Fracture Patterns and Efficacy of Prophylactic Vertebroplasty in Osteoporotic Vertebral Compression Fractures: A Retrospective Single-Center Study

doi:10.21203/rs.3.rs-5327306/v1

Background: The concept of prophylactic vertebroplasty (PrVP) has been proposed to prevent recurrent fractures after vertebroplasty (VP); however, its efficacy remains controversial. The purpose of this study was to analyze fracture patterns and evaluate the effectiveness of PrVP in reducing refracture rates.

Methods: A retrospective analysis was conducted from January 2015 to December 2023 involving consecutive patients who underwent VP for osteoporotic vertebral compression fractures (OVCFs). Fractures were classified according to the German Society for Orthopedics and Trauma (DGOU) Classification of Osteoporotic Fractures, and further divided into subgroups. Patients were categorized into PrVP or non-PrVP groups. The follow-up assessments included radiographic evaluations, pain scores, and disability indices between the two groups.

Results: A total of 121 patients were included. PrVP was associated with reduced occurrence of subsequent vertebral compression fractures (VCFs) and adjacent vertebral fractures (AVFs) in the biendplate-involvement subgroup (7.7% versus 28.6%, P=0.031; 2.6% versus 23.8%, P=0.009). The postoperative disability scores at 3 months (12.1 ± 2.1 versus 12.9 ± 2.1, P=0.034) and at 6 months (11.7 ± 2.6 versus 12.8 ± 2.5, P=0.014) differed significantly between the groups. No significant differences were observed in AVF occurrence among the other fracture subgroups. Postoperative pain relief was significant in both groups, but the difference was not statistically significant.

Conclusions: Our study highlights the potential benefits of PrVP in reducing AVF occurrence in patients with biendplate-involved. Postoperative disability scores improved significantly with PrVP, especially in patients receiving postoperative osteoporosis medication.

Trial registration: This study was approved by the Research Ethics Committee of China Medical University Hospital (Approval number: CMUBH2019-001).

Prophylactic vertebroplasty

Osteoporotic vertebral compression fractures

DGOU classification

Endplate

Subsequent vertebral compression fractures

Globally, approximately 8.6 million patients suffer from OVCFs [1]. The estimated lifetime risk of developing an OVCF in white women is approximately 15%, and it increases to 27% in patients over 65 years of age [2, 3]. Overall, managing an acute OVCF includes pain control, activity modification, education, and treatment of the underlying osteoporosis. Patients can be treated conservatively with rest and/or medications or surgical management, such as vertebroplasty and kyphoplasty. However, conservative management often leads to increased incidences of new fractures at other vertebral levels [4]. Up to 17.5% of OVCF patients receiving conservative treatment were found to have subsequent new compression fractures, kyphosis progression, chronic pain and diminished functional conditions [5]. The impact of vertebral compression fractures (VCFs) on patients' physical function, quality of life (QoL), and societal burden is substantial.

Vertebral augmentation (VA), comprising vertebroplasty and kyphoplasty, has become a widely accepted therapeutic option for osteoporosis-related VCFs resistant to conservative measures. While effectively relieving pain and enhancing functional recovery, concerns have arisen regarding the increased risk of new fractures, especially adjacent vertebral fractures (AVFs) and remote vertebral fractures (RVFs). The likelihood of subsequent vertebral fractures is influenced by factors such as the number of affected vertebrae and the shape of existing deformities. The risk of further vertebral fractures is 3-fold greater after the first fracture has occurred and increases to 23 times greater after the third fracture [6].

Ongoing studies on the efficacy of PrVP have produced inconclusive results. Given the current literature, it is crucial to provide recommendations for treatment decision-making. Additionally, the assessment and treatment of OVCFs require a multidisciplinary approach involving spine specialists and bone disease experts [7]. Two key aspects under investigation in VCF management are the correlation between fracture patterns and the occurrence of new adjacent fractures post- vertebroplasty and the potential of the PrVP in reducing refracture rates in patients with OVCFs. Consequently, we conducted a research study to analyze fracture patterns and PrVP in OVCFs. This study aimed to examine fracture patterns and evaluate the efficacy of PrVP in reducing the occurrence of recurrent fractures.

