Percutaneous mesh-container-plasty versus percutaneous kyphoplasty in the treatment of osteoporotic compression fractures with up-endplate injury: a retrospective study

doi:10.21203/rs.3.rs-4295922/v1

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Percutaneous mesh-container-plasty versus percutaneous kyphoplasty in the treatment of osteoporotic compression fractures with up-endplate injury: a retrospective study

https://doi.org/10.21203/rs.3.rs-4295922/v1

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Background: Percutaneous mesh-container-plasty（PMCP），a modified traditional percutaneous kyphoplasty（PKP）technique，is increasingly being used to treat osteoporotic vertebral compression fractures（OVCF） with up-endplate injury. This retrospective study aimed to compare the clinical and radiological results of PKP and PMCP for the treatment of this disease.

Methods: We reviewed the records of patients with osteoporosis compression fracture and upper endplate injury in our hospital from January 2019 to December 2021.One hundred and ninety-two patients who sustained osteoporosis compression fracture and upper endplate injury without neurological deficits were included in this study according to the inclusion and exclusion criteria.103 patients underwent PKP surgery，and 89 patients underwent PMCP surgery.

Results: The VAS and ODI scores improved in the PKP and the PMCP. The anterior vertebral body height ratio (AVBHr) and Cobb's angle showed recovery, but there was no significant statistical difference between BMCP and PKP groups. The amount of bone cement injection and the duration of patient hospitalization were similar between the two groups. But the incidence of cement leakage and adjacent vertebral fracture was lower in the PMCP group (9/89 and 3/89) than in the PKP group (24/103 and 12/103) (p < 0.05). The operation time and fluoroscopy time in the PMCP group (35.23 ± 8.54 minutes and 13.26 ± 3.34 minutes) were significantly lower than that in the PKP group（44.64 ± 9.88 minutes and 18.43 ± 4.87 minutes）(p < 0.05).

Conclusions：The BMCP group demonstrated favorable treatment outcomes in managing osteoporotic compression fractures with up-endplate injury. Additionally, it showed shorter operation and fluoroscopy times. Moreover, the postoperative probabilities of adjacent vertebral fractures and bone cement leakage were lower.

Osteoporotic vertebral compression fractures with up-endplate injury

Percutaneous kyphoplasty

Percutaneous mesh-container-plasty

In recent years, with the improvement of people's living standards and medical levels, the average life expectancy has increased, leading to an aging population. [1]Osteoporosis has become more prevalent in the elderly population due to decreased bone density and bone quality, microstructural damage, and increased bone fragility, resulting in systemic bone diseases prone to fractures.[2–4] One common complication of osteoporosis in the elderly is osteoporotic vertebral compression fractures (OVCF). OVCF often occurs in the thoracolumbar region of elderly individuals with osteoporosis, causing significant pain and limited mobility, severely impacting the quality of life.[5] Current clinical treatments mainly focus on percutaneous vertebral augmentation techniques such as percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP). PKP, developed from PVP, has shown advantages in restoring vertebral height, rapidly relieving pain, improving kyphotic deformities, and minimizing surgical trauma. [6–10]However, even with PKP, there is a risk of bone cement leakage, reported to be as high as 22%-88%.[11] Patients with OVCF and damaged vertebral walls have an increased risk of cement leakage, leading to severe surgical complications such as nerve compression, spinal cord or nerve dysfunction, and postoperative paralysis.[12]Endplate damage is the most common in vertebral wall fractures, making the long-term maintenance of vertebral height and prevention of cement leakage a significant research focus.[13]

To reduce the probability of cement leakage, minimize surgical risks, and decrease the occurrence of complications, bone-filling mesh container (BMFC) has emerged. When facing complex and severe vertebral wall fractures, BMFC can help restore vertebral height while reducing the leakage of bone cement, thus decreasing postoperative complications.[14] Applying BMFC in percutaneous vertebral balloon dilation procedures involves placing a balloon dilator into the fractured vertebra to partially restore its height and create a cavity. After removing the balloon, BMFC containing bone cement is inserted to elevate the injured vertebra and restore its height. The unique mesh structure of BMFC can encapsulate bone cement, preventing its leakage. The use of BMFC in vertebral augmentation procedures is gradually gaining popularity in clinical surgeries.[15] However, there is limited reported evidence on the effectiveness of BMFC, and this study aims to evaluate whether BMFC vertebral augmentation has better clinical outcomes for patients with OVCF.

