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Background and objectives: Tumor-related vertebral compression fractures often result in severe back pain as well as progressive neurologic impairment and additional morbidities. The fixation of these fractures is essential to obtain good pain relief and to improve the patients’ quality of life. Thus far, several spine implants have been developed...
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Context 1
... right and left pedicle version is available to provide the option to access the vertebral body from each pedicle. This design of delivery in a spiral loop shape allows to mechanically reduce the fracture: Each loop added to the spiral uplifts the vertebral endplate by a few millimeters, and the amount of the implant delivered is customized by the physician during the procedure (Figure 2). The tubular and perforated design of the implant allows injection of cement contained only in the inside of the spiral, thus preventing cement leakage. ...
Citations
... Kyphoplasty has come out as an evolution of vertebroplasty, permitting to associate its stabilizing and analgesic effect regarding the application of intravertebral cement, to the restoration of the height of the fractured vertebral body, by creating intrasomatic cavities with an expandable balloons, which are then filled with cement. Besides reducing the fractured vertebral body, the creation of previous intrasomatic cavities with less pressure and covered by impacted bone trabeculae (which work as a shield) and by the walls of the vertebral body, decreases the possibility of cement extravasation, reducing the risks of related complications (28,33,34,35,36,37). However, one of the criticisms pointed out to kyphoplasty concerns its incapacity to keep the restored height of the vertebral body after balloon removal and before cement application, leading to vertebra flattening through elastic recoil by ligament and annulotaxis (also known as deflation effect). ...
... However, one of the criticisms pointed out to kyphoplasty concerns its incapacity to keep the restored height of the vertebral body after balloon removal and before cement application, leading to vertebra flattening through elastic recoil by ligament and annulotaxis (also known as deflation effect). Even when the patient lies down on the table with the spine in hyperextension, compression forces of approximately 110 N keep acting on the fractured vertebra, resulting in its flattening (12,28,29,30,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49). In order to try to compensate for this disadvantage, expandable intravertebral implants EFORT Open Reviews (2024) 9 309-322 https://doi.org/10.1530/EOR-23-0190 ...
Purpose
The aim of the study was to assess the role of kyphoplasty and expandable intravertebral implants in the treatment of traumatic vertebral compression fractures.
Design
This is a systematic review.
Methods
A bibliographic search was carried out in the PubMed/MEDLINE database according to PRISMA guidelines regarding kyphoplasty and expandable intravertebral implants in the treatment of traumatic thoracolumbar vertebral fractures.
Results
A total of 611 records were screened. In total, 51 studies were obtained referring to traumatic vertebral fractures treated with kyphoplasty; however, of these, only studies addressing traumatic burst fractures were selected, resulting in 12 studies: 10 about kyphoplasty and 2 regarding armed kyphoplasty. In all studies, there was a statistically significant improvement in clinical and functional parameters, restoration of vertebral height and decreasing of vertebral and segmental kyphosis. Overall, there was only a residual loss of height and a slight increase in kyphosis throughout the follow-up period, while complications consisted essentially of cement leakage, all with no clinical repercussions.
Conclusion
After the discussion, where we address the concepts of direct and indirect reduction, the association of kyphoplasty with pedicle fixation, the potential advantages of expandable intravertebral implants, as well as the vertebral body type of filling in kyphoplasty, it is concluded that kyphoplasty demonstrates favorable outcomes as a method of posterior percutaneous transpedicular access for reconstruction of the anterior column in burst fractures. It allows for the reconstruction of the vertebral body closer to its original anatomy, carried out in a minimally invasive and safe way, which provides a clinical-functional and imaging improvement maintained at the medium–long term.
... [129][130][131] To treat spinal fractures and stabilize vertebral bodies, PEEK-based implants are used in vertebral augmentation procedures like kyphoplasty and vertebroplasty. [132] PEEK implants are used in sacroiliac joint fusion procedures, providing a minimally invasive method of treating pain and dysfunction in the sacroiliac joint. [133,134] In order to treat various spinal conditions while maintaining motion at particular spinal segments, PEEK-based dynamic stabilization devices are used, such as pedicle-based systems and posterior motion preservation devices. ...
