Risk factors associated with bone cement leakage following percutaneous kyphoplasty: a retrospective analysis.

Introduction

Osteoporotic vertebral compression fractures (OVCF) are among the most common types of vertebral fractures in clinical practice and are also the most frequent and representative complication of osteoporosis [ 1 , 2 ]. With the continued aging of the population in China, the incidence of OVCF has been rising annually. In 2017, the incidence of osteoporotic vertebral compression fractures (OVCF) in the urban population aged 50 and above in China was 152.13 per 100,000 person-years [ 3 ]. This condition is often accompanied by severe back pain and functional impairment, which significantly affects patients’ daily activities. Without timely and effective treatment, some patients may remain bedridden for extended periods, leading to a series of complications such as pressure sores, pulmonary infections, urinary tract infections, and lower limb venous thrombosis, potentially even endangering their lives [ 4 – 6 ].

Percutaneous kyphoplasty (PKP), a minimally invasive, safe, and easy-to-operate treatment, has been widely used in the clinical management of OVCF in recent years [ 7 , 8 ] . This technique involves percutaneously inserting a balloon into the fractured vertebral body to create a cavity, followed by the injection of bone cement into the cavity to enhance vertebral strength, restore vertebral height, and relieve pain [ 9 ]. Numerous studies have confirmed that PKP can effectively alleviate symptoms in OVCF patients in a short period and improve their quality of life [ 8 , 10 ].

However, despite the increasing maturity of PKP technology, postoperative complications still present certain risks. The most common complication is bone cement leakage. Although bone cement leakage is relatively common and typically benign, if it enters the venous system or spinal canal, it can lead to severe complications, such as nerve damage [ 11 ] paralysis [ 12 ], or even death [ 11 , 13 ]. However, to date, there has been limited research on the establishment of visual models to predict the risk factors for bone cement leakage following PKP.

Therefore, this study developed and validated a nomogram to predict the potential risk factors for bone cement leakage after PKP and evaluated its predictive performance through validation. The aim is to provide a more reliable theoretical basis and decision support tool for clinicians to guide preoperative risk assessment and precision treatment, ultimately improving patient prognosis.

Methods

This study was designed and reported in accordance with the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines and the completed STROBE checklist is provided as supplementary material. To minimize potential selection bias, all eligible patients during the study period were consecutively included. Measurement bias was reduced by having imaging parameters independently confirmed by two senior radiologists. BMD was measured using dual-energy X-ray absorptiometry (DXA). Radiological parameters were independently assessed by two experienced spine surgeons blinded to patient grouping, and disagreements were resolved by consensus.

All clinical and imaging data were retrospectively retrieved from the electronic medical record system. Potential confounding factors were controlled using multivariable logistic regression. Because all data were extracted directly from electronic medical records, recall bias—typically associated with retrospective studies—was minimized.

Patients

A total of 308 patients with osteoporotic vertebral compression fractures (OVCF) who received percutaneous kyphoplasty (PKP) treatment at Zhejiang Provincial People’s Hospital from January 2021 to December 2024 were analyzed, involving 349 vertebral bodies. Cement leakage was confirmed on postoperative CT or X-ray performed after PKP. Leakage was classified by two independent spine surgeons. The sample size was determined based on all eligible cases available during the study period.

This study was approved by the Medical Ethics Committee of Zhejiang Provincial People’s Hospital. Inclusion criteria were as follows: (1) patients with OVCF presenting with back pain unresponsive to conservative treatment; (2) first-time PKP; (3) complete clinical and radiological data. Exclusion criteria included: (1) pathological vertebral compression fractures caused by multiple myeloma, spinal metastases, etc.; (2) secondary osteoporosis; (3) coagulopathy or cardiopulmonary dysfunction rendering the patient unable to tolerate surgery; (4) OVCFs associated with spinal cord or nerve injury.

Outcome measurement

Cement leakage was assessed using postoperative CT or X-ray performed after PKP. All CT or X-ray images were independently evaluated by two experienced spine surgeons who were blinded to the group allocation. Leakage was defined as any extravasation of cement outside the vertebral body observed on axial or sagittal CT or X-ray images. Discrepancies between the two reviewers were resolved by consensus.

Cement leakage was assessed using postoperative CT or X-ray performed after PKP. All CT or X-ray images were independently evaluated by two experienced spine surgeons who were blinded to the group allocation. Leakage was defined as any extravasation of cement outside the vertebral body observed on axial or sagittal CT or X-ray images. Discrepancies between the two reviewers were resolved by consensus.

