacrylate, barium sulfate, benzoyl peroxide. The liquid is constituted by methyl methacrylate, N, N-dimethylphenol, and hydroquinone
Usage	To fill the gaps in the spine column

1.4 Surgical method

Improved PVP group: The affected vertebra was positioned under the G-arm, and then the skin was sterilized and sterile sheets were placed with the patient lying face down. The mixture of 2% lidocaine and normal saline at 1:1 was injected so that it can infiltrate the surgical site layer by layer, finally achieving the purpose of local anesthesia. In the stage of primary injection, puncture needles were inserted into IVC from two sides at an angle planned before surgery. The inlet of the channel was placed at the ventral side of IVC while the outlet was arranged at the back side of IVC. This arrangement is good for the discharge of gas and liquid from the cavity. Then the water injection test was conducted. If there was liquid flowing out of the outlet after normal saline was injected into the inlet, it indicated the connector-like channel was successfully built. Afterwards, a long puncture needle was used to remove all the remaining liquid in the IVC cavity. Bone cement was prepared into the mixing or sticky phase when it has good mobility. Then a 10ml injector was connected to the injector jacket to inject bone cement at a slow and uniform speed into the ventral side of IVC. When there was bone cement flowing out of the outlet, the IVC cavity was considered full. Front and lateral views were taken by a G-arm X-ray machine for the evaluation of bone cement distribution. In the pressure injection stage, the outlet was connected to the injector to cut the connector-like channel, and bone cement was injected multiple times in small amounts under the G-arm X-ray machine so that bone cement was distributed more uniformly. It was observed under the machine that bone cement was all within the vertebral body, with no leakage to the spinal canal. The puncture needle was removed after the hardening of bonce cement.

Traditional bilateral PVP group: The skin of the surgical area was disinfected and sterile sheets were put on it with the patient lying face down. The affected vertebra was positioned horizontally by a G-arm machine and a positioning pin. The mixture of 2% lidocaine and normal saline at 1:1 was injected so that it can infiltrate the surgical site layer by layer for local anesthesia of the articular process. A Kirschner wire penetrated through the soft tissue and bilateral pedicles, and finally entered the affected vertebra under the dynamic monitoring of the G-arm machine from the front and lateral positions. The puncture needle casing was then used to wrap the Kirschner wire and led into the front middle part of the vertebra along the trajectory of the Kirschner wire. The Kirschner wire was removed and the puncture needle was placed in the puncture needle casing. The powder and liquid components of bone cement were mixed at 1:1, and after the puncture needle was taken out, the sticky-phase bone cement was injected into the IVC cavity until the cavity was full. During the injection process, the vertebra was X-rayed when every 0.5ml of bone cement was injected to make sure no leakage to the spinal canal. The puncture needle was removed after the hardening of bone cement.

Both PVP operations comply with PVP standards and were conducted by the same group of surgical physicians. The bone cement injection channels of improved and traditional bilateral PVP are shown in Figs. 1a and 1b, respectively. The water injection test is shown in Fig. 2. Figure 3 shows the flow of bone cement from the channel outlet of the improved PVP surgery in the primary injection period. Figure 4 depicts the precision pressure injection period.

1.5 Postoperative treatment

The patient was told to stay in bed and do moderate functional exercise to prevent thrombosis on the same day after surgery. On the first day after surgery, the patient should do proper off-bed activities with thoracolumbar fixation braces on. The patient was only allowed to discharge from the hospital when the front and lateral images of the thoracic or lumbar vertebra were normal. After discharge, the patient was told to wear thoracolumbar fixation braces for 1 month and take vitamin D or risperidone orally for regular ant-osteoporosis treatment.

1.6 Follow-up method

Patients were followed-up by telephone or outpatient re-examination.

1.7 Indicator

The indicators include intraoperative bone cement injection volume, fluoroscopic frequency, operation time, VAS and ODI before operation, 1d after operation, and at the last follow-up, and postoperative complications (e.g., bone cement leakage, nerve injury, acute pulmonary embolism and refracture).

1.8 Statistical analysis

All the data were analyzed statistically using SPSS 27.0. Measurement data were represented with Ẍ±S, and the independent-sample t test was used for group comparison. Counting data were compared using the Fisher exact test. P<0.05 indicates significant difference.