Study population

From January 2015 to December 2023, we conducted a retrospective analysis involving consecutive patients who underwent VP for OVCFs at our department. Data concerning sex, age, hospital stay, fracture level, bone mass density (BMD), medications, and complications were extracted from medical records and operative protocols. The research was approved by the China Medical University Hospital Research Ethics Committee. (IRB: CMUBH2019-001)

The inclusion criterion was patients admitted to the hospital for their first-ever acute or subacute VCF. Additionally, patients had to have undergone unsuccessful conservative treatment and/or had MRI with edema demonstrated in the fractured vertebra. The exclusion criteria included pathological fractures (caused by malignancy, infection, or other medical conditions), incomplete plain lateral radiographic follow-up (at least 6 months), burst fractures with retro-pulsed bony fragments into the spinal canal accompanied by neurological signs prior to surgery, refracture of a cemented vertebra, a history of previous spinal surgery, and multilevel osteoporotic vertebral body fractures.

Commonly used trauma classification systems (AOSpine, Denis, TLICS, etc.) were not originally designed for osteoporotic fractures [8, 9]. Therefore, the fracture patterns in our study were categorized on the basis of the German Society for Orthopedics and Trauma (DGOU) Classification of Osteoporotic Fractures (Table 1) and further divided into three subgroups: (1) upper endplate involvement (OF2.1, OF3.1); (2) lower endplate involvement (OF2.3, OF3.3); and (3) biendplate involvement (OF4). A detailed explanation and representative images of each fracture type are presented (Figure 1). Preoperative fracture patterns and AVFs were studied on plain lateral radiographs preoperatively, postoperatively, at 3 months, and at the final follow-up.

Consequently, all enrolled patients were assigned to either the PrVP group or the non-PrVP group. In the PrVP group, we omitted preventive cementing in the upper instrumented vertebra (UIV) if the fracture was near or at the superior endplate. Similarly, we omitted the preventive procedure in the lower instrumented vertebra (LIV) if the fracture was near or at the inferior endplate. The PrVP was used for both the UIV and LIV when both endplates were thin or fractured (Figure 2).

Data collection

Patients were regularly followed up for an average of 34 months. Radiographic assessments included standing plain lateral radiographs taken before surgery, immediately after surgery, at 3 months postsurgery, and at the final follow-up. The visual analog scale (VAS) score and Oswestry Disability Index (ODI) score were documented before the procedure, 3 months after the procedure, and at the 6-month mark. The incidence of new vertebral fractures and their patterns were systematically assessed for all patients. All measurements were conducted by the first and last authors, and any discrepancies were resolved through a consensus approach by measuring the endplates together to ensure accuracy.

Statistical analysis

Continuous data with a normal distribution are presented as the means and standard deviations. Student’s t test was used to compare continuous variables. A chi-square test or Fisher’s exact test was used to compare dichotomous values (gender, incidence of new VCFs and AVFs). A significance level of p < 0.05 was considered statistically significant.

Initially, 121 patients met the inclusion criteria for the analysis, with a mean follow-up duration of 34 months (range 5–62 months). A total of 121 levels of VPs were used in our study. Follow-up at 6 months was completed for all 41 patients in the nonprophylactic group and 80 patients in the prophylactic group. The demographic characteristics of the three subgroups are presented in Table 2. There were no significant differences in patient age (P = 0.155), sex (P = 0.271), BMD (P = 0.159), or duration of follow-up (P=0.06) between the two groups.

A total of 51 levels (42.1%) were classified into the upper endplate involvement group, 10 levels (8.3%) into the lower endplate involvement group, and 60 levels (49.6%) into the biendplate involvement group on the basis of preoperative anterior‒posterior (AP) and lateral spine plane films, dynamic views, and MR images. There were 13 AVFs, including 7 cases (13.7%) in the upper endplate involvement group and 6 cases (10%) in the biendplate involvement group (Table 3).

In the upper endplate involvement group, 32 patients were treated with PrVP, and 19 patients were treated with index-level vertebroplasty only. AVFs were detected in 5 (15.6%) patients in the prophylactic group and in 2 (10.5%) patients in the nonprophylactic group. Six AVFs occurred over the superior caudal endplate, and one AVF occurred over the inferior cranial endplate. Additionally, a new RVF was found in 13 (40.6%) patients in the prophylactic group and in 5 (26.3%) patients in the nonprophylactic group. No significant differences were observed between the two groups regarding AVF (odds ratio [OR]=0.64, P=0.609) or new RVF (OR=0.52, P=0.301).