Observation indicators

We conducted a review of previously published literature on the potential risk factors for bone cement leakage following percutaneous kyphoplasty (PKP), as well as the possible clinical characteristics and radiological parameters of patients. The following factors were considered as potential risk factors: age, gender, height, weight, BMI, hypertension, diabetes, disease duration, fracture site, volume of bone cement used, pain assessment (NRS), bone mineral density (BMD), preoperative vertebral height, postoperative vertebral height, fracture morphology (Fig. 1 ), degree of vertebral collapse, cortical continuity status, integrity of the posterior vertebral wall, intervertebral vacuum cleft (IVC), and Cobb angle. Patients who did not take medications regularly before admission, leading to subdued pain symptoms, were classified as asymptomatic.

Based on disease duration, we categorized patients into three groups: acute (< 2 weeks), subacute (2 weeks to 2 months), and chronic (> 2 months). Vertebral fractures were classified into wedge-shaped, biconcave, and compression fractures. The criteria for determining IVC were as follows: on X-ray or CT, the water-like gap was located at or near the center of the vertebral upper or lower endplates; on MRI, the gap typically appeared as abnormal, well-defined, linear or cystic, with low signal intensity within the vertebral body, resembling air, and displaying high or low signal intensity on T2 images. Cortical continuity status disruption was defined as a localized discontinuity of low-signal bone cortex on MRI or interruption of cortical continuity status on X-ray or CT. The Cobb angle was defined as the angle formed by the upper and lower endplates of the fractured vertebral body. Integrity of the posterior vertebral wall referred to the absence of protrusion into the spinal canal in axial CT images. The degree of vertebral collapse was classified based on the percentage of vertebral height collapse: mild (20–25%), moderate (26–40%), and severe (> 40%).

Surgical methods

First, position the patient in the prone position, and use a C-arm fluoroscopy to locate the bilateral damaged pedicles of the vertebra. Mark the designated site. Next, disinfect the surgical site and administer local anesthesia with 1% lidocaine at the puncture site. Begin the procedure on the left side, making a 1-cm incision through the skin and subcutaneous tissue at the left pedicle prominence. At approximately the 10 o’clock position, puncture the pedicle, paying attention to the sagittal and coronal angles, while confirming the puncture site using C-arm fluoroscopy in both the anteroposterior and lateral views. Remove the puncture needle and insert a guidewire, followed by the working cannula, which should be placed about 0.5 cm anterior to the posterior edge of the vertebral body. Remove the guidewire and insert a dilator into the working cannula. After removing the dilator, collect an appropriate amount of bone tissue for pathological examination. Insert a compression rod, remove the compression rod, inject the contrast agent, and then place the balloon, inflating it to the appropriate pressure. After removing the contrast agent and balloon, repeat the same procedure on the right side, approximately at the 2 o’clock position of the opposite pedicle. In each working cannula, place a mesh bag and inject bone cement. All surgeries were performed by two surgeons with over 10 years of spinal surgery experience, minimizing procedural errors.

Statistical analysis

Statistical analysis was performed using SPSS 26.0 and R (4.2.0) software. Continuous variables were expressed as means ± standard deviations, and intergroup comparisons were conducted using independent samples t -test. Categorical variables were expressed as percentages, with intergroup comparisons made using the Chi-square test. Lasso regression was used to identify risk factors. Based on the risk factors selected by Lasso regression, a logistic regression model was constructed for prediction. The identified risk factors were input into a predictive nomogram using R software. A p -value of < 0.05 was considered statistically significant. The study size was determined by including all available eligible cases during the study period.

Results

Characteristics of patients

The patients were randomly divided into a training set and a validation set in a 7:3 ratio. The model was established using the training set and validated using the validation set. Among the 255 vertebral bodies in the training group, 49 (19.2%) developed cement leakage. In the control group, the average age was 72.73 ± 9.30 years, and the bone mineral density (BMD) was − 3.10 (− 3.90 to − 2.30) kg/m 2 . In the cement leakage group, the average age was 72.76 ± 10.26 years, and the BMD was − 3.10 (− 3.80 to − 2.50) kg/m 2 . In the validation group, consisting of 94 patients, 20 (21.2%) developed cement leakage. In the control group, the average age was 74.69 ± 10.55 years, and the BMD was − 3.65 (− 4.20 to − 2.70) kg/m 2 . In the cement leakage group, the average age was 77.20 ± 8.31 years, and the BMD was − 2.65 (− 3.42 to − 2.17) kg/m 2 . The clinical characteristics of the patients are shown in Table 1 . All surgeries were successful, and no severe postoperative complications occurred.