Selection criteria

This study was supported and approved by the Ethics Committee of the First Affiliated Hospital of Soochow University. We reviewed the records of patients with osteoporosis compression fracture and upper endplate injury in our hospital from January 2019 to December 2021. One hundred and ninety two patients who sustained osteoporosis compression fracture and upper endplate injury without neurological deficits were included in this study according to the inclusion and exclusion criteria(Fig. 1). The inclusion criteria were as follows: 1) All patients and their families signed informed consent forms and approved by the medical ethics committee. 2) OVCF with up-endplate injury was confirmed by imaging examination. Magnetic resonance imaging showed obvious edema signal in the vertebral body on fat suppression image. 3) Patients were diagnosed with single-segment thoracolumbar fracture (T10-L5). 4) The follow-up time was over 1 year. 5) Unipedicular PKP or PMCP was performed in the hospital. The exclusion criteria were as follows: 1) pathologic vertebral lesions such as vertebral metastatic carcinoma, vertebral hemangioma, and myeloma; 2) patients with systematic diseases such as severe liver and kidney dysfunction, and cardiovascular and cerebrovascular diseases; 3) patients who were lost to follow-up. One hundred and three according to the methods of surgery, these patients were divided into groups A and B: group A: the method of surgery is PKP; group B: the method of surgery is PMCP.

Surgical Technique

All operations were performed by 2 senior spine surgeons under general anesthesia. Patients were placed in the prone position with the abdomen suspended. Two 0.5-cm skin incisions was made lateral to the desired entry point of the pedicle percutaneously. Both groups were treated with transpedicular puncture approach After successful puncture, an inflatable balloon was inserted to restore the height and shape of the vertebral body. A trocar (Shandong Guanlong Medical Utensils Co., Ltd., Jinan City, Shandong Province, China) in a cannula was inserted into the pedicle as a working channel. After removing the trocar, a balloon was placed into the working channel and slowly inflated by contrast agent to restore the vertebral height and create a low-pressure cavity for cement injection.

In the PKP group, poly-(methyl methacrylate) (PMMA) cement (Heraeus Medical, Wehrheim, Germany) was slowly and carefully injected into the vertebral body through the cannula under continuous fluoroscopic monitoring. Poly-methyl methacrylate insertion was considered complete when it reached the posterior third of the vertebral body or until the point at which cortical, epidural, and anterior venous cement leakage were considered possible.

In the PMCP group, a mesh container (Shandong Guanlong Medical Utensils Co., Ltd.) was placed into the cavity. The material of the mesh container is 75D/36F high-strength wire comprising 100% polyethylene terephthalate with a fineness of 166.5 dtex and a strength of 6.75 cN/dtex. The mesh container is made of a relatively thick high-strength wire that exhibits good biocompatibility. The bone cement was carefully injected into the mesh container in the treated vertebra body by applying the cement perfusion apparatus under fluoroscopic guidance. The bone cement was filled into the mesh container just like the balloon expansion until it leaked outside of the mesh container from the meshes and entered the bone trabeculae at a certain injection amount.(Fig. 2)

After the surgical procedure, the patients were monitored for 6 h. The patients were encouraged to walk while wearing a 3-point fixation brace after surgery.

Assessed Parameters

Operative time, fluoroscopy time, and cement volume were recorded during the operation. All patients were postoperatively followed up clinically and radiologically immediately and at 1, 3, and 6 months and 1 year postoperatively.

The Cobb angle and anterior vertebral body height ratios (AVBHr,) were measured by X-ray lateral films from case data and outpatient reexamination preoperatively, as described in a previous study.

The visual analogue scale (VAS) was used to evaluate the degree of back pain, and the pain increased with the increase in numerical value through the horizontal line from 0 to 10. In addition, the Oswestry Disability Index (ODI) score was used to assess improvements in quality of life before operation, 1 day after operation,1 month after operation and 1 year after operation.

Statistical Methods

The average deviation and standard deviation of surgical time, fluoroscopy time, cement volume,VAS,ODI, AVHr and Cobb angles were calculated and analyzed using SPSS software (SPSS 23.0, USA). The basic characteristics and result evaluation parameters of the 2 groups of AVHr and VAS were compared by the t test of the group design data. The chi-squared test was used to compare the cement leakage and adjacent vertebral fractures in the 2 groups. When P < 0.05, the difference was significant.