In the lower endplate involvement group, 9 patients were treated with PrVP, and 1 patient was treated with index level vertebroplasty only. No AVFs occurred at all levels, but a new VCF was observed in 3 (33.3%) patients in the prophylactic group.

In the biendplate-involvement group, 39 patients were treated with PrVP, and 21 patients were treated with index -level vertebroplasty only. AVFs were found in 1 (2.6%) patient in the prophylactic group and in 5 (23.8%) patients in the nonprophylactic group. Five AVFs were located over the superior caudal endplate, and one AVF was located over the inferior cranial endplate. In addition, a new RVF was found in 2 (2.5%) patients in the prophylactic group and in 1 (2.4%) patient in the nonprophylactic group. There were significant differences observed between the two groups regarding AVF (OR=11.88, P=0.009), but no significant differences were observed between the two groups regarding new RVF (OR=0.93, P=0.95; Table 4).

Following the VP intervention, both cohorts experienced notable alleviation of pain and enhancement of daily functioning. The mean VAS score decreased dramatically from a baseline (preoperative) value of approximately 7 to 2 after three months for both groups. Similarly, the mean ODI score significantly decreased from approximately 38 before surgery to 12 after surgery in both groups. At the 6-month follow-up, there was a slight further decline in the VAS and ODI scores. Notably, the postoperative ODI scores at 3 and 6 months were significantly different between the two groups (at 3 months: 12.9 ± 2.1 vs. 12.1 ± 2.1, P=0.034; at 6 months: 12.8 ± 2.5 vs. 11.7 ± 2.6, P=0.014). However, no statistically significant differences were observed in the mean VAS score or preoperative ODI score between the two groups (Table 4, Figure 3).

In terms of postoperative anti-osteoporotic medication (AOM), 71 patients were administered anti-osteoporotic medication, including the following: (1) Denosumab: 60 mg subcutaneously every 6 months. (2) Teriparatide: 20 mcg subcutaneously daily. (3) Alendronate: 70 mg orally once a week. (4) Raloxifene: 60 mg orally daily. (5) Zoledronic acid: 5 mg intravenously once a year. Dosages were standardized on the basis of current guidelines for managing osteoporosis in patients with vertebral fractures. The mean VAS score and ODI score were documented for both groups at various time points: preoperatively, at the 3-month mark, and at the 6-month mark (Table 5, Figure 3). Notably, there was a significant difference in the postoperative ODI score at 6 months between the two groups (11.1 ± 2.8 vs. 12.4 ± 2.5, P=0.014). However, no statistically significant differences were observed in the mean VAS score or ODI score among the other groups.

The characteristics of OVCFs dictate whether conservative or surgical treatment is appropriate. Approximately one in five cases of conservatively managed OVCFs result in complications such as new fractures at other levels, chronic or persistent low back pain, progressive kyphotic deformity, and neurological compromise [5]. On the other hand, cement augmentation is a valuable treatment option for OVCFs and plays a crucial role in preventing further vertebral height loss and ongoing kyphotic deformity, thus preventing immobilization [4, 10-13]. Compared with balloon kyphoplasty and nonsurgical treatment, Zhu et al. identified it as the most effective method for improving pain, functional status, and quality of life [14]. Despite being less complex and more cost-effective than kyphoplasty, VP may entail a greater risk of complications. Subsequent fractures significantly impact the efficacy of VP, with new AVFs occurring in 20–25% of cases [15]. Additionally, a meta-analysis of more than 2 million patients revealed that those with OVCFs who underwent VA were 22% less likely to die within up to 10 years posttreatment than those who received non-surgical treatment [16]. Regarding the cause, no convincing conclusion has been obtained from current studies. Yen et al. reported a protective effect of VP within six months post surgery, reducing the incidence of any adjacent fracture by 21% [17]. In contrast, Buchbinder et al. reported no significant benefit of VP in terms of pain, disability, quality of life, or treatment success for acute or subacute osteoporotic vertebral fractures [18]. Consequently, there is a need to investigate the mechanism of refracture and explore alternative preventive strategies [19, 20]. This study represents the first attempt to scrutinize fracture patterns and evaluate the advantages of the PrVP for single-segment OVCFs.