ABSTRACT
The emergence of Polyether Ether Ketone (PEEK) in implant fabrication is a sign of the revolution in healthcare that has been sparked by the convergence of 3D printing technology and advanced materials. This review paper investigates the multifaceted impact of PEEK on changing the implant manufacturing landscape. This paper explores the significance of implant fabrication, the critical function of 3D printing, and the emergence of PEEK as a leading 3D printing material through a thorough analysis of PEEK’s exceptional biocompatibility, mechanical properties, and adaptability. It explores the various PEEK-based 3D printing applications in the dental, orthopedic, spinal, cranial, cardiovascular, and emerging implant domains, supported by real-world case studies and success stories. The review also discusses difficulties, developments, and sustainability issues related to PEEK-based 3D printing. The revolutionary impact of PEEK-based 3D printing on healthcare is highlighted in this paper, which also charts future directions and provides insights into how patient care is changing and the changing paradigm of implantology.
... Unlike minimally invasive injectable cement materials, vertebral implants are primarily composed of implantable metals (Cornelis et al., 2019) (Figure 7). These include the Vertebral Body Stenting (VBS), SpineJack, Kiva, and Osseofix systems, which are based on a similar principle of percutaneous implantation of an expandable vertebral body stent (to restore vertebral height) and the correction of kyphosis; this procedure is referred to as third-generation vertebral body augmentation (Dong et al., 2022). ...
Vertebral compression fractures are becoming increasingly common with aging of the population; minimally invasive materials play an essential role in treating these fractures. However, the unacceptable processing-performance relationships of materials and their poor osteoinductive performance have limited their clinical application. In this review, we describe the advances in materials used for minimally invasive treatment of vertebral compression fractures and enumerate the types of bone cement commonly used in current practice. We also discuss the limitations of the materials themselves, and summarize the approaches for improving the characteristics of bone cement. Finally, we review the types and clinical efficacy of new vertebral implants. This review may provide valuable insights into newer strategies and methods for future research; it may also improve understanding on the application of minimally invasive materials for the treatment of vertebral compression fractures.
... Furthermore, VPT does not allow a suitable action in the local treatment of the tumor and is associated with a moderate rate of cement leaks [15]. Balloon kyphoplasty and other vertebral implants have been developed to further improve the cement deposition and stabilization of cancer-related fractures [16,17]. SpineJack is an expandable intravertebral titanium implant that allows the restoration of vertebral height and the maintenance of a correct kyphotic angle of the spine resulting in a more balanced distribution of the craniocaudal thrust forces on the fractured vertebrae and on the whole spinal column [18]. ...
... In 2022, Cornelis et al. published a single-center retrospective review study on 13 patients to evaluate the applicability of SJ, using cone-beam CT guidance, in the treatment of vertebral fractures secondary to tumor infiltration with promising results [16]. ...
Citation: Pusceddu, C.; Marsico, S.; Derudas, D.; Ballicu, N.; Melis, L.; Zedda, S.; de Felice, C.; Calabrese, A.; De Francesco, D.; Venturini, M.; et al. Percutaneous Vertebral Reconstruction (PVR) Technique of Pathological Compression Fractures: An Innovative Combined Treatment of Microwave Ablation, Bilateral Expandable Titanium SpineJack Implants Followed by Vertebroplasty. Abstract: (1) Background: to retrospectively evaluate safety and efficacy of combined microwave ablation (MWA) and bilateral expandable titanium SpineJack (SJ) implants followed by vertebro-plasty (VP) for the treatment of painful thoracolumbar pathological vertebral compression fracture. (2) Methods: from July 2017 to October 2022, twenty-eight patients (13 women and 15 men; mean age 68 ± 11 years) with a history of primary neoplasm and thirty-six painful vertebral metastases with vertebral compression fracture underwent combined MWA and bilateral expandable titanium SpineJack implants with vertebroplasty. We analyzed safety through complications rate, and efficacy through vertebral height restoration and pain decrease, evaluated using a visual analogue scale (VAS), and Functional Mobility Scale (FMS), and local tumor control. Contrast-enhanced CT scans were performed at 1, 3, and 6 months and a contrast-enhanced spine MRI at 6 months after the procedure. (3) Results: Technical success rate was 100%. No procedure-related major complications or death occurred. Vertebral height restoration was observed in 22 levels (58%), with a mean anterior height restoration of 2.6 mm ± 0.6 and a mean middle height restoration of 4.4 mm ± 0.6 (p < 0.001). Mean VAS score of pain evaluation on the day before treatment was 6.3 ± 1.5 (range 4-9). At the 6-month evaluation, the median VAS score for pain was 0.4 ± 0.6 (range 0-2) with a mean reduction of 93.65% (6.8 ± 0.7 vs. 0.4 ± 0.6; p < 0.000) compared with baseline evaluation. Contrast-enhanced CT scans were performed at 1, 3, and 6 months and a contrast-enhanced spine MRI was performed at 6 months after the procedure, showing no local recurrence, implant displacement, or new fractures in the treated site. (4) Conclusions: combined microwave ablation and bilateral expandable titanium SpineJack implants with vertebroplasty is a safe and effective procedure for the treatment of pathological compressive vertebral fractures. The vertebral stabilization achieved early and persistent pain relief, increasing patient mobility, improving recovery of walking capacity, and providing local tumor control.