Construction of a Lasso-logistic regression-based prediction model

Lasso regression was used to select variables, and the changes in the coefficients of these variables are shown in Fig. 2 A. Tenfold cross-validation was performed for iterative analysis (Fig. 2 ), resulting in a model with excellent performance and the fewest variables. The selected variables include gender, hypertension, degree of vertebral collapse, cortical continuity status of the vertebral body, integrity of the posterior vertebral wall, different segments, volume of bone cement, height, and age (Table 2 ). Based on these selected variables, a nomogram was developed (Fig. 3 ).

Model performance

To validate the discriminative ability of the model, the ROC curve was plotted (Fig. 4 ). The AUC for the training set was 0.982 (CI 0.980–0.984), and the AUC for the validation set was 0.92 (CI 0.857–1.000), indicating that the model has excellent discriminative power. The calibration curves for both the training and validation sets demonstrate good consistency between the predicted and actual outcomes (Fig. 5 ). In both the training and validation sets, the DCA curves show that the model provides a net benefit in predicting the risk of cement leakage (Fig. 6 A, B). Overall, the model is feasible and can be used for reasonable prediction.

Discussion

Unlike traditional percutaneous vertebroplasty (PVP), percutaneous kyphoplasty (PKP) involves the use of a balloon catheter to expand the fractured vertebral body before bone cement injection [ 14 ] The inflation of the balloon can partially restore the height of the compressed vertebral body and correct some of the kyphotic deformity [ 15 , 16 ]. This pre-formed cavity helps control the dispersion of the bone cement and significantly improves the restoration of vertebral height and correction of the kyphotic deformity, making PKP superior to PVP in these aspects [ 17 – 19 ]. While the clinical application of PKP has become increasingly widespread, research on the risk factors for bone cement leakage following PKP is still limited. Based on common risk factors for bone cement leakage after PVP, this study introduces additional risk factors such as bone mineral density, hypertension, intervertebral vacuum cleft (IVC), and vertebral height, further exploring their roles in bone cement leakage after PKP.

This study analyzed the clinical data of 349 OVCF vertebral bodies and developed and validated a nomogram model to predict the risk of bone cement leakage following PKP. This provides a simple and effective tool for preoperative assessment. The ROC curves (Fig. 4 A, B) showed AUCs of 0.928 and 0.92, respectively, indicating that the model has high diagnostic ability and can effectively distinguish between high-risk and low-risk patients. To further validate the stability and reliability of the model, we used calibration curves (Fig. 5 A, B) for evaluation. The results showed that, across different predicted probability ranges, the predicted values closely aligned with the actual probabilities, especially in the moderate and low-risk ranges, where the model demonstrated good predictive ability. Although there was some deviation in the high-risk range, the model generally maintained high reliability.

To further evaluate the risk factors for bone cement leakage after PKP, we selected the relevant factors, which reduce the interference of unrelated variables and enhance the predictive accuracy of the model (Fig. 6 A, B).

Our study found that hypertension is also a significant independent risk factor for bone cement leakage after PKP. The possible mechanism is that hypertensive patients often experience vascular sclerosis and increased vascular fragility, which impair the local microcirculation of the vertebra. This makes it easier for the injected bone cement to leak along blood vessel gaps or rupture sites, leading to serious complications such as pulmonary embolism [ 20 ].This finding suggests that for patients with hypertension, a thorough preoperative assessment of blood pressure control is essential, and during the procedure, careful control of the bone cement injection speed and pressure is necessary.

The degree of vertebral collapse is also a high-risk factor for bone cement leakage, which is consistent with previous studies [ 21 , 22 ]. Severe vertebral compression often indicates significant damage to the trabecular bone structure within the vertebra, with the presence of more irregular microcracks and cavities [ 23 ]. These structural defects can serve as pathways for the outward dispersion of bone cement [ 24 ]. Furthermore, the integrity of the vertebral cortex, especially the continuity of the posterior wall, is a key anatomical factor in predicting bone cement leakage [ 25 , 26 ]. If preoperative imaging reveals cortical bone fractures, damage to the posterior vertebral edge, or vertebral fractures involving the posterior wall, this significantly increases the risk of bone cement extravasation into the spinal canal or adjacent venous systems, potentially causing neurological deficits or even leading to severe complications such as pulmonary embolism [ 27 , 28 ]. Therefore, during preoperative imaging assessment, the integrity and condition of the vertebral structure should be carefully evaluated. For patients with significant posterior wall damage or severe vertebral compression, it is recommended to use high-viscosity bone cement [ 29 ], low-pressure injection, and staged injection techniques [ 30 , 31 ] to reduce the incidence of leakage.