New VCFs after VP included those that affected the AVFs, recompression of cemented vertebral bodies, and RVFs. Hsieh et al demonstrated an unmet need to prevent symptomatic subsequent VCF in the first 6 months after primary VP (subacute phase), since the protective effects of AOMs are questionable during this period [21]. After VP, the redistribution of load-bearing kinetics shifts to other vertebrae, particularly those neighboring the original fracture site, thereby increasing the risk of AVFs. Clinical studies have demonstrated that most fractures occur at adjacent levels [22, 23]. On the basis of our published data, the incidence of AVFs was 17.1% (7/41) in the nonprophylactic group and 7.5% (6/80) in the prophylactic group, with no statistically significant difference between the groups (P = 0.107). While the incidence of new fractures in remote vertebrae is relatively lower than that in adjacent levels, preventing this complication is equally important. Previous studies have suggested that there is no statistically significant difference in the occurrence of remote fractures between the prophylactic and nonprophylactic groups [15, 19, 24]. These findings are consistent with our findings; the incidence of RVFs was 14.6% (6/41) in the nonprophylactic group and 22.5% (18/80) in the prophylactic group, with no statistically significant difference between the groups (P=0.304). This finding indicates that prophylactic augmentation does not influence the reduction of remote fractures.

Previous studies have identified various factors associated with the recurrence of VCFs following augmentation procedures. Staples et al. reported no correlation between subsequent fractures and the injected cement volume, cement leakage, or VP level [25]. Yu et al. emphasized factors such as a preoperative intravertebral cleft, affected vertebrae in the thoracolumbar region, severe preoperative kyphotic deformity, a solid lump cement distribution pattern, and greater vertebral height restoration as primary risk factors [26]. Additionally, sarcopenia and advanced age are recognized as independent risk factors [27, 28]. Furthermore, Hsieh et al demonstrated that age, osteoporosis or osteopenia, and the Charlson comorbidity index (CCI) were identified as risk factors in the initial 6 months, but only osteoporosis or osteopenia and the CCI persisted as risk factors thereafter [21]. Biomechanically, the VP increases pressure in adjacent intervertebral discs by 19% and stresses in adjacent endplates and trabecular bone by 17% and 5%, respectively. Trabecular bone near endplates plays an important biomechanical role, distributing up to 85% of the applied load [29, 30]. Cement-induced stiffness modifies load transfer, potentially straining adjacent vertebrae. Nagaraja et al. reported that bone cement increases subsidence in the posterior regions of the treated endplates and the anterior region of the superior caudal endplate [31]. Consequently, increased subsidence may be the initial mechanism precipitating subsequent compression fractures after VP, particularly in vertebrae superior to the treated level.

Clinical studies have shown variations in the predominant location (superior or inferior) of adjacent vertebral fractures after VP. Yen et al. reported a greater incidence of new fractures in upper adjacent vertebrae than in lower ones (36% versus 15%) [17]. Kobayashi et al. further performed PrVP in only the upper adjacent vertebrae because the incidence of new fractures was relatively low in the lower adjacent vertebrae [32]. Our findings align well with these studies, as 84.6% (11/13) of AVFs were located at the cranial endplate. Additionally, Han et al. demonstrated the beneficial effects of PrVP at the UIV and adjacent vertebra, indicating potential delays in the progression of proximal junctional kyphosis (PJK), proximal junctional failure (PJF), and proximal junctional fracture (PJFx), consequently reducing the reoperation rate following PJFX [22]. Similarly, Gassie et al. reported minimal occurrences of PJK and PJF following PrVP and UIV cement augmentation (11.1% and 4.2%, respectively) [33].

There is limited evidence regarding the treatment of biendplate-involved OVCFs classified as OF4 fractures. Most patients treated conservatively experienced minor symptoms and lower complication rates, but had a high incidence of neurological deficits at follow-up (14%). Conversely, surgical treatment resulted in lower rates of neurological deficits but higher rates of subsequent fractures (26% and 10%, respectively) [34]. Our published data indicate that the incidence of AVFs in the biendplate-involved subgroup was 23.8% (5/21) in the nonprophylactic group and 2.6% (1/39) in the prophylactic group, with a statistically significant difference (P = 0.009). Thus, PrVP appears to be a valid treatment strategy for biendplate OVCFs.

