The process of population aging in industrialized nations is currently an irreversible trend. In Europe, the percentage of individuals aged over 65 was 10.8% in 1950, and according to some estimates, it is projected to reach 42.2% by 2050. Moreover, the proportion of individuals aged over 75 has increased from 2.7% in 1950 to a projected 4.6% by 2050. As life expectancy continues to rise and chronic diseases are increasingly well-managed, the future of medical treatment will be centered on preserving and restoring a satisfactory quality of life. The demographic shift towards an older Western population will lead to a growing number of individuals suffering from severe osteoporosis, consequently increasing the demand for the treatment of osteoporotic spinal fractures, this also holds true for the healthcare system in Poland.

Regarding the state of the issue in Poland, it is worth noting that as of the beginning of the new decade, the direct average annual costs for osteoporosis treatment amounted to approximately 690 million euros annually. These costs encompass pharmacological interventions, fracture treatments, and disability-related expenses. Notably, when adjusted for inflation, the expenses associated with treating osteoporotic fractures have continued to escalate over the years, reaching approximately 18 euros per capita. This places Poland 28th in the European ranking of the cost of such interventions. Although these costs are relatively lower compared to other European countries, they still account for about 2% of the healthcare budget. It is essential to consider that around 4.8% of the population, roughly 2 million individuals, suffer from osteoporosis, with 80% of them being women.

Of particular significance is the fact that some of these fractures can have fatal consequences, especially those affecting the spine. The mortality rate for such injuries hovers around 110 per 100 thousand people aged 50 and older, which is slightly lower than the European average. This means that the number of deaths in Poland due to osteoporotic fractures surpasses the rates typical for conditions like diabetes mellitus and chronic respiratory diseases. Given the aging population, it is anticipated that the incidence of osteoporotic fractures will increase from 61000 to 267000 per year in the near future [7]. This underscores the pressing need to develop new treatment methods for these conditions, with a focus on optimizing them to align with the realities of the Polish healthcare system. Additionally, there is a crucial aspect of addressing complications that may arise during extensive interventions.

Special emphasis should be placed on the cement-augmented pedicle screw instrumentation method within this context. Ever since the advent of pedicle screw instrumentation, the enduring challenges of pedicle screw displacement and extraction have remained prevalent and widely acknowledged within the domain of spinal surgery. These ongoing issues carry substantial implications for patient outcomes and the overall effectiveness of spinal procedures. Loosening, in this context, denotes a gradual decrease in the stability of pedicle screws within the bone over time. This phenomenon can be attributed to various factors, including inadequate initial fixation, biomechanical stresses, or bone quality concerns, particularly relevant in patients with conditions like osteoporosis. When pedicle screws become loose, they may fail to provide sufficient spinal stabilization, resulting in pain, instability, and potential complications for the fusion process.

On the other hand, pull-out entails the complete displacement of pedicle screws from their intended position within the vertebrae. This can transpire due to a range of factors, including insufficient screw anchorage, suboptimal bone quality, or excessive mechanical forces. Pull-out poses serious risks, necessitating revision surgery to reposition or replace the screws, often accompanied by additional surgical complications and patient discomfort. These enduring challenges underscore the continual necessity for advancements in spinal instrumentation techniques and materials, aimed at effectively addressing the issues of pedicle screw loosening and pull-out. Such advancements ultimately hold the potential to enhance the long-term success and safety of spinal surgeries. An enduring and significant challenge in spine surgery involves enhancing screw stability in individuals with compromised bone architecture. In such patients, the primary objective of spinal instrumentation is to achieve a robust fusion, while a common complication encountered is the occurrence of loosening at the interface between the bone and the screws, particularly prevalent among those with osteoporosis. The ability of screws to maintain their grip within osteoporotic bone diminishes as BMD decreases [33].