... Various Percutaneous Implant Techniques (PITs) were introduced in order to reduce the secondary loss of vertebral body height associated with PKP after balloon deflation and till cementation and to allow persistent restoration of vertebral height and restoration of a normal kyphotic angle (7). ...
Objective
To retrospectively evaluate the feasibility and effectiveness of vertebroplasty using Spinejack implantation for the treatment and stabilization of painful vertebral compression fractures, in patients diagnosed with Multiple Myeloma (MM), to allow both an effective pain reduction and a global structural spine stabilization.Materials and Methods
From July 2017 and May 2022 thirty-nine patients diagnosed MM, with forty-nine vertebral compression fractures underwent percutaneous Vertebroplasty using Spinejack Implants. We analyzed the feasibility and complications of the procedure, the decrease in pain using visual analogue scale (VAS) and Functional Mobility Scale (FMS).ResultsThe technical success rate was 100%. No procedure-related major complications or death occurred. In the 6-month follow-up, the mean VAS score decreased from 5.4 ± 1.0 to 0.2 ± 0.5 with a mean reduction of 96.3%. FMS decreased from 2.3 ± 0.5 vs. 1.2 ± 0.4 with a mean reduction of −47.8%. There were no major complications related to incorrect positioning of the Expandable Titanium SpineJack Implants. In five patients, a cement leak was observed with no associated clinical manifestations. The average length of hospital stay was 6–8 Hours6.6 ± 1.2 h. No new bone fractures or local disease recurrence occurred during a median contrast-enhanced CT follow-up of 6 months.Conclusions
Our results suggest that vertebroplasty, using Spinejack implantation for the treatment and stabilization of painful vertebral compression fractures, secondary to Multiple Myeloma is a safe and effective procedure with long - term pain relief and restoration of vertebral height.
... Next, these bilateral balloon's spaces are filled with bone cement and this way, the fractured vertebral body is reduced and stabilized. Furthermore, these previously created lower pressure intrasomatic cavities covered by the vertebral body's walls and by body impacted bone trabeculae, minimize cement leakage risk, making it possible to diminish the possibility of complications due to this extravasation such as radicular pain, paraplegia or even death (14,17,(21)(22)(23). Nevertheless, kyphoplasty is criticized based on the incapacity to keep the restored vertebral body height after removing the balloons and before cement application, which leads to vertebra flattening due to elastic recoil by annulotaxis and ligamentotaxis. ...
... Nevertheless, kyphoplasty is criticized based on the incapacity to keep the restored vertebral body height after removing the balloons and before cement application, which leads to vertebra flattening due to elastic recoil by annulotaxis and ligamentotaxis. Moreover, even if the patient is placed on the table with the spine in hyperextension, compression forces of about 110 Newtons keep impacting the fractured vertebra, therefore influencing its flattening (17,(18)(19)(20)(21)(22)(24)(25)(26)(27)(28)(29)(30). ...
Background:
The optimal treatment of osteoporotic vertebral fractures is still a controversial and under discussion topic. Armed kyphoplasty with expansive intravertebral implants is an emerging procedure, which, in theory, it not only makes it possible to achieve instant analgesia, and to get stabilization gains of benefits of kyphoplasty and vertebroplasty, but also, allows for a more effective maintenance of the restored vertebral height.
Methods:
A retrospective observational study is presented, in which 30 patients participated, including a total of 33 osteoporotic thoracolumbar compression burst vertebral fractures with involvement of one or both vertebral platforms and of more than one fifth of the posterior wall. These individuals underwent armed kyphoplasty with VBS® stents (or stentoplasty) filled with bone cement over 10 years (between 2012 and 2022) at the same center. Clinical (visual analogue scale, Oswestry Disability Index and Patient Global Impression of Change) and imaging results (restoration and maintenance of vertebral body heights) achieved were investigated. The mean follow-up time was 4.5 years (range, 1-10 years).
Results:
There was a statistically significant improvement in all clinical and functional parameters evaluated, as well as a statistically significant difference in the various vertebral body heights between preoperative and end of follow-up time [increase of 10.7-15.2-5.0 mm (anterior-median-posterior) in the sagittal plane and 6.7-11.6-9.7 mm (right-median-left) in the coronal plane]. There was a statistically significant direct correlation between vertebral heights in the coronal plane, and between the Beck index assessed at the end of the follow-up period and the improvement in functional disability.
