A prospective multicenter randomized study comparing the SpineJack system and nonsurgical management with a brace in acute traumatic vertebral fractures: the SPICO study.

OBJECTIVE: The objective of this study was to evaluate the efffectiveness of a titanium vertebral augmentation device (SpineJack system) in terms of back pain, radiological outcomes, and economic burden compared with nonsurgical management (NSM) (bracing) for the treatment of vertebral compression fractures. Complications were also evaluated for both treatment methods. METHODS: A prospective multicenter randomized study was performed at 9 French sites. Patients (n = 100) with acute traumatic Magerl type A1 and A3.1 vertebral fractures were enrolled and randomized to treatment with the SpineJack system or NSM consisting of bracing and administration of pain medication. Participants were monitored at admission, during the procedure, and at 1, 12, and 24 months after treatment initiation. Primary outcomes included visual analog scale back pain score, and secondary outcomes included disability (Oswestry Disability Index [ODI] score), health-related quality of life (EQ-5D score), radiological measures (vertebral kyphosis angle [VKA] and regional traumatic angulation [RTA]), and economic outcomes (costs, procedures, hours of help, and time to return to work). RESULTS: Ninety-five patients were included in the analysis, with 48 in the SpineJack group and 47 in the NSM group. Back pain improved significantly for all participants with no significant differences between groups. ODI and EQ-5D scores improved significantly between baseline and follow-up (1, 12, and 24 months) for all participants, with the SpineJack group showing a larger improvement than the NSM group between baseline and 1 month. VKA was significantly lower (p < 0.001) (i.e., better) in the SpineJack group than in the NSM group at 1, 12, and 24 months of follow-up. There was no significant change over time in RTA for the SpineJack group, but the NSM group showed a significant worsening in RTA over time. SpineJack treatment was associated with higher costs than NSM but involved a shorter hospital stay, fewer medical visits, and fewer hours of nursing care. Time to return to work was significantly shorter for the SpineJack group than for the NSM group. There were no significant differences in complications between the two treatments. CONCLUSIONS: Overall, there was no statistical difference in the primary outcomes between the SpineJack treatment group and the NSM group. In terms of secondary outcomes, SpineJack treatment was associated with better radiological outcomes, shorter hospital stays, faster return to work, and fewer hours of nursing care.

Percutaneous Vertebral Reconstruction (PVR) Technique of Pathological Compression Fractures: An Innovative Combined Treatment of Microwave Ablation, Bilateral Expandable Titanium SpineJack Implants Followed by Vertebroplasty.

(1) Background: to retrospectively evaluate safety and efficacy of combined microwave ablation (MWA) and bilateral expandable titanium SpineJack (SJ) implants followed by vertebroplasty (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.

Re-expansion of vertebral compression fractures in patients with multiple myeloma with percutaneous vertebroplasty using spinejack implants: a preliminary and retrospective study.

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). Results: The 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.

Sagittal correction after short percutaneous fixation for thoracolumbar compression fractures: comparison of the combination of SpineJack® kyphoplasty and fractured vertebra screw fixation.

PURPOSE: The aim of this study was to compare two percutaneous pedicle fixations for the treatment of thoracolumbar fractures: one associating a jack kyphoplasty (SpineCut) and the other using intermediate screws (Trident). METHODS: All adult patients treated for single-level Magerl/AO type A thoracolumbar traumatic fractures in four orthopaedic departments, with SpineCut or Trident, with a one year minimum follow-up, were retrospectively included. Neurological disorders and osteoporotic fractures were not included. The following data were collected: age, sex, Magerl/AO type, type of surgery, and complications. Radiological parameters were analyzed on pre-operative CT scan, and on standing X-rays before discharge, at three months and one year post-operative: vertebral wedge angle (VWA), regional kyphosis angle (RKA), and traumatic regional angulation (TRA: difference between RKA and physiological values for each vertebra). RESULTS: Eighty patients were included, with 42 patients in SpineCut group and 38 in Trident group. Mean age was 41 ± 15.7 years. TRA correction did not differ between the groups: respectively 11.2 ± 8.1° in SpineCut versus 10.2 ± 9.1° in Trident group (p = 0.52). TRA loss of correction between early post-operative and three months was statistically higher in Trident group: -4 ± 5.1° versus -1.5 ± 3.8° (p = 0.03). After 3 months, TRA correction loss was comparable between the groups. Multivariate analysis demonstrated that pre-operative VWA was the only factor significantly associated with early TRA correction loss (p = 0.01). VWA correction and loss of correction did not differ significantly between the groups. No complications were observed. CONCLUSION: Percutaneous pedicle fixations of traumatic thoracolumbar fractures associating jack kyphoplasty and intermediate screws are both safe and efficient techniques.

