Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

Noriega, David; Maestretti, Gianluca; Renaud, Christian; Francaviglia, Natale; Ould-Slimane, Mourad; Queinnec, Steffen; Ekkerlein, Helmut; Hassel, Frank; Gumpert, Rainer; Sabatier, Pascal; Huet, H.; Plasencia, Miguel; Theumann, Nicolas; Kunsky, Alexander; Krüger, Antonio

doi:10.1155/2015/173872

Cited by 49 publications

(53 citation statements)

References 33 publications

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“…A significant improvement in back pain has been reported with a mean VAS score decreasing from 6.6 AE 2.6 at baseline to 1.4 AE 1.3 within 48 hours posttreatment and a mean ODI score improvement at 3-month follow-up decreasing from 76.2 AE 20.0 at baseline to 14.2 AE 16.6. 28 Compared with BKP, the SpineJack system did not show any significant loss of intraoperative height gain with durable vertebral fracture reduction. It demonstrated an increased height restoration > 300% better than BKP.…”

Section: Resultsmentioning

confidence: 80%

“…SpineJack was designed for the anatomical reduction of vertebral compression fractures of traumatic origin (VCF type A1, A2, and A3 in Magerl's classification). 28,29 The device must always be implanted bilaterally in each hemisection of the vertebral body to obtain a symmetrical restoration of the end-plate level. As for VBS, implant technique, indications, and contraindications are similar.…”

Section: Spinejackmentioning

confidence: 99%

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Percutaneous Treatment of Vertebral Fractures

Muto

Giurazza

Guarnieri

et al. 2017

Semin Musculoskelet Radiol

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The thoracolumbar junction and lumbosacral segment are the portions of the spinal column most prone to acute traumatic fractures. Multiple classifications and injury severity score systems have been published to standardize the management of patients, establishing stable/unstable and surgical/nonsurgical fractures. In the past, patients could be treated only by surgical stabilization or conservative methods. The latter implied bed rest, long immobilization periods, prolonged drugs therapies, and, at worst, the evolution of kyphosis. Percutaneous mini-invasive treatments have been developed to improve the quality of life of patients affected by stable fractures, by rapidly recovering mobility and preventing deformity of the spinal column. These approaches, based on assisted techniques, imply the placement of different types of expandable bone implant systems. We discuss the treatment of vertebral fractures, focusing on percutaneous procedures and analyzing indications, contraindications, and outcomes of patients affected by vertebral nonosteoporotic/nonneoplastic but traumatic fractures.

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Section: Resultsmentioning

confidence: 80%

Section: Spinejackmentioning

confidence: 99%

Percutaneous Treatment of Vertebral Fractures

Muto

Giurazza

Guarnieri

et al. 2017

Semin Musculoskelet Radiol

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“…No additional new fracture was observed at 12-month follow up. These results are higher than those reported in the literature with different devices: With the use of VBS, the risk of adjacent vertebral fracture was 9% [26] and 3% with SpineJack [29]. In these studies, the cohorts of patients were similar and these were performed on osteoporotic subjects with spontaneous fractures or minor trauma in osteoporosis.…”

Section: Discussionmentioning

confidence: 89%

Efficacy of a Novel Vertebral Body Augmentation System in the Treatment of Patients with Symptomatic Vertebral Body Fractures

Marcia

Piras

Hirsch

et al. 2020

Cardiovasc Intervent Radiol

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Purpose To evaluate the safety and efficacy of a novel augmentation implant in the treatment of patients with symptomatic vertebral body fractures. Materials and Methods Thirty consecutive patients (seven males and 23 females), mean age of 70 years (range 56 to 89) with osteoporotic fractures and/or low-energy trauma fractures (osteoporosis confirmed by CT), were enrolled in an IRB-approved prospective study. The type of fracture was classified according to the Magerl classification. The patients were treated with the Tektona® dedicated vertebral body augmentation system. Visual analogue scale (VAS) and Oswestry Disability Index (ODI) scores were obtained after 1, 6 and 12 months. Quality of life was assessed with the SF36 score. Results A total of 37 vertebral bodies, mostly from T6 to L5, were treated in the 30 enrolled patients. In 67.6% of the cases (n = 25), lumbar fractures were treated. Most of the fractures (43%; n = 16) were A1.1 according to the Magerl classification. A significant pain reduction evaluated by VAS scores (p < 0.0001) was observed on average 7.6 (before the procedure) to 2.8 (immediately post-treatment), 2.1 and 2.7 (after 6 and 12 months later, respectively). The mean ODI score was 55.5% before treatment, and this was statistically significant reduced to 22.3% and 26.9%, respectively, at 6 and 12 months after treatment (p < 0.0001). The SF36 scores, both physical and mental components, showed statistically significant variations (p < 0.0001) whose direction was subpopulation dependent. Conclusion Patients with confirmed osteoporosis, suffering from symptomatic vertebral body fractures (osteoporotic and/or low-energy traumatic), were treated safely and effectively using this novel implant.

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“…The decade following these two publications witnessed further expansion of their technique and the introduction of additional devices including balloon kyphoplasty (BKP), which was developed as a tool intended for fracture reduction and vertebral height restoration 7. More recently, innovation has resulted in the availability of vertebral body implant-based technology (instrumented kyphoplasty), biologic cements, and radiofrequency ablative technologies, permitting the treatment of a wider array of patients with more complex presentations including osteoporotic, traumatic, and neoplastic lesions 8–10…”

Section: Introductionmentioning

confidence: 99%

The evidentiary basis of vertebral augmentation: a 2019 update

Leacy

Chandra

Barr

et al. 2020

J NeuroIntervent Surg

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No aspect of neurointerventional practice has been associated with as longstanding contention and debate as to its effectiveness as has vertebroplasty (VP). Four blinded randomized controlled trials published since 2009 have demonstrated conflicting results regarding a conferred benefit in pain reduction and functional improvement for patients who undergo VP for osteoporotic vertebral compression fractures. Significant heterogeneity exists between each of these trials, which has resulted in difficulty for interventionalists and surgeons to translate the trial findings into routine clinical practice. In addition, patients and their families are ever more enlightened and enabled via the internet and social media to review both medical literature and websites. Without the proper background and context, their decisions may be lacking appropriate and necessary scientific discussion. This review article summarizes the randomized controlled trial data to date, with particular focus on the aforementioned four blinded studies. We will also evaluate the profound impact of the decrease in vertebral augmentation utilization on short- and long-term patient morbidity and mortality using available national and administrative datasets from both within the USA and internationally. We also consider future trial design to help evaluate this procedure and determine its role in modern neurointerventional practice.

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Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

Cited by 49 publications

References 33 publications

Percutaneous Treatment of Vertebral Fractures

Percutaneous Treatment of Vertebral Fractures

Efficacy of a Novel Vertebral Body Augmentation System in the Treatment of Patients with Symptomatic Vertebral Body Fractures

The evidentiary basis of vertebral augmentation: a 2019 update

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