Conclusions:
The percutaneous transpedicular posterior approach, the ability to anatomically restore the fractured vertebra and to maintain it in the medium-long term, as well as the reduced risk of adverse effects, make stent-armed kyphoplasty a very attractive treatment option for osteoporotic compressive thoracolumbar fractures. A clinical-morphological correlation was demonstrated regarding the surgical treatment of these fractures, it was found that a more effective morphological restoration of vertebral heights in both the sagittal and coronal planes is associated with superior satisfactory clinical functional parameters.
... Cianfoni et al. have published multiple studies looking at the stent and screw-assisted internal fixation (SAIF) technique [24][25][26][27][28]. Utilizing this method, extremely complex osteoporotic and neoplastic fractures can be approached, stabilized, and anatomically corrected, confirming results from preliminary biomechanical studies. ...
Vertebral augmentation has been used to treat painful vertebral compression fractures and metastatic lesions in millions of patients around the world. An international group of subject matter experts have considered the evidence, including but not limited to mortality. These considerations led them to ask whether it is appropriate to allow the subjective measure of pain to so dominate the clinical decision of whether to proceed with augmentation. The discussions that ensued are related below.
... Kyphoplasty emerged as an evolution of vertebroplasty, allowing to combine its analgesic and stabilizing effect concerning the application of intravertebral cement, with the restoration of the fractured vertebral body's height, by creating an intrasomatic cavity with an expansive balloon, a space that is then filled with cement. In addition to the advantages of reducing the fractured vertebral body, the creation of a previous intrasomatic cavity with less pressure and supposedly covered by impacted bone trabeculae and by the walls of the vertebral body, which is filled with cement, reduces the risk of its extravasation, thereby allowing to minimize the risks of complications from this extravasation [5,9,[13][14][15]. Nevertheless, one of the criticisms against kyphoplasty is the inability to maintain the restored height of the vertebral body after balloon removal and before applying the cement, resulting in vertebra flattening through elastic recoil by ligament and annulotaxis. ...
... Nevertheless, one of the criticisms against kyphoplasty is the inability to maintain the restored height of the vertebral body after balloon removal and before applying the cement, resulting in vertebra flattening through elastic recoil by ligament and annulotaxis. Even with the patient's positioning on the table with the spine in hyperextension, compression forces of approximately 110 Newtons continue to act on the fractured vertebra, contributing to its flattening [4][5][6][13][14][15][16][17][18][19][20][21][22]. ...
... The application of expandable intravertebral implants, also known as armed kyphoplasty, in addition to allowing for the aforementioned analgesia and stabilization benefits of vertebroplasty and kyphoplasty, also theoretically enables the maintenance of restored vertebral height in the long term. This is made possible because the vertebral endplates, after their reduction, stay mechanically supported by the expanded device (they work as an interior support), which decreases or prevents vertebral flattening after expansion, reducing the risk of posttraumatic local and segmental kyphosis, and ensuring stable anterior column support at the level of the vertebral body [5,6,13,15,[23][24][25][26]. ...
Expandable intravertebral implants are self-expanding devices applied percutaneously by the posterior transpedicular approach. These devices introduce the concept of anatomical restoration of vertebral body endplates and direct anatomical reduction performed from the interior of the vertebral body with a compression fracture. This paper aims to provide a narrative review on the concept, indications, biomechanical characteristics, as well as functional and radiographic outcomes of the main expandable intravertebral implants currently available, in terms of their application to thoracolumbar spine traumatology. To this end, we performed a search in July 2021 on the MEDLINE/PubMed platform with the words "expandable intravertebral implant", "armed kyphoplasty", "Vertebral Body Stenting" or "stentoplasty" and "SpineJack". The search yielded 144 papers, and of those, we included 15 in this review. We concluded that percutaneous transpedicular posterior access, the ability to reduce vertebral body fractures, particularly of the vertebral endplates and to maintain the vertebral body height, makes the application of expandable intravertebral implants an attractive option in the treatment of thoracolumbar vertebral compression fractures. However, more prospective, randomized, and large-scale blinded studies are still warranted, especially comparative studies between treatments and about the preferential use of an expansive implant over others, in order to gain definitive insights into the effectiveness and indications of each of these devices.