Implant removal after short percutaneous pedicle fixation associated with SpineJack® kyphoplasty: is correction sustained?

PURPOSE: This study objective was to evaluate sagittal correction loss after instrumentation removal in patients treated for thoracic or lumbar compression fractures treated with SpineJack® kyphoplasty associated with short percutaneous pedicle screw fixation. METHODS: This retrospective multicenter study was carried out in three major French trauma centers. All patients with a single type A thoracic or lumbar fracture, treated by the studied technique between 2017 and 2020, have been included. Demographic data, fracture type, removal procedure achievement and term were collected. Radiological parameters were measured at five timepoints: pre-operative, intra-operative, immediate post-operative, early post-operative (< 3 months) and at follow-up (1 year). Vertebral wedge angle (angle between the two endplates of the fractured vertebra) and traumatic regional angulation (TRA-calculated by subtracting regional kyphosis from the physiological reference values). RESULTS: 150 patients were included. Mean age was 48.6 ± 17.8 years. Average follow-up was 14.4 ± 3 months. 82 patients had secondary instrumentation removal. Mean time to removal was 6.4 ± 2.4 months. TRA correction loss between immediate post-operative and last follow-up was greater in removal group: 5.1 ± 5.6° versus 2.7 ± 4.7° (p = 0.01). Material was removed earlier in younger patients (p = 0.002). TRA correction loss was similar in the early and late removal groups (p = 0.83). Multivariate analysis identified only Magerl/AO A3 fractures as risk factor for loss of TRA correction (p = 0.007). CONCLUSION: Instrumentation removal was associated with good radiological outcomes with a non-significant loss of vertebral wedge angle and tolerable loss of traumatic regional angulation (+ 2.4° compared to the no-removal group), even if performed early.

"Double Cross Sign" Could Be an Indicator of an Adequate Amount of Bone Cement in Kyphoplasty with the SpineJack System: A Retrospective Study.

Kyphoplasty with the SpineJack system was able to restore vertebral height and stabilize the vertebra with an injection of bone cement. The goal of this study was to seek a reliable assessing method during the surgery in determining the minimum amount of bone cement required for the SpineJack system to restore vertebral height and stabilize the vertebra. We defined the "double cross sign" as bone cement that expanded vertically along the bilateral SpineJack system, and spread across the midline of the vertebral body as viewed in the anteroposterior (AP) view of the radiographic image. Sixty-five patients aged 74.5 ± 8.5 years with vertebral compression fracture were included in the study. Patients with a positive double cross sign had better ODI score than those without the double cross sign (20.0 ± 6.9 vs. 32.3 ± 8.2; p < 0.001). Postoperative regional kyphotic and local kyphotic angle were significantly better in the positive double cross sign group (11 ± 8.8 degrees vs. 5.3 ± 3.2 degrees; p = 0.001/11.7 ± 6.2 degrees vs. 6.6 ± 4.1 degrees; p = 0.001, respectively). The more stable construct was built once the double cross sign was achieved during surgery. In this study, a convenient and intuitive method in identifying the minimum but sufficient quantity of injected cement during the SpineJack procedure was developed.

Treatment of thoracolumbar burst fractures: SpineJack vs. posterior arthrodesis-comparison of clinical and radiological outcomes.