2.1Analysis of the patients included

A total of 39 patients were included for analysis.

2.2 Analysis process

2.3 Comparison of basic information between two groups of patients before surgery

Of 18 patients in the improved PVP group, 2 were males and 16 were females, aged between 65 and 87. There were 5 males and 16 females in the traditional PVP group, who aged between 59 and 89. There was no significant difference in gender, age, and disease vertebrae between the two groups. The results are detailed in Table 1.

Table 1
Comparison of basic information of two groups of patients
Basic information	Improved PVP group (18 cases)	Traditional PVP group (21 cases)	Statistical value	p
Gender
Male/female	2/16	5/16	/	0.418
Age (year)	75.389 ± 6.643	74.048 ± 7.082	t = 0.154	0.878
Lesion segment
T8-T10/T11-L2/L3-L5	4/11/3	7/10/4	χ² = 0.783	0.676

2.4 Comparison of intraoperative conditions

All the 39 patients were informed of the surgical method via conversation and signed the informed consent form. The surgery was completed smoothly as planned in all patients. No acute pulmonary embolism, nerve injury and other serious complications occurred during surgery. Compared with those in the traditional PVP group, the operation time was significantly shorter (P<0.05), the C-arm fluoroscopic frequency was significantly less (P<0.01), and the bone cement injection volume was significantly higher (P<0.01) in the improved PVP group. More details are shown in Table 2.

Table 2
Comparison of intraoperative conditions
Indicator	Improved PVP group (18 cases)	Traditional PVP group (21 cases)	t	p
Operation time (min)	30.167 ± 6.776	36.624 ± 9.527	-2.400	0.022
C-arm fluoroscopic frequency (times)	4.222 ± 0.647	8.286 ± 0.644	-19.611	p<0.01
Bone cement injection volume (ml)	8.967 ± 0.612	5.010 ± 1.017	14.406	p<0.01

2.5 Comparison of postoperative effects

All the 39 patients were followed-up for more than 6 months (average: (9.28 ± 1.99) months), with complete follow-up data. Compared with those before surgery, the symptoms in both groups of patients were greatly relieved, and the VAS and ODI scores were significantly decreased after surgery. There was no significant difference in VAS and ODI scores between the two groups of patients 1d after surgery and at the last follow-up (P>0.05). More information is summarized in Tables 3 and 4.

Table 3
Comparison of preoperative and postoperative VAS scores in two groups of patients (Ẍ±S, point)
Time point	Improved PVP group (18 cases)	Traditional PVP group (21 cases)	t	p
Before surgery	7.278 ± 1.074	7.191 ± 1.078	0.253	0.802
1d after surgery	2.222 ± 0.732	2.048 ± 0.669	0.778	0.442
Last follow-up	2.389 ± 0.502	2.429 ± 0.746	-0.196	0.845

Table 4
Comparison of preoperative and postoperative ODI scores in two groups of patients (Ẍ±S, %)
Time point	Improved PVP group (18 cases)	Traditional PVP group (21 cases)	t	p
Before surgery	71.872 ± 4.406	71.148 ± 2.919	0.613	0.543
1d after surgery	25.661 ± 2.463	24.571 ± 2.134	1.481	0.147
Last follow-up	25.094 ± 2.023	25.491 ± 2.104	-0.596	0.555

2.6 Comparison of complications

Of all the patients, 28 (71.79%) had bone cement leakage, including 12 (66.67%) from the improved PVP group and 16 (76.19%) from the traditional PVP group. No acute pulmonary embolism, nerve injury, wound infection and other complications were detected. There was no significant difference in bone cement leakage between the two groups of patients (P = 0.723>0.05). Tables 5 and 6 compare complications and bone cement leakage between the two groups, respectively.

Table 5
Complication	Improved PVP group (18 cases)	Traditional PVP group (21 cases)
Bone cement leakage	12	16
Acute pulmonary embolism	0	0
Nerve injury	0	0
Wound infection	0	0

Table 6
Bone cement leakage	Primary injection stage	Pressure injection stage	Total leakage
Improved PVP group (18 cases)	2	10	12
Traditional bilateral PVP group (21 cases)	/	/	16

2.7 Typical imaging data

A-C are his X ray, CT and MRI before surgery, respectively. D and E are front and lateral images under the C-arm machine during surgery, respectively. The images suggest uniform distribution of bone cement. F and G are front and lateral images of the lumbar vertebra at the last follow-up, indicating bone cement is uniformly distributed.