Furthermore, several studies have indicated that the major cause of recurrent fracture is the progression of osteoporosis rather than therapeutic augmentation. Ebeling et al. reported that AOMs reduce the risk of subsequent vertebral fractures by 40–70% [35]. Therefore, patients diagnosed with OVCFs should receive appropriate anti-osteoporotic therapy promptly. Anabolic agents have greater anti-fracture efficacy and produce greater increases in bone density than antiresorptive drugs do. However, as the effects of anabolic agents are temporary, sequential treatment with antiresorptive drugs following anabolic therapy is necessary [7, 36].

In summary, PrVP in the biendplate-involved subgroup remains necessary for several reasons. First, the presence of OVCFs with biendplate-involved indicates poor bone quality, suggesting a likelihood of further fractures due to progressive deterioration. Second, the effectiveness of sequential osteoporosis medications takes several months to manifest, necessitating strict medication compliance to prevent new VCFs. Additionally, a significant proportion of AVFs occur shortly after VP, with 62% reported within 6 months in the non-preventive group [37]. Finally, the rapid relief of pain following VP may lead patients to engage in early physical activity without adequate protective measures or short-term AOMs, thereby heightening the risk of subsequent VCFs.

Our study has several limitations. First, it was a single-center retrospective, nonrandomized design with a limited number of patients in each subgroup. Second, we did not include data on newly occurring VCFs managed through conservative treatment. Additionally, some asymptomatic patients have declined imaging studies, impacting the assessment of new VCFs. Moreover, challenges in obtaining bone density measurements hinder preoperative and postoperative assessments. Finally, the strict selection criteria (single-segment fractures, no prior spinal surgery) resulted in a relatively small sample size. These limitations warrant the need for further research utilizing a randomized controlled trial approach to construct a predictive model for refracture risk after VP. This model (Figure 4) will assist clinicians in identifying high-risk patients for refracture, enabling the implementation of targeted intervention measures for the UIV and/or LIV.

We established a novel classification system and evaluated the correlation between fracture pattern and the occurrence of AVFs after VP. The PrVP in the biendplate involvement group demonstrated a decrease in the occurrence of subsequent VCFs and AVFs. In addition, there were significant differences observed in the PrVP group regarding postoperative ODI scores at the 3-month and 6-month follow-ups. Furthermore, statistically significant differences were observed in the postoperative ODI score at the 6-month follow-up among patients receiving postoperative osteoporosis medication.

AOM: Anti-osteoporotic Medication

AVF: Adjacent Vertebral Fracture

BMD: Bone Mass Density

DGOU: German Society for Orthopedics and Trauma

LIV: Lower Instrumented Vertebra

ODI: Oswestry Disability Index

OVCF: Osteoporotic Vertebral Compression Fracture

PJK: Proximal Junctional Kyphosis

PJF: Proximal Junctional Failure

PJFX: Proximal Junctional Fracture

PrVP: Prophylactic Vertebroplasty

QoL: Quality of Life

RVF: Remote Vertebral Fracture

UIV: Upper Instrumented Vertebra

VA: Vertebral Augmentation

VAS: Visual Analog Scale

VCF: Vertebral Compression Fracture

VP: Vertebroplasty

Acknowledgements

Not applicable

Author contributions

JH: data acquisition and analysis, drafting and revision of article

KX: data analysis and interpretation, revision of article

YJ: for independent resolution of conflicts during data extraction and interpretation

CM: for independent resolution of conflicts during data extraction and interpretation

PH: data extraction and interpretation

CY: data extraction and interpretation

HT: for independent resolution of conflicts during data screening and vetting of article

CT: research design, data screening, drafting and revision of article, correspondence

Funding

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

Data availability

No datasets were generated or analysed during the current study.

Ethical approval

This study was approved by the Research Ethics Committee of China Medical University Hospital (Approval number: CMUBH2019-001), and all patients written informed consent.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.