Background: Thoracolumbar fractures sometimes require anterior support and post-traumatic deformity correction. SpineJack proved favorable results in cadaveric and clinical studies, with satisfactory pain relief, vertebral height restoration, and low rates of above adjacent fractures, in neurologically intact fractures. We compared patients' clinical and radiological outcomes of thoracolumbar fractures treated either with posterior arthrodesis or SpineJack. Methods: We prospectively collected A2 split and A3, and A4 burst fractures between 2017 and 2021. Patients were stratified in posterior arthrodesis (PA group) and SpineJack (SJ group) and included if age ≥18 years, T11-L3 level, emergent or elective surgery, single or multiple, and neurologically intact. Age, sex, type and level, pain, operative and discharge time, vertebral body heights (VBH), posterior wall retropulsion (PWR), vertebral kyphosis (VK) and local kyphosis (LK) angles, vertebral body (VB) volume, and complications were collected. We then compared clinical-radiographic outcomes between the two groups. Results: We found no significant differences in median postoperative pain while operative time and discharge time were shorter for SJ patients than PA ones (P<0.001). Mean anterior VBH increase was 20.7%, mid-VBH was 25.5%, and posterior VBH was 8.8%, while increase in VB volume was 26.2%. SJ patients had non-inferior VK e LK angles correction to PA ones. Mean PWR value between pre and post SJ implantation was 0.15±0.65 mm, and no adjacent above-level fractures occurred. Conclusions: We showed satisfactory outcomes in a selected range of neurologically intact thoracolumbar split or burst fractures. SJ leads to shorter operative and discharge time and good VB angles and diameters restoration.

Vertebral Augmentation Compared to Conservative Treatment of Vertebra Plana and High-Degree Osteoporotic Vertebral Fractures: A Review of 110 Fractures in 100 Patients.

This is a retrospective study that evaluated surgical versus non-surgical treatment of 100 patients followed for up to six years diagnosed with severe osteoporotic vertebral compression fractures (VCF). Fractures were classified by percent collapse of vertebral body height as "high-degree fractures" (HDF) (>50%) or vertebra plana (VP) (>70%). A total of 310 patients with VCF were reviewed, identifying 110 severe fractures in 100 patients. The HDF group was composed of 47 patients with a total of 50 fractures. The VP group was composed of 53 patients with a total of 60 fractures. Surgical intervention was performed in 59 patients, comprised entirely of percutaneous vertebral cement augmentation procedures, including vertebroplasty, balloon kyphoplasty, or cement with expandable titanium implants. The remaining 41 patients only underwent conservative treatment that is the basis of the comparison study. All procedures were performed as an outpatient under local anesthesia with minimal sedation and there were no procedural complications. The initial or pre-procedural visual analog scale (VAS) score averaged 8.4 in all patients, with surgical patients having the most marked drop in VAS, averaging four points. This efficacy was achieved to a greater degree in surgically treated VP fractures compared to HDF. Non-surgical patients persisted with the most pain in both short- and long-term follow-up. This large series, with follow-up up to six years, demonstrated that the more severe fractures respond well to different percutaneous cement augmentation procedures with reduction of pain without increased complications in a comparison to conservatively treated patients.

Numerical Comparison of Restored Vertebral Body Height after Incomplete Burst Fracture of the Lumbar Spine.

BACKGROUND AND OBJECTIVES: Vertebral compression fracture is a major health care problem worldwide due to its direct and indirect negative influence on health-related quality of life and increased health care costs. Although a percutaneous surgical intervention with balloon kyphoplasty or metal expansion, the SpineJack, along with bone cement augmentation has been shown to efficiently restore and fix the lost vertebral height, 21-30% vertebral body height loss has been reported in the literature. Furthermore, the effect of the augmentation approaches and the loss of body height on the biomechanical responses in physiological activities remains unclear. Hence, this study aimed to compare the mechanical behavior of the fractured lumbar spine with different restored body heights, augmentation approaches, and posterior fixation after kyphoplasty using the finite element method. Furthermore, different augmentation approaches with bone cement and bone cement along with the SpineJack were also considered in the simulation. MATERIALS AND METHODS: A numerical lumbar model with an incomplete burst fracture at L3 was used in this study. Two different degrees of restored body height, namely complete and incomplete restorations, after kyphoplasty were investigated. Furthermore, two different augmentation approaches of the fractured vertebral body with bone cement and SpineJack along with bone cement were considered. A posterior instrument (PI) was also used in this study. Physiological loadings with 400 N + 10 Nm in four directions, namely flexion, extension, lateral bending, and axial rotation, were applied to the lumbar spine with different augmentation approaches for comparison. RESULTS: The results indicated that both the bone cement and bone cement along with the SpineJack could support the fractured vertebral body to react similarly with an intact lumbar spine under identical loadings. When the fractured body height was incompletely restored, the peak stress in the L2-L3 disk above the fractured vertebral body increased by 154% (from 0.93 to 2.37 MPa) and 116% (from 0.18 to 0.39 MPa), respectively, in the annular ground substance and nucleus when compared with the intact one. The use of the PI could reduce the range of motion and facet joint force at the implanted levels but increase the facet joint force at the upper level of the PI. CONCLUSIONS: In the present study, complete restoration of the body height, as possible in kyphoplasty, is suggested for the management of lumbar vertebral fractures.