Demographics

From January 2019 to December 2021, after screening for inclusion and exclusion criteria, a total of 192 patients completed the 1-year follow-up in Table 1. In group PKP, the average age of the 103 patients (71 females and 42 males) was 65.39 ± 6.72 years. The average BMD was − 2.78 ± 0.79. In group PMCP, the average age of the 89 patients (59 females and 30 males) was 66.89 ± 7.78 years. The average BMD was − 2.87 ± 0.56. There were no significant differences between the two groups in terms of age, gender, bone mineral density (BMD), and follow-up time.

Table 1

**Basic information about both sets of data**
Parameters	PKP	PMCP	P
Patients
Number	103	89
Age (years)	65.39 ± 6.72	66.89 ± 7.78	0.234
Sex (F/M)	71/42	59/30	0.127
BMD	-2.78 ± 0.79	-2.87 ± 0.56	0.478

PKP percutaneous kyphoplasty, PMCP percutaneous mesh-container-plasty, BMD Bone mineral density.

Operation condition

The Operation condition was shown in Table 2, The operation time of the PMCP group (35.23 ± 8.54 min) was significantly lower than that of the PKP group (44.64 ± 9.88 min). The number of the fluoroscopy time in the PMCP group (13.26 ± 3.34 times) was significantly lower than that in the PKP group (18.43 ± 4.87 times) (P < 0.05). In the PMCP group ,the injection volume of bone cement in the PMCP group was 5.23 ± 0.97 ml, the hospital-stay-time was 3.94 ± 0.86 days. In the PMCP group ,the injection volume of bone cement in the PMCP group was 4.97 ± 1.12 ml, the hospital-stay-time was 4.04 ± 0.89 days. There were no significant difference of the injection volume of bone cement and the hospital-stay-time between the two groups (P > 0.05).

Table 2

Operation condition of both sets of data
Parameters	PKP	PMCP	P
Operation time (minutes)	44.64 ± 9.88	35.23 ± 8.54	< 0.05
Fluoroscopy time (times)	18.43 ± 4.87	13.26 ± 3.34	< 0.05
Injected cement volume (mL)	4.97 ± 1.12	5.23 ± 0.97	0.129
Hospital stay (days)	4.04 ± 0.89	3.94 ± 0.86	0.683

Radiographic prognosis

Table 3 showed that anterior vertebral body height ratio and Cobb angle scores improved from 55.23%±10.28% and 24.28°± 6.94° preoperatively to 82.14%±8.36% and 9.92°± 4.38°,postoperatively in the PKP group and from 54.09%±11.77%, and 23.79°±7.23° preoperatively to 83.08%±7.94% and 9.71°±4.13°, respectively, postoperatively in the PMCP group (P < 0 .05). Moreover, the long-term follow-up results showed that the AVBHr, and Cobb angle in the PKP and PMCP groups did not change significantly at 1 year follow-up. No statistically significant difference was noted in the improvement of AVBHr and correction of the Cobb angle between the PMCP and PKP groups (P > 0 .05).

Table 3

Clinical data of both groups
Parameters	PKP	PMCP	P
VAS
Preoperatively	7.76 ± 0.97	7.83 ± 0.89	0.434
1 day postoperatively	2.23 ± 0.76	2.17 ± 0.68	0.278
3 months postoperatively	1.94 ± 0.96	2.01 ± 0.71	0.302
1 year postoperatively	1.97 ± 0.83	1.88 ± 0.92	0.283
ODI
Preoperatively	65.18 ± 4.52	66.71 ± 5.42	0.472
1 day postoperatively	21.96 ± 4.84	22.37 ± 5.90	0.319
3 months postoperatively	18.72 ± 6.18	19.23 ± 4.87	0.389
1 year postoperatively	18.89 ± 7.01	17.97 ± 7.48	0.412
AVBHr (%)
Preoperatively	55.23 ± 10.28	54.09 ± 11.77	0.376
1 day postoperatively	82.14 ± 8.36	83.08 ± 7.94	0.245
3 months postoperatively	79.23 ± 9.14	81.23 ± 8.23	0.154
1 year postoperatively	78.82 ± 7.81	80.07 ± 8.1	0.134
The Cobb angle (°)
Preoperatively	24.28 ± 6.94	23.79 ± 7.23	0.393
1 day postoperatively	9.92 ± 4.38	9.71 ± 4.13	0.158
3 months postoperatively	10.23 ± 5.87	10.01 ± 5.13	0.194
1 year postoperatively	10.35 ± 4.93	10.17 ± 5.07	0.176
Complications
Cement leakage	24	9	< 0.05
Adjacent vertebral fracture	12	3	< 0.05

PKP percutaneous kyphoplasty, PMCP percutaneous mesh-container-plasty, VAS Visual analogue scale, ODI Oswestry disability index, AVBHr anterior vertebral body height ratio.