A-C are her X ray, CT and MRI before surgery, respectively. D and E are lateral and front images under the C-arm machine during surgery, respectively. The images suggest uniform distribution of bone cement. F and G are front and lateral images of the lumbar vertebra at the last follow-up, indicating bone cement is uniformly distributed.

OVCFs often occur in the elderly, with the main manifestation of lower back pain. OVCFs are hard to detect at the early stage, and most elderly patients pay little attention to it and only consider it as common backaches ^[15]. However, when they seek medical treatment for other reasons, they are diagnosed with hunchback and vertebral compression fractures ^[16]. Kummell’s disease is a serious complication of OVCFs, with an incidence of 7%-37% in elderly OVCF patients ^[7]. With the aggravation of population aging and the development and renovation of imaging technology and equipment, it becomes easier to treat Kummell’s disease, resulting in the increase of its incidence. Kummell’s disease is classified into three stages. Stage-I is defined as a height loss of the affected vertebrae by less than 20% and no adjacent intervertebral disc degeneration. In stage-II, the height loss of the affected vertebrae exceeds 20% and intervertebral disc degeneration occurs. In stage-III, the posterior wall of the affected vertebra ruptures and protrudes into the spinal canal, compressing the dural sac. The main manifestation of stage-III patients is lower back pain, with or without neurological symptoms. Some clinical studies show that many patients with stage-III Kummell’s disease have no neurological symptoms. Thus, these patients are further divided into stage-IIIa and stage-IIIb. Li believes that stage-III is a contraindication for the use of bone cement ^[17], so only Kummell’s disease patients at stages I and II without neurological symptoms were included in the present study. Some studies reveal the mechanisms underlying the treatment of stage-I and -II Kummell’s disease without neurological symptoms by PVP and PKP, in which bone cement is injected into the affected vertebra. Specifically, bone cement can fix the affected vertebra and enhance its hardness. Moreover, as a chemical substance, bone cement produces cytotoxic effects and heat during hardening after it is injected into the affected vertebra, thus destroying vertebral nerve endings ^[18]. The mechanisms explain high heat and swelling pain in the affected vertebra during surgery and adjacent vertebral fractures after surgery.

With the development of minimally invasive spine surgery technique, many modifications have been made to the traditional minimally invasive surgery. Fox example, a stepwise sequential infusion method of bone cement is proposed based on previous experimental theories ^[19]. Bone cement at different phases is injected several times into IVC, which reduces leakage and improves the treatment effect. Before this study, the author found that overly large resistance often causes unsmooth injection of bone cement during surgery, and forceful infusion easily leads to leakage. In order to ensure safety and achieve the expected treatment effect, bone cement needs to be injected several times in small amounts and fluoroscopic procedures should be performed frequently. In addition, the study by Fu et al. shows that pain relief in post-PVP patients is positively correlated with the bone cement injection volume. Thus, more bone cement should be injected into the affected vertebra on the premise of ensuring safety ^[20]. For the above-mentioned reasons, the author intended to conduct a study to develop a method of injecting more bone cement to improve surgical efficiency while keeping patients safe. Connectors are a container with open upper ends and a connected bottom. U-tubes are a type of simple connector. Whether a liquid is injected from the right or left tube, the liquid level in both tubes will ultimately maintain at the same level. The author thought that if bilateral puncture pathways were connected in the IVC cavity, a U-tube-like channel for bone cement injection was constructed. After multiple successful water-injection tests (approved by the Ethics Committee of Loudi Central Hospital), the principle was finally applied to traditional PVP. The connector-like PVP channel featuring “inlet-IVC-outlet” that is connected with the external world enables the full filling of the IVC cavity by one constant-low-speed injection theoretically. Full filling means there is bone cement flowing out from the outlet. The operation time saved can be used for multiple precision pressure injections of bone cement in small amounts to achieve its uniform distribution. This method improves surgical efficiency, reduces the C-arm fluoroscopic frequency, mitigates harm caused by radiation to the health of patients and medical workers, and increases the bone cement injection volume. To verify the feasibility and effectiveness of the improved method, patients with stage-I and -II Kummell’s disease treated by traditional bilateral PVP were taken as controls in the present study. Many studies suggest that there is no significant difference in the treatment effect of Kummell’s disease without neurological symptoms between unilateral and bilateral PVP ^{[21, 22]}. To make sure there was only one variable and reduce experimental errors, Kummell’s disease patients who received traditional bilateral PVP were included in the control group of the present study.