Does intraoperative 3D navigation improve SpineJack vertebral augmentation in thoracic and lumbar compression fracture?

INTRODUCTION: The aim of this retrospective study was to evaluate the effect of navigation on the positioning of the SpineJack implant in the treatment of thoracic and lumbar compression fractures. METHODS: Between January 2018 and December 2019, all patients operated on for thoracic or lumbar fracture using the SpineJack device in stand-alone were included in this single-center study. The positioning of the SpineJack implant was analyzed on axial CT views by measuring the angle between the axis of the pedicle and the axis of the final implant. The relationships between implant positioning and the use of navigation or fluoroscopy, pedicle dimensions and levels of injury were analyzed. Surgical time, radiation exposure, radiological findings and complications were assessed. RESULTS: One hundred patients were included, for 103 fractured vertebrae and a total of 205 implants, 148 placed under standard fluoroscopy and 57 with the Surgivisio navigation system. For pedicle diameters≥5mm (165 implants), the positioning of the implant relative to the axis of the pedicle was significantly better in the navigation group: 2°±1.4° (range, 0-7°) in the fluoroscopy group versus 1.2°±1.1° (range, 0-5°) in the navigation group (p=0.04). There were no significant differences in reduction of vertebral kyphosis angle or mean operating time. Dose area product (DAP) was significantly higher with navigation: 4.43Gy.cm2 versus 0.47Gy.cm2 (p<0.001) and dose to the surgeon significantly lower: 0.5 versus 1.6µSv (p<0.001). No difference was found regarding complications. Subgroup analysis showed significantly greater operative time and patient irradiation in the fluoroscopy group when pedicle diameter was less than 5mm. CONCLUSION: This study demonstrates the interest of navigation for positioning the SpineJack implant with respect to the pedicle axis in vertebrae with pedicle diameter≥5mm. This study also confirmed the reliability of navigation and lower radiation dose to the surgeon, regardless of the fracture level. Navigation reduced operating time and patient irradiation for vertebrae with pedicle diameter<5mm. LEVEL OF EVIDENCE: IV; retrospective study.

Clinical outcomes and safety of the SpineJack vertebral augmentation system for the treatment of vertebral compression fractures in a United States patient population.

The SpineJack implant system was recently FDA approved for treatment of vertebral compression fractures (VCF), however United States-based outcomes data is lacking. We sought to examine the safety and clinical outcomes following vertebral augmentation using the SpineJack implant for treatment of VCF in a U.S. patient population. An IRB-approved, retrospective study of SpineJack implants used in vertebral augmentation was performed from 11/2018 to 2/2020. Outcome objectives included pain improvement, vertebral body height (VH) restoration, improvement in local kyphotic angle (LKA), and incidence of adjacent level fractures (ALF). Complications were reviewed to assess safety of the procedure. Thirty patients with VCF (60% female; mean [SD] age of 62.7 [±12.8] years) underwent a total of 53 vertebral augmentations with 106 SpineJack implants. Worst pain scores decreased significantly from 8.7 to 4.3 (95%CI of the change [Δ]: 4.3-4.4; p < 0.001). Middle and anterior VH significantly increased from 13.1 ± 0.2 to 15.9 ± 0.2 mm (95%CI Δ: 2.6-2.9 mm; p < 0.001) and 15.6 ± 0.2 to 16.8 ± 0.2 mm (95%CI Δ: 1.1-1.4 mm; p < 0.001), respectively. LKA was significantly decreased from 10.0 ± 2.1 to 7.4 ± 2.1 degrees (95%CI Δ: 2.4-2.8 degrees; p < 0.001). Four patients (13%) sustained ten ALF over a median (IQR) follow up period of 94 (17.5-203) days. There were no major adverse events during the follow up period. To summarize, vertebral augmentation with SpineJack implants of patients with VCF resulted in significantly decreased pain, restored VH, and improved LKA, without major adverse events. However, 13% of patients sustained ALF during a median follow up period of 3 months.

Re-expansion and Stabilization of Vertebra Plana Fractures Using Bilateral SpineJack® Implants.