Clinical evaluation

Preoperatively, the ODI, and VAS scores in the PKP group were 65.18 ± 4.52 and 7.76 ± 0.97 points, respectively, while those in the PMCP group were 66.71 ± 5.42 and 7.83 ± 0.89 points, respectively; there was no significant difference between the two groups (P > 0.05). Postoperatively, the ODI and VAS scores decreased significantly (P < 0.05) and remained at the same level one year after the surgery. However there was no significant difference of VAS and ODI between the two groups in the different time (P > 0.05, Table 3).

Surgical complications

Cement leakage was observed in 23.3% (24/103) of patients in the PKP group and in 10.1% (9/89) of patients in the PMCP group (P < 0.05) (Table 3). During the 1-year follow-up period, 15 patients suffered from adjacent vertebral fractures, including 12 patients in the PKP group and 4 patients in the PMCP group. The difference in the incidence of adjacent vertebral fractures between groups 1 year postoperatively was significant (P < 0.05).

OVCF is a common type of fractures in the elderly, characterized by back pain in the affected vertebral segment, sometimes leading to restricted mobility. While some patients may find relief through bed rest for a few weeks, about one-third of patients experience persistent pain and discomfort. Currently, PKP has become an effective method for treating OVCF, providing rapid pain relief and vertebral height restoration.[16] However, PKP still carries a risk of cement leakage, potentially resulting in various complications.[17] The use of BMFC has gained attention due to its safety, especially in cases of vertebral wall fractures.[18]

Among patients with vertebral compression fractures, the rate of cement leakage in osteoporotic vertebral compression fractures is higher than other types of compression fractures, such as those caused by tumors.[19] Patients with OVCF and vertebral wall damage are more prone to cement leakage during PKP procedures, leading to a series of complications.[20] Concerns about complications related to cement leakage have led clinicians to reconsider the use of PKP in the treatment of explosive vertebral fractures. However, explosive vertebral fractures should not be considered a contraindication for surgery instead,[14] careful and meticulous surgical techniques can achieve favorable outcomes. The use of BMFC is seen as a beneficial addition, significantly reducing the risk of cement leakage.[21] Studies have indicated that the application of BMFC technology or traditional PKP can effectively relieve pain and improve Cobb angle. However, the use of BMFC significantly reduces the rate of cement leakage, improving patient outcomes.[22] Additionally, retrospective studies have shown that both percutaneous spinal kyphoplasty and percutaneous bone-filling mesh container procedures can rapidly improve pain and restore vertebral height in the treatment of malignant thoracolumbar compression fractures.[23] Still, BMFC has a lower rate of cement leakage and better distribution of bone cement.