Post-PVP bone cement leakage is a common surgical complication ^{[23, 24]} that many researchers are concerned about. Wang et al. ^[25] divide the IVC cavity of patients with Kummel’s disease into two types. One type is close to the incomplete endplate and connected with the intervertebral space. The other type passes through the anterior cortical bone of the affected vertebra. The features of the IVC cavity may lead to bone cement leakage during surgery. Research shows that the incidence of intra-PVP bone cement leakage is 38%-75%^[26]. In the present study, there were 12 patients (66.67%) in the improved PVP group and 16 patients (76.19%) in the traditional PVP group having bone cement leakage. The difference in the incidence of bone cement leakage between the two groups was not significant (P>0.05). In addition, many studies show that an increase in the bone cement injection volume leads to an increase in the incidence of bone cement leakage ^{[20, 27]}. The bone cement injection volume (8.967 ± 0.612) in the improved PVP group was significantly higher than that (5.010 ± 1.017) in the traditional PVP group (P<0.01). Therefore, theoretically, the incidence of bone cement leakage in the improved PVP group is higher than that in the traditional PVP group. However, that was not the case. It is possibly related to the experimental design. The curing process of bone cement is divided into mixing, sticky, working and hardening phases. The improved PVP approach proposed in the present study includes two stages, namely, primary injection and pressure injection. In the primary injection stage, bone cement of mixing or sticky phase, which has good mobility, is injected slowly at a constant rate into the IVC cavity through the connector-like PVP channel. This channel is connected with the external world and thus can reduce infusion resistance, which helps lower the incidence of bone cement leakage. A comparison analysis of the incidence of bone cement leakage between the primary injection stage of improved PVP and traditional PVP was made. In the primary injection stage of improved PVP, the IVC cavity is considered full when bone cement flows out of the channel outlet. Similarly, in traditional bilateral PVP, the surgery is considered finished when the IVC cavity is filled to the full. Bone cement leakage was detected in 2 patients in the primary injection stage of the improved PVP group and 16 patients in the traditional bilateral PVP group. Fisher exact tests showed that there was significant difference in the incidence of bone cement leakage between the two groups (P<0.01). This result provides data support for the effectiveness of the connector-like PVP channel featuring “inlet-IVC-outlet”. However, the present study has a small sample size, and bone cement used in the pressure injection stage has poor mobility as it enters the later sticky or working stage. It helps with the monitoring of the distribution of bone cement, but may lead to bone cement leakage since bone cement is injected several times in small amounts, just like what is done in traditional bilateral PVP. Therefore, a larger size of samples should be included in further studies to provide stronger data support for the results of the present study.

Based on the statistical analysis above, the VAS and ODI scores of both the improved and traditional PVP groups were decreased after surgery. There were no serious complications such as acute pulmonary embolism or nerve injury detected during surgery. The incidence of bone cement leakage was not significantly different between the improved and traditional PVP groups. The results show that improved and traditional PVP are both safe and effective in the treatment of stage-Ⅰ and -Ⅱ Kummell’s disease without neurological symptoms. Compared with the traditional PVP method, the improved PVP method has the advantages of a lower C-arm fluoroscopic frequency and higher bone cement injection volume. Taken above, the present study provides data and theoretical support for the application and promotion of the improved PVP method in the treatment of stage-Ⅰ and -Ⅱ Kummell’s disease without neurological symptoms. Since a relatively small sample size may lead to sampling errors, more patients will be included in the surgical group in future studies to achieve more convincing conclusions.

Author Contribution

Chen and Zheng performed the surgery; Kang, Yang, and Liu assisted with the surgery and postoperative follow-up; Luo, a graduate student, assisted with the surgery, collected data, and wrote the paper, which was reviewed by all

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No competing interests reported.

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A clinical study of improved percutaneous vertebroplasty for treatment of Kummell’s disease without neurological symptoms

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