The surgical treatment of osteoporotic vertebral fractures with greater than 70% collapse, known as "Vertebra Plana (VP)" has been controversial. Originally VP was a considered a contraindication to vertebroplasty or kyphoplasty because of presumed difficulty of entering the collapsed vertebra as well as obtaining significant re-expansion or correct associated sagittal kyphosis. In some cases, multilevel pedicle screw fixation with or without attempts to correct the collapse is still performed to correct the kyphosis or prevent progression. With experience it was clear that the pedicle could be accessed and VP could be treated without added risk of epidural leak of cement or epidural extravasation. Now, with the introduction of newer third-generation intraspinal expansion devices that are larger and need to be placed bilaterally, their use in cases of VP was again an issue since VP cases were excluded from the original multicenter studies used for worldwide approval. This report reviews six cases of VP treated with bilateral SpineJack® implants (Stryker Corp, Kalamazoo, Michigan, USA) demonstrating it is not only feasible to place these larger size implants but achieve significant reconstitution of vertebral height as well as correction of the kyphotic deformity.

[Percutaneous kyphoplasty using expandable SpineJack® implant for the treatment of osteoporotic vertebral fractures]. / Traitement de la fracture vertébrale ostéoporotique par kyphoplastie percutanée avec un extenseur de type SpineJack®.

ABSTRACT: The purpose of this study was to assess the outcome of surgical management of osteoporotic vertebral fractures with percutaneous kyphoplasty using expandible SpineJack® implant. METHODS: We conducted an analytical retrospective single-center study over a period of 33-months (April 2015 - December 2017). It involved patients treated with kyphoplasty for an osteoporotic vertebral fracture. The kit consisted of a Vexim SpineJack® expandable titanium implant and acrylic cement. Patients with back pain increasing in intensity despite treatment for an osteoporotic vertebral fracture were included in the study as well as those who had undergone surgery and had given their informed consent. The vertebral fracture was diagnosed based on CT scan results and its recent state was confirmed by MRI. RESULTS: Between april 2015 and december 2017, thirty-seven patients with osteoporotic vertebral fractures were treated with kyphoplasty using expandable titanium vertebral implant. The average age of patients was 73.4 years, with a sex ratio of 0.6. Mean visual analog scale score was 7.3. Mean Oswestry score was 81.6. The patients mainly had fractures of the thoracolumbar hinge. Mean vertebral kyphotic angle was 18.45°. Kyphoplasty was used for the treatment of 44 vertebrae. Four patients had surgical complications. The average length of stay in hospital was 5.4 days. After a follow-up period of 6 months, 9 patients were still receiving analgesic therapy. After one year, no adjacent level fracture was found. CONCLUSION: Percutaneous kyphoplasty using expandible titanium implant is a safe and effective therapeutic mean for osteoporotic vertebral fractures. Given its almost immediate result, patients can rapidly get back to their active lives.

Implante intramedular expandible SpineJack® para el tratamiento de fracturas vertebrales por compresión / Spinejack® Expandable Intramedullary Implant for Treating Vertebral Compression Fractures

RESUMEN Introducción: Las fracturas vertebrales por compresión han sido tratadas usando cemento óseo en su interior, con técnicas como la cifoplastia y vertebroplastia. Sin embargo, son conocidos los potenciales efectos adversos, principalmente la fuga del cemento a los tejidos aledaños y, en la mayoría de los casos, la consiguiente afección a la altura vertebral. Es importante lograr una adecuada reducción de la fractura, ya que la esta influye directamente en la calidad de vida de los pacientes. Objetivo: Describir la aplicación, por primera vez, del implante intramedular expandible SpineJack® como método para el tratamiento de fracturas vertebrales por compresión. Presentación del caso: Se presenta una paciente de 65 años que sufrió un traumatismo en su columna lumbar a nivel de L1, con fractura tipo burst, a la que, en junio de 2016, se le realizó un acceso transpedicular percutáneo con guía fluoroscópica con el propósito de insertar el dispositivo SpineJack® en el cuerpo vertebral. Se utilizaron expansores del implante especialmente diseñados para este dispositivo, los cuales abrieron los extremos y desplegaron el componente central de titanio; esto facilitó la inyección de polimetilmetacrilato, el cual finalmente envolvió a los implantes, lo que garantizó la estabilización de la fractura. Resultados: La tomografía de control permitió observar una adecuada reducción del declive central de la vértebra L1 de la paciente y una recuperación de la altura del cuerpo vertebral con valores similares a los reportados por otros investigadores que han trabajado con este método en otros países. Conclusiones: La capacidad anátomo-funcional de la vértebra fracturada, así como la mejoría clínica de la paciente. y su calidad de vida fueron notables. No se observaron complicaciones. El seguimiento del empleo de este dispositivo en otros pacientes en Ecuador, permitirá profundizar en su evaluación(AU)