... Despite concerns about their safety and efficacy, interventional radiology procedures such as percutaneous vertebroplasty improve the clinical outcomes of cancer patients [3]. However, vertebroplasty alone appears insufficient to adequately drive the cement deposition and to correct the structural deformities observed after VCF [4]. Cement leakage may be observed in cases of lytic lesions involving the posterior wall of the vertebral body, and the height of the vertebrae is often not restored, leading to further instability [5]. ...
... Three different intravertebral implants were used: Spinejack ® (Stryker, Kalamazoo, MI, USA) ( Figure 1); V-Strut ® (Hyprevention, Pessac, France) ( Figure 2); and KIVA ® (IZI medical, Owing Mills, MD, USA) ( Figure 3). These devices are detailed in [6] and their differences in [4]. They were carefully deployed in order to ensure correct placement and control potential posterior wall protrusion. ...
Background and objectives: Cancer-related vertebral compression fractures (VCF) may cause debilitating back pain and instability, affecting the quality of life of cancer patients. To further drive cement deposition during vertebroplasty, the aims of this restrospective case series study were to report the feasibility, safety and short term efficacy (≤6 months) of percutaneous vertebral fixation in cancer-related vertebral compression fractures using various intravertebral implants. Methods: All consecutive cancer patients treated with percutaneous vertebral fixation for VCF were retrospectively included. Various devices were inserted percutaneously under image guidance and filled by cement. Descriptive statistics were used and a matched paired analysis of pain scores was performed to assess for changes following interventions. Results: A total of 18 consecutive patients (12 women (66.6%) and 6 men (33.3%); mean age 59.7 ± 15.5 years) were included. A total of 42 devices were inserted in 8 thoracic and 16 lumbar vertebrae. Visual analogue scale measurement significantly improved from 5.6 ± 1.8 preoperatively to 1.5 ± 1.7 at 1 week (p < 0.01) and to 1.5 ± 1.3 at 6 months (p < 0.01). No severe adverse events were observed, but three adjacent fractures occurred between 1 week and 5 months after implantation. Conclusions: Percutaneous vertebral fixation of cancer-related VCF is feasible and safe and allows pain relief.
... The expansion of the implant allows for the restoration of the prefracture height [82]. Satisfactory height restoration and deformity correction may reduce the incidence of possible future spinal fractures which are relatively frequently seen in patients with a history of OVCFs and provide better clinical outcomes and an improvement in the QoL of the patient [82,83]. Furthermore, back pain is reduced in the 12-month follow-up period. ...
... Adjacent fracture events 1 year after surgery were reported at only 2.9%. The SJ appears to be an effective low-risk procedure for patients with traumatic vertebral compression fracture allowing for a fast and substantial improvement in the patients' QoL [55,83]. These results bring an optimistic prognosis for OVCF and KD treatment. ...
This narrative review provides the outcomes of minimally invasive surgery (MIS) and describes the available conservative treatment options for patients with osteoporotic vertebral compression fractures (OVCFs) that have risk factors for Kummell’s disease (KD). It aims to explore the evidence, emphasize the possible therapy complications, and aims to propose the most efficient clinical strategies for maintaining a good overall condition of individuals who may suffer from neurological deficits from a late-diagnosed OVCF complication. The secondary objective is to sum up the diagnostic particularities concerning individuals prone to OVCFs and KD, as the major risk factor for developing these severe conditions remains osteoporosis. Findings of our narrative review are based on the results found in PubMed, Embase, and Google Scholar from the beginning of their inception to December 2020, described independently by two authors. All of the studies included in the review focus on reporting the following treatment methods: conservative methods, vertebroplasty, kyphoplasty, targeted percutaneous vertebroplasty, frontal and side-opening cannula vertebroplasty, SpineJack, bone-feeling mesh container treatment, and the difference in the cement viscosity used (high vs. low) and the approach used (unilateral vs. bilateral). The comparison of randomized control trials (RCTs) as well as prospective and retrospective case series showed a comparable efficacy of kyphoplasty and vertebroplasty, and described cement-augmented screw fixation and the SpineJack system as effective and safe. Although it should be noted that several studies revealed inconsistent results in regards to the efficacy of using back braces and analgesics in patients who had vertebral fractures that were overlooked or not enrolled in any active surveillance program to track the patient’s deterioration immediately. Nevertheless there are non-standardized guidelines for treating patients with OVCFs and their complications already established. Using these guidelines, a treatment plan can be planned that takes into consideration the patients’ comorbidities and susceptibilities. However, the primary approach remains the management of osteoporosis and that is why prophylaxis and prevention play a crucial role. These measures reduce the risk of disease progression. Unfortunately, in the majority of cases these measures are not taken into account and KD develops.