In spine surgery, a persistent concern revolves around improving the stability of screws, especially in patients with compromised bone quality. The ultimate goal of spinal instrumentation in such cases is to ensure a robust fusion, yet a frequent complication that arises is the loosening of screws at the juncture between the bone and the hardware, a challenge particularly pronounced among osteoporotic individuals. It is noteworthy that the holding capacity of screws within osteoporotic bone diminishes proportionally with decreasing BMD [24]. This issue underscores the pressing need for innovative approaches to address screw fixation challenges in patients with diminished bone quality, ultimately contributing to better outcomes in spinal surgeries. Cement augmentation of transpedicular screws increases the pull-out strength by 49-200%, as stated by various cadaveric studies [14]. Given the challenges associated with conservative treatment for osteoporotic fractures, spinal instrumentation is now a prevalent procedure for such patients. Various alternative methods have been proposed to address the issue of reduced bone-metal integration, but the most optimal construct stability has been achieved using PMMA-augmented screws [26].

Although widely utilized, PMMA is not without its drawbacks in spinal surgeries. The heat generated during the intratissue hardening process can potentially cause harm to nearby neural and vascular structures [11]. Local necrosis has even been observed when large amounts of cement are injected into large bone structures such as the femur or hip [6,32]. Administering PMMA under pressure can result in the leakage of cement into the spinal canal and surrounding structures, potentially causing pain, radicular symptoms, and neurological deficits [2]. Furthermore, the leakage of cement through the epidural veins and vena cava may cause a pulmonary embolism [35]. The relatively rare complication of cement pulmonary embolism has been quite well described in the literature. Numerous case study reports describe this complication, which may be characterized by a diverse clinical picture. Many cases have been reported to be asymptomatic, particularly where small amounts of cement have leaked [1,17]. Furthermore, randomized trials have been carried out, demonstrating that there is no statistically noteworthy variance in the survival rates of asymptomatic patients who do not receive treatment because of the presence of cement in their pulmonary vessels, as compared to patients who do not experience this complication [12].

Numerous case reports of cement pulmonary embolism describe instances where patients remained asymptomatic immediately after surgery but subsequently sought medical attention due to sudden onset of symptoms such as acute shortness of breath, breathing difficulties, and the like, either within a few months or even several years later [25,37]. Unfortunately, the course of the complication can be severe and occur shortly after the procedure, additionally not responding to conservative treatment, where the only option is surgery [34]. Cardiac cement embolism is a less frequently described complication in the literature, but it is characterized by a rapid course and severe symptoms leading to life-threatening damage to the heart [28]. The dramatically deteriorating condition of patients often precludes conservative treatment, requiring urgent endovascular surgery and, more often, open-heart surgery [4,36]. In the extended follow-up after the removal of the embolic material, the patients remained asymptomatic [20]. Case studies covering organ-related complications of cement embolism include the kidney and the brain, in this scenario, it is referred to as an embolic stroke caused by a foreign body, where, due to the limited data available, it is not possible to develop effective management strategies [8,18].

Despite the high risk of cement leakage with CAPS, a significant number of patients remain asymptomatic. This case report provides an example of asymptomatic PMMA pulmonary embolism and symptomatic PMMA nerve compression. The importance of adequate pressure during PMMA implantation and the possibility of meticulous monitoring of PMMA injection with good quality fluoroscopy in two planes should be emphasized. If any indication of even minor cement leakage into the veins surrounding the vertebrae or behind the rear wall is noticed, the procedure must be halted promptly [15]. Unambiguous determination of the location of potential cement embolism is not possible and is based mainly on the calculus of probability, so it is extremely important to observe the patient after such an incident, and educate them on how to proceed in the event of sudden deterioration of health. Drawing from the existing literature, it can be inferred that the choice of treatment strategy relies on the embolus’s location and the overall health status of the patient. However, it is essential to conduct treatment within a hospital equipped with vascular or cardiac surgery capabilities. Despite being a severe complication, cement embolism can be effectively managed with favorable outcomes in both the short and long term. Given the substantial economic repercussions of osteoporotic fractures, a strong advocacy for a more comprehensive approach is made, encompassing increased research efforts and enhanced funding in this field.