ABSTRACT Introduction: Vertebral compression fractures have been treated using internal bone cement, using techniques such as kyphoplasty and vertebroplasty. However, the potential adverse effects are known, mainly the leakage of cement to the surrounding tissues and, in most cases, the consequent affection at the vertebral level. Achieving adequate reduction of the fracture is important since it directly influence on the quality of life of patients. Objective: To describe the application, for the first time, of SpineJack® expandable intramedullary implant as a method for treating vertebral compression fractures. Case report: We report a 65-year-old female patient who suffered trauma to her lumbar spine at L1 level, a burst-type fracture, who, in June 2016, underwent percutaneous transpedicular access with fluoroscopic guidance with the purpose of inserting SpineJack® device into her vertebral body. Specially designed implant expanders were used for this device, which opened the ends and deployed the central titanium component. This facilitated the injection of polymethylmethacrylate that eventually enveloped the implants, ensuring stabilization of the fracture. Results: The control tomography allowed to observe adequate reduction of the central decline of the L1 vertebra of this patient and the recovery of the vertebral body height with values similar to those reported by other researchers who have worked with this method in other countries. Conclusions: The anatomy-functional capacity of the fractured vertebra, as well as the clinical improvement of this patient, and her quality of life were remarkable. No complications were observed. Following up the use of this device in other patients in Ecuador will allow to deepen its evaluation(AU)

The Use of SpineJack Intravertebral Implant for the Correction of Recurrent Vertebral Fracture After Kyphoplasty.

This report presents a case of short-term symptomatic failure with continued vertebral collapse after a T12 kyphoplasty for an acute fracture in a severely osteoporotic elderly patient. The original trajectory of the unilateral balloon and subsequently injected bone cement failed to fill the fracture, allowing further vertebral collapse that resulted in a rapid return of pain. Within 30 days, a titanium intravertebral body implant, SpineJack® (Stryker Corp, Kalamazoo, MI), combined with injection of polymethylmethacrylate (PMMA) bone cement, was placed in the collapsed area. This provided both sagittal and coronal partial correction of the collapse, fuller distribution of bone cement throughout the fractured vertebrae, and rapid reduction of pain. which was found to have been maintained at the long-term follow-up. The article reviews the technical issues causing failure of vertebral augmentation (VA) as well as the advantage of providing a permanent internal scaffolding to ensure stabilization of any fracture, especially where there is a high risk for progressive instability, such as the thoracic-lumbar junction.

Clinical and radiological outcomes in thoracolumbar fractures using the SpineJack device. A prospective study of seventy-four patients with a two point three year mean of follow-up.

PURPOSE: The aim of this study was to assess clinical and radiological results of SpineJack on the treatment of vertebral body fractures in a continuous prospective series of patients. MATERIAL AND METHODS: Between May 2012 and April 2015, all patients operated using the SpineJack device were prospectively included in this monocentric study. Demographic data, clinical, and radiological results were recorded. Complications and surgical managements were recorded. RESULTS: At a mean follow-up of 2.3 years, 74 patients with 77 fractured vertebrae were included. The stand-alone SpineJack group comprised 60 patients with 63 fractured vertebrae (group 1) and the group with additional posterior fixation 14 patients with 14 fractured vertebrae (group 2). The average initial vertebral wedge angle was 13.3 ± 6.1 degrees for group 1 and 15.3 ± 5.7 degrees for group 2 (p = 0.25). Post-operative values were 6.5 ± 4.6 degrees for group 1 and 5.1 ± 3.9 degrees for group 2 (p = 0.31). The differences within the same group were highly significant (p < 0.0005). The loss of reduction at last follow-up was 0.8 ± 1.6 degrees in group 1 and 0.6 ± 2.0 degrees in group 2 (p = 0.77). Subjective results were considered as very good or good for 57 patients (95%) in group 1 and for 11 patients (79%) in group 2, p = 0.07. CONCLUSION: The SpineJack seems to be a promising tool in the treatment of traumatic vertebral fractures with a correction in the sagittal plane comparable with what can be found in the literature.