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Table 1. DGOU Osteoporotic Fracture (OF) Classification System

OF1	OF2	OF3	OF4	OF5
No deformation	Deformation of one endplate with posterior wall < 1/5 involvement	Deformation of one endplate with posterior wall > 1/5 involvement	Deformation of Bi-endplate	Anterior or posterior tension band failure
	OF2.1 Superior	OF3.1 Superior	OF4.1 Loss of vertebral frame structure
	OF2.2 Lateral	OF3.2 Lateral	OF4.2 Vertebral body collapse
	OF2.3 Inferior	OF3.3 Inferior	OF4.3 Pincer

Table 2. The demographic and baseline characteristics of patients

	Total	Nonprophylactic group	Prophylactic group	P value
Number of patients	121	41	80	-
Mean age in yrs	77.3 ± 8.4	76.2 ± 9.1	77.9 ± 8.0	0.155
Gender (M/F)	31/90	8/33	23/50	0.271
BMD (T-score)	-2.93 ± 1.02	-2.77 ± 0.99	-3.02 ± 1.03	0.159
Mean follow-up in mos	33.9 ± 28.4	28.2 ± 14.7	36.8 ± 32.9	0.063
Fracture subgroup
Upper endplate	51	19	32	-
Lower endplate	10	1	9	-
Bi-endplate	60	21	39	-

— = not applicable.

* Statistically significant.

Table 3. Classification of adjacent vertebral fractures (AVFs)

	Total	Upper endplate	Lower endplate	Bi-endplate
	121	51	10	60
VCFs (%)	35 (28.9%)	23 (45.1%)	3 (30%)	9 (15%)
RVFs (%)	24 (19.8%)	18 (35.3%)	3 (30%)	3 (5%)
AVFs (%)	13 (10.7%)	7 (13.7%)	0 (0%)	6 (10%)
At inferior cranial endplate	11	6	0	5
At superior caudal endplate	2	1	0	1

Table 4. Clinical status of patients

	Nonprophylactic group	Prophylactic group	P value
VAS score
Pre-OP	7.0 ± 1.0	6.8 ± 1.0	0.262
Post-OP at 3mo	1.8 ± 1.0	2.0 ± 0.9	0.094
Post-OP at 6mo	1.3 ± 0.6	1.3 ± 0.6	0.435
ODI score
Pre-OP	37.0 ± 4.5	38.0 ± 4.4	0.122
Post-OP at 3mo	12.9 ± 2.1	12.1 ± 2.1	0.034*
Post-OP at 6mo	12.8 ± 2.5	11.7 ± 2.6	0.014*
VCFs (%)	12 (29.2%)	23 (28.8%)	0.953
Upper endplate	6 (31.6%)	17 (53.1%)	0.135
Lower endplate	0 (0%)	3 (33.3%)	1
Bi-endplate	6 (28.6%)	3 (7.7%)	0.031*
AVFs (%)	7 (17.1%)	6 (7.5%)	0.107
Upper endplate	2 (10.5%)	5 (15.6%)	0.609
Lower endplate	0 (0%)	0 (0%)	1
Bi-endplate	5 (23.8%)	1 (2.6%)	0.009*
RVFs(%)	6 (14.6%)	18 (22.5%)	0.304
Upper endplate	5 (26.3%)	13 (40.6%)	0.301
Lower endplate	0 (0%)	3 (33.3%)	1
Bi-endplate	1 (2.4%)	2 (2.5%)	0.95

Table 5. Osteoporosis medication after procedure for patients

	Non-medication group	Medication group	P value
VAS score
Pre-OP	6.8 ± 1.2	6.9 ± 1.0	0.323
Post-OP at 3mo	2.0 ± 0.7	2.0 ± 1.0	0.478
Post-OP at 6mo	1.2 ± 0.7	1.4 ± 0.6	0.084
ODI score
Pre-OP	37.3 ± 4.2	37.8 ± 4.8	0.326
Post-OP at 3mo	11.9 ± 2.1	12.6 ± 2.2	0.093
Post-OP at 6mo	11.1 ± 2.8	12.4 ± 2.5	0.014*

No competing interests reported.

Fracture Patterns and Efficacy of Prophylactic Vertebroplasty in Osteoporotic Vertebral Compression Fractures: A Retrospective Single-Center Study

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Abstract

Figures

Background

Materials and Methods

Results

Discussion

Conclusion

Abbreviations

Declarations

References

Tables

Additional Declarations

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