Láinez Ramos-Bossini et al. [15] conducted an extensive analysis of multiple studies to assess the effectiveness of various procedures in comparison to placebos and conservative treatments. The results indicated that interventions showed a predictable short-term advantage over placebos, but this advantage was not consistently observed in the medium and long term. When comparing vertebroplasty to conservative methods, the short-term effectiveness significantly improved, but the impact in the medium term was less pronounced. The overall analysis revealed notable differences between the outcomes of surgical and conservative approaches. The study also examined interventions at different time intervals from the onset of the fracture. It was observed that performance measures taken within 6 weeks of the fracture demonstrated significant improvements, and disability rates were consistently reduced across all time groups. Thus, this study confirms the viewpoint established during the research on the effectiveness of the intervention, although it places more emphasis on short-term effectiveness. The medium and short-term perspectives require further investigation.

Japanese researchers, led by Noguchi et al. [22,23], conducted a comprehensive analysis of potential complications associated with the intervention, which included the ones previously mentioned as well as others like allergic reactions, shock states during surgery, and infectious consequences due to an unsterile surgical field. The incidence of complications ranged from 1.9% to 3.9%, with mortality rates as low as 0.0018% to 0.002%. Given that individuals with untreated spinal fractures face an annual risk of death of up to 5%, and over a 10-year period, the risk can reach 85.1%, the procedure can be considered relatively safe. However, it is essential to note that no surgical intervention can be entirely devoid of risk. Regarding pulmonary complications, in addition to the previously described pulmonary embolism, isolated cases of respiratory arrest were reported, none of which were fatal. Concerning heart-related complications, aside from embolism, which was symptomatically observed in 0.33% of cases, there were instances of cardiogenic hypotension due to the activation of vagal reflexes and myocardial infarction in 0.05% of cases. Since the procedure is typically performed under conditions with respiratory and cardiac support, no fatal cases were reported. Postoperative infections are a rare but possible complication, with a prevalence ranging from 0.1% to 0.46%. This complication should be primarily considered in patients with infectious fractures, especially those with significant antibiotic resistance and individuals with primary or secondary immunodeficiency conditions. Mandatory antibiotic prophylaxis is recommended to mitigate the risk, as infections can originate from various sources within the body and not solely from nosocomial flora. Despite advancements in modern medicine, allergic reactions remain a challenge, occurring in approximately 1% of cases during the procedure and, although rare, can lead to fatal outcomes. In another study, highlight a mechanical error involving the puncture directly into the spinal canal, which occurs in 0.8% to 4% of cases. While all these cases were asymptomatic and diagnosed retrospectively, the occurrence of such situations can potentially lead to the development of more complex complications.

According to Kobayashi et al. [13], there is a distinct issue of procedure-related fractures. These fractures can involve neighboring or distant vertebrae or other anatomical structures. Vertebral refractures seem to occur independently of the procedure in 5% to 19% of cases. To prevent such occurrences, it is recommended to perform procedures without rods on healthy vertebrae above and below the affected area. In 0.5% of cases, a refracture of the initially affected vertebra is possible, which can be associated with the previously mentioned issues. Additionally, in 1% to 2% of cases, fractures of other bone structures, such as the humerus or ribs, may occur. It is important to note that patients with osteoporosis need to exercise caution since such fractures may happen before surgery, not as a result of it. This underscores the importance of comprehensive preoperative evaluation. Japanese researchers have made a significant contribution to the examination of complications arising during this intervention. However, these studies are strictly epidemiological and do not delve into the clinical aspects of both the intervention and complications, which markedly contrasts with the presence of a practical component in this study.