A prospective, international, randomized, noninferiority study comparing an implantable titanium vertebral augmentation device versus balloon kyphoplasty in the reduction of vertebral compression fractures (SAKOS study).

BACKGROUND CONTEXT: Balloon kyphoplasty (BKP) is a commonly performed vertebral augmentation procedure for painful osteoporotic vertebral compression fractures (OVCFs). OBJECTIVE: This study aimed to support a non-inferiority finding for the use of a titanium implantable vertebral augmentation device (TIVAD) compared to BKP. STUDY DESIGN: Prospective, parallel group, controlled comparative randomized study. PATIENT SAMPLE: Patients who presented with one or two painful OVCFs located between T7 and L4 aged <3 months, failed conservative treatment, and had an Oswestry Disability Index (ODI) score ≥30/100 were eligible for the study. OUTCOME MEASURES: The primary composite endpoint was defined as: reduction in VCF fracture-related pain at 12 months from baseline and maintenance or functional improvement (ODI) at 12 months from baseline, and absence of device-related adverse event or surgical reintervention. If the primary composite endpoint was successful, a fourth component (absence of adjacent level fracture) was added for analysis. If the analysis of this additional composite endpoint was successful, then midline target height restoration at 6 and 12 months was assessed. Secondary clinical outcomes included back pain intensity, ODI score, EQ-5D index score (range 0=death to 1=full health) and EQ-VAS score (range 0-100). METHODS: Patients were recruited in 13 hospitals across 5 countries and were randomly assigned (1:1) to either TIVAD or BKP with electronic randomization as described in the protocol. A total of 152 patients with OVCFs were initially randomized. Eleven patients were excluded (six met exclusion criteria, one with evidence of tumor, and four patients had T score out of requested range). Anterior vertebral body height ratio, midline vertebral body height ratio, and Cobb angle were measured preoperatively and postoperatively by an independent imaging core lab. Adjacent and subsequent fractures and safety parameters were recorded throughout the study. Cement extravasation was evaluated on X-rays. All patients were followed at screening at 5 days, 1 month, 6 months, and 12 months postoperatively. This study was supported by Vexim SA. Seven authors received study-specific support less than $10,000 per year and seven authors received no study-specific support. RESULTS: Among the 141 patients (78.7% female, mean age 73.3±9.5 years) who underwent surgery (TIVAD=68; BKP=73), 126 patients (89.4%) completed the 12-month follow-up period (TIVAD=61; BKP=65). The analysis of primary endpoint on the ITT population demonstrated non-inferiority of the TIVAD to BKP. The analysis of the additional composite endpoint demonstrated the superiority of TIVAD over BKP (p<0.0001) at 6 months (88.1% vs. 60.9%) and at 12 months (79.7% vs. 59.3%). Midline VB height restoration was more improved for TIVAD than for BKP at 6 months (1.14±2.61 mm vs. 0.31±2.22 mm); p=0.0246) and 12 months after surgery (1.31±2.58 mm vs. 0.10±2.34 mm; p=0.0035). No statistically significant differences were shown between procedures for improvement in functional capacity and quality of life. Pain relief was significantly more marked in the TIVAD group compared to the BKP group at 1 month (p=0.029) and at 6 months (p=0.021) after surgery. No patient required surgical reintervention or retreatment at the treated level. No symptomatic cement leakage was reported. Adverse events were similar for both groups (41.2% in the TIVAD group and 45.2% in the BKP group). The incidence of adjacent fractures was significantly lower after the TIVAD procedure than after BKP (12.9% vs. 27.3%; p=0.043). CONCLUSIONS: Study results demonstrated non-inferiority of the TIVAD to the predicate BKP with an excellent risk/benefit profile for results up to 12 months.

Re-expansion of Osteoporotic Compression Fractures Using Bilateral SpineJack Implants: Early Clinical Experience and Biomechanical Considerations.