Additionally, this study observed that the segmental level of the affected vertebra has a significant impact on the risk of bone cement leakage, particularly in the middle thoracic segments (T6, T8), where the leakage incidence is higher [ 19 , 32 ]. The reason may be that performing PKP at these specific segments presents greater challenges in terms of puncture needle path selection, balloon inflation positioning, and injection path control, leading to inaccurate bone cement placement during the procedure and subsequently increasing the risk of leakage. Moreover, the narrow anatomical structure of the thoracic vertebrae, smaller vertebral body size, rich surrounding venous plexuses, and uneven distribution of bone mineral density also contribute to the increased risk of bone cement leakage [ 26 , 33 ]. Therefore, both preoperative and intraoperative attention should be given to the details of the procedure in high-risk segments. Enhancing intraoperative imaging monitoring (such as fluoroscopy or 3D navigation) and controlling injection time and pressure can help improve the safety and precision of the surgery.

Beyond hypertension, the degree of vertebral collapse, and lesion segment, our findings indicate that the amount of bone cement injected is also closely associated with the risk of postoperative leakage. Specifically, excessive cement volume may increase the likelihood of leakage by elevating intravertebral pressure, thereby facilitating cement extravasation through weakened cortical regions. Conversely, insufficient cement volume may fail to adequately support the vertebral structure, increasing the risk of recurrent vertebral collapse postoperatively, which in turn may compromise fracture healing and pain relief. Previous studies have suggested that maintaining the cement volume at approximately 20–25% of the total vertebral body volume can achieve a balance between adequate vertebral stability and minimizing the risk of leakage [ 34 ]. Additionally, research by Wang et al. has highlighted the importance of tailoring the cement volume based on vertebral segment: cement volume should be limited to less than 3.5 mL in the thoracic spine and less than or equal to 4 mL in the lumbar spine [ 35 ]. These findings underscore the need for preoperative CT-based three-dimensional reconstruction to measure total vertebral volume and to adjust cement volume accordingly, especially in cases with posterior wall or cortical disruptions. For vertebrae with moderate or severe degrees of vertebral collapse, we recommend using a small volume of cement injected slowly to achieve an optimal balance between mechanical support and leakage risk. Overall, the predictive model developed in this study has significant clinical application value. By using this model preoperatively, doctors can identify high-risk patients and take appropriate preventive measures, thereby reducing the incidence of bone cement leakage and minimizing related complications. Additionally, the model can be used for preoperative communication between doctors and patients, as well as postoperative resource allocation, helping to improve treatment safety, precision, and patient satisfaction. However, this study also has some limitations. Firstly, as a single-center retrospective study, it is inevitably influenced by data loss and selection bias. Moreover, since all the data were obtained from the same tertiary hospital, the patient population is relatively concentrated and may not fully represent the overall characteristics of bone cement leakage in PKP patients with OVCF from different regions or types of medical institutions. This could limit the model’s applicability in some hospitals or areas. Future studies should further expand the sample size and include more influencing factors to enhance the model’s external validation and scope of application.

Conclusions

This study, based on retrospective clinical data, constructed and validated a nomogram model for predicting the risk of bone cement leakage after percutaneous kyphoplasty (PKP). The model exhibited excellent discrimination and calibration. The findings suggested that hypertension, the degree of vertebral collapse, cortical continuity status, posterior wall integrity status, and the affected segment were significant factors for leakage occurrence, providing a scientific basis for preoperative risk assessment and individualized surgical decision-making, which could provide a scientific basis for preoperative risk assessment and individualized surgical decision-making.

Supplementary Information

Supplementary Material 1.

Abbreviations

New vertebral compression fractures

Percutaneous kyphoplasty

Osteoporotic vertebral compression fractures

Bone mineral density

Body mass index

The area under the curve

Decision curve analyses

Author contributions

Conceptualization: WM; methodology: WM and AZ; validation: WM; formal analysis: AZ; investigation: XZ and JT; data curation: XZ and JC; writing—original draft preparation: WM and AZ; writing–review and editing: JT and XZ supervision: ZC and PF; project administration: ZC. All authors read and approved the final manuscript.

Funding

This work was supported by the National Natural Science Foundation of China [No. 81873128] and the Zhejiang Province Traditional Chinese Medicine Science and Technology Project [No. 2023ZL461] and National Nature and Science Foundation of China (81873128).

Data availability

No datasets were generated or analysed during the current study.

Declarations

Ethics approval and consent to participate

This study was approved by the Ethics Committee of Zhejiang Provincial People’s Hospital. This retrospective study was a retrospective analysis of anonymized data, so the institutional review board approved the waiver of informed consent. All experiments were approved by the medical ethics committee of the Zhejiang Provincial People’s Hospital. The requirement for informed consent was waived due to the retrospective analysis of anonymous data.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

Footnotes

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Associated Data

Supplementary Materials

Supplementary Material 1.

Data Availability Statement

No datasets were generated or analysed during the current study.