Wan et al. [31] have investigated the phenomenon of cement entering the bloodstream and have linked this occurrence to the material’s properties (specifically its viscosity) and the technique used during implantation (the injection pressure). They emphasize that the pressure applied during implantation plays a crucial role in fixation. Insufficient pressure during material injection is associated with ineffective fixation, while excessively high pressure can lead to material entering the bloodstream and the development of material embolism. The authors introduce the concept of “bone cement implantation syndrome” (BCIS), which is a multisystemic injury caused by the introduction of surgical material into the bloodstream. BCIS results in consequences such as arrhythmia, primarily of cardiac origin, hypotension, and hypoxia. The pathogenesis of BCIS is linked not only to the circulation of the interventional material, in this case, PMMA but also to bone particles, fat, and other substances. This is largely attributed to hyperthermia during the procedure and material injection. BCIS has several severity levels : grade 1 (hypoxia SpO₂ <94% or hypotension >20%), grade 2 (hypoxia SpO₂ <88% or hypotension >40%). In all documented cases, a correlation was observed either with the material’s viscosity or with the injection pressure. In a broader sense, the application of PMMA in these procedures may offer a relatively safer choice when compared to alternative materials; however, it is essential to emphasize that these subject merits additional in-depth research and analysis to provide a more comprehensive understanding of its safety and effectiveness. Similarly, the study by colleagues also highlights the importance of the pressure at which cement material is introduced. However, the research primarily examines cases of material leakage during interventions on large bones of the pelvis and lower extremities. Consequently, these findings are complementary, but nevertheless, it is crucial to underscore that these aspects warrant further in-depth research and analysis for a more comprehensive insight into their safety and effectiveness.

Song et al. [29] in their study noted, that despite the successful management of complications, osteoporosis remains a severe chronic condition that necessitates ongoing treatment, regardless of the outcomes of fracture treatment. It is crucial to note that in some instances, osteoporosis is not the primary ailment but rather complicates the course of other medical conditions. Patients with osteoporosis can experience improved health and a reduced risk of recurrent fractures through the use of medications like calcitonin preparations, bisphosphonates, and selective estrogen receptor modulators. Current cutting-edge research in the realm of cellular aging, molecular biochemistry, and the human biome microbiology also hints at the potential utilization of substances such as alpha-ketoglutarate, hydrogen sulfide derivatives, probiotics, and senolytics. These drugs have shown a high level of safety in their application, although there is still a need for further investigation into their pathogenic aspects and effectiveness in this domain.

The results of this study emphasize the overall safety and efficacy of pedicle screw fixation with cement in patients with osteoporosis, especially when appropriate surgical procedures and precautions are followed, as evidenced by the minimal likelihood of problems. Although cement leakage and embolism are recognized causes of problems, their rare occurrence indicates that with sufficient training, experience, and the use of sophisticated imaging tools, surgery can be performed with a high success rate. The findings are significant because they have the potential to improve patient outcomes by improving surgical procedures, detecting problems early, and creating standardized guidelines. The study shows that even when problems occur, conservative treatments such as revision surgery and anticoagulant therapy can lead to positive outcomes, emphasizing the need for careful postoperative follow-up and timely intervention when necessary. In clinical practice, these data provide an opportunity to optimize the treatment regimen and guarantee patient safety.

It should be noted, that a primary obstacle in cement-augmented pedicle screw fixation is effectively controlling the risk of sequelae, including cement leakage and pulmonary embolism, especially in patients with advanced osteoporosis. The intricate nature of the operation necessitates a considerable degree of surgical accuracy and expertise, therefore underscoring the need for surgeons to possess extensive training in the method. The requirement for specialized equipment, such as high-resolution fluoroscopy for immediate monitoring of cement injection, is a major factor to take into account, particularly in outpatient or under-resourced facilities. One further difficulty arises from the diversity of patient anatomy and bone quality, which might impact the dispersion and durability of the cement, resulting in inconsistent results. The growing elderly population and the rising widespread occurrence of osteoporosis require a meticulous equilibrium between providing efficient therapies and controlling the inherent hazards associated with surgical procedures. Ongoing research is required to optimize protocols, enhance cement materials, and devise techniques to reduce problems, while maintaining the accessibility and safety of the treatment for a wider patient group.