Thoraco-lumbar osteoporotic compression fractures have a higher incidence of continued collapse with development of deformity and progression to vertebra plana when untreated and even after vertebral augmentation (VA) or balloon kyphoplasty (BKP). Even when there is the restoration of height and improvement in angulation, multiple long-term follow-up series have repeatedly documented that over time, many patients lose the initial height correction and in a smaller group the vertebral body re-collapses leading to the development of progressive deformity with an increased risk for adjacent level fractures. At first, larger balloons and more cement were used to try and avoid these problems, but it did not reduce the risk of adjacent fractures. Several procedures were developed to place various types of intervertebral implants combined with bone cement to maintain the initial height correction. Initial studies with these implants showed a reduction in adjacent level fractures but the systems did not proceed to market. The SpineJackR (SJ) system (Stryker Corp, Kalamazoo, MI), consisting of bilateral expandable titanium implants supplemented with bone cement, was first used approximately 10 years ago in Europe and recently gained FDA approval in the United States. This system provides more symmetric and balanced lateral and anterior support and is effective with lesser amounts of bone cement compared to BKP. Follow-up studies have documented that there is equal or better pain control, with better long-term results based both on maintaining vertebral height restoration and deformity correction. Most importantly, statistically it clearly reduces the risk of adjacent level fractures by at least 60%. The biomechanical effects of intravertebral implants for osteoporotic fractures in regard to the risk of adjacent level fractures and preliminary experience with the use of the SJ is reviewed.

Treatment of a High-risk Thoracolumbar Compression Fracture Using Bilateral Expandable Titanium SpineJack Implants.

In this case, an 80-year-old active patient developed an acute osteoporotic fracture after a fall at L1 above a previous interlaminar implant at L4-5 for stenosis with neurogenic claudication. Radiologic studies found both intra-discal and intra-vertebral vacuum clefts that are highly correlated with instability and progressive kyphosis. Long-term experience with kyphoplasty has shown that acute and subacute fractures can often be re-expanded; however, over three months to one year, the correction is frequently lost and the vertebral height continues to decrease leading to increased risk of both continued deformity and especially adjacent level fractures. The use of newly available titanium intra-vertebral implants combined with bone cement restores and maintains vertebral height and correction of deformities. Long-term studies also demonstrate a reduced risk of adjacent level fractures compared to balloon kyphoplasty. Using vertebral body implants that remain in place within the fractured vertebral body the initial height correction can be better maintained leading to less adjacent level fractures.

Long-term safety and clinical performance of kyphoplasty and SpineJack® procedures in the treatment of osteoporotic vertebral compression fractures: a pilot, monocentric, investigator-initiated study.

This pilot monocenter study in 30 patients with painful osteoporotic vertebral compression fractures compared two vertebral augmentation procedures. Over a 3-year post-surgery follow-up, pain/disability/quality of life remained significantly improved with both balloon kyphoplasty and SpineJack® techniques, but the latter allowed better vertebral body height restoration/kyphosis correction. INTRODUCTION: Patient follow-up rarely exceed 2 years in trials comparing vertebral augmentation procedures for the treatment of painful osteoporotic vertebral compression fractures (VCFs). This pilot, investigator-initiated, prospective study aimed to compare long-term results of SpineJack® (SJ) and balloon kyphoplasty (BKP). Preliminary results showed that SJ resulted in a better restoration of vertebral heights and angles, maintained over 12 months. METHODS: Thirty patients were randomized to SJ (n = 15) or BKP (n = 15). Clinical endpoints were analgesic consumption, back pain intensity (visual analog scale (VAS)), the Oswestry Disability Index (ODI), and quality of life (EQ-VAS score). They were recorded preoperatively, at 5 days (except EQ-VAS), 1, 3, 6, 12, and 36 months post-surgery. Spine X-rays were taken 48 h prior to the procedure and 5 days, 6, 12, and 36 months after. RESULTS: Clinical improvements were observed with both procedures over the 3-year period without significant inter-group differences, but the final mean EQ-5Dindex score was significantly in favor of the SJ group (0.93 ± 0.11 vs 0.81 ± 0.09; p = 0.007). Vertebral height restoration/kyphotic correction was still evident at 36 months with a greater mean correction of anterior (10 ± 13% vs 2 ± 8% for BKP, p = 0.007) and central height (10 ± 11% vs 3 ± 7% for BKP, p = 0.034) and a larger correction of the vertebral body angle (- 5.0° ± 5.1° vs 0.4° ± 3.4°; p = 0.003) for SJ group. CONCLUSIONS: In this study, both techniques displayed very good long-term clinical efficiency and safety in patients with osteoporotic VCFs. Over the 3-year follow-up, vertebral body height restoration/kyphosis correction was better with the SpineJack® procedure.