Concerns have been raised about uneven cement dispersion and the inability to restore proper height and mechanical performance of vertebrae due to the application of BMFC. However, studies comparing BMFC with traditional spinal kyphoplasty in fresh cadavers have shown no significant differences in vertebral bone density, strength, and stiffness. BMFC, such as Vessel-X, has demonstrated mechanical performance and height recovery comparable to traditional procedures. [24]In cases where BMFC is used, there is less cement leakage, and the distribution within the vertebra is better. Other studies have explored the use of a novel double-layer mesh bone-filling container in vitro for the treatment of vertebral compression fractures, showing reduced cement leakage, good recovery of vertebral height, and hardness.[25] The application of bone-filling containers has shown excellent results not only in vitro but also in clinical practice. In a comparative study of 20 cases treated with BMFC and 20 cases treated with PKP for Kümmell's disease, both groups showed postoperative improvements in VAS scores, ODI, and Cobb angle, with no significant difference in adjacent vertebral refracture rates. However, the PKP group had more cement leakage compared to the BMFC group.[26] Adequate contact between bone cement and upper and lower endplates has been reported to effectively restore vertebral strength, maintain vertebral height, and reduce the risk of vertebral re-compression and long-term pain.[27] In this study, both the BMFC and PKP groups achieved good vertebral height recovery and kyphosis correction, with the BMFC group showing better maintenance of vertebral height after one year. The mechanism behind this better height maintenance and kyphosis correction in the BMFC group is attributed to the even expansion of the container within the vertebra, minimal cement leakage from the container, and effective bonding between the container and surrounding vertebral bone tissue, achieving a "rivet" effect. In PKP, the injection of cement after balloon dilation may cause the vertebra to "rebound," leading to a potential decrease in height. Additionally, cement is more likely to leak from the damaged upper endplate into the intervertebral space. The container can slow down the dispersion of cement through small pores, effectively compensating for these shortcomings, ensuring a tight bond between bone cement and vertebra, and controlling cement leakage.[28] Therefore, the use of BMFC in the treatment of osteoporotic compression fractures allows for good cement distribution within the vertebra, significantly relieving patient symptoms, restoring vertebral height, and correcting kyphosis. Moreover, it minimizes cement penetration, reducing surgical risks and the occurrence of postoperative complications.

In our study, both groups of patients showed significant improvement in VAS and ODI scores at different time points after surgery compared to the day before surgery. However, the BMFC group had a lower rate of cement leakage, and the difference was statistically significant. These results suggest that BMFC technology can effectively relieve pain and promote vertebral function recovery in the treatment of osteoporotic compression fractures with vertebral wall damage. Additionally, BMFC technology is safer than PKP, offering better cement distribution, lower cement leakage rates, improved vertebral height recovery, and kyphosis correction.

To sum up, the application of (BMFC)in the treatment of osteoporotic compression fractures with vertebral wall damage allows for rapid pain relief, vertebral height restoration, and correction of kyphotic deformities. Its greatest advantage lies in reducing the rate of cement leakage, thus lowering the risk of complications related to cement leakage .[29] However, the use of BMFC is not without drawbacks. Compared to traditional ༈PKP)surgery, it comes with higher surgical costs, making it financially challenging for some impoverished families. Therefore, in the future, there is hope for the invention of more cost-effective bone-filling mesh containers that can be applied to clinical patients.

Certainly, this study has its limitations. It specifically focused on osteoporotic compression fractures with vertebral wall damage but did not classify the extent and types of fractures involving the vertebral body walls. Additionally, the sample size is relatively small, and further prospective controlled studies with larger, multicenter samples are needed for in-depth research. Moreover, there is limited data on mesh bags and long-term follow-up, necessitating extended follow-up studies to further validate the conclusions of this research.

Ethics approval and Consent to participate:

Approval was obtained from the ethics committee of the First Affiliated Hospital of Soochow University. The procedures used in this study adhere to the tenets of the Declaration of Helsinki. Informed consent was obtained from all individual participants included in this study.

Consent for publication:

All authors approved the manuscript and its publication.

Availability of data and material:

Data is available via a request to the corresponding author.

Conflicts of Interest:

All authors declare that they have no conflict of interest.

Funding:

No funding.

Authors' contributions:

Haifu Sun: Conceptualization, Methodology, Investigation, Software, Writing – original draft. Lei Deng: Conceptualization, Data curation, Investigation.Chengyue Wang: Conceptualization, Methodology, Writing – original draft. Qiang Gu: Methodology, Data curation, Investigation. Yonggang Li: Conceptualization, Methodology, Data curation. Zhonglai Qian: Conceptualization, Methodology, Data curation, Validation, Writing - review & editing, Funding acquisition. Yimeng Wang: Conceptualization, Methodology, Data curation, Validation, Writing - review & editing.

Acknowledgements:

Thank you for all the support from the First Affiliated Hospital of Soochow University.

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No competing interests reported.

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Percutaneous mesh-container-plasty versus percutaneous kyphoplasty in the treatment of osteoporotic compression fractures with up-endplate injury: a retrospective study

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Version 1

Abstract

Figures

Introduction

Methods

Selection criteria

Surgical Technique

Assessed Parameters

Statistical Methods

Results

Demographics

Operation condition

Radiographic prognosis

Clinical evaluation

Surgical complications

Discussion

Declarations

References

Additional Declarations

Status